Minutes 321 RB

MINUTES OF 321ST MEETING OF REGISTRATION BOARD
HELD ON 20-22ND SEPTEMBER, 2022
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Item Detail of Item Pages

No.
I. Confirmation of Minutes of 320 meeting of RB 2
II. Division of Pharmaceutical Evaluation & Registration --------------
Pharmaceutical Evaluation Cell (PEC) --------------------------------- 3-1765
Registration-I Section ----------------------------------------------------- 1766-1770
Registration-II Section ---------------------------------------------------- 1770-1773
Post Registration-I Section ----------------------------------------------- 1774-1776
Post Registration-II Section ---------------------------------------------- 1777-1783
Import & Vet-I Section --------------------------------------------------- 1784-1787
Import & Vet-II Section -------------------------------------------------- 1787-1794
RRR Section ---------------------------------------------------------------- 1795-1798
III. Division of Biological Evaluation & Research 1799-1834
IV. Division of Quality Assurance & Laboratory Testing 1835-1888
V. Additional Agenda
a. Pharmaceutical Evaluation & Registration Division 1889-2017
b. Division of Biological Evaluation & Research 2018-2031
Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 1

321st meeting of Registration Board was held on 20-22nd September, 2022 in the Committee
Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by Dr.
Obaidullah, Chairman Registration Board DRAP. The meeting started with recitation of the Holy
Verses.
The Board decided to co-opt Dr. Shabnum Firdous, Secretary / Registrar, Pakistan Veterinary
Medical Council, as member under Rule 24 (6) of the Drugs (Licensing, Registering & Advertising)
Rules, 1976 of the Drugs Act, 1976, in order to facilitate the Registration Board regrading opinion on
the applications for registration of veterinary products.
Following members attended the meeting:
1. Ch. Zeeshan Nazir Bajar, Additional Director (BE&R/PE&R), DRAP. Member/ Secretary
2. Lt.Gen.(R) Prof. Dr. Karamat A. Karamat (HI-M.SI-M), Former Member
Surgeon General Pakistan.
3. Maj. Gen. (R) Dr. Tahir Mukhtar Sayed, Inspector General (Hospitals), Member
Fauji Foundation, Rawalpindi
4. Dr. Qurban Ali, Ex-Director General, National Veterinary Laboratories, Member
Islamabad
5. Dr. Noor us Saba, Director, Biological Evaluation & Research Division, Member
DRAP
6. Dr. Muhammad Akram, Animal Husbandry Commissioner, M/o Co-opted Member
NFS&R
7. Dr. Ali Ahmad Agha, Director, DTL, Quetta Member
8. Muhammad Hafeez ur Rehman, DTL, Rawalpindi Member
9. Mr. Muhammad Aslam, Deputy Draftsman-I, Ministry of law & Justice, Member
Islamabad.
10. Mr. Ghulam Mujtaba, Deputy Director, Representative of IPO
11. Dr. Imran Khan, Director, DTL, Peshawar Member
12. Mr. Akhtar Abbas Khan, Representative of QA&LT Division Member
13. Mr. Abdullah, Representative of Division of MD&MD Member
14. Dr. Shabnum Firdous, Secretary / Registrar, Pakistan Veterinary Co-opted Member
Medical Council
Mr. Nadeem Alamgir (Pharma Bureau), Hafiz Muhammad Azeem, Mr. Hamid Raza & Mr.
Jalal-ud-Din (PPMA) and Mr. Ziaulhaq & Mr. Amir (PCDA) attended the meeting as observers.
Director, BE&R was assisted by respective Additional Director and Assistant Directors for
presentation of the agenda.
Item No. I: Confirmation of Minutes of 320th meetings of Registration Board.
320th meeting of Registration Board was held on 20-22nd September, 2022. The draft minutes
of Registration Board were circulated among the members of Board on 16th September, 2022 for
perusal/approval/comments (if any) within five days. All members agreed the draft minutes on 21st
September, 2022 during 321st meeting of Registration Board.
Accordingly, fair minutes were processed to Chairman, Registration Board for perusal/approval.
After approval from Chairman Registration Board, fair minutes of 320th meeting of Registration Board
were circulated among concerned divisions/sections for implementation of decisions.
Decision: Registration Board confirmed the minutes of 320th meeting of Registration Board.

Item No. II Division of Pharmaceutical Evaluation & Registration
Pharmaceutical Evaluation Cell (PEC)
Sr. No Name of Evaluator Title
1. Mr. Farooq Aslam Evaluator PEC-I

2. Mr. Ammar Ashraf Awan Evaluator PEC-II
3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III
4. Mst.Farzana Raja Evaluator PEC-IV
5. Mst. Iqra Aftab Evaluator PEC-V
6. Mr. Muhammad Umar Latif Evaluator PEC-VI
7. Dr. Sidra Khalid Evaluator PEC-VII
8. Dr. Hanif Ullah Evaluator PEC-IX

9. Dr. Farhadullah Evaluator PEC-XI
10. Mr. Shahid Nawaz Evaluator PEC-XIII
11. Mr. Ahsan Hafiz Evaluator PEC-XIV

12. Mst. Saima Evaluator PEC-XV
13. Mr. Akbar Ali Evaluator PEC-XVI
14. Mr. Zia Ullah Evaluator PEC-XVII

15. Mr. Muneeb Ahmed Cheema Evaluator PEC-XVIII
16. Mr. Sarfraz Nawaz Evaluator PE&R

Agenda of Evaluator PEC-VII
1. Name, address of Applicant / Marketing M/s News Pharma Plot 42, Sundar Industrial
Authorization Holder Estate Lahore
Name, address of Manufacturing site. M/s News Pharma Plot 42, Sundar Industrial
Estate Lahore
Details of Drug Manufacturer License DML No.:
Address: M/s News Pharma
Plot 42, Sundar Industrial Estate Lahore
Validity: 18/02/2018 valid till 5 year
Status of the applicant ☒ Manufacturer
☐ Importer
☐ Is involved in none of the above (contract
giver)
Status of application ☐ New Drug Product (NDP)
☒ Generic Drug Product (GDP)
Intended use of pharmaceutical product ☒ Domestic sale
☐ Export sale
☐ Domestic and Export sales
Dy. No. and date of submission Dy. No. 6138 dated: 7 March 2022
Details of fee submitted PKR 30,000/-: dated 02-03-2022
The proposed proprietary name / brand name Newsfen 100 mg / 5 mL Suspension
Strength / concentration of drug of Active Each 5 mL contains:
Pharmaceutical ingredient (API) per unit Ibuprofen .... 100 mg
Pharmaceutical form of applied drug Clear sweet strawberry flavored
homogeneous oral suspension filled in
amber glass bottle sealed with aluminium
cap and packed in printed unit cartons.
Pharmacotherapeutic Group of (API) NSAID
Reference to Finished product specifications BP
Proposed Pack size 1 ×60 mL, 1 x 90 mL, 1x120 mL, 1x 400 mL
Proposed unit price As per SRO
The status in reference regulatory authorities Ibuprofen 100 mg / 5 mL suspension by M/s
Pinewood healthcare UK (MHRA Approved)
For generic drugs (me-too status) Brufen Suspension by Abbott Laboratories
Reg. No. 004595
GMP status of the Finished product manufacturer New additional section of Oral Liquid Syrup
approved on: 12-11-2021
Name and address of API manufacturer. Zenith Chemical Industries (Pvt.) Limited.
Moaza Dhondhay, Jia Bagga, Raiwind Road
Lahore
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD
template. Summarized information related to
nomenclature, structure, general properties,
solubilities, physical form, manufacturers,
description of manufacturing process and
controls, impurities, specifications, analytical
procedures and its verification, batch analysis
and justification of specification, reference
standard, container closure system and stability
studies of drug substance and drug product is
submitted.
Module III (Drug Substance) Official monograph of Ibuprofen is present in
BP. The firm as submitted detail of
controls, tests for impurity F & related
substances (impurities A J, N), unspecified &
total impurities), specifications, analytical
studies of drug substance
Stability studies Stability study conditions:
Real time: 30°C ± 2°C / 65% ± 5%RH for 36
months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6
months
Batches:(ZIBU11-001ZIBU11-002, ZIBU11-
003)
Module-III (Drug Product): The firm has submitted detail of manufacturers,
procedure (including dissolution testing at
acidic and buffer medium) and its verification
studies, batch analysis and justification of
specification, reference standard, container
closure system and stability studies of drug
product.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been
dissolution profile established against Brufen 100 mg/5 mL Susp.
By M/s Abbott Laboratories by performing
quality tests (Identification, Assay, Uniformity
of dosage unit and determination of 4 - Isobutyl
acetophenone (Ibuprofen impurity E).
CDP – Not applicable

Analytical method validation/verification of product Method verification studies have submitted
including linearity, range, accuracy, precision,
specificity.
STABILITY STUDY DATA

Manufacturer of API Zenith Chemical Industries (Pvt.) Limited.
Moaza Dhondhay, Jia Bagga, Raiwind Road Lahore
API Lot No. ZIBU21-029
Description of Pack Clear sweet strawberry flavored homogeneous oral
(Container closure system) suspension filled in amber glass bottle sealed with aluminium
cap and packed in printed unit carton
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: 0, 2, 4, 6 (Months)
Real Time: 0, 3, 6 (Months)

Batch No. T-01 T-02 T-03
Batch Size 100 Bottles 100 Bottles 100 Bottles
Manufacturing Date 09-2021 09-2021 09-2021
Date of Initiation 08-09-2021 08-09-2021 08-09-2021
No. of Batches 03
Administrative Portion
1. Reference of previous approval of applications with Submitted
stability study data of the firm (if any)
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 141/2019-DRAP
manufacturer issued by concerned regulatory (AD 813875-228) dated 22-05-2019 issued by
authority of country of origin. DRAP
3. Documents for the procurement of API with approval NA
from DRAP (in case of import).
4. Data of stability batches will be supported by attested Submitted

respective documents like chromatograms, Raw data
sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR & Audit Trail submitted

audit trail reports on product testing
6. Record of Digital data logger for temperature and
humidity monitoring of stability chambers (real time Submitted
and accelerated)
Remarks of
Evaluator:
analytical procedure of drug substance from drug substance manufacturer is missing
S. No Sections Observations/Deficiencies/ Response
Short-comings
1. 2.3.R.1.1 method mentioned in BMR’s Critical parameters were only
is not same mentioned in mentioned in BMR both 3.2.P.2.3 and
section 3.2.P.2.3 and 3.2.P.3.5 have been revised and
3.2.P.3.5. Clarification is attached
required.
2. Batch size 100 bottles The actual batch size was 45 bottles,
mentioned while in stability 100 was mentioned by mistake
sheets and COA’s 45 bottles
mentioned.
3. 3.2.S.4.2 Analytical procedures used for Submitted
routine testing of the Drug
substance /Active
Pharmaceutical Ingredient by
Drug substance is required.
4. 3.2.S.4.3 In B.P and as per your method Verification studies are conducted by
Assay is carried out by titration titration method is provided
method while Verification
studies are conducted by
HPLC. Clarification is
required.
5. 3.2.P.2.5 Preservative effectiveness Provided
studies to be performed as per
recommendations of
pharmacopoeia) shall be
provided
6. 3.2.P.4.4 The copies of complete Complete analysis of at least two
analysis of at least two batches batches is provided
shall be provided.
Decision: Approved.
• Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months as per the commitment submitted in the
registration application.
• Manufacturer will perform process validation of first three batches as per the commitment submitted
in the registration application.
2. Name, address of Applicant / Marketing M/s News Pharma Plot 42, Sundar Industrial
Authorization Holder Estate Lahore
Name, address of Manufacturing site. M/s News Pharma Plot 42, Sundar Industrial
Estate Lahore
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 6139 dated 07 March 2022
Details of fee submitted PKR 30,000/-: dated 02-03-2022 (77876249)
The proposed proprietary name / brand name Newsfen DS 200 mg / 5 mL Suspension
Strength / concentration of drug of Active Each 5 mL contains:
Pharmaceutical ingredient (API) per unit Ibuprofen .... 200 mg
Pharmaceutical form of applied drug Clear sweet Orange flavored
homogeneous oral suspension
filled in amber pet bottle sealed
with aluminium cap and packed
in printed unit carton.
Proposed Pack size 1 ×60 mL, 1 x 90 mL, 1x120 mL, 1x 400 mL
The status in reference regulatory authorities Ibuprofen Twelve Plus Pain Relief 200mg/5ml
oral suspension by M/s Aspire Pharma Ltd,
Unit 4, Rotherbrook Court, Bedford Road
Petersfield Hampshire GU32 3QG United
Kingdom
(MHRA Approved)
For generic drugs (me-too status) Brufen Suspension 200 mg/5 mL by Abbott
Laboratories
Reg. No. 070851
GMP status of the Finished product manufacturer New additional section of Oral Liquid Syrup
approved on: 12-11-2021
Name and address of API manufacturer. Zenith Chemical Industries (Pvt.) Limited.
Moaza Dhondhay, Jia Bagga, Raiwind Road
Lahore
submitted.
Module III (Drug Substance) Official monograph of Ibuprofen is present in
BP. The firm as submitted detail of
controls, tests for impurity F & related
substances (impurities A J, N), unspecified &
total impurities), specifications, analytical
months
months
Batches:(ZIBU11-001ZIBU11-002, ZIBU11-
003)
product.

dissolution profile established against Brufen 200 mg/5 mL Susp.
By M/s Abbott Laboratories by performing
quality tests (Identification, Assay, Uniformity
of dosage unit and determination of 4 - Isobutyl
acetophenone (Ibuprofen impurity E).

specificity.

Manufacturer of API Zenith Chemical Industries (Pvt.) Limited.
Moaza Dhondhay, Jia Bagga, Raiwind Road Lahore
Description of Pack Clear sweet Orange flavored homogeneous oral suspension
(Container closure system) filled in amber pet bottle sealed with aluminium cap and
packed in printed unit carton.
No. of Batches 03
1. Reference of previous approval of applications with Submitted
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 141/2019-DRAP
manufacturer issued by concerned regulatory (AD 813875-228) dated 22-05-2019 issued by
authority of country of origin. DRAP
3. Documents for the procurement of API with approval NA

respective documents like chromatograms, Raw data
sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR & Audit Trail submitted

humidity monitoring of stability chambers (real time Submitted
and accelerated)
Remarks OF Evaluator:
S. No Sections Observations/Deficiencies/ Response

Short-comings
1. 2.3.R.1.1 method mentioned in BMR’s Critical parameters were only
is not same mentioned in mentioned in BMR both 3.2.P.2.3 and
section 3.2.P.2.3 and 3.2.P.3.5. 3.2.P.3.5 have been revised and
Clarification is required. attached
2. Batch size 100 bottles The actual batch size was 45 bottles,
mentioned while in stability 100 was mentioned by mistake
sheets and COA’s 45 bottles
mentioned.
3. 3.2.S.4.2 Analytical procedures used for Submitted
routine testing of the Drug
substance /Active
Pharmaceutical Ingredient by
Drug substance is required.
4. 3.2.P.2.5 Preservative effectiveness Provided
studies to be performed as per
recommendations of
pharmacopoeia) shall be
provided
5. 3.2.P.4.4 The copies of complete complete analysis of at least two
analysis of at least two batches batches is provided
shall be provided.
Decision: Approved.

3. Name, address of Applicant / Marketing M/s Sayyed Pharmaceutical ( Pvt) Ltd,Hattar.

Authorization Holder
Name, address of Manufacturing site. Plot no 67/2,Phase 3,Industrial estate, hattar,
Haripur.
☐ Importer
☐ Is involved in none of the above (contract giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 9917 dated 19/04/2022
Details of fee submitted PKR 30,000/-: dated 05/04/2022
The proposed proprietary name / brand name Brosyd 3mg tablet
Strength / concentration of drug of Active Each tablet contains:
Pharmaceutical ingredient (API) per unit Bromazepam…….3mg
Pharmaceutical form of applied drug Tablet
Pharmacotherapeutic Group of (API) Benzodiazepine
Reference to Finished product specifications Mgr. Specs
Proposed Pack size 3×10’s

The status in reference regulatory authorities Lexotan 3mg tablet by ROCHE. TGA; Australia
Approved
For generic drugs (me-too status) Calmease 3mg tablet by Wilsons.
GMP status of the Finished product New Section approved. GMP inspection conducted
manufacturer on 23 june 2021
Name and address of API manufacturer. M/s Cambrex Proformaco Milano Via Curiel
34-20067 Paullo ML-Italy.
description of manufacturing process and controls,
impurities, specifications, analytical procedures and
its verification, batch analysis and justification of
specification, reference standard, container closure
system and stability studies of drug substance and
drug product is submitted.
Module III (Drug Substance) The firm as submitted detail of nomenclature,
structure, general properties, solubilities, physical
form, manufacturers, description of manufacturing
process and controls, tests for impurity & related
substances, specifications, analytical procedures and
system and stability studies of drug substance
Real time: 30°C ± 2°C / 65% ± 5%RH for 72 months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 months
impurities, specifications, analytical procedure
(including dissolution testing at acidic and buffer
medium) and its verification studies, batch analysis
and justification of specification, reference standard,
container closure system and stability studies of drug
product.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been established
dissolution profile against the Comparator that is LExotanil 3mg tablet
by Martin Dow Pharma by performing quality tests
(Identification, Assay, Dissolution, Uniformity of
dosage form).
CDP has been performed against the same brand that
is Lexotanil 3mg tablet by Martin Dow Pharma in
Acid media (pH 1.0-1.2) & Phosphate Buffer (pH
6.8). The values for f1 and f2 are in the acceptable
range.
Analytical method validation/verification of Method verification studies have submitted including
product linearity, range, accuracy, precision, specificty.
Manufacturer of API M/s Cambrex Proformaco Milano Via Curiel 34-20067 Paullo ML-Italy.
API Lot No. 871120
Description of Pack
Alu-Pvc blister packed in unit carton (3×10’s)
(Container closure system)
Batch No. Trial-01 Trial-02
Batch Size 5000 tab 5000 tab
Manufacturing Date 12-2021 12-2021
Date of Initiation 02-12-2021 02-12-2021
No. of Batches 02
1. Reference of previous approval of applications Alprazolam 0.25mg,0.5mg and 1mg Tablet.
with stability study data of the firm (if any) Clonazepam 0.5mg and 2mg Tablet.
2. Approval of API/ DML/GMP certificate of API API manufacturer is approved by the regulatory
manufacturer issued by concerned regulatory authority of Italy which is a reference regulatory
authority of country of origin. authority.

3. Documents for the procurement of API with • Invoice No 1000000757 dated 28-04-2021.
approval from DRAP (in case of import).
4. Data of stability batches will be supported by Data of stability batches are supported by attested
attested respective documents like respective documents like chromatograms, Raw data
chromatograms, sheets, COA, summary data sheets etc.
Raw data sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR Submitted
& audit trail reports on product testing
6. Record of Digital data logger for temperature Submitted
and humidity monitoring of stability chambers
(real time and accelerated)
Remarks of Evaluator:
S Section #. Deficiencies Reply
No
1. 1.6.5 Valid Drug Manufacturing License issued by The GMP compliance
the relevant regulatory authority of country certificate # IT-
of origin is needed as the provided one is API/57/H/2022 issued by
valid till January 2021 AIFA valid for 3 years from
01/10/2021
2. 3.2.P.5 Documents for the procurement of API with Invoice for the procurement
approval from DRAP (in case of import). of API with approval from
DRAP is provided
3. 3.2.S.5 COA of primary / secondary reference COA of primary / secondary
standard including source and lot number reference standard including
shall be provided. source and lot number is
provided
4. 3.2.P.8.2 Provides stability study protocols Submitted
5. • As per relevant guidelines & As analysis of formulation

structure of Form 5F, Comparative development was finished
Dissolution profile and comparative assay before two days of CDP end
has to be performed at the time of date, that’s why that date on
formulation development, while according which formulation
to your submitted data, Comparative development analysis was
Dissolution profile studies and comparative finished, was considered as
assay have been performed after initial stability date
commencing stability studies. Justification
shall be submitted.
Decision: Approved with Innovator’s specifications.
• Manufacturer will perform process validation of first three batches as per the commitment
submitted in the registration application.
4. Name, address of Applicant / Marketing M/s MedAsia Pharmaceutical (Pvt) Ltd. Plot #7
Authorization Holder Nowshera industrial estate Risalpur KPK
Pakistan.
Name, address of Manufacturing site. M/s MedAsia Pharmaceutical (Pvt) Ltd. Plot #7
Nowshera industrial estate Risalpur KPK
Pakistan.
☐ Importer

giver)
GMP status of the firm GMP certificate issued on 2
8/12/2021
Evidence of approval of manufacturing facility Firm has submitted copy of section approval
letter dated 13-01-2022 which specifies Oral
Dry powder suspension (general) section.
Intended use of pharmaceutical product ☐ Domestic sale
☐ Export sale
☒ Domestic and Export sales
Dy. No. and date of submission Dy. No: 5413 25/02/2022
Details of fee submitted PKR 30,000/-: 25/02/2022 (#255776532)
The proposed proprietary name / brand name Antra 20mg Capsule
Strength / concentration of drug of Active Each Capsule Contains:

Pharmaceutical ingredient (API) per unit Omeprazole as Enteric Coated Pellets…20mg
Pharmaceutical form of applied drug Dark Blue color cap and light blue color body
containing off white color Enteric Coated
pellets
Pharmacotherapeutic Group of (API) PPI (Proton pump Inhibitor)
Reference to Finished product specifications USP
The status in reference regulatory authorities Omeprazole capsule is USFDA Approved
For generic drugs (me-too status) Getz Pharma (Risk 20 mg Capsule)
GMP status of the Finished product manufacturer New license granted on 11/11/2021
Tablet General, Capsule General& General
Dry Suspension section approved.
Name and address of API manufacturer. M/S Vision pharmaceuticals
Plot No22,23, Industrial Triangle Kahuta
Road Islamabad.
submitted.
Module III (Drug Substance) Official monograph of Omeprazole Capsule is
present in USP. The firm as submitted detail of
controls, tests for impurity D, G & related
substances (impurity A & unspecified),
specifications, analytical procedures and its
verification, batch analysis and justification of
substance
months
months
Batches: (OMP073, OMP074, OMP075)
product.
dissolution profile established against the brand leader that is
Risek 20 mg Capsule by Getz Pharma (#
C04005) by performing quality tests
(Identification, Assay, Dissolution, Uniformity
of dosage form).
CDP has been performed against the same
brand that is Risk 20 mg capsule by Getz
Pharma in Acid media (pH 1.0-1.2) &
Phosphate Buffer (pH 6.8). The values for f1
and f2 are in the acceptable range.
specificity.
Manufacturer of APIs Omeprazole Vision Pharmaceuticals Plot # 22-23,
industrial triangle Kahuta road Islamabad
API Lot No. Omeprazole OMP860
Description of Pack
Alu-Alu blister packed in unit carton (2×7’s)
Real time: 30°C ± 2°C / 65% ± 5%RH
Stability Storage Condition
Real time: 6 months
Time Period
Accelerated: 0, 3, 6 (Months)
Frequency
Batch No. 028 41 47
Batch Size 35106 35106 35106
No. of Batches 03
st th nd
Minutes of of 321 meeting of Registration Board (20 -22 September, 2022) 14
1. Reference of previous approval of applications with The firm has not submitted any document.
stability study data of
the firm (if any)
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. F.326/2019-
manufacturer issued by concerned regulatory addl.Dir (QA&LT-I) issued by Govt of
authority of country of origin. Pakistan ministry of Health valid till
10/02/2022.
3. Documents for the procurement of API Omeprazole pallets are locally procured from
with approval from DRAP (in case of vision pharma Islamabad
Import).
4. Data of stability batches will be supported by Firm has submitted data of stability batches
attested respective documents like chromatograms, along with Chromatograms, raw data sheets,
Raw data sheets, COA, summary data sheets etc. COAs and summary data sheets.
5. Compliance Record of HPLC software 21CFR & Firm has submitted 21 CFR evidence and audit
audit trail reports on product testing. trail reports of product testing.
6. Record of Digital data logger for temperature & Firm has submitted Record of Digital data
humidity monitoring of stability chambers logger for temperature & humidity monitoring
(real time and accelerated) of stability chambers (real time and accelerated)
S. No Observations/Deficiencies/ Short- Reply

comings
1. Approval of API/ DML/GMP certificate Copy of GMP certificate No. F.326/2019-
of API manufacturer issued by addl.Dir (QA&LT-I) issued by Govt of
concerned regulatory authority of Pakistan ministry of Health valid till
country of origin. 10/02/2022 is provided
2. Provide evidence of purchase including Invoice document #302848 from M/S
commercial invoice of the drug vision pharma is provided
substance.
3. Provide copy of BMR of the stability Provided
batches
4. Provide COA of reference standard COA of reference standard which is
which is actually used in the analysis of actually used in the analysis of drug
drug substance in section 3.2.S.5. substance in section is provided
5. Justify why the pharmaceutical Pharmaceutical Equivalence have been
equivalence study does not include established against the brand leader that is
complete testing of the drug product Risek 20 mg Capsule by Getz Pharma (#
and the comparator product including C04005) by performing quality tests
the tests recommended by innovator (Identification, Assay, Dissolution,
product as well as the tests Uniformity of dosage form).
recommended in general monographs CDP has been performed against the same
of official pharmacopoeia. brand that is Risk 20 mg capsule by Getz
Phosphate Buffer (pH 6.8). The values for
f1 and f2 are in the acceptable range. All
the results are provided which concludes
that the developed formulation of
omeprazole 20 mg capsule have
comparable product quality and
performance profile with that of
comparator product

6. Compliance Record of HPLC software Compliance Record of HPLC software
21CFR & audit trail reports on product 21CFR & audit trail is provided
testing.
7. Record of Digital data logger for Record of Digital data logger for
temperature & humidity monitoring of temperature & humidity monitoring of
stability chambers (real time and stability chambers is provided
accelerated)
Decision: Approved.
• Registration Board further decided that registration letter will be issued after submission of CDP and
pharmaceutical equivalence studies, performed against the innovator’s drug product i.e., Losec
capsule 20mg.
5. Name, address of Applicant / Marketing M/s MedAsia Pharmaceutical (Pvt) Ltd. Plot #7
Authorization Holder Nowshera industrial estate Risalpur KPK
Pakistan.
Name, address of Manufacturing site. M/s MedAsia Pharmaceutical (Pvt) Ltd. Plot #7
Nowshera industrial estate Risalpur KPK
Pakistan.
☐ Importer
giver)
GMP status of the firm GMP certificate issued on 8/12/2021
Evidence of approval of manufacturing facility Firm has submitted copy of section approval
letter dated 13-01-2022 which specifies Oral
Dry powder suspension (general) section.
☐ Export sale
Dy. No. and date of submission Dy. No: 12605 24/ May/2022
Details of fee submitted PKR 30,000/-: 25/04/2022 (#7178762428)
The proposed proprietary name / brand name Antra 40mg Capsule

Pharmaceutical ingredient (API) per unit Omeprazole as Enteric Coated Pellets…40mg
Pharmaceutical form of applied drug Dark Blue color cap and light blue color body
pellets
The status in reference regulatory authorities Omeprazole capsule is USFDA Approved

For generic drugs (me-too status) Getz Pharma (Risk 40 mg Capsule)
Tablet General, Capsule General& General
Plot No22,23, Industrial Triangle Kahuta
Road Islamabad.
submitted.
Module III (Drug Substance) Official monograph of Omeprazole Capsule is
substance
months
months
Batches: (OMP073, OMP074, OMP075)
product.
Risek 40 mg Capsule by Getz Pharma by
performing quality tests (Identification, Assay,
Dissolution, Uniformity of dosage form).
brand that is Risk 40 mg Capsule Getz Pharma
in Acid media (pH 1.0-1.2) & Phosphate Buffer
(pH 6.8). The values for f1 and f2 are in the
acceptable range..

specificty.
Manufacturer of APIs Omeprazole Vision Pharmaceuticals Plot # 22-23,
industrial triangle Kahuta road Islamabad
API Lot No. Omeprazole OMP 812
Description of Pack
Real time: 30°C ± 2°C / 65% ± 5%RH
Stability Storage Condition
Real time: 6 months
Time Period
Frequency
Batch No. 030 46 451
Batch Size 21276 21276 21276
No. of Batches 03
stability study data of
the firm (if any)
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. F.326/2019
manufacturer issued by concerned regulatory issued by Govt of Pakistan ministry of Health
authority of country of origin. valid till 10/02/2022.
3. Documents for the procurement of API Omeprazole pallets are locally procured from
with approval from DRAP (in case of vision pharma Islamabad
Import).
attested respective documents like chromatograms, along with Chromatograms, raw data sheets,
Raw data sheets, COA, summary data sheets etc. COAs and summary data sheets.
5. Compliance Record of HPLC software 21CFR & Firm has submitted 21 CFR evidence and audit
audit trail reports on product testing. trail reports of product testing.
6. Record of Digital data logger for temperature & Firm has submitted Record of Digital data
humidity monitoring of stability chambers logger for temperature & humidity monitoring
(real time and accelerated) of stability chambers (real time and accelerated)
comings
1. Submit details including Batch number, Copy of GMP certificate No. F.326/2019-
manufacturing and expiry date of the addl.Dir (QA&LT-I) issued by Govt of
comparator product against which Pakistan ministry of Health valid till
pharmaceutical equivalence as well as 10/02/2022 is provided
CDP studies were conducted.

substance.
batches
which is actually used in the analysis of
actually used in the analysis of drug
equivalence study does not include established against the Risek 40 mg
complete testing of the drug product Capsule by Getz Pharma by performing
and the comparator product including quality tests (Identification, Assay,
the tests recommended by innovator Dissolution, Uniformity of dosage form).
product as well as the tests CDP has been performed against the same
recommended in general monographs brand that is Risk 20 mg capsule by Getz
of official pharmacopoeia. Pharma in Acid media (pH 1.0-1.2) &
omeprazole 40 mg capsule have
comparator product
testing.
accelerated)
Decision: Approved.
6. Name, address of Applicant / Marketing M/s Medasia Pharmaceuticals
Authorization Holder Nawashera Industrial Estate Risalpur KPK
Name, address of Manufacturing site. M/s Medasia Pharmaceuticals
Nawashera Industrial Estate Risalpur KPK
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Diary # 12607 dated: 24 May 2022
The proposed proprietary name / brand name Esasia 20 mg Capsule
st th nd
Strength / concentration of drug of Active Each Capsule contains:
Pharmaceutical ingredient (API) per unit Esomeprazole (Enteric Coated pellets)….20
mg
Pharmaceutical form of applied drug Sky Blue color cap and white color body
pellets
The status in reference regulatory authorities NEXIUM 20 mg CAPSULES
by M/s AstraZeneca Pharmaceuticals,
USFDA Approved
For generic drugs (me-too status) Getz Pharma (Nexum 20 mg Capsule)
GMP status of the Finished product New license granted on 11/11/2021
manufacturer Tablet General, Capsule General& General
Plot No22,23,Industrial Triangle Kahuta
Road Islamabad.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-
PD template. Summarized information related
to nomenclature, structure, general properties,
standard, container closure system and
stability studies of drug substance and drug
product is submitted.
structure, general properties, solubilities,
physical form, manufacturers, description of
manufacturing process and controls,
substance
Real time: 30°C ± 2°C / 65% ± 5%RH
months
Batches: (EMZ044440, EMZ044440,
EMZ044440)
Module-III (Drug Product): The firm has submitted detail of
manufacturers, description of manufacturing
process and controls, impurities,
specifications, analytical procedure (including
dissolution testing at acidic and buffer
medium) and its verification studies, batch
analysis and justification of specification,
reference standard, container closure system
and stability studies of drug product.
Nexum by Getz pharma by performing quality
tests (Identification, Assay, Dissolution,
Uniformity of dosage form).
brand that is Nexum 20 mg capsule by Getz
Phosphate Buffer (pH 6.8). The values for f1
and f2 are in the acceptable range.
Analytical method validation/verification of Method verification studies have submitted
product including linearity, range, accuracy, precision,
specificty.
Manufacturer of API M/S Vision pharmaceuticals
API Lot No. EMZ046082

Description of Pack
Batch No. 029 44 45
Batch Size 34900 34900 34900
No. of Batches 03
1. Reference of previous approval of applications The firm has not submitted any document.
with stability study data of the firm (if any)
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. F.326/2019
manufacturer issued by concerned regulatory issued by Govt of Pakistan ministry of Health
3. Documents for the procurement of API with Esomeprazole pallets are locally procured
approval from DRAP (in case of import). from vision pharma Islamabad
attested respective documents like along with Chromatograms, raw data sheets,
chromatograms, COAs and summary data sheets.
5. Compliance Record of HPLC software 21CFR & Firm has submitted 21 CFR evidence and
audit trail reports on product testing audit trail reports of product testing.
6. Record of Digital data logger for temperature and Firm has submitted Record of Digital data
humidity monitoring of stability chambers (real logger for temperature & humidity monitoring
time and accelerated) of stability chambers (real time and
accelerated)

comings
1. Approval of API/ DML/GMP certificate Copy of GMP certificate No. F.326/2019-
of API manufacturer issued by addl.Dir (QA&LT-I) issued by Govt of
concerned regulatory authority of Pakistan ministry of Health valid till
country of origin. 10/02/2022 is provided
substance.
batches
complete testing of the drug product Nexum 20 mg Capsule by Getz Pharma by
and the comparator product including performing quality tests (Identification,
the tests recommended by innovator Assay, Dissolution, Uniformity of dosage
product as well as the tests form).
of official pharmacopoeia. brand that is Nexum 20 mg Capsule by
Getz Pharma in Acid media (pH 1.0-1.2) &
esomeprazole 20 mg capsule have
comparator product
testing.
accelerated)
Decision: Decision: Approved.
7. Name, address of Applicant / Marketing M/s Medasia Pharmaceuticals Nawashera Industrial

Authorization Holder Estate Risalpur KPK
Name, address of Manufacturing site. M/s Medasia Pharmaceuticals Nawashera Industrial
Estate Risalpur KPK
☐ Importer
☐ Export sale
Dy. No. and date of submission Diary # 12606 dated: 24 May 2022
The proposed proprietary name / brand name Esasia40 mg Capsule
Pharmaceutical ingredient (API) per unit Esomeprazole (Enteric Coated pellets) ….40 mg
Pharmaceutical form of applied drug Sky Blue color cap and white color body containing
off white color Enteric Coated pellets
The status in reference regulatory authorities NEXIUM 40 mg CAPSULES
by M/s AstraZeneca Pharmaceuticals, USFDA
Approved
For generic drugs (me-too status) Getz Pharma (Nexum 40 mg Capsule)
manufacturer Tablet General ,Capsule General& General Dry
Suspension section approved.
Plot No22,23,Industrial Triangle Kahuta Road
Islamabad.
process and specifications, analytical procedures
and its verification, batch analysis and justification
of specification, reference standard, container
substance
months
Batches: (EMZ044440, EMZ044440, EMZ044440)
container closure system and stability studies of
drug product.

dissolution profile against the brand leader that is Nexum 40 mg
capsule by Getz Pharma by performing quality tests
dosage form).
is Nexum 40 mg capsule by Getz Pharma in Acid
media (pH 1.0-1.2) & Phosphate Buffer (pH 6.8).
The values for f1 and f2 are in the acceptable range.
specificty.
Manufacturer of API M/S Vision pharmaceuticals
API Lot No. EMZ046082

Description of Pack
Batch No. 055 056 057
Batch Size 21500 21500 21500
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. F.326/2019 issued by
manufacturer issued by concerned regulatory Govt of Pakistan ministry of Health valid till
authority of country of origin. 10/02/2022.
3. Documents for the procurement of API with Esomeprazole pallets are locally procured from
approval from DRAP (in case of import). vision pharma Islamabad
4. Data of stability batches will be supported by

Firm has submitted data of stability batches along
attested respective documents like
with Chromatograms, raw data sheets, COAs and
chromatograms,
summary data sheets.
Raw data sheets, COA, summary data sheets
etc.
5. Compliance Record of HPLC software 21CFR Firm has submitted 21 CFR evidence and audit trail
& audit trail reports on product testing reports of product testing.
6. Record of Digital data logger for temperature Firm has submitted Record of Digital data logger for
and humidity monitoring of stability chambers temperature & humidity monitoring of stability
(real time and accelerated) chambers (real time and accelerated)

comings
1. Submit details including Batch number, Copy of GMP certificate No. F.326/2019-
manufacturing and expiry date of the addl.Dir (QA&LT-I) issued by Govt of
comparator product against which Pakistan ministry of Health valid till
pharmaceutical equivalence as well as 10/02/2022 is provided
CDP studies were conducted.
substance.
batches
complete testing of the drug product Nexum 40 mg Capsule by Getz Pharma by
and the comparator product including performing quality tests (Identification,
the tests recommended by innovator Assay, Dissolution, Uniformity of dosage
product as well as the tests form).
of official pharmacopoeia. brand that is Nexum 40 mg Capsule by
Getz Pharma in Acid media (pH 1.0-1.2)
& Phosphate Buffer (pH 6.8). The values
for f1 and f2 are in the acceptable range.
All the results are provided which
concludes that the developed formulation
of esomeprazole 40 mg capsule have
comparator product
testing.
accelerated)
Decision: Approved.
Case no. 02 Registration applications of drugs for which stability study data is submitted Registration
applications for Form 5F
c) Form 5F (Human)
8. Name, address of Applicant / Marketing M/s Martin Dow Marker Limited,7-Jail Road,
Authorization Holder Quetta
Name, address of Manufacturing site. M/s Martin Dow Marker Limited,7-Jail Road,
Quetta
☐ Importer

giver)
☐ Export sale
(#512065708279)
The proposed proprietary name / brand name Zaroxetine Tablet 20mg
Strength / concentration of drug of Active Each film coated tablet contains:

Pharmaceutical ingredient (API) per unit Paroxetine HCl Hemihydrate, USP eq.
to Paroxetine …… 20mg
Pharmaceutical form of applied drug White, Oblong Biconvex FCT with R1 on one
side.
Pharmacotherapeutic Group of (API) Selective Serotonin-Reuptake
Inhibitors (SSRIs) (Anti-Depressant)
Proposed Pack size 3×10’s (30’s)
The status in reference regulatory authorities AG-PAROXETINE Tablet 20mg by M/s Angita
Pharma Inc. HEALTH CANADA Approved.
For generic drugs (me-too status) Pronitron Tablet 20mg by Nabiqasim Industries
(Pvt.) Ltd. , Reg. No. 07990
GMP status of the Finished product manufacturer Certificate No:015/2021-DRAP (Q)/K issued on
10th September 2021
Tablet (General & Psychotropic), Capsule
(General), Oral Liquid Syrup (General), Sterile
Liquid Injection/Ampoule, Ointment/Cream,
Dry Powder Sachet (General), Dry Powder
Suspension (General) section approved.
Name and address of API manufacturer. M/s Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai 317024, Zhejiang, China
submitted.
Module III (Drug Substance) Official monograph of Paroxetine Hydrochloride
Hemihydrate is present in USP. The firm has
submitted detail of nomenclature, structure,
general properties, solubilities, physical form,
substances, specifications, analytical procedures
and its verification, batch analysis and
justification of specification, reference standard,
drug substance
months
months
Batches:
Accelerated Time: C5320-09-001, C5320-09-
002, C5320-09-003
Real Time: 5320-14-003, 5320-14-004, 5320-
14-005
procedure (including dissolution testing at acidic
and buffer medium) and its verification studies,
batch analysis and justification of specification,
reference standard, container closure system and
stability studies of drug product.
Seroxat Tablets 20mg by GlaxoSmithKline
Pharmaceutical S.A by performing quality tests
(Identification, Assay, Dissolution).
CDP has been performed against the same brand
that is Seroxat Tablets 20mg by
GlaxoSmithKline Pharmaceutical S.A in Acid
media (pH 1.2), Acetate Buffer (pH 4.5) &
Phosphate Buffer (pH 6.8). The values for f1 and
f2 are in the acceptable range.
Analytical method validation/verification of Method validation studies have submitted
specificity.

Manufacturer of API M/s Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai
317024, Zhejiang, China
API Lot No. 5301-20-013
Description of Pack
Frequency Accelerated: 0, 3, 6 (Months)
Batch Size 10000 Tablets 10000 Tablets 10000 Tablets

Date of Initiation 10-2020 10-2020 10-2020
No. of Batches 03
1. Reference of previous approval of applications with Not Applicable as it is non-inspection product
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. ZJ20180073
manufacturer issued by concerned regulatory issued by CFDA valid till 25/06/2023.
authority of country of origin.
3. Documents for the procurement of API with ADC Invoice No: HH20201310, 11-June-2020
approval from DRAP (in case of import). is submitted wherein the permission to import
API (Paroxetine Hydrochloride) for the
purpose of test/analysis and stability studies is
granted.

attested respective documents like chromatograms,
Raw data sheets, COA, summary data sheets etc. Submitted
5. Compliance Record of HPLC software 21CFR &

audit trail reports on product testing Submitted
humidity monitoring of stability chambers (real Submitted
time and accelerated)
Decision: Approved.
9. Name, address of Applicant / Marketing M/s Relizon Pharmaceuticals Plot No. 118 Sundar
Authorization Holder Industrial estate Lahore
Name, address of Manufacturing site. M/s Relizon Pharmaceuticals Plot No. 118 Sundar
Industrial estate Lahore
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Azith 250mg Tablet
Pharmaceutical ingredient (API) per unit Azithromycin as Dihydrate ……250mg.
Pharmaceutical form of applied drug Brilliant Blue oblong shaped film coated tablets
having break line on one side and engraved “

relizon’’ on other side. Packed in ALU-ALU
blister.
Pharmacotherapeutic Group of (API) Macrolide Antibiotic
Proposed Pack size 1×6’s & 1×10’s. (As per SRO)
The status in reference regulatory authorities Azith 250mg tablet by M/s Zetamax, USFDA
Approved.
For generic drugs (me-too status) Zetamax 250mg Tablet by M/s Pfizer
Pharmaceuticals, Reg. No. 82148
GMP status of the Finished product cGMP granted on 10/06/2022
manufacturer Tablet (General Tablet Capsule Dry Powder
suspension) section approved.
Name and address of API manufacturer. M/s HEBEI Dongfeng Pharmaceutical Co., LTD.
China
Module-II (Quality Overall Summary) Relizon Pharma has submitted QOS as per WHO
QOS-PD template. Summarized information
related to nomenclature, structure, general
properties, solubilities, physical form,
process and controls, impurities, specifications,
analytical procedures and its verification, batch
analysis and justification of specification, reference
submitted.
Module III (Drug Substance) Official monograph of Azithromycin Dihydrate is
description of manufacturing process and controls),
monthsAccelerated: 40°C ± 2°C / 75% ± 5%RH
for 6 months
Batches: (AZ001, AZ002, AZ003).
Module-III (Drug Product): The Relizon Pharma has submitted detail of
analytical procedure (including dissolution testing)
and its verification studies, batch analysis and
drug product.
dissolution profile against the brand leader that is Zetamax 250mg
tablet by Pfizer Pharmaceuticals by performing
quality tests (Identification, Assay, Dissolution,
that is Azith 250mg tablet Tablet by Relizon
Pharma in Acid media (pH 1.0-1.2) & Phosphate
Buffer (pH 6.8). The values for f1 and f2 are in the
acceptable range.
specificity.

Manufacturer of API M/s HEBEI Dongfeng Pharmaceutical Co., LTD. China.
API Lot No. AZ20200152
Description of Pack
Alu-Alu blister packed in unit carton (1×6’s) (1x10’s).As per SRO.
Batch No. AZ001 AZ002 AZ003
Batch Size 1500 tab 1500 tab 1500 tab
No. of Batches 03
1. Reference of previous approval of The Relizon Pharma has not submitted any
applications with stability study data of the document.
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. HB18364705 issued
API manufacturer issued by concerned by CFDA valid till 05/02/2023.
regulatory authority of country of origin.
3. Documents for the procurement of API with • Copy of letter No.SE20N00417/DRAP-AD-CD

approval from DRAP (in case of import). (I&E) dated 10/03/2020 is submitted wherein the
permission to import different APIs including
Azithromycin Dihydrate for the purpose of
test/analysis and stability studies is granted.
• DHL No.GXPEW20046920 dated 22/04/2020
4. Data of stability batches will be supported by Submitted
chromatograms,
etc.
5. Compliance Record of HPLC software Submitted
21CFR & audit trail reports on product
testing
and humidity monitoring of stability
chambers (real time and accelerated)
S No Deficiencies Reply
1. Approval of API/ DML/GMP certificate of API The API/ DML/GMP certificate #
manufacturer issued by concerned regulatory 11120190003 of HEBEI Dongfeng
authority of country of origin Pharmaceutical Co., LTD. China
issued by China food and drug
administration china valid till
13/1/2024
2. Analytical Procedures Analytical Procedures and
(a) Summary of the analytical procedures (e.g. Summary of the analytical
key method parameters, conditions, system procedures (e.g. key method
suitability testing) parameters, conditions, system
suitability testing is provided
3. Compliance Record of HPLC software 21CFR & Submitted
4. Record of Digital data logger for temperature and Submitted

humidity monitoring of stability chambers (real
5. Documents for the procurement of API with Copy of letter
approval from DRAP (in case of import). No.SE20N00417/DRAP-AD-CD
(I&E) dated 10/03/2020 is
submitted wherein the permission
to import different APIs including
Azithromycin Dihydrate for the
purpose of test/analysis and
stability studies is granted.DHL
No.GXPEW20046920 dated
22/04/2020
Decision: Approved.
proposed shelf life and on accelerated studies for six months as per the commitment submitted in
the registration application.
10. Name, address of Applicant / Marketing M/s Relizon Pharmaceuticals Plot No. 118 Sundar
Authorization Holder Industrial estate Lahore
Name, address of Manufacturing site. M/s Relizon Pharmaceuticals Plot No. 118 Sundar
Industrial estate Lahore
☐ Importer
☐ Export sale
The proposed proprietary name / brand
Azith 500mg Tablet
name
Pharmaceutical ingredient (API) per unit Azithromycin as Dihydrate ……500mg.

Pharmaceutical form of applied drug Brilliant Blue oblong shaped film coated tablets
having break line on one side and engraved “
relizon’’ on other side. Packed in ALU-ALU blister.
Proposed Pack size 1×6’s & 1×10’s. (As per SRO)
The status in reference regulatory authorities Azith 500mg tablet by M/s Zetamax, USFDA
Approved.
For generic drugs (me-too status) Zetamax 500mg Tablet by M/s Pfizer
Pharmaceuticals, Reg. No. 076685
GMP status of the Finished product cGMP granted on 10/06/2022
manufacturer Tablet (General Tablet Capsule Dry Powder
suspension) section approved.
Name and address of API manufacturer. M/s HEBEI Dongfeng Pharmaceutical Co., LTD.
China
Module-II (Quality Overall Summary) Relizon Pharma has submitted QOS as per WHO
QOS-PD template. Summarized information related
Module III (Drug Substance) Official monograph of Azithromycin Dihydrate is
description of manufacturing process and controls),
Batches: (AZ001, AZ002, AZ003).
Module-III (Drug Product): The Relizon Pharma has submitted detail of
manufacturers, description of manufacturing process
and controls, impurities, specifications, analytical
procedure (including dissolution testing) and its
verification studies, batch analysis and justification
closure system and stability studies of drug product.
dissolution profile against the brand leader that is Zetamax 250mg tablet
by Pfizer Pharmaceuticals by performing quality
tests (Identification, Assay, Dissolution, Uniformity
of dosage form).
is Azith 250mg tablet Tablet by Relizon Pharma in
Acid media (pH 1.0-1.2) & Phosphate Buffer (pH

6.8). The values for f1 and f2 are in the acceptable
range.
specificity.

Manufacturer of API M/s HEBEI Dongfeng Pharmaceutical Co., LTD. China.
API Lot No. AZ20200152
Description of Pack
Alu-Alu blister packed in unit carton (1×6’s) (1x10’s).As per SRO.
Batch No. AZ004 AZ005 AZ006
No. of Batches 03
1. Reference of previous approval of The Relizon Pharma has not submitted any
applications with stability study data of the document.
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. HB18364705 issued
API manufacturer issued by concerned by CFDA valid till 05/02/2023.
3. Documents for the procurement of API with • Copy of letter No.SE20N00417/DRAP-AD-CD

approval from DRAP (in case of import). (I&E) dated 10/03/2020 is submitted wherein the
permission to import different APIs including
Azithromycin Dihydrate for the purpose of
• DHL No.GXPEW20046920 dated 22/04/2020
chromatograms,
etc.
testing
S No Deficiencies Reply

1. Approval of API/ DML/GMP certificate of API The API/ DML/GMP certificate #
manufacturer issued by concerned regulatory 11120190003 of HEBEI Dongfeng
authority of country of origin Pharmaceutical Co., LTD. China
issued by China food and drug
administration china valid till
13/1/2024
2. Analytical Procedures Analytical Procedures and
(a) Summary of the analytical procedures (e.g. Summary of the analytical
key method parameters, conditions, system procedures (e.g. key method
suitability testing) parameters, conditions, system
suitability testing is provided

5. Documents for the procurement of API with Copy of letter
approval from DRAP (in case of import). No.SE20N00417/DRAP-AD-CD
(I&E) dated 10/03/2020 is
submitted wherein the permission
to import different APIs including
Azithromycin Dihydrate for the
purpose of test/analysis and
stability studies is granted.DHL
No.GXPEW20046920 dated
22/04/2020
Decision: Approved.
11. Name and address of manufacturer / Applicant M/s PharmEvo (Pvt.) Limited, A-29, North
Western Industrial Zone, Port Qasim, Karachi.
Brand Name +Dosage Form + Strength Erlin-S 5/100 mg Tablet
Composition "Each Film Coated Tablet Contains:

Ertugliflozin L-Pyroglutamic Acid 6.48 Eq. to
Ertugliflozin…5mg
Sitagliptin Phosphate Monohydrate 128.5 mg Eq. to
Sitagliptin…100mg"
Diary No. Date of R& I & fee Diary No. Date of R& I & fee Dy.No 4208 dated
08-04-2021 Rs.50,000/- Dated 21-2-2019
(0794087)
Pharmacological Group Anti-Diabetic (A10BK04), (A10BD24)
Type of Form Form-5D
Finished product Specification Innovator specifications
Pack size & Demanded Price As per SOP
Approval status of product in Reference STEGLUJAN™ (ertugliflozin and sitagliptin)
Regulatory Authorities USFDA Approved with box warning.
Me-too status NA

GMP status GMP inspection dated 26-10-2021 showed that the
firm was considered to be operating at an acceptable
level of compliance with GMP standards.
Remarks of the Evaluator
Drug Erlin-S 5/100 mg Tablet
Name of Manufacturer M/s PharmEvo (Pvt.) Limited, A-29, North Western Industrial Zone, Port
Qasim, Karachi.
Manufacturer of API Ertugliflozin as L-Pyroglutamic acid: Shanghai Pharma group
Changzhou kony Pharmaceuticals co., Ltd Daixi street Luoyang town Wujin
district Changzhou, Jiangsu China is submitted
Sitagliptin Phosphate Monohydrate: Zhejiang yonta pharmaceutical co
LTD No 1 4th Donghai avenue Zhejiang provincial chemical and medical raw
material base Linhai zone Linhai city Zhejiang province China
API Lot No. Ertugliflozin L-Pyroglutamic Acid: ETG20190101
Sitagliptin Phosphate Monohydrate: 1827-0001-19049
Description of Pack
Alu-Alu Blister
Frequency Accelerated: 0,1,2,3,4,6 months
Real Time: 0,3,6 months
Batch No. 19PD-3057-03-T 19PD-3058-04-T 19PD-3059-05-T
Batch Size 2500 2500 2500
No. of Batches 03
Date of Submission 22-12-2020 (Dy. No.34038)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. Documents to Be Provided Status

No.
1. Reference of previous approval of applications Firm has referred to onsite inspection report of
with stability study data of the firm their product Erli Plus XR Tablet 5/1000mg,
10/1000mg, 12.5/1000mg & 25/1000mg
(Empagliflozin + Metformin HCl XR) which was
conducted on 05th December, 2019 and were
presented in 293rd meeting of Registration Board
held on 6th -8th Jan, 2020.
According to the report following points were
confirmed.
• Firm has 21 CFR compliant HPLC
software.
• Firm has audit trail reports available.
• Firm possesses stability chambers with
digital data loggers.
2. Certificate of Analysis of API from both API Ertugliflozin- LPGA: Copy of COA of
Manufacturer and Finished Product Ertugliflozin L-pyroglutamic acid eq to
manufacturer. Ertugliflozin (L-Pyroglutamic acid) (Batch#
ETG20190101)) from M/s Shangai Pharma

Group Changzhou Kony Pharmaceutical Co.,
Ltd.,
Daixi Street, Louyang Town, Wujin District,
Changzhou, Jiangsu 213105, China is submitted.
Copy of COA from M/s PharmEvo (private)
Limited is submitted.
Sitagliptin Phosphate:
Copy of COA of Sitagliptin Phosphate (Batch#
1827-0001-19049) from Zhejiang Yontai
Pharmaceutical co. ltd-Donghai 4th Avenue,
Zhejiang Provincial Chemical and Medical Raw
Material Base Linhai Zone, Linhai City, Zhejiang
Province is submitted.
Copy of COA (Batch# 1827-0001-19049) from
M/s PharmEvo (private) Limited is submitted.
3. Method used for analysis of API from both API
Manufacturer and Finished Product Provided
Manufacturer
4. Stability study data of API from API Ertugliflozin: Provided (The firm has submitted
manufacturer accelerated & real time stability studies for 3
batches (ETG20161201, ETG20161202,
ETG20170101) at Real time: 30°C ± 2°C / 65% ±
5%RH and Accelerated: 40°C ± 2°C / 75% ±
5%RH)
Sitagliptin: Provided (The firm has submitted
accelerated & real time stability studies for 3
batches (1827-0001-18001, 1827-0001-18002,
1827-0001-18003) at Real time: 30°C ± 2°C / 65%
± 5%RH and Accelerated: 40°C ± 2°C / 75% ±
5%RH)
5. Approval of API/ DML/GMP certificate of API Ertugliflozin: Copy of GMP certificate

manufacturer issued by concerned regulatory (certificate No.JS20180935) issued to Shanghai
authority of country of origin. pharma group Changzhou by CFDA. It is valid
until 26/11/2023
Sitagliptin: cGMP certificate # ZJ20170014
issued by china food and drug administration to the
manufacturer (Zheijiang Youngtai
pharmaceuticals co ltd) and its valid till 3rd May
2022
6. Documents for the procurement of API with Ertugliflozin The firm has submitted copy of
approval from DRAP (in case of import). invoice for the purchase (1.2 kg) attested by
Assistant Director DRAP, dated 7-1-2020
Sitagliptin:
The firm has submitted copy of invoice for the
purchase (500 kg) attested by Assistant Director
DRAP, but commercial invoice was attested
provided by Hangzhou biobounce technology co
LTD
7. Protocols followed for conduction of stability

Yes
study
8. Method used for analysis of FPP Yes
9. Drug-excipients compatibility studies (where Drug-excipients compatibility studies were not
applicable) performed as the firm has used the same
excipients as of innovator.

10. Complete batch manufacturing record of three The firm has submitted copy of Trial batch
stability batches. manufacturing record. Details are as under:
Batch no. Batch Size Mfg.
Started
19PD-3057- 2500 12-2019
03-T
19PD-3058- 2500 12-2019
04-T
19PD-3059- 2500 12-2019
05-T
11. Record of comparative dissolution data (where Firm has submitted Comparative dissolution
applicable) study of their product with Innovator’s Brand
Steglujan”.
The details are as follows:
Feature Reference Product of
Product PharmEvo
Brand Name Steglujan Erlin-S
Tablet Tablet
5mg/100mg 5/100mg
Batch No. T011927 19PD-3057-
03-T
Comparative dissolution studies have been
performed in following mediums:
1. pH 1.2 HCl buffer
2. pH 4.5 Acetate buffer
3. pH 6.8 Phosphate buffer
12. Data of 03 batches will be supported by attested
respective documents like chromatograms, Raw The firm has submitted photocopy of Batch
data sheets, COA, summary data sheets etc. Manufacturing Record of three stability batches

Provided
audit trail reports on product testing.
humidity monitoring of stability chambers (real Provided
REMARKS OF EVALUATOR VII
S No Deficiency Response
1. Need valid GMP issued by the Copy of DML# 20120015 issued by
province as the current GMP NMPA valid upto 31-05-2027 has been
certificate issued by Zheijang medical submitted.
Centre for economic development is
valid till 30-06-2021
2. The GMP, quality control department The Shanghai Pharma Group Changzhou
analysis report and COA is from Kony Pharmaceutical Co., Ltd. Jiangsu
Shanghai Pharma Group Changzhou China is the manufacturer which might be
Kony Pharmaceutical Co., Ltd. confirmed by the submitted GMP
Jiangsu China. And on many whereas shanghai Pansopharm
documents including commercial technology co Ltd is an exporter of
invoice name is mentioned as Ertugliflozin. Declaration letter is
Shanghai Pansopharma technology provided.
Co., Ltd. Jiangsu China. Provide the
relationship.

3. Commercial invoice of sitagliptin Commercial invoice of sitagliptin was
wasn’t attested and provided by attested and provided by Hangzhou
Hangzhou biobounce technology Co biobounce technology Co LTD which is
LTD not zheijang youngtai pharma. the exporter of sitagliptin. zheijang
Clarification is needed youngtai pharma co Ltd is the
manufacturer of sitagliptin
4. Reference of previous approval of Submitted
applications with stability study data
of the firm is needed
5. Certificate of analysis of API from Certificate of analysis of API from both

both drug substance and drug product drug substance and drug product
manufacturer manufacturer were provided
6. Record of comparative dissolution Submitted
data is needed

12. Name and address of manufacturer / Applicant M/s PharmEvo (Pvt.) Limited, A-29, North Western
Industrial Zone, Port Qasim, Karachi.
Brand Name +Dosage Form + Strength Erlin-M 7.5/1000 mg Tablet
Composition Each film coated tablet contains:

9.71 mg Ertugliflozin L-pyroglutamic acid (as
Ertugliflozin) …….. 7.5 mg
Metformin hydrochloride……..1000 mg
Diary No. Date of R& I & fee Diary No. Date of R& I & fee Dy.No 6452 dated 26-
02-2021 Rs.50,000/- 4 march 2019)
Anti-Diabetic (A10BK04), (A10BD24)
Pharmacological Group Anti-Diabetic (A10BK04), (A10BD24)

Finished product Specification Innovator specifications
Pack size & Demanded Price As per SOP
Approval status of product in Reference SEGLUROMET (ertugliflozin and Metformin)
Regulatory Authorities USFDA Approved
Me-too status NA
GMP status GMP inspection dated 26-10-2021 showed that the
firm was considered to be operating at an
acceptable level of compliance with GMP
standards
Drug Erlin-M 7.5/1000 mg Tablet
Name of Manufacturer M/s PharmEvo (Pvt.) Limited, A-29, North Western Industrial Zone, Port
Qasim, Karachi.
Manufacturer of API Ertugliflozin:
M/s Shangai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd.,
Daixi Street, Louyang Town, Wujin District, Changzhou, Jiangsu 213105,
China.
Metformin HCl:
Smruthi Organics Limited, A-27, MIDC Chincholi, Tal-Mohol, Solapur
413255 Maharashtra State, India.
API Lot No. Ertugliflozin L-Pyroglutamic Acid: LPGA: ETG20190101
Metformin: MET-559/19
Description of Pack
Alu-Alu Blister
Frequency Accelerated: 0,1,2,3,4,6 months
Real Time: 0,3,6 months
Batch Size 2500 Tablet 2500 Tablet 2500 Tablet
No. of Batches 03
Date of Submission 22-12-2020 (Dy. No.34038)
Sr. Documents to Be Provided Status

No.
1. Reference of previous approval of applications Firm has referred to onsite inspection report of
with stability study data of the firm their product Erli Plus XR Tablet 5/1000mg,
10/1000mg, 12.5/1000mg & 25/1000mg
(Empagliflozin + Metformin HCl XR) which was
conducted on 05th December, 2019 and were
presented in 293rd meeting of Registration Board
held on 6th -8th Jan, 2020.
confirmed.
• Firm has 21 CFR compliant HPLC
software.
• Firm has audit trail reports available.
• Firm possesses stability chambers with
digital data loggers.

2. Certificate of Analysis of API from both API Ertugliflozin- LPGA: Copy of COA of
Manufacturer and Finished Product Ertugliflozin L-pyroglutamic acid eq to
manufacturer. Ertugliflozin (L-Pyroglutamic acid) (Batch#
ETG20190101)) from M/s Shangai Pharma
Group Changzhou Kony Pharmaceutical Co.,
Ltd.,
Daixi Street, Louyang Town, Wujin District,
Changzhou, Jiangsu 213105, China is submitted.
Copy of COA from M/s PharmEvo (private)
Limited is submitted.
Metformin HCl:
Copy of COA (Batch# MET-559/19) from
Smruthi Organics Limited A-27, MIDC
Chincholi, Tal- Mohol, Solapur 413255
Maharashtra State, India is submitted.
Copy of COA (Batch# 1835) from M/s PharmEvo
(private) Limited is submitted.
3. Method used for analysis of API from both API
Manufacturer and Finished Product Provided
Manufacturer
4. Stability study data of API from API The firm has submitted accelerated & real time
manufacturer stability studies for 3 batches at Real time: 30°C ±
2°C / 65% ± 5% RH and Accelerated: 40°C ± 2°C
/ 75% ± 5%RH)
5. Approval of API/ DML/GMP certificate of API Ertugliflozin- LPGA: Copy of GMP (#
manufacturer issued by concerned regulatory JS20180935) for M/s Shangai Pharma Group
authority of country of origin. Changzhou Kony Pharmaceutical Co., Ltd., China
issued by China Food and Drug Administration of
the People’s Republic of China is submitted, valid
up to 26-11-2023.
Metformin: of Drug manufacturing license
(License no. NEW-WHO-
GMP/CERT/PD/86368/2019/11/30111) for
Smruthi Organics Limited
A-27, MIDC Chincholi, Tal-Mohol, Solapur
413255 Maharashtra State, India is submitted,
valid up to 13-Nov-2022
6. Documents for the procurement of API with Ertugliflozin the firm has submitted copy of
approval from DRAP (in case of import). invoice for the purchase (1.2 kg) attested by
Assistant Director DRAP, dated 7-1-2020
Metformin: Firm has submitted copy of
commercial invoice specifying import of 3000 Kg
metformin dated 27-11-2018. The invoice is
signed by AD (I&E) DRAP Lahore.
7. Protocols followed for conduction of stability
Yes
study
8. Method used for analysis of FPP Yes
9. Drug-excipients compatibility studies (where Drug-excipients compatibility studies were not
applicable) performed as the firm has used the same
excipients as of innovator.

10. Complete batch manufacturing record of three The firm has submitted copy of Trial batch
stability batches. manufacturing record. Details are as under:
Batch no. Batch Size Mfg. Started
19PD-3010- 2500 11-2019

05-T
19PD-3011- 2500 11-2019

06-T
19PD-3012- 2500 11-2019

07-T
11. Record of comparative dissolution data (where Firm has submitted Comparative dissolution
applicable) study of their product with Innovator’s Brand
“Segluromet” The details are as follows:
Feature Reference Product of

Product PharmEvo
Brand Segluromet Erlin-M
Name Tablet Tablet
2.5mg/1000 7.5/500mg
mg
Batch No. T042906 19PD-3041-
02-T
Comparative dissolution studies have been
performed in following mediums:
1. pH 1.2 HCl buffer
2. pH 4.5 Acetate buffer
3. pH 6.8 Phosphate buffer
Firm submit letter and clarify that our products
Ertugliflozin L-pyroglutamic acid eq to
Ertugliflozin + Metformin HCl Tablets 2.5mg +
500mg, 2.5mg + 1000mg, 7.5mg + 500mg &
7.5mg + 1000mg are dose proportional in
accordance with EMA Guidelines on the
Investigation of Bioequivalence (extract
attached) which states that:
- The pharmaceutical products are manufactured
by the same manufacturing process.
- The Qualitative composition of the different
strengths is the same.
- The composition of strengths are Quantitatively
proportional i.e., amount of all the excipients in
the
tablet range is similar to each other with respect
to tablet weight except filler for which the active
substance is adjusted.
In view of the above, we have benchmarked
Segluromet Tablet 2.5mg + 1000mg as reference
product for all the strengths.

12. Data of 03 batches will be supported by attested
respective documents like chromatograms, Raw The firm has submitted photocopy of Batch
data sheets, COA, summary data sheets etc. Manufacturing Record of three stability batches
such as.
Ertugliflozin/Metformin
Batch No. Date of Batch Size
Mfg.
19PD- 30-10- 2500 Tablets
3010-05-T 2019
19PD- 30-10- 2500 Tablets
3011-06-T 2019
19PD- 30-10- 2500 Tablets
3012-07-T 2019

Yes
audit trail reports on product testing.
humidity monitoring of stability chambers (real Yes
REMARKS OF EVALUATOR VII
S No Deficiency Response
1. The GMP, quality control department The Shanghai Pharma Group Changzhou
analysis report is from Shanghai Pharma Kony Pharmaceutical Co., Ltd. Jiangsu
Group Changzhou Kony Pharmaceutical China is the manufacturer which might be
Co., Ltd. Jiangsu China. And on man confirmed by the submitted GMP whereas
documents including commercial invoice shanghai pansopharm technology co Ltd is
name is mentioned as Shanghai an exporter of ertigluphlozin. Declaration
Pansopharma technology Co., Ltd. letter is provided.
Jiangsu China. Provide the relationship.
2. Reference of previous approval of Provided

applications with stability study data of
the firm is needed
3. Certificate of analysis of API from both Certificate of analysis of API from both
drug substance and drug product drug substance and drug product
manufacturer manufacturer were provided
4. Record of comparative dissolution data Firm submit letter and clarify that our
is needed products Ertugliflozin L-pyroglutamic acid
eq to Ertugliflozin + Metformin HCl
Tablets 2.5mg + 500mg, 2.5mg + 1000mg,
7.5mg + 500mg & 7.5mg
+ 1000mg are dose proportional in
accordance with EMA Guidelines on the
Investigation of Bioequivalence (extract
attached) which states that:
- The pharmaceutical products are
manufactured by the same manufacturing
process.
- The Qualitative composition of the
different strengths is the same.
- The composition of strengths is
Quantitatively proportional i.e., amount of
all the excipients in the tablet range is
similar to each other with respect to tablet

weight except filler for which the active
substance is adjusted.

• Registration Board further decided that registration letter will be issued after submission of CDP
and pharmaceutical equivalence studies, performed against the innovator’s product.
13. Name, address of Applicant / Marketing "M/s PharmEvo Private Limited. Plot # A-29, North
Authorization Holder Western Industrial Zone, Port Qasim, Karachi"
Name, address of Manufacturing site. "M/s PharmEvo Private Limited. Plot # A-29, North
Western Industrial Zone, Port Qasim, Karachi"
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 12620 dated 24 May 2022
The proposed proprietary name / brand name Budetrol 400 mcg/12 Mcg DPI capsule
Pharmaceutical ingredient (API) per unit Budesonide.................................400mcg
per unit Formoterol fumarate dihydrate..............12mcg
Pharmaceutical form of applied drug Transparent Cap & Transparent body of HPMC
Capsule
Pharmacotherapeutic Group of (API) Corticosteroid/Selective β2 Adrenoceptor (i.e. Short
acting and Long acting).
Reference to Finished product specifications As per Innovator Specification
Proposed Pack size 7’s, 10’s, 14’s, 20’s, 28’s, 30’s and as per SRO
The status in reference regulatory authorities SYMBICORT TUBOHALER 400/12mcg
INHALATION
POWDER” by AstraZeneca UK Limited (MHRA
approved)
For generic drugs (me-too status) Formiget 400mcg + 12mcg DPI capsule of M/s Getz
Pharma (Reg # 098723)
GMP status of the Finished product New additional section of Oral Liquid Syrup approved
manufacturer on: 12-11-2021
Name and address of API manufacturer. Budesonide: M/s Vamsi Labs LTD, A-14/15, MIDC
area, Chincholi Solapur-413255
Maharashtra, INDIA
Formoterol fumarate dihydrate: M/s Vamsi Labs
LTD, A-14/15, MIDC area, Chincholi Solapur-413255
Maharashtra, INDIA
nomenclature, structure, general properties, solubilities,
manufacturing process and controls, impurities,
system and stability studies of drug substance and drug
Module III (Drug Substance) The firm as submitted detail of nomenclature, structure,
and controls, tests for impurity & related substances,
system and stability studies of drug substance.
Budesonide:
Batches: (BDS/R&D/001/12, BDS/R&D/002/12,
BDS/R&D/003/12)
Formoterol Fumarate:
Batches: (FF-006/07, FF-007/07, FF-008/07)
medium) and its verification studies, batch analysis and
product.
dissolution profile against the innovator that is Symbicort Turbuhaler
400mcg/12mcg DPI Capsule by Astrazeneca UK
Limited by performing quality tests (Identification,
Assay, APSD, DDU of dosage form).
CDP is not applicable.
product linearity, range, accuracy, precision, specificity, LOD,
LOQ.
Manufacturer of API Budesonide: M/s Vamsi Labs Ltd., A-14/15, MIDC area, Chincholi, Solapur-
413255, Maharashtra, India
Formoterol fumarate dihydrate: M/s Vamsi Labs Ltd., A-14/15, MIDC area,
Chincholi, Solapur-413255, Maharashtra, India
Description of Pack
DPI capsule
Batch No. 21-PD-3624-03-T 21-PD-3625-04-T 21-PD-3626-05-T
Batch Size 4000 Capsule 4000 Capsule 4000 Capsule
Manufacturing Date Mar-2021 Mar-2021 Mar-2021
No. of Batches 03
1. Reference of previous approval of applications Submitted
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP Certificate
API manufacturer issued by concerned (#NEW-WHO
regulatory authority of country of origin. GMP/CERT/PD/103627/2021/11/37422) for M/s M/s
Vamsi Labs Ltd., A-14/15, MIDC area, Chincholi,
Solapur-413255, Maharashtra, India
issued by Food and Drugs Administration
(Maharashtra State), India. It is valid till 04 Oct 2024.
3. Documents for the procurement of API with Budesonide: Firm has submitted copy of invoice
approval from DRAP (in case of import). specifying purchase of 20 g of Budesonide
(micronised) attested by AD Karachi dated 03-12-
2020.
Formoterol Fumarate Dihydrate: Firm has submitted
copy of invoice specifying purchase of 10 g of
Formoterol Fumarate Dihydrate (micronized) attested
by AD Karachi dated 07-01-2020
chromatograms, Raw data sheets, COA,
summary data sheets etc.
5. Compliance Record of HPLC software 21CFR Audit Trail submitted
6. Record of Digital data logger for temperature
and humidity monitoring of stability chambers Submitted
Details of DPI device:
Model no.: BDD07
Manufacturer: M/s ShangHai HuaRui Aerosol Co., Ltd. No.222, Yuanchun Road, Pudong New Area,
Shanghai, China
Shelf life: 3 years
S# Section Query Reply

1. 3.2.S.4 Control of drug substance Submitted
2. (2.3.S.4.3) Provide summarized tabulated Summarized tabulated results of
results of verification studies verification studies including
including specificity, accuracy and specificity, accuracy and
repeatability (method precision) Repeatability (method
performed by the Drug Product precision) is submitted
manufacturer
3. (3.2.S.4.4) Provide results of analysis of Results of analysis of relevant

relevant batch(es) of Drug Substance
batch(es) of Drug Substance performed by Drug Product
performed by Drug Product Manufacturer along with COA’s
manufacturer used during product has been submitted.
development and stability studies,
along with Certificate of Analysis
(CoA) of the same batch from Drug
Substance /Active Pharmaceutical
Ingredient manufacture
4. ” (3.2.S.4) Submitted specifications does not Submitted specifications

include test for “Particle size include test for "Particle size
distribution since, reference product distribution” (copy of relevant
literature states that “The particle section is provided
size distribution is crucial to
achieving the required delivered
dose and lung deposition
characteristics
5. (3.2.P.2.2.1). The reference products referred by Innovator has directly filled
you, is an inspiratory flow-driven, Active Pharmaceutical
multidose powder inhaler containing Ingredients and Excipients in a
metered doses, wherein inhaler is blister foil, however we have
made used capsule as a container of
of different plastic materials, while Dry Powder Inhaler products
the applied formulation is primarily therefore practically it is not
pre-dispensed in unit dose hard possible to fill such a minute
capsules. Justification shall be quantity of Lactose (as in case of
submitted for innovator) during encapsulation.
pharmaceutical equivalence of the Furthermore, Pharmaceutical
applied product against the reference Equivalence has also been done
product with respect to change which exhibit similar result as
in primary container closure system, that of innovator product.
compatibility of applied formulation Pharmaceutical equivalence
with the hard gelatin capsule & including Deliver Dose
method of administration Uniformity by DUSA &
Aerodynamic Particle Size
Distribution by Cascade
Impaction has been conducted
with the Innovator Product
(Symbicort Turbo haler); results
are similar as that of innovator
product. As far as the primary
container closure system is
concern, we would like bring it
in your kind information that
HPMC Capsule Shell which is
inert in nature; has been used in
our formulation. Hence there is
no impact of capsule shells on
the formulation.
6. (3.2.P.3.3). Clarification shall be submitted Multi-dimensional mixer is used

regarding how the required to blend formulation rather than
micronized particle size of the reducing or controlling the
formulation blend has been achieved particle. Since all the excipients
using Multi-dimensional and API used in the formulation
mixer is micronized particle size i.e.
DPI grade (COA’s enclosed for
your reference) therefore there is
no need of further reduction in
particle size at our end.
7. Evidence of availability of requisite Evidence of manufacturing &
manufacturing & analytical analytical equipment’s
equipment as decided by We have submitted the
Registration Board in its 290th Installation Qualification and
meeting at the time of manufacturing Operational Qualification
of trial batches, shall be submitted. Protocol and report as the
evidence of manufacturing &
analytical equipment’s.
• The firm will use DPI device Model no.: BDD07 of Manufacturer: M/s ShangHai HuaRui Aerosol
Co., Ltd. No.222, Yuanchun Road, Pudong New Area, Shanghai, China
14. Name, address of Applicant / Marketing "M/s PharmEvo Private Limited. Plot # A-29, North
Authorization Holder Western Industrial Zone, Port Qasim, Karachi"
Name, address of Manufacturing site. "M/s PharmEvo Private Limited. Plot # A-29, North
Western Industrial Zone, Port Qasim, Karachi"
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 12814 dated 25 May 2022
The proposed proprietary name / brand name Budetrol 200 mcg/6 mcg DPI capsule
Strength / concentration of drug of Active Each DPI capsule contains:
Pharmaceutical ingredient (API) per unit Budesonide .......... 200mcg
Formoterol Fumarate …... 6mcg
Each delivered dose (the dose that leaves the
mouthpiece) contains Budesonide 160mcg/inhalation
and Formoterol fumarate
dihydrate 4.5mcg/inhalation
Pharmaceutical form of applied drug Hard gelatin capsule
Pharmacotherapeutic Group of (API) Corticosteroid/Selective β2 Adrenoceptor (i.e. Short
acting and Long acting).
The status in reference regulatory authorities SYMBICORT TUBOHALER 200/6mcg
INHALATION
POWDER” by AstraZeneca UK Limited (MHRA
approved)
For generic drugs (me-too status) Formiget 200mcg + 6 mcg DPI capsule of M/s Getz
Pharma

GMP status of the Finished product New additional section of Oral Liquid Syrup approved
manufacturer on: 12-11-2021
Name and address of API manufacturer. Budesonide: M/s Vamsi Labs LTD, A-14/15, MIDC
area, Chincholi Solapur-413255
Maharashtra, INDIA
Formoterol fumarate dihydrate: M/s Vamsi Labs
LTD, A-14/15, MIDC area, Chincholi Solapur-413255
Maharashtra, INDIA
and controls, tests for impurity & related substances ,
Budesonide:
Batches: (BDS/R&D/001/12, BDS/R&D/002/12,
BDS/R&D/003/12)
Batches: (FF-006/07, FF-007/07, FF-008/07)
product.
dissolution profile against the innovator that is Symbicort Turbuhaler
200mcg/6mcg DPI Capsule by Astrazeneca UK
Limited by performing quality tests (Identification,
Assay, APSD, DDU of dosage form).
product linearity, range, accuracy, precision, specificity.

Manufacturer of API Budesonide: M/s Vamsi Labs Ltd., A-14/15, MIDC area, Chincholi, Solapur-
413255, Maharashtra, India
Formoterol fumarate dihydrate: M/s Vamsi Labs Ltd., A-14/15, MIDC area,
Chincholi, Solapur-413255, Maharashtra, India
API Lot No. Budesonide:
BDS-0260920
FF-0071119
Description of Pack
DPI capsule
Batch No. 21PD-3632-01 21PD-3633-02-T 21PD-3634-03-T
Manufacturing Date April-2021 April-2021 April-2021
No. of Batches 03
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. NEW-WHO-
API manufacturer issued by concerned GMP/CERT/PD/103627/2021/11/37422 issued by
regulatory authority of country of origin. Food & Drug Administration, Mumbai, Maharashtra
state, India valid till 04/10/2024.
3. Documents for the procurement of API with • Copy of letter No.10105/20,DRAP/K dated
approval from DRAP (in case of import). 07/1/2020 is submitted wherein the permission to
import different APIs including Budesonide
propionate & Formoterol Fumarate for the purpose
of test/analysis and stability studies is granted.
Budesonide:
• Commercial invoice attested by DRAP-AD dated
03-12-2020.
02-3-2020.
5. Compliance Record of HPLC software 21CFR Audit Trail submitted


Model no.: BDD07
Shanghai, China
Shelf life: 3 years

manufacturer


characteristics
5. (3.2.P.2.2.1). The reference products referred by Innovator has directly filled
you, is an inspiratory flow-driven, Active Pharmaceutical
multidose powder inhaler Ingredients and Excipients in a
containing metered doses, wherein blister foil, however we have
inhaler is made used capsule as a container of
of different plastic materials, while Dry Powder Inhaler products
the applied formulation is primarily therefore practically it is not
pre-dispensed in unit dose hard possible to fill such a minute
capsules. Justification shall be quantity of Lactose (as in case of
submitted for innovator) during encapsulation.
pharmaceutical equivalence of the Furthermore, Pharmaceutical
applied product against the Equivalence has also been done
reference product with respect to which exhibit similar result as
change that of innovator product.
in primary container closure Pharmaceutical equivalence
system, compatibility of applied including Deliver Dose
formulation with the hard gelatin Uniformity by DUSA &
capsule & Aerodynamic Particle Size
method of administration Distribution by Cascade
Impaction has been conducted
with the Innovator Product
(Symbicort Turbo haler); results
are similar as that of innovator
product. As far as the primary
container closure system is
concern, we would like bring it
in your kind information that
HPMC Capsule Shell which is
inert in nature; has been used in
our formulation. Hence there is
no impact of capsule shells on
the formulation.

formulation blend has been particle. Since all the excipients
achieved using Multi-dimensional and API used in the formulation
15. Name, address of Applicant / Marketing M/s PharmEvo Private Limited., Plot # A-29, North
Authorization Holder Western Industrial Zone, Port Qasim, Karachi
Name, address of Manufacturing site. M/s PharmEvo Private Limited., Plot # A-29, North
Western Industrial Zone, Port Qasim, Karachi
☐ Importer
Intended use of pharmaceutical product ☐Domestic sale
☐ Export sale
Dy. No. and date of submission Dy. No. 12813 dated 25/May/2022
The proposed proprietary name / brand name TIOBRE 18mcg DPI CAPSULE
Pharmaceutical ingredient (API) per unit

22.5mcg of Tiotropium Bromide Monohydrate
equivalent to Tiotropium……18mcg
(The delivered dose – the dose that leaves the mouth
piece is 10.4 mcg Tiotropium)
Pharmaceutical form of applied drug Pink Cap & Transparent body of HPMC Capsule
Pharmacotherapeutic Group of (API) Tiotropium is used to treat lung diseases such as
asthma and COPD (bronchitis, emphysema).
The status in reference regulatory authorities SPIRIVA by M/s BOEHRINGER INGELHEIM
USFDA Approved.
For generic drugs (me-too status) Aprexo 18mcg DPI Capsule by M/s High-Q, Reg. No.
058490
GMP status of the Finished product New section granted on 29/04/2022
manufacturer Dry Powder Inhaler Capsule (General) section
approved.
Name and address of API manufacturer. M/s Vamsi Labs. Ltd. A-14/15, MIDC Area,
Chincholi, Solapur-413255, Maharashtra. INDIA.
substances , specifications, analytical procedures and
Batches: (MDR-VI/001/11, MDR-VI/002/11, MDR-
VI/003/11)
product.
dissolution profile against the innovator that is Spiriva 18mcg Capsule
by BOEHRINGER INGELHEIM by performing

quality tests (Identification, Assay, APSD, DDU of
dosage form).
product linearity, range, accuracy, precision, specificity,
LOD, LOQ.
Manufacturer of API M/s Vamsi Labs. Ltd. A-14/15, MIDC Area, Chincholi, Solapur-413255,
Maharashtra. INDIA
API Lot No. TBM-0161019
Description of Pack
Alu-Alu blister packed in unit carton
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. NEW-WHO-
manufacturer issued by concerned regulatory GMP/CERT/PD/103627/2021/11/37422 issued by
authority of country of origin. Food & Drug Administration, Mumbai, Maharashtra
approval from DRAP (in case of import). 07/1/2020 is submitted wherein the permission to
import different APIs including Tiotropium
Bromide for the purpose of test/analysis and
stability studies is granted.
02-3-2020.
Submitted
chromatograms,
5. Compliance Record of HPLC software 21CFR
Submitted

Model no.: BDD07
Shanghai, China

Shelf life: 3 years

manufacturer


characteristics
5. (3.2.P.2.2.1). Justification shall be submitted for Our developed product Tiobre
pharmaceutical equivalence of the 18mcg DPI Capsule is same as
applied product against the reference that Reference product i.e.
product with respect to change in Spiriva Handihaler consists of
primary container closure system, pre-dispensed unit dose hard
compatibility of applied formulation capsules.
with the hard gelatin capsule &
method of administration
formulation blend has been achieved particle. Since all the excipients
using Multi-dimensional and API used in the formulation

☐ Importer
☐ Export sale
Details of fee submitted PKR 30,000/-: (450903543966) dated 10/06/2022
The proposed proprietary name / brand name Ezhale 100mcg+50mcg DPI Capsule
Pharmaceutical ingredient (API) per unit Fluticasone Propionate ......... 100mcg
Salmeterol Xinafoate ......... 50mcg
Capsule
Pharmacotherapeutic Group of (API) Steroids/Long-acting beta-agonists (LABAs).
The status in reference regulatory authorities Seretide Accuhaler 50 microgram/100 microgram
by M/s GSK UK Limited., MHRA Approved.
For generic drugs (me-too status) Salmicort 100mcg+50mcg DPI Capsule by M/s
Macter Int. Ltd., Reg. No. 095137
approved.
Name and address of API manufacturer. Fluticasone:
M/s Vamsi Labs. Ltd. A-14/15, MIDC Area,
Salmeterol:
M/s Vamsi Labs. Ltd. A-14/15, MIDC Area,
Module III (Drug Substance) Official monograph of Fluticasone Propionate &
Salmeterol Xinafoate is present in USP. The firm as
submitted detail of nomenclature, structure, general
months
months
Fluticasone Propionate:
Batches: (FTP-0020218(M), FTP-0030218(M),
FTP-0040318(M))
Salmeterol Xinafoate:
Batches: (SX-0020515, SX-0030515, SX-0040515)
drug product.
dissolution profile against the innovator that is Seretide
Accuhaler/Diskus 100/50mcg DPI by GSK group of
companies by performing quality tests
(Identification, Assay, APSD, DDU of dosage
form).
specificity.
Maharashtra. INDIA
API Lot No. Fluticasone Propionate: FTP-0150819
Salmeterol Xinafoate: SX-0091119
Description of Pack

Batch Size 4000 capsules 4000 capsules 4000 capsules

No. of Batches 03
approval from DRAP (in case of import). 07/1/2020 is submitted wherein the permission
to import different APIs including Fluticasone
& Salmeterol for the purpose of test/analysis
and stability studies is granted.
• Commercial invoice attested by DRAP-AD
dated 02-3-2020.
dated 02-3-2020.
chromatograms,
etc.
The applied formulation is approved in USFDA is supplied as a disposable purple plastic inhaler containing a
foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil
Firm provides the details of DPI device purchased by shangai Huarui aerosol co. Ltd Shangai china.

Model no.: BDD07
Shanghai, China
Shelf life: 3 years
S# Query Reponses
1. Clarification regarding intended manufacturing We have established a segregated
area, since applied formulation contains facility for the manufacturing of Dry
Fluticasone, which is a steroid Powder Inhalers (DPI) Capsules.
Layout of the said facility has been
approved and section approval has
also been granted by DRAP on 29th

April, 2022 (copy enclosed for your
ready reference).
We would like to bring it in your
kind information that below are the
measures will be taken in order to
control cross-contamination during
the manufacturing of subject
products:
1. Dedicated change parts are
available for the encapsulation of
that will ensure and minimize the
risk cross contamination during
filling process.
2. Dedicated change parts
along with auto feeder is installed
and available for the blistering of
that will further ensure the control of
cross contamination during
blistering and primary packaging
process.
3. Separate gowning
procedure will be followed.
4. New HEPA filter will be
employed.
5. Specialized dedicated
dispensing booth.
6. PRE/POST cleaning
validation studies on approved
protocol for steroidal formulations
has been done so as to make sure the
prevention of cross contamination.
We also would like to bring to your
kind attention that DRAP has
already approved the manufacturing
of all DPI’s (Steroidal) in General
DPI section in its 294th & 297th
meeting minutes (copy of relevant
pages are enclosed for your ready
reference).
2. Evidence of availability of requisite We have submitted the Installation
manufacturing & analytical equipment’s as Qualification and Operational
decided by Registration also Evidence of Qualification Protocol and Report as
equipment’s for performing the test of the evidence of manufacturing &
“Uniformity of Delivered Dose” and analytical equipment’s as per
“Aerodynamic Particle Size Distribution” as per Pharmacopoeia.
Pharmacopoeia
3. In reference products referred by you, Pharmaceutical equivalence
formulation is pre-dispensed in a foil blistered including Deliver Dose Uniformity
strips, whereas applied formulation is primarily by DUSA & Aerodynamic Particle
pre-dispensed in hard capsules. Justification Size Distribution by Cascade
shall be submitted for change in primary Impaction has been conducted with
container closure system with respect to the Innovator Product (Seretide
compatibility of applied formulation with the Diskus); results are similar as that of
hard gelatine capsules. innovator product.
2. As far as the primary
container closure system is concern,
we would like bring it in your kind
information that HPMC Capsule
Shell which is inert in nature; has
been used in our formulation. Hence
there is no impact of capsule shells
on the formulation.
We also would like to bring your
already approved Salmeterol +
Fluticasone propionate in HPMC
capsules in its 275th DRB meeting
for M/s Macter International Ltd.,
Karachi with the brand name of
Salmicort DPI Capsule and in 291st
DRB meeting for M/s Getz (Pvt.)
Ltd., Karachi with the brand name of
Saltra DPI Capsule (extract
attached).
4. Details of reference product batch # import Pharmaceutical equivalence report
details Mfg. date etc against which enclosed which comprises the detail
pharmaceutical equivalence was established of reference product i.e. Seretide
Diskus, including batch number,
manufacturing date, expiry date etc.
5. Under standardized in vitro test conditions, Label claim for deliver dose have
ADVAIR DISKUS delivers 465mcg of been submitted with initial
fluticasone propionate and 45mcg of salmeterol registration dossier however we are
base per blister from ADVAIR DISKUS when again submit the copy of relevant
tested at a flow rate of 60L/min. for 2 seconds section for your reference.
while you have not submitted any label claim for
delivered dose
6. Clarification shall be submitted regarding how Multi-dimensional mixer is used to
the required micronized particle size of the blend formulation rather than
formulation blend has been achieved using reducing or controlling the particle.
Multi-dimensional mixer Since all the excipients and API used
in the formulation is micronized
particle size i.e. DPI grade (COA’s
attached) therefore there is no need
of further reduction in particle size at
our end.
7. Provide summarized tabulated results of Summarized tabulated results of

verification studies including specificity, verification studies including
accuracy and repeatability (method precision) specificity, accuracy and
performed by the Drug Product manufacturer repeatability (method precision) is
(2.3.S.4.3) already submitted with initial
registration dossier, however we are
again submit the copy of relevant
section for your reference.
8. Provide results of analysis of relevant batch(es) Results of analysis of relevant

of Drug Substance performed by Drug Product batch(es) of Drug Substance
manufacturer used during product development performed by Drug Product
and stability studies, along with Certificate of Manufacturer along with COA’s has
Analysis (CoA) of the same batch from Drug been submitted with initial
Substance /Active Pharmaceutical Ingredient registration dossier, however we are
manufacture (3.2.S.4.4) again submit the COA’s for your
reference.
9. Submitted specifications does not include details Submitted specifications include test
of test for “Particle size distribution since for "Particle size distribution” (copy
reference product literature states that “The of relevant section is enclosed for
particle size distribution is crucial to achieving your ready reference).
the required delivered dose and lung deposition
characteristics (3.2.S.4)
again submit the copy of relevant in
Annexure-7 for your further
proceeding.

☐ Importer
☐ Export sale
Capsule

For generic drugs (me-too status) Salmicort 250mcg+50mcg DPI Capsule by M/s
Macter Int. Ltd., Reg. No. 095138
approved.

months
months
FTP-0040318(M))
Batches: (SX-0020515, SX-0030515, SX-0040515)
drug product.
form).
specificity.
Maharashtra. INDIA

Description of Pack

No. of Batches 03
dated 02-3-2020.
dated 02-3-2020.
chromatograms,
etc.
Model no.: BDD07
Shanghai, China
Shelf life: 3 years

S# Query Reponses
ready reference).
products:
filling process.
process.
3. Separate gowning
employed.
dispensing booth.
reference).
Pharmacopoeia
on the formulation.
attached).
delivered dose
our end.


manufacture (3.2.S.4.4)
again submit the COA’s for your
reference.

☐ Importer
☐ Export sale
Capsule
For generic drugs (me-too status) Oxytide-F 500+50mcg Capsule by M/s Werrick
Pharmaceutical, Reg. No. 095348
approved.

months
months
FTP-0040318(M))
Batches: (SX-0020515, SX-0030515, SX-0040515)
drug product.
form).
specificity.
Maharashtra. INDIA

Description of Pack

No. of Batches 03
dated 02-3-2020.
dated 02-3-2020.
chromatograms,
etc.
S# Query Reponses

ready reference).
products:
filling process.
process.
3. Separate gowning
employed.
dispensing booth.
reference).
Pharmacopoeia
on the formulation.
attached).
delivered dose
our end.


manufacture (3.2.S.4.4) again submit the COA’s for your
reference.
Case No. 02 Registration applications of drugs for which stability study data is submitted Registration
a) Form 5F Import (Human)
19. Name, address of Applicant / Importer M/s Al-Habib Pharmaceuticals, Plot #81, block
B, SMCHS, Karachi.
Details of Drug Sale License of importer DSL No.: 0230
Address: Al-Habib Pharmaceuticals, 81-B, block B,
SMCHS, Karachi.
Godown:
1. Plot No. 393/7 & 393/8 Sector 7-A KIA Karachi
Validity: 18/05/2024
Status: Drug License by way of wholesale
Name and address of marketing M/s Laboratories IMA S.A.I.C, Palpa 2862, Ciudad
authorization holder (abroad) Autonoma de Buenos Aires, Argentina.
Name, address of manufacturer(s) M/s Laboratorios IMA S.A.I.C, Palpa 2862, Ciudad
Autonoma de Buenos Aires, Argentina.
Name of exporting country Argentina
Detail of certificates attached (CoPP, CoPP:

Freesale certificate, GMP certificate) Original legalized CoPP (certificate No. 191106)
valid till 30-10-2021 issued by National Institute of
Drugs, Argentina. The applied product is available
for free sale in exporting country. The facilities and
operations conform to WHO-GMP.
Details of letter of authorization / sole Notarized copy of sole agency agreement is

agency agreement submitted whereby M/s Laboratorios IMA S.A.I.C,
authorizes M/s Al-Habib Pharmaceuticals to Import
and commercialize different products including
Gemcitabine injection.
Status of the applicant ☐ Manufacturer

☒ Importer
☐ Export sale
For imported products, specify one the these ☒ Finished Pharmaceutical product import
☐ Buk import and local repackaging

☐ Buk import and local repackaging for export
purpose only
Dy. No. and date of submission Dy. No.22751: 20-08-2021
Details of fee submitted PKR 100,000 Dated: 29-03-2021
Differential fee : PKR 50,000 Dated : 05-07-2021
The proposed proprietary name / brand GEMSTAR 200 mg
name
Strength / concentration of drug of Active Each Vial contains:
Pharmaceutical ingredient (API) per unit Gemcitabine HCl ……………. 200 mg
Pharmaceutical form of applied drug Lyophilized Powder for injection

Pharmacotherapeutic Group of (API) Anti-Cancer (Nucleoside) (L01BC05)
Reference to Finished product USP
specifications
Proposed Pack size 1 Vial
The status in reference regulatory Gemzar® 200 mg injection (USFDA Approved) by
authorities Eli Lilly
For generic drugs (me-too status) Gemzar® 200 mg injection by Eli Lilly Pakistan
(PvtP Ltd
template. Firm has summarized information related
its validation, batch analysis and justification of
Name, address of drug substance Hetero Labs Limited Survey.No.10, I.D.A.,
manufacturer Gaddapotharam Village, Jinnaram Mandal,
Medak District, Andhra Pradesh,
INDIA
Module-III Drug Substance: Firm has submitted detailed drug substance data for
both sources related to nomenclature, structure,
analytical procedures and its validation, batch
studies of drug substance.
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches
(Conditions & duration of Stability studies) of API at accelerated as well as real time conditions.
The real time stability data is conducted at 25°C ±
2°C. The stability study data is till 36 months.
Module-III Drug Product: Firm has submitted data of drug product including
its description, composition, pharmaceutical
development, manufacture, manufacturing process
and process control, process validation protocols,
control of excipients, control of drug product,
specifications, analytical procedures, validation of
analytical procedures, batch analysis, justification

of specifications, reference standard or materials,
container closure system and stability.
Pharmaceutical Equivalence and Pharmaceutical equivalence has been established
Comparative Dissolution Profile against the reference product Gemzar® 200mg
injection by Eli Lilly
Analytical method validation/verification of Firm has submitted analytical method validation

product studies for the applied product.
Container closure system of the drug Type I, amber glass vial 50 ml
product Bromobutyl elastomeric stopper.
Aluminum capsule with flip off closure.
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches
life and storage conditions 24 months real time stability data at 30°C ± 2°C /
75% ± 5%RH of 03 batches
06 month accelerated stability data 40°C ± 2°C /
75% ± 5%RH of 03 batches
Evaluation by PEC:
S Section #. Deficiencies Response

No
1. 1.33 Importer shall provide valid Certificate Original legalized CoPP (certificate
of Pharmaceutical Product (CoPP) / Free No. 191106) valid till 30-10-2021
Sale certificate issued by relevant issued by National Institute of
regulatory authority in the country of Drugs, Argentina. The applied
origin and name of exporting country. product is available for free sale in
exporting country. The facilities
and operations conform to WHO-
GMP. Firm submitted that “This get
expired during its period in R& I
that’s why as per rule it will be
considered as valid”
2. 1.33 The GMp of shanghai acebright pharma Hetero Labs Limited
co ltd. China is provided as API Survey.No.10, I.D.A.,
manufacture but at some place Hetero Gaddapotharam Village, Jinnaram
Labs Limited Survey.No.10, I.D.A., Mandal, Medak District, Andhra
Gaddapotharam Village, Jinnaram Pradesh, INDIA is API
Mandal, Medak District, Andhra manufacturer, its GMP is provided
Pradesh, INDIA is mentioned as API
manufacturer clarification is needed in
this regard.
3. 1.33 The GMP certificate of Laboratories The GMP certificate of
IMA SAIC Argentina issued by Laboratories IMA SAIC Argentina
National administration of drug, food issued by National administration
and medical devices (ANMAT)is valid of drug, food and medical devices
till 2 April 2021. Provides Valid GMP (ANMAT) valid till 3 April 2022 is
provided
4. 2.3.S On API stability both IMA lab and No justification is given
Hetro lab is mentioned justify
Decision: Deferred for following:
• Clarification regarding the site wherein stability studies of drug substance have been performed,
since in submitted stability sheets both IMA lab and Hetro lab is mentioned.
Case no. 02 Registration applications of drugs for which stability study data is submitted Registration
a) Form 5F Deferred (Human)

20. Name, address of Applicant / Marketing M/s Nawan Laboratories Ltd. 136, sector 15, KIA,
Authorization Holder Korangi Karachi from M/s Bio-Labs (Pvt) Ltd
Name, address of Manufacturing site. M/s Bio-Labs (Pvt) Ltd. Plot No 145 Industrial
Triangle, Kahuta road, Islamabad.
☐ Importer
☒ Is involved in none of the above (contract giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 8005 dated 11-03-2021
Details of fee submitted PKR 50,000/- (#2009144) dated 17-02-2021
Nevitix Injection 500mcg
name
Strength / concentration of drug of Active Each ml contains:
Pharmaceutical ingredient (API) per unit Mecobalamin ……. 500mcg
Pharmaceutical form of applied drug Almost red colour solution filled in amber glass
ampoule.
Pharmacotherapeutic Group of (API) Antianemia
Reference to Finished product
Innovator’s
specifications
Proposed Pack size 1ml x 10’s
The status in reference regulatory
Methycobal Injection PMDA approved
authorities
For generic drugs (me-too status) Amcobal Injection 500mcg/ml by Amson Vaccine
& Pharma 069899
GMP status of the Finished product GMP certificate issued based upon inspection
manufacturer conduct 23-4-2019, valid upto 22-4-2022.
Name and address of API manufacturer. M/s. Vital Laboratories (Pvt) Ltd.
Plant II, Plot No. 1710, GIDC Estate, Phase III,
Vapi – 396 195 Gujrat India

template.
Firm has summarized information related to
Characterization, specifications, analytical
procedures and its validation, batch analysis and
drug substance. The firm has summarized
information of drug product including its
description, composition, pharmaceutical
specifications, analytical procedures,
validation/verification of analytical procedures,
batch analysis, justification of specifications,
reference standard or materials, container closure
system and stability.
Module III (Drug Substance) Firm has submitted detailed data for both drug
substance data related to nomenclature, structure,
manufacturers, description of
validation, batch analysis and justification of
(assay by HPLC with PDA detector, limit 98to
101%), residual solvent by GC
Stability studies Firm has submitted stability study data of 3 batches
of drug substance at both accelerated as well as real
time conditions. The accelerated stability data is
conducted at 40 O ± 2 O C /75% ± 5% RH for 6
months. The real time stability data is conducted at
30OC ± 2 O C / 65% ± 5% RH for 48 months (batch
no. 7805016001, 7805016002 & 7805016003).
impurities, specifications, analytical procedure and
its validation studies, batch analysis and
drug product.
Pharmaceutical equivalence and Firm has performed pharmaceutical equivalence
comparative dissolution profile against the product Methycobal 500 mg injection by
Hilton Pharma
Analytical method validation/verification of Method validation studies have submitted including
Manufacturer of API Vital Laboratories (Pvt) Ltd.
Plant II, Plot No. 1710, GIDC Estate, Phase III, Vapi – 396 195 Gujrat
India
API Lot No. MCB2010061
Description of Pack Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. A-431 A-443 A-456
Batch Size 37,000 Ampoules 10,000 Ampoules 10,800 ampoules
No. of Batches 03
1. Reference of previous approval of NA
applications with stability study data of the
firm (if any)
2. Approval of API/ DML/GMP certificate of GMP certificate # 20031928 of M/s. Vital
API manufacturer issued by concerned Laboratories (Pvt) Ltd. Plant II, Plot No. 1710,
regulatory authority of country of origin.GIDC Estate, Phase III, Vapi – 396 195 Gujrat
India
valid upto 16-03-2023
3. Documents for the procurement of API with Firm has submitted attested copy of invoice
approval from DRAP (in case of import). (invoice # HHM/2021/00256) attested by AD
DRAP
4.Data of stability batches will be supported Firm has submitted record of testing of all batches
by attested respective documents like along with chromatograms, raw data sheets, COA
chromatograms, Raw data sheets, COA, and summary data sheets.
5. Compliance Record of HPLC software N/A
testing
6. Record of Digital data logger for Firm has submitted record of data logger for
temperature and humidity monitoring of temperature and humidity monitoring of real time
stability chambers (real time and and accelerated stability chambers.
accelerated)
Remarks of Evaluator VII:
Sr. No. Section #. Deficiencies Reply
1. 3.2.P.2 How much overage is added in 30% overage is added

the formulation? Justify the
percentage of overage added in
the formulation
2. 3.2.P.8 Justify the selection of limit of For the case of Vitamin
assay test as “90 – 150 %” while preparations normally and
the official limit of vitamin most of the cases followed
preparations is 120%. Compendial limits are 90-
130%. In our nivitex inj
500mcg we have added 30% of
overage in the batch formula.
Unit contains 30% of overage
of API,
So considering the addition of
30% of overage, assay limits
are set as 90-150%.

We have now revised the specs
and make it more stringent
after complete stability data
and market feedback, so the
revised limits are now set as
90-130%.
3. 3.2.P.8 Justify how UV method was M/s Bio-labs have the
adopted for the testing of drug registration of our product
product, since the testing method Mine injection as per
of drug substance manufacturer manufacture specification and
for assay of mecobalamin was UV-VIS Spectrophotometer
based on HPLC method is DRAP approved
method. Since stability data is
proved at old batches of 2018
so the applied method is UV-
VIS Spectrophotometer which
has been updated now.
Validation of the applied
testing method has been
provided in terms of all the
parameters as per validation
guidelines.
4. 3.2.P.8 Justify the effective date on Effective data on stability data
stability data sheet is 01-01-2020 sheet is 01-01-2020 because
but the stability starts at 29-08- old data has been provided on
2018 the new formats. Formats for
interpretations of stability
results are new and revised
with old stability data for
presentation.
5. 3.2.P.8 Justify the results of assay as all Results of assay showed

the batches just showed minor normal decrease in assay
decrease in assay results less than results, which is well within
which is usually observed in the trend as of vitamins
vitamin preparations. Scientific preparation. In the stability
justification / clarification is data provided, assay results
required in this regard. decrease gradually e.g. in batch
number A-431 assay results
decreases from 122…62% to
109-93% (stability sheet for
real time analysis provided), in
batch number A-433 assay
results decreased from
121.21% to 107-23% and in
batch number A-456 results
decreased from 121.2% to 106-
83%.

Decision of 316: Deferred for the following
Justify how UV method was adopted for the testing of drug product, since the testing method of drug
substance manufacturer for assay of mecobalamin was based on HPLC
Justification for the results of assay
Justification of the percentage of overage added in the formulation
Remarks of evaluator PEC VII
S. No. Deficiency in 316th Meeting Documents Attached
1. Deferred for: Bio-Labs has registration of
• Justification of applying UV mecobalamine injection as per
Spectrophotometric method for the manufacturer specifications. Since
assay test of drug product, since the stability data has been provided of
testing method of drug substance old batches so applied testing
manufacturer for assay of method along with method
mecobalamin was based on HPLC. validation was submitted.
However, the testing method of the
mecobalamine injection has been
updated to HPLC. The method
validation of the new method is
attached herewith. Both the
methods (UV-spectrophotometric
and HPLC) are validated in all
aspects of ICH guidelines.
• Justification for declining trend of As the mecobalamin is light
assay results. sensitive product and gradually
degrades with the time, due to this
reason there is declining trend in
the analysis of assay. In order to
achieve patient compliance and
provision of complete dose,
overage has been added so that the
contents of API remain within
claim limit during product shelf
life.
• Justification of the percentage of As the mecobalamine is light
overage added in the formulation. sensitive product and gradually
degrades with the time, due to this
reason there is declining trend in
the analysis of assay. In order to
achieve patient compliance and
provision of complete dose,
overage has been added so that the
contents of API remain within
claim limit during product shelf
life.
Decision: Registration Board noted the fact that the %age overage used in the applied formulation was
above the general permissible limits of overage hence the Board deferred the case for submission of new
6 month stability studies data of drug product at accelerated and long term conditions of Zone IVA, with
revised formulation excluding overage, drug product specifications and drug product analytical
procedure based upon HPLC Assay method.
21. Name, address of Applicant / Marketing M/s Novamed Pharmaceuticals (Pvt.) Ltd
Authorization Holder Lahore
Name, address of Manufacturing site. M/s Novamed Pharmaceuticals (Pvt.) Ltd.,

28km Ferozepur Road Lahore

☐ Importer
giver)
Status of application ☒New Drug Product (NDP)
☐Generic Drug Product (GDP)

☐ Export sale
Details of fee submitted PKR 50,000/-: dated 18/5/2020 (#2004310)
The proposed proprietary name / brand name Invid -3 Injection 300,000IU
Strength / concentration of drug of Active Each ml contains:
Pharmaceutical ingredient (API) per unit Cholecalciferol…………..…300,000IU
Pharmaceutical form of applied drug Clear colorless oily liquid free from foreign
particles
Pharmacotherapeutic Group of (API) Fat soluble vitamin, Vitamin-D Analogue
(IM injection)
Reference to Finished product specifications Manufacturer Specs
Proposed Pack size 1’s (1ml), 5’s (1ml), 100’s
The status in reference regulatory authorities XARENEL 300,000 IU / ml solution for injection
Italy Approved
For generic drugs (me-too status) N/A
GMP status of the Finished product manufacturer License granted on 08/04/2006 and renewed on
08/04/2021 General liquid section approved and
GMP certificate on 06/08/2021
Name and address of API manufacturer. Sichuan Province Yuxin Pharmaceutical Co.,
Ltd. Weicheng Jinhe East Road, Shifang City,
Sichuan
submitted.
manufacturing process and controls, tests for
impurity D, G & related substances (impurity A
& unspecified), specifications, analytical

Real time: 5°C ± 3°C / 65% ± 5% RH for 48
months
months
Batches: (B-3-01-130601 , B-3-01-130602 ,
B-3-01-130603)
dissolution profile established against the innovator that is Dibase
by Abiogen Pharmaceuticals by performing
quality tests (Identification, Assay, Dissolution,).
CDP has not been applicable
specificity.
Remarks:
The excipient use is XARENEL 300,000 IU / ml solution for injection: refined olive oil for injectable
use.
The overage added is 25%
The membrane filtration is done
Particulate matter is counted by particulate counter
Manufacturer of API Sichuan Province Yuxin Pharmaceutical Co., Ltd.
Weicheng Jinhe East Road, Shifang City, Sichuan
API Lot No. B-1-51-M190105
Description of Pack USP Type-1 Glass ampoule blistered in Alu - PVC and further
(Container closure system) packed in unit carton (1’s ,5’s (1ml)
Batch No. TP-140-T2 TP-140-T3 TP-140-T4
Batch Size 5000 Ampoule 5000 Ampoule 5000 Ampoule
No. of Batches 03
1. Reference of previous approval of applications with The firm has submitted copy of Last inspection
stability study data of the firm (if any) Report conducted on 24/01/2018.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. SC20160032

3. Documents for the procurement of API with • Copy of AD Attested invoice No F 1919090
approval from DRAP (in case of import). vide No.5354/2019/DRAP-AD-CD(I&E)
dated 16/04/2019 is submitted wherein the
permission to import Vitamin D3 API is
granted.

respective documents like chromatograms,

humidity monitoring of stability chambers (real time
and accelerated)
Remarks OF Evaluator VII:
S. Sections Observations/ Short- Remarks

No comings
1. 1.3.4 Valid Drug Manufacturing Copy of valid DML is submitted
License (DML) of
manufacturer/Applicant shall
be submitted as submitted
DML was not valid.
2. 2.3.R.1.1 Provide copy of Batch Copies of Executed/Trial batches &
manufacturing record Commercial batch BMR were
(BMR) for all the attracted in 3.2.R.
batches of the drug However, Copies of BMR of all the
product for which batches of the drug product for which
stability study data is stability study data are provided in
provide in module 3 2.3.R.1.1.
section 3.2.P.8.3.
3. 3.2.P.8 Stability: on commercial As per COA,40MIU is the potency of
Invoice the quantity vitamin D3 i.e 40,000,000 IU/gm , as
mentioned was Vit D3 40MIU per label claim of the applied strength
but the prepare strength is the quantity of vitamin d3 with this
300,000IU potency is calculated which is
equivalent to vitamin d3 300,000IU
(7.5 mg).
COA and calculation is attached.
4. 3.2.P.1 The composition contains Compatibility of crodamol oil and
BHA and Crodamol oil but BHA were performed against Vitamin
in the reference product d3 Active, no interference was
Xarenel 300,000IU/ml observed during the compatibility
solution for injection. The Analysis
excipient use is refined olive
oil for injectable use.
5. 3.2.P.1 Description and composition Overage was reflecting in the amount
of the drug product Details of API /unit, however composition
of Overage not provide in the with overage details is attached.
formulation
6. 3.2.S.7.3 Justification of the stability Revised Stability Data of new
of the drug substance at batches is provided
25˚C±2˚C/
60%RH±5%RH.
In case where the real time
stability data of the drug
substance is conducted at
25˚C±2˚C/60%RH±5%RH,
The firm shall submit the
record of data logger for the
storage condition throughout
the transportation.
7. 3.2.S.4.1 Specification assay limit is According to USP 42 NF 37
mentioned as 97-103% but in Acceptance criteria limit for
USP the limit is from 90- Cholecalciferol material is 97-
120%. 103%.Copy of USP monograph is
provided for reference.
8. 3.2.P.1 In composition no Overage is Overage was reflecting in the amount
mentioned in this section. of API /unit, however composition
with overage details is provided.
9. 2.3.P.3.2 In 2.3.P.3.2 batch formula it Vitamins generally have tendency to
is mentioned that after 6 degrade. As vitamin D3 is photolytic,
month of accelerated and real thermally unstable and have oxidative
time stability studies product nature but at the same time it is a fat-
is stable so overage will be soluble vitamin and more stable with
omitted during commercial Crodamol Oil, because of this
validation batches but in the property product show no significant
assay, there is a steady change in assay as defined in
decrease in assay limit. guideline.
Justification is needed about
this statement.
10. 3.2.A and 3.2R Appendices and regional Appendices and regional information
information is missing. as per approved checklist of 296th
DRB is attached.
11. 3.2.P.8 Justify the result of Assay as Vitamins generally have tendency to
all the batches just showed degrade. As vitamin D3 is photolytic,
minor decrease in assay thermally unstable and have oxidative
results less than which is nature but at the same time it is a fat-
usually observed in vitamin soluble vitamin and more stable with
preparations. Scientific Crodamol Oil, because of this
Justification/clarification is property product show no significant
required in this regard. change in assay as defined in
guideline.
12. 3.2.P.2.1.1 As As per relevant guidelines Owing to the prevailed condition of
& structure of Form 5F, covid throughout the world We had
Comparative assay performed PE after formulation
Pharmaceutical equivalence development due to unavailability of
has to be performed at the the Innovator pack. So, as per the need
time formulation of hour or to overcome this challenge
development, while according we deviated from the chronological
to your submitted data, it has flow. However, we confirm that this
been performed after deviation will not be repeated.
commencing stability studies.
Justification shall be
submitted.
Decision of 316:
Deferred for the following
The applied product’s monograph is present in BP but the specification and methods applied are not
according to BP monograph.
Remarks of evaluator VII
In BP monograph method given for assay analysis is by UV spectroscopy while invid-3 was tested by more
stringent HPLC method. As a matter of fact, HPLC method exhibited the advantage of high precision and high
recovery and high sensitivity
Decision of 321st meeting: Deferred for comparative analysis of drug product specification proposed by
the applicant and those recommended by BP monograph of Vitamin D3 injection.
22. Name, address of Applicant / Marketing M/s Valor Pharmaceuticals, 124/A Industrial
Authorization Holder Triangle, Kahuta Road Islamabad.
Name, address of Manufacturing site. M/s Valor Pharmaceuticals, 124/A Industrial
Triangle, Kahuta Road Islamabad
☐ Importer

☐ Export sale
Dy. No. and date of submission Dy. No. 23210 dated 30-aug-2021
Details of fee submitted PKR 20,000/- + 10,000
dated 11/12/2020
The proposed proprietary name / brand name Valofam 250mg Tablet
Pharmaceutical ingredient (API) per unit Famciclovir ………250mg
Pharmaceutical form of applied drug White, Round shaped, bisect oral tablet
Pharmacotherapeutic Group of (API) Antivirals for systemic use. Nucleosides and
nucleotides excluding reverse transcriptase
inhibitors
Reference to Finished product specifications Innovator Specifications
Proposed Pack size 1×10’s, 21’s,30’s
The status in reference regulatory authorities Famvir by M/s Novartis, USFDA Approved.
For generic drugs (me-too status) Famvir (Reg.018994) of M/s. Novartis, Pakistan.
GMP status of the Finished product manufacturer GMP granted on 10/09/2020
Tablet section approved.
Name and address of API manufacturer. M/s Shanghai Pharma Group Changzhou Kony
Pharmaceutical Co., Ltd. Daixi Street, Luoyang
Town, Wujin District, Changzhou, Jiangsu, China
impurities, specifications, analytical procedures
substance and drug product is submitted.
Module III (Drug Substance) Official monograph of Famciclovir is not present.
The firm as submitted detail of nomenclature,
process and controls, tests for impurity D, G &
related substances (impurity A & unspecified),
Stability studies of drug substance Stability study conditions:
months
Batches: (FCV20150304), (FCV20150304),
(FCV20150304)
studies of drug product.
dissolution profile against the brand leader that is Viracure 250mg
tablet by ATCO Laboratory by performing quality
tests (Identification, Assay, Dissolution,
that is Viracure 250mg Tablets by ATCO
Laboratory in Acid media (pH 1.0-1.2) &
Phosphate Buffer (pH 6.8). The values for f1 and f2
are in the acceptable range.
specificity.
Remarks:

Manufacturer of API M/s Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd. Daixi
Street, Luoyang Town, Wujin District, Changzhou, Jiangsu, China
API Lot No. 20200618
Description of Pack
Batch No. T-007 T-007 T-007
Date of Initiation 15.11.2020 15.11.2020 15.11.2020
No. of Batches 03

2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. JS20180935 issued
manufacturer issued by concerned regulatory by CFDA valid till 26/11/2023.
3. Documents for the procurement of API with • Copy of documents dated 16/07/2020 is
approval from DRAP (in case of import). submitted wherein the permission to import
different APIs including Paroxetine HCl for the
granted.
• AWB No.157-HKG-2717-3381 dated
16/07/2020

Remarks of Evaluator VII:
S No Section #. Deficiencies Replies

1. 1.6.5 Valid Drug Manufacturing Drug Manufacturing License # 000496
License issued by the relevant Valid till 3-2022 issued by the DRAP
regulatory authority of country of to valor pharma is provided
origin is needed
2. 3.2.P In Pharmaceutical equivalence As Famvir of Novartis was not
submit date of analysis, the available immediately at time of
comparison of the developed comparative equivalence studies so
formulation was made by using therefore Viracure of Atco was used. In
local product viracure of Atco both the samples and reference
when innovators product by products showed more than 85%
Novartis is available in Pakistan. dissolution are with in first 15 minutes
so results are satisfactory
3. 3.2.P.4.5 Regarding query that Excipients The firm provided the certificate
of Human or Animal Origin shall showing that the magnesium stearate is
be addressed for the use of of plant origin.
“Magnesium stearate” in the
applied formulation
For excipients of human or
animal origin, a certificate shall
be provided, confirming that the
excipient(s) are free from BSE
and TSE. the firm provided the
certificate from “Peter geven”
that this magnesium stearate is
from plant source
4. Composition is different from In innovators formulation sodium
reference product of USFDA lauryl sulphate is not included
5. 2.3.P.4 Control of excipients is missing Provided
6. 3.2.P.3.4 Tests and acceptance criteria Provided
should be provided (with
justification, including
experimental data) performed at
the critical steps identified in
3.2.P.3.3 of the manufacturing

process, to ensure that the process
is controlled
7. 3.2.P.5.4 In the specifications of coated It was a typographical error which is
tablets for batch T-008 is corrected to innovators specification
mentioned as USP but the tablet
is not available in monograph
8. 3.2.P.6 COA of primary / secondary Provided
reference standard including
source and lot number shall be
provided
9. 3.2.P.8 Compliance Record of HPLC Compliance Record of HPLC software
software 21CFR & audit trail 21CFR & audit trail reports on product
reports on product testing testing is provided
10. 3.2.P.8 Record of Digital data logger for Record of Digital data logger for
temperature and humidity temperature and humidity monitoring
monitoring of stability chambers of stability chambers is provided
Decision of 316:
Deferred for the following
Submission of Comparative dissolution profile (CDP)
For the Clarification of difference in composition from the reference product and submission of compatibility
study of excipients since the reference product doesn’t contains sodium lauryl sulphate.
Remarks of evaluator:
Justification of Sodium Lauryl Sulphate (SlS) In Valofam 250mg Tablets Formulation
During product development we encountered a problem in the dissolution rate of VALOFAM 250MG
TABLETS (Famciclovir), as Famciclovir base is used in the formulation, which has low solubility profile,
therefore sodium lauryl sulphate 0.85% has been used in the master formulation to enhance the dissolution
profile.
2. The allowable limit for SLS in tablet formulation is 0.5% - 2.5% w/w.
3. So therefore SLS was used according standard formulation protocols.
4. The documentary evidence of Hand book of Pharmaceutical excipients regarding SLS has been attached.
5. Excipients compatibility studies of VALOFAM (Famciclovir) 250mg Tablets, has been performed and
submitted.
Submission of Comparative dissolution profile (CDP)
Submitted
Decision of 321st meeting: Approved.

Agenda of Evaluator PEC-IX
Case no. 01 Registration applications for local manufacturing of (Human) drugs

a. New cases
23. Name and address of manufacturer / M/s Ameer Pharma 23 KM-Sheikhupura Road, Lahore
Applicant
Brand Name +Dosage Form + Strength Amenor 400mg Tablet
Composition Each Film Coated Tablet Contains:
Norfloxacin ……………………………400mg
Diary No. Date of R& I & fee Dy. No. 12821 dated 06.03.2019
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Fluoroquinolones antibacterial
Type of Form Form 5
Finished Product Specification The firm has claimed USP specifications.
Pack size & Demanded Price 2x7’s; As per SRO
Approval status of product in Reference Norfloxacin-ratiopharm® 400 mg tablets. MHRA
Regulatory Authorities. approved
Me-too status Urac 400mg film-coated Tablets. Reg. No. 64219
GMP status The firm was inspected on 09.12.2019 and 26.01.2020,
wherein renewal of DML was recommended,
Remarks of the Evaluator. • The firm’s title is Ameer Pharma (Pvt.) Limited in
fee challan and DML renewal inspection report.
Decision: Registration Board discussed the matter of the incomplete title of the firm declared
in Form 5 and while acknowledging the fact that coveing letter of firm’s application declared
full title of firm i.e., M/s Ameer Pharma (Pvt.), 23 KM-Sheikhupura Road, Lahore and also
each page of Form 5 has been stamped with the title as “M/s Ameer Pharma Pvt. Ltd.” decided
to approve the product.
Applicant
Brand Name +Dosage Form + Strength Ameset 4mg Tablet
Ondansetron as hydrochloride dihydrate …..… 4mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antiemetics and antinauseants
Type of Form Form 5
Pack size & Demanded Price 10’s; As per SRO
Approval status of product in Reference Ondansetron 4 mg Film-coated Tablets. MHRA
Me-too status Ondan Tablet film-coated 4mg.
Remarks of the Evaluator. • The firm initially submitted all the documents meant
for 8mg strength. Then, revised these for 4mg.
• The firm had already adjusted the weight of API in
the master formulation. Then, revised
“Ondansetron as hydrochloride dihydrate” to
Ondansetron hydrochloride dihydrate in master
formulation.
• The firm submitted Rs. 7500 fee (challan-
8412424583)
Applicant
Brand Name +Dosage Form + Strength Aqua Pro Injection 10ml
Composition Each 10ml Ampoule Contains:
Sterile water for injection…10ml
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Fluoroquinolones antibacterial
Type of Form Form 5
Pack size & Demanded Price 25’s, 50’s; As per SRO
Approval status of product in Reference Sterile water for injection (1ml, 2ml, 3.2ml, 5ml and
Regulatory Authorities. 10ml) ampule Glass class I. MHRA approved
Me-too status Mini Wfi Injection 10ml. Reg. No. 84526
fee challan and GMP inspection report.
• You have mentioned filled volume as 10.5ml
(extractable volume 10ml), however, you have
mentioned 100L for 10,000 ampoules batch.
Revised 100 L to 105 L.
• The firm was asked to specify the packaging
materials. The firm did not specify the primary
packaging material.
79741570017)
Applicant
Brand Name +Dosage Form + Strength Carbaphen 400/325mg Tablet
Composition Each Tablet Contains:
Methocarbamol…………………………400mg
Acetaminophen…………………………325mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group methocarbamol, combinations excl. psycholeptics.
Type of Form Form 5
Finished Product Specification The firm has claimed USP specifications. Revised to
in-house specs.
Approval status of product in Reference Robaxacet tablet, 325/400mg. Health Canada approved
Regulatory Authorities.
Me-too status Baxamin tablet, 325/400mg. Reg. No. 064558
Remarks of the Evaluator. • The firm’s title is Ameer Pharma (Pvt) Limited in
• Revised the pharmacological group from muscle
relaxant + antipyretic to methocarbamol,
combinations excl. psycholeptics.

54841093975)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Domcin 15/20 mg Tablet
Domperidone as maleate………………15mg
Cinnarizine………………………….…20mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antiemetic and antihistaminic agent
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specifications.
Approval status of product in Reference Not confirmed
Me-too status Dozin Tablets. Reg. No. 033098
• Provide evidence of approval of applied formulation
in reference regulatory authorities/agencies which
were adopted by the Registration Board in its
275th meeting.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275th meeting.
Applicant
Brand Name +Dosage Form + Strength Ebasin 10mg Tablet
Ebastine ………………………………10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Non-sedating antihistaminic agent
Type of Form Form 5
Available in JP
Approval status of product in Reference EBASTINE ARROW 10 mg film-coated tablets
Regulatory Authorities. ANSM Approved
Me-too status Atmos Tablets 10mg (Reg# 056116)
Remarks of the Evaluator. • Submitted latest GMP inspection report / certificate.
• The firm’s title is Ameer Pharma (Pvt) Limited in
each page of Form 5 has been stamped with the title as “M/s Ameer Pharma Pvt. Ltd.”
decided to approve the product with JP specifications. Firm shall submit the fee of Rs. 7,500/-
for correction/pre-approval change/ in product specifications, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021
Applicant
Brand Name +Dosage Form + Strength Epilev 500mg film coated Tablet

Levetiracetam …………………..…. 500mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antiepileptic
Type of Form Form 5
Available in USP
Approval status of product in Reference Levetiracetam 500 mg film-coated tablets. MHRA
Me-too status Leveticam film-coated 500mg Tablets. Reg. No. 84221
to approve the product with USP specifications. Firm shall submit the fee of Rs. 7,500/- for
correction/pre-approval change/ in product specifications, as per notification No.F.7-11/2012-
B&A/DRAP dated 13-07-2021
Applicant
Brand Name +Dosage Form + Strength Fexofed 120mg Tablet
Fexofenadine HCl……………120mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antihistaminic agent, systemic H1 receptor antagonist
Type of Form Form 5
Available in USP, BP and JP
Approval status of product in Reference Fexofenadine Cipla 120 mg film-coated tablets.
Regulatory Authorities. MHRA approved
Me-too status Kovence 120mg Tablets. Reg. No. 33464
to approve the product with JP specifications. Firm shall submit the fee of Rs. 7,500/- for
Applicant
Brand Name +Dosage Form + Strength Finride 5mg Tablet
Finestaride ………………………..…5mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Testosterone-5-alpha reductase inhibitors
Type of Form Form 5
Available in USP and BP
Approval status of product in Reference Finasteride 5 mg Film-coated Tablets. MHRA
Me-too status Finastic Tablets 5mg. Reg. No. 33930
• Revised finestaride to Finasteride.
• Revised the pharmacological group from 5-alpha
reductase inhibitors to Testosterone-5-alpha
reductase inhibitors
Decision: Registration Board approved registration of product with innovator’s specifications
in general manufacturing areas with condition that manufacturer shall provide safety and
protective measures for workers and personnel which remain in direct contact or are involved
in close handling of these drugs
Applicant
Brand Name +Dosage Form + Strength Histamer 8mg Tablet
Betahistine di hydrochloride ………….…8mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antivertigo
Type of Form Form 5
Approval status of product in Reference Betahistine uncoated tablet 8mg. MHRA approved
Me-too status Vetinil 8mg Tablet. Reg. No. 40956
• Applied for Betahistine di hydrochloride…8mg and
mentioned Betahistine di hydrochloride…16mg
in the composition. Revised it to 8mg.
993244102)
to approve the product with JP specifications. Firm shall submit the fee of Rs. 7,500/- for
Applicant
Brand Name +Dosage Form + Strength Loratmer 10mg Tablet
Loratadine ……………………..…10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group antihistamines for systemic use
Type of Form Form 5
Minutes of of 321 meeting of Registration Board (20th -22nd September, 2022)
st
90
Approval status of product in Reference Loratadine 10 mg uncoated tablet. MHRA approved
Me-too status Loren Tablets 10mg. Reg. No. 41496
• Revised the pharmacological group from
antiallergic to antihistamines for systemic use.
Applicant
Brand Name +Dosage Form + Strength Mebspa 135mg Tablet
Mebeverine HCl ………………..…. 135mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Drugs for functional gastrointestinal disorders
Type of Form Form 5
Finished Product Specification The firm has claimed BP specifications.
Approval status of product in Reference COLESE mebeverine hydrochloride 135mg tablet
Regulatory Authorities. film-coated. TGA approved
Me-too status Mebofac Tablets 135mg film-coated. Reg. No. 74267
Remarks of the Evaluator. • Revised the pharmacological group from
antispasmodic, antichlenergic to Drugs for
functional gastrointestinal disorders.
Applicant
Brand Name +Dosage Form + Strength Pantrop 20mg Tablet
Composition Each Enteric Coated Tablet Contains:
Pantoprazole as sodium sesquihydrate…….…20mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Proton pump inhibitor
Type of Form Form 5
Available in USP.
Approval status of product in Reference PROTONIX (pantoprazole sodium) delayed-release
Regulatory Authorities. tablets 20mg, for oral use. USFDA approved
Me-too status Qtum Tablet 20mg. Reg. No. 82647

Applicant
Brand Name +Dosage Form + Strength Piopride Forte Tablet 30/4mg
Pioglitazone……………………..30mg
Glimepiride……………………….4mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Combinations of oral blood glucose lowering drugs
Type of Form Form 5
Pack size & Demanded Price 3x10’s, 14’s, 2x10’s; As per SRO
Approval status of product in Reference DUETACT (pioglitazone and glimepiride) tablets
Regulatory Authorities. uncoated (30mg/2mg, 30mg/4mg). USFDA approved
Me-too status Zoliget Tablet. Reg. No. 50714
• Had already adjusted the weight of Pioglitazone HCl
in the composition as per salt factor. Revised
Pioglitazone…30mg to Pioglitazone as
HCl…30mg in Form 5.
• Revised the pharmacological group from oral
antihyperglycemic drugs to Combinations of oral
blood glucose lowering drugs.
• Submitted Rs. 7500 (challan- 13374174663)
Applicant
Brand Name +Dosage Form + Strength Rostan 10mg Tablet
Rosuvastatin as calcium ………………..…10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Lipid modifying agent
Type of Form Form 5
Available in USP.
Approval status of product in Reference Crestor 10mg film-coated tablets. MHRA approved
Me-too status Rosan 10mg Tablet. Reg. No. 81462

• Had already mentioned film-coated tablet in the
compostion. Revised the label claim in Form 5 to
each film-coated tablet contains.
Revised label claim is as under;
Each film coated Tablet Contains:
Applicant
Rosuvastatin as calcium ……………………20mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Available in USP.
Me-too status Rostat 20mg Tablet. Reg. No. 55731
composition. Revise the label claim in Form 5 to
• Revise the pharmacological group from oral
Applicant

Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Available in USP.
Me-too status Rostat 5mg Tablet. Reg. No. 55729
compostion. Revise the label claim in Form 5 to
• Had applied for 5mg tablet and the composition
depicted the same, but the label claim in Form 5
was Rosuvastatin as calcium…10mg. Revised it
to 5mg.
Applicant
Brand Name +Dosage Form + Strength Solifen 5mg Tablet
Solifenacin Succinate ……………….…5mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Drugs for urinary frequency and incontinence.
Type of Form Form 5
Approval status of product in Reference Solifenacin succinate 5 mg film-coated tablets (Each
Regulatory Authorities. film-coated tablet contains 5 mg solifenacin succinate,
corresponding to 3.8 mg solifenacin). MHRA approved
Me-too status Solina 5mg Tablet. Reg. No. 61212
competitive muscarinic receptor antagonist to
Drugs for urinary frequency and incontinence.
to approve the product with innovator’s specifications. Firm shall submit the fee of Rs. 7,500/-
11/2012-B&A/DRAP dated 13-07-2021
Applicant
Brand Name +Dosage Form + Strength Tizadin 2mg Tablet
Tizanidine as HCl …………………2mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Muscle relaxants, centrally acting agents
Type of Form Form 5
Approval status of product in Reference Tizanidine (as HCl) 2 mg Tablets. MHRA approved
Me-too status Mylex Tablets 2mg. Reg. No. 63031
• Revised the pharmacological group from alpha-2
receptor antagonist to Muscle relaxants, centrally
acting agents.
Applicant
Brand Name +Dosage Form + Strength Vastamer 10mg Tablet
Atorvastatin as calcium …………………10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group HMG CoA reductase inhibitors
Type of Form Form 5
Approval status of product in Reference ACH-ATORVASTATIN CALCIUM (film-coated) by
Regulatory Authorities. Accord Healthcare Inc. Health Canada approved
Me-too status Torvia 10mg Tablet by Pakistan Pharmaceutical
Products. Reg. No. 81162
• Had already adjusted the weight of API as per salt
factor. The reference product in Health Canada
contains Atorvastatin as calcium trihydrate.
Revised the label claim from Atorvastatin as
calcium to Atorvastatin as calcium trihydrate, and
Atorvastatin calcium to Atorvastatin calcium
trihydrate in the master formula.
in Form 5 and while acknowledging the fact that coveing letter of firm’s application
declared full title of firm i.e., M/s Ameer Pharma (Pvt.), 23 KM-Sheikhupura Road,
Lahore and also each page of Form 5 has been stamped with the title as “M/s Ameer
Pharma Pvt. Ltd.” decided to approve the product as per following label claim:
“Each film coated tablet Contains:
Atorvastatin as calcium …………………10mg”
Firm shall submit revised label claim along woth master formulation for film coated tablet
alongwith fee of Rs. 7,500/- for correction/pre-approval change/ in product label clam frm
uncoated to film coated tablet, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-
2021.
Applicant
Brand Name +Dosage Form + Strength Vastamer 40mg Tablet
Atorvastatin as calcium ……………..…40mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference ACH-ATORVASTATIN CALCIUM (film-coated) by
Regulatory Authorities. Accord Healthcare Inc. Health Canada approved
Me-too status Fatilor 40mg Tablet by Lisko Pakistan Ltd. Reg No.
58163 (does not depict film-coating)
factor. The reference product in Health Canada
contains Atorvastatin as calcium trihydrate.
Revised the label claim from Atorvastatin as
calcium to Atorvastatin as calcium trihydrate, and
Atorvastatin calcium to Atorvastatin calcium
trihydrate in the master formula.
Pharma Pvt. Ltd.” decided to approve the product as per following label claim:
“Each film coated tablet Contains:
Atorvastatin as calcium …………………10mg”
• Firm shall submit revised label claim along woth master formulation for film coated
tablet alongwith fee of Rs. 7,500/- for correction/pre-approval change/ in product
label clam frm uncoated to film coated tablet, as per notification No.F.7-11/2012-
B&A/DRAP dated 13-07-2021.
Applicant
Brand Name +Dosage Form + Strength Zematin 10mg Tablet
Memantine HCl …………………….…10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Anti-dementia drugs
Type of Form Form 5
Approval status of product in Reference Memantine 10 mg film-coated tablets by Aristo Pharma
Regulatory Authorities. GmbH. Approved by MHRA
Me-too status Memlip 10mg Tablets by WnsFeild Pharmaceuticals.
Hattar. Reg. No. 84222
• Revised the pharmacological group from NMDA
receptor antagonist to anti-dementia drugs.
Pharma Pvt. Ltd.” decided to approve the product.
45. Name and address of manufacturer / M/s Treat Pharmaceutical Industry Pvt Ltd. A-37,
Applicant Small Industrial Estate, Township Kohat Road, Bannu
Brand Name +Dosage Form + Strength Fibret 100mg Capsule
Composition Each Capsule Contains:
Fenofibrate …………………..…. 100mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Fibrates
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specifications. Available
in USP
Approval status of product in Reference Could not be confirmed
Me-too status LIPOMIN CAP 100mg. Reg. No. 10601
GMP status The firm was inspected on 06.11.2018 with satisfactory
level of GMP compliance.
Remarks of the Evaluator. • The drug product specifications have not been
evaluated.
• Stamped signature of the production manager is
placed on the file.
• The firm was asked to revise the pharmacological
group to fibrates. The firm did not comply.
• The firm was asked to specify the capsule shell
materials in the composition/master formula. The
firm did not comply.
• The firm was asked to submit clear manufacturing
outlines. The firm did not comply.
• The reference product in USFDA contains
micronized fenofibrate. The firm was asked to
revise it accordingly. The firm did not comply.
• Submitted Rs. 7500 (challan-925973487112)
• The provided reference was discontinued in USFDA.
Provide proof of international availability of same
formulation and same strength in reference
regulatory authorities as defined in 275th meeting of
Registration Board.
Decision: Deferred for the following:
• Revision of pharmacological group of the applied formulation.
• Type of the capsule shell materials in the composition/master formula.
• Clear manufacturing outlines of the applied formulation.
• Latest GMP certificate/inspection report conducted within last three years.
• Evidence of approval of applied formulation in reference regulatory authorities as
defined in 275th meeting of Registration Board.
Brand Name +Dosage Form + Strength Fibret 134mg Capsule
Fenofibrate (micronized) …. 134mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Fibrates
Type of Form Form 5
in USP
Approval status of product in Reference Ticor 134mg capsule (micronized). Not discontinued or
Regulatory Authorities. withdrawn for safety or effectiveness reasons in USFDA
Me-too status Fenoget 134mg Capsule. Reg. No. 55692
evaluated.
placed on the file.
group to fibrates. The firm did not comply.
micronized fenofibrate. The firm revised it
accordingly.
Decision: Approved with USP specifications. Registration letter will be issued after submission
of type of the capsule shell materials in the composition/master formula, revision of
pharmacological group, clear manufacturing outlines and Latest GMP
certificate/inspection report conducted within last three years alongwith pre-
variation registration fee.
Brand Name +Dosage Form + Strength Itazon 100mg Capsule
Itraconazole …………………….…. 100mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Triazole and tetrazole derivatives.
Type of Form Form 5
Approval status of product in Reference ITRACONAZOLE 100mg Capsules. MHRA approved
Me-too status Soprazole-100mg Capsules. Reg. No. 29044

evaluated.
placed on the file.
group to Triazole and tetrazole derivatives. The
• The firm submitted the composition, label claim and
manufacturing outlines for fenofibrate capsule.
Then, revised it.
Decision: Approved with innovator’s specifications. Registration letter will be issued after
submission of type of the capsule shell materials in the composition/master formula, revision
of pharmacological group, clear manufacturing outlines and Latest GMP certificate/inspection
report conducted within last three years alongwith pre-variation registration fee.
Brand Name +Dosage Form + Strength Pregab 100mg Capsule
Pregabalin ……………………… ..… 100mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antiepileptics
Type of Form Form 5
Approval status of product in Reference Lyrica 100 mg hard capsules (EMA Approved)
Me-too status Gabica 100mg Capsules by Getz Pharma
evaluated.
placed on the file.
submission of clear manufacturing outlines and Latest GMP certificate/inspection report
conducted within last three years alongwith pre-variation registration fee.
Pregabalin …………………………..… 150mg
Rs. 20,000/- dated 06.03.2019

Pharmacological Group Antiepileptic’s
Type of Form Form 5
Approval status of product in Reference Pregabalin Noumed 150 mg capsules. MHRA Approved
Me-too status Gabica 150mg Capsules by Getz Pharma. Reg. No.
48724
evaluated.
placed on the file.
Pregabalin ………………………… ..… 50mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference Alzain 50 mg Capsules, Hard. MHRA approved
Me-too status Scirica 50mg Capsule. Reg. No. 82187
evaluated.
placed on the file.
Pregabalin ……………………………..… 75mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference Alzain 75 mg Capsules, Hard. MHRA approved
Me-too status Scirica 75mg Capsule. Reg. No. 82186
evaluated.
placed on the file.
submission of type of the capsule shell materials in the composition/master formula, clear
manufacturing outlines and Latest GMP certificate/inspection report conducted within last
three years alongwith pre-variation registration fee.
Brand Name +Dosage Form + Strength TEGAP 100mg Capsule
Gabapentin ………………………..…… 100mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
in USP
Approval status of product in Reference Gabapentin 100mg Capsules. MHRA approved
Me-too status Pentowan 100mg Capsule. Reg. No. 79688
evaluated.
placed on the file.
of clear manufacturing outlines and Latest GMP certificate/inspection report conducted within
last three years alongwith pre-variation registration fee.
Gabapentin ………………………… 300mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
in USP
Me-too status Pentowan 300mg Capsule. Reg. No. 82103
evaluated.
placed on the file.
Gabapentin…… 400mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
in USP
Me-too status NEURONTIN CAPSULES 400mg. Reg. No. 16141
evaluated.
placed on the file.
Brand Name +Dosage Form + Strength Tremsin Capsule 0.4mg
Tamsulosin HCl (As Modified Release Pellets) Eq. To
Tamsulosin …. 0.4mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Alpha-1 blocking agent
Type of Form Form 5
Approval status of product in Reference FLOMAX® (tamsulosin hydrochloride, USP) Capsules,
Regulatory Authorities. for oral use. USFDA approved
Me-too status Tamsolin 0.4mg Capsule. Reg. No. 50392
evaluated.
• Add capsule sealing process in the manufacturing
outlines.
• The firm was asked to provide the source of pellets
along with GMP certificate of the firm, COA and
stability summary sheets of three batches of the
pellets. The firm submitted the source of pellets as
M/s Vision Pharmaceuticals.
Decision: Approved with BP specifications. Registration letter will be issued after submission
of Latest GMP certificate/inspection report conducted within last three years.
Brand Name +Dosage Form + Strength Tritamol 50mg Capsule
Tramadol Hydrochloride …………….… 50mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group other opioids
Type of Form Form 5
Approval status of product in Reference Tramadol 50 mg Capsules. MHRA approved
Me-too status Campex 50mg Capsule. Reg. No. 075893
evaluated.
placed on the file.
group from non-narcotic analgesic to other opioids.
The firm did not comply.
• Had submitted the composition, label claim and
manufacturing outlines for fenofibrate capsule.
Then, revised it.
clear manufacturing outlines and Latest GMP certificate/inspection report conducted within
Brand Name +Dosage Form + Strength Trestat 120mg Capsule

Orlistat ……………………..….. 120mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Peripherally acting antiobesity products
Type of Form Form 5
Approval status of product in Reference XENICAL 120mg Hard Gelatin Capsule,
Regulatory Authorities. CHEPLAPHARM
Arzneimittel GmbH
Ziegelhof 24 17489 Greifswald Germany
Me-too status Orlifit 120mg capsule. Reg. No. 058474
evaluated.
placed on the file.
• Revise the pharmacological group to Peripherally
acting antiobesity products.
• Revise the label claim from "Orlistat…..120mg" to
“Orlistat IR pellets equivalent to
Orlistat……120mg”.
• Specify the capsule shell materials in the
composition/master formula.
• Revise orlistat to Orlistat IR pellets in the composition
and adjust its weight as per strength of the pellets.
• Add capsule sealing process in the manufacturing
outlines.
• Clarify the use of excipients in the composition.
• Provide the source of pellets along with GMP
certificate of the firm, COA and stability summary
sheets of three batches of the pellets along with
other requirements.
• For revision, submit the applicable fee as per
notifications 7-11/2012-B&A/DRAP dated
07.05.2021 and 13.07.2021.
• Submission of source of pellets in which stability studies of the pellets have been
conducted at real time conditions i.e., 30°C ± 2°C/65% RH ± 5% RH along with
quantification of degradation products throughout the stability studies / assigned shelf
life.
• Revision of the pharmacological group to Peripherally acting antiobesity products.
• Revision of the label claim from "Orlistat…..120mg" to “Orlistat IR pellets equivalent
to Orlistat……120mg.
• Specify the capsule shell materials in the composition/master formula.
• Revise orlistat to Orlistat IR pellets in the composition and adjust its weight as per
strength of the pellets.
• Add capsule sealing process in the manufacturing outlines.
• Clarify the use of excipients in the composition.
• Provide the source of pellets along with GMP certificate of the firm, COA and stability
summary sheets of three batches of the pellets along with other requirements.
• For revision, submit the applicable fee as per notifications 7-11/2012-B&A/DRAP
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Cefifort 250mg Injection
Composition Each Vial Of Dry Substance Contains:
Sterile Ceftazidime As (Pentahydrate) …….… 250mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Third-generation cephalosporins
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specifications. available
in USP
Approval status of product in Reference Fortum® 250 mg powder for solution for injection (vial).
Me-too status Fortez Injection 250mg IM/IV. Reg. No. 82751
evaluated.
• The reference product contains sodium bicarbonate as
excipient. The firm did not mention it. The firm
mentioned it later.
Latest GMP certificate/inspection report conducted within last three years.
Brand Name +Dosage Form + Strength Cefifort 500mg Injection
Sterile Ceftazidime As (Pentahydrate) …….… 500mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Third-generation cephalosporin.
Type of Form Form 5
in USP
Approval status of product in Reference Fortum® 500 mg powder for solution for injection (vial).
Me-too status Fortez Injection 500mg IM/IV. Reg. No. 82750
evaluated.
mentioned it later.
Brand Name +Dosage Form + Strength Cefifort 1g Injection
Sterile Ceftazidime As (Pentahydrate) ………… 1g
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Third-generation cephalosporins
Type of Form Form 5
in USP
Approval status of product in Reference Fortum® 1 g powder for solution for injection (vial).
Me-too status Fortez Injection 1g IM/IV. Reg. No. 82749
evaluated.
mentioned it later.
Brand Name +Dosage Form + Strength Gluti Injection 40mg / 0.4mg /4ml
Composition Each Ampule Contains:
Phloroglucinol Hydarte … 40mg
Trimethylphloroglucinol …. 0.04mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Other drugs for functional gastrointestinal disorders.
Type of Form Form 5
Pack size & Demanded Price 6’sx4ml; As per SRO
Approval status of product in Reference SPASFON, solution injectable en ampoule (4ml).
Regulatory Authorities. ANSM approved
Me-too status Spadix Injection. Reg. No. 29528
evaluated.
group from antispasmodic to Other drugs for
functional gastrointestinal disorders. The firm did
not comply.
• Had mentioned both vial and ampoule in packaging.
The firm mentioned ampoule later.
81517128336
submission Latest GMP certificate/inspection report conducted within last three years.
Brand Name +Dosage Form + Strength Webtum-500mg Injection
Composition Each Vial Contains:
Cefoperazone Sodium Equivalent To 250mg Of
Cefoperazone Sulbactam Sodium Equivalent To 250mg
Sulbactam
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Third-generation cephalosporins and beta lactams.
Type of Form Form 5
Finished Product Specification The firm has claimed JP specifications.
Approval status of product in Reference Sulperazon Injection 0.5 g (0.25g/0.25g). PMDA
Regulatory Authorities. Approved
Me-too status Perabactum Injection 500mg IV/IM. Reg. No. 80380
evaluated.
group from Third-generation cephalosporins to
Third-generation cephalosporins and beta lactams.
The firm mentioned vials later.
• The reference product contains pH regulator. The firm
was asked to add in the composition accordingly.
Decision: Approved. Registration letter will be issued after submission of revised
pharmacological group, addition of pH regulator in the formulation and Latest GMP
certificate/inspection report conducted within last three years alongwith pre-variation
registration fee.
By
M/s Nicholas Pharmaceuticals. Plot # 34, St. # SS-02,
National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Merop 500mg Injection IV
Meropenem As Trihydrate ………………500mg
Diary No. Date of R& I & fee Dy. No.13076 dated 06.03.2019
Rs. 50,000/- dated 06.03.2019
Pharmacological Group Carbapenem
Type of Form Form 5
Approval status of product in Reference Meropenem 500 mg Powder for Solution for Injection or
Regulatory Authorities. Infusion. MHRA Approved
Me-too status Meroget Powder for Solution for Infusion or Injection.
Reg. No. 83174
GMP status Nicholas pharma: Firm has submitted copy of GMP
certificate dated 25-02-2020 issued on the basis of
inspection dated 28-01-2020
evaluated.
• The signature of the signatory on Form 5 for contract
manufacturing is different from the other dossiers
submitted on the same date.
• The firm was asked to mention the quantity of sodium
carbonate in the composition. The firm submitted
that meropenem is a blend with sodium carbonate
Registration Board in its 307th meeting discussed the

capacity inspection report in details. Deliberations were
made on used and available manufacturing and quality
control capacity keeping in view all registered product
and currently applied products. After thorough
deliberation, the Board decided to allow contract
manufacturing from M/s Nicholas Pharmaceuticals, Plot
# 34, St. # SS-02, National Industrial Zone, Rawat,
Islamabad for following sections:
• Dry Powder Injection (Cephalosporin) Section
• Dry Powder for Suspension (Cephalosporin) Section
• Capsule (Cephalosporin) Section
• Dry Powder Injection (Carbapenem) Section
Lately M/s Nicholas Pharmaceuticals in compliance to
the decision of the 307th meeting of Registration Board
vide its letter Dy. No. 6357 dated 08-03-2022 submittted
that they have purchased two HPLC systems and
submitted its purchase documents including invoice No.
RI-22-52 dated 05-01-2022 for Azura Isocratic HPLC
system including all accessories and invoice No. TS100-
58/22 dated 5th March 2022 for Perkin elmer HPLC with
column oven and gradient system.
Decision: Approved. Registration letter will be issued after submission of Latest GMP
certificate/inspection report conducted within last three years of the applicant.
By
M/s Nicholas Pharmaceuticals. Plot # 34, St. # SS-02,
National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Merop 1g Injection IV
Meropenem As Trihydrate…1g
Rs. 50,000/- dated 06.03.2019
Pharmacological Group Carbapenem
Type of Form Form 5
Approval status of product in Reference Meropenem 1g Powder for Solution for Injection or
Regulatory Authorities. Infusion. MHRA Approved
Me-too status Meroget Powder for Solution for Infusion or Injection.
Reg. No. 83175
The firm was inspected on 03.08.2018 with satisfactory
evaluated.
• The signature of the signatory on Form 5 for contract
manufacturing is different from the other dossiers
submitted on the same date.
• The firm was asked to mention the quantity of sodium
carbonate in the composition. The firm submitted
that meropenem is a blend with sodium carbonate
Decision: Approved. Registration letter will be issued after submission of Latest GMP
certificate/inspection report conducted within last three years of applicant.
65. Name and address of manufacturer / M/s Rotex Pharma Pvt Ltd. Plot No. 206 & 207.
Applicant Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Brutex 400mg Tablet
Ibuprofen ……………………400mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group NSAIDs
Type of Form Form 5
Finished Product Specification Claimed USP specs.
Pack size & Demanded Price 10x10’s, 25x10’s, 500’s, 1000’s; As per SRO
Approval status of product in Reference Ibuprofen 400mg Tablets film-coated. MHRA
Me-too status Hebofen 400mg Tablets. Reg. No. 68392
GMP status GMP certificate issued on the basis of inspection dated
12.08.2020.
Remarks of the Evaluator. • Stamped signatures of the QCM and PM are placed
in the file.
Decision: Approved.
Brand Name +Dosage Form + Strength C-Zole 500mg Tablet
Clotrimazole …………………..…500mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group
Type of Form Form 5
Finished Product Specification Claimed BP specs.
Approval status of product in Reference Clotrimazole 500mg Vaginal Tablet vaginal. MHRA
Me-too status Amclotrim Vaginal Tablets 500 mg. Reg. No. 69937
12.08.2020.
in the file.
• The firm was asked to provide pharmacological
group. The firm mentioned it as antivertigo.
• Had applied for film-coated tablet, and had
mentioned oral route of administration. The
international reference product is vaginal tablet.
Changed the route to vaginal. Revised the
composition and manufacturing outlines meant for
uncoated tablet.
• Submitted Rs. 7500/- (challan- 01823603453)
Decision: Approved. Registration letter will be issued after submission of differential fee of Rs.
22,500/- for correction/pre-approval change, as per notification No.F.7-11/2012-
• Firm will also submit corrected pharmacological group alongwith pre-registration
variation fee.
Brand Name +Dosage Form + Strength Motim 10mg Tablet
Domperidone ……………………….…10mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Propulsives
Type of Form Form 5
Finished Product Specification Claimed in-house specs. Available in BP
Pack size & Demanded Price 30’s, 50’s, 60’s; As per SRO
Approval status of product in Reference Domperidone (as maleate) 10mg Tablets. MHRA
Domperidone (as maleate) 10mg Film-Coated Tablets.
MHRA approved.
DOMPERIDONE (base) ALMUS 10 mg film-coated
tablets. ANSM approved
Me-too status Nendone Tablets 10mg. Reg. No. 29785
12.08.2020.
in the file.
• Revised the pharmacological group to “propulsives”.
Decision: Approved with BP specificationsand following label claim;
Each Film Coated Tablet Contains:
Domperidone as maleate ……………………….…10mg
• Registration letter will be issued after submission of fee of Rs. 30,000/- for
correction/pre-approval change, as per notification No.F.7-11/2012-B&A/DRAP
dated 13-07-2021.
• Firm will also submit revised label claim as per reference product i.e. Domperidone
(as maleate) 10mg Tablets.
Brand Name +Dosage Form + Strength Panamol 500mg Tablet
Paracetamol …………………….…500mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Analgesics
Type of Form Form 5
Pack size & Demanded Price 100’s, 200’s, 500’s, 1000’s; As per SRO
Approval status of product in Reference Paracetamol 500mg Tablets. MHRA approved
Me-too status PANADOL TAB. Reg. No. 000817
12.08.2020.
in the file.
Decision: Approved.
Brand Name +Dosage Form + Strength Ropim 0.25mg Tablet
Ropinirole as Hcl…0.25mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Antiparkinson
Type of Form Form 5
Approval status of product in Reference Ropinirole 0.25 mg film-coated tablets (as
Regulatory Authorities. hydrochloride) 1mg. MHRA approved.
Me-too status Requip Tablets 0.25mg. 28442
12.08.2020.
Remarks of the Evaluator. • Scanned signatures of the QCM and PM are placed in
the file.
factor in the master formula. Revised Ropinirole as
Hcl to Ropinirole Hcl in the master formula
• Submitted Rs. 7500/- (challan- 6531332952)
Decision: Approved.
Brand Name +Dosage Form + Strength Rovit 5% Cream
Composition Each Gram Contains:
Acyclovir …………………………..…50mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Antivirals
Type of Form Form 5
Finished Product Specification The firm has claimed BP specs.
Pack size & Demanded Price 2g, 5g, 10g; As per SRO
Approval status of product in Reference ZOVIRAX® (acyclovir) cream, for topical use 5%.
Regulatory Authorities. USFDA approved.
Me-too status Ciavir 5% Cream. Reg. No. 85089
12.08.2020.
the file.
• Had not mentioned sealing of tubes in the
manufacturing outlines. Revised it.
Decision: Approve. Registration letter will be issued after submission of fee of Rs. 7500/- for
correction/pre-approval change, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-
2021.
Brand Name +Dosage Form + Strength Texklar XR 500mg Tablet
Composition Each Extended Release Film Coated Tablet Contains:
Clarithromycin ………………….…500mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Macrolide
Type of Form Form 5
Finished Product Specification The firm has claimed USP specs.
Approval status of product in Reference Klaricid XL 500 mg Tablets film-coated. MHRA
Regulatory Authorities. approved.
Me-too status Canter-OD Tablet 500 mg film-coated (extended
release). Reg. No. 82133
12.08.2020.
the file.
Decision: Approved.
Brand Name +Dosage Form + Strength V-Fox 50mg Tablet
Composition Each Uncoated Tablet Contains:
Venlafaxine as HCl ……………..…50mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group N06A Antidepressants.
Type of Form Form 5
Approval status of product in Reference Venlafaxine (as hydrochloride) uncoated tablet (25 mg,
Regulatory Authorities. 37.5 mg, 50 mg, 75 mg, 100 mg). USFDA approved
Me-too status Venix Tablets 75mg. Reg. No. 32563
12.08.2020.
the file.
Decision: Approved.
Brand Name +Dosage Form + Strength V-Fox 75mg Tablet
Composition Each Uncoated Tablet Contains:
Venlafaxine as HCl ………………….…75mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group N06A Antidepressants.
Type of Form Form 5
Approval status of product in Reference Venlafaxine (as hydrochloride) uncoated tablet (25 mg,
Regulatory Authorities. 37.5 mg, 50 mg, 75 mg, 100 mg). USFDA approved
Me-too status Venix Tablets 75mg. Reg. No. 32564
12.08.2020.
the file.
Decision: Approved.
Brand Name +Dosage Form + Strength Zentex 150mg Tablet
Ranitidine as HCl ……………………150mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group H2-receptor antagonists
Type of Form Form 5
Approval status of product in Reference Zantac Tablets 150 mg, uncoated. MHRA approved
Me-too status Monocid Tablets 150mg. Reg. No. 32828
12.08.2020.
the file.
• Revised the pharmacological group from H2 blockers
to H2-receptor antagonists.
Decision: Deferred till the decision by reference regulatory authorities regarding ranitidine
containing medicinal products.
75. Name and address of manufacturer / Genix Pharma (Pvt) Ltd,
Applicant 44-45-B, Korangi Creek Road, Karachi 75190,
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Brimon Eye Drops 10mg/5ml
Composition Each ml contains:
Brimonidine tartrate ………………….…2mg
Rs.20,000/- dated 06.03.2019
Pharmacological Group Sympathomimetics in glaucoma therapy
Type of Form Form 5
Finished Product Specification The firm has claimed In-house specs. Available in
USP.
Pack size & Demanded Price 5ml; As per SRO
Approval status of product in Reference Alphagan 0.2% w/v (2 mg/ml) eye drops, solution.
Regulatory Authorities. Approved in MHRA
Me-too status Alzagan Ophthalmic solution. Reg. No. 82055
GMP status The firm was inspected on 16.11.2018, wherein the
FIDreported average level of GMP compliance.
evaluated.
• The address in Form 5 is Genix Pharma (Pvt) Ltd, 44-
45-B, Korangi Creek Road, Karachi 75190,
Pakistan, Pakistan, while it is Genix Pharma (Pvt)
Ltd, 44-45-B, Korangi Creek Road, Karachi in the
DML
• Had referred to Form 5D in the cover letter, while the
submitted enclosure and data as per Form 5.
Revised the cover letter.
• The reference product contains benzalkonium
chloride as microbial preservative, and water for
injection. The firm did not mention the same. The
firm revised the formulation. Moreover, the firm
removed potassium chloride and calcium chloride
as alkalinizing agents.
• Revised the master formula /batch size as per 5 ml
pack size.
• Had claimed filled volume of 5ml, but the claimed
bottle is 4ml. revised it 5ml.
• Submitted Rs. 10000 as differential fee (challan-
34537381)
Decision: Approved with innovator specifications. Registration letter will be issued after
submission of latest GMP certificate/last inspection report conducted within last three years.
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Allop Tablet 300mg
Composition Each tablet contains:
Allopurinol…………………………..…300mg
Rs.20,000/- dated 06.03.2019
Pharmacological Group antigout
Type of Form Form 5
Approval status of product in Reference ALLOPURINOL- allopurinol tablet, 300mg
Regulatory Authorities. (uncoated). Approved in USFDA.
Me-too status Alzagan Ophthalmic solution. Reg. No. 82055
GMP status The firm was inspected on 16.11.2018, wherein the FID
reported average level of GMP compliance.
evaluated.
DML
• Added blistering and packing steps to the
manufacturing outlines
753575439)
Decision: Approved. Registration letter will be issued after submission of latest GMP
certificate/last inspection report conducted within last three years.
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Everos Tablet 0.25mg
Everolimus ………………….… 0.25 mg
Rs.20,000/- dated 06.03.2019
Pharmacological Group Antineoplastic agent
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specs.
Approval status of product in Reference Certican 0.25 mg tablets, uncoated. MHRA approved.
Me-too status Certican tablet 0.25mg. Reg. No. 044829
GMP status
evaluated.
DML
• Provide proof of me-too product (name and
registration) already approved by DRAp;
otherwise, submit your application on Form 5D
along with stability data and fee applicable as per
notification 7-11/2012-B&A/DRAP dated
07.05.2021 and 13.07.2021.
972245896)
Decision: Registration Board considering the fact that Everolimus belongs to both “L01-
Antineoplastic” and “L04-Immunosuppressant” class of drug hence deferred for further
deliberation regarding its manufacturing requirement.
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Everos Tablet 2.5mg
Everolimus …………………………… 2.5 mg
Rs.20,000/- dated 06.03.2019
Pharmacological Group Antineoplastic agent
Type of Form Form 5
Approval status of product in Reference Everolimus Sandoz 2.5 mg Tablets, uncoated. MHRA
Me-too status AFINITOR 2.5MG TABLETS. Reg. No. 78105
GMP status
evaluated.
DML
13078284773)
Decision: Registration Board considering the fact that Everolimus belongs to both “L01-
Antineoplastic” and “L04-Immunosuppressant” class of drug hence deferred for further
deliberation regarding its manufacturing requirement.
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Talim ER Tablet 1mg
Composition Each extended release tablet contains:
Tacrolimus ……………………… 1mg
Rs.50,000/- dated 06.03.2019
Pharmacological Group Immunosuppressant
Type of Form Form 5
Finished Product Specification The firm has claimed innovator’s specs.
Approval status of product in Reference ENVARSUS XR® (tacrolimus extended-release
Regulatory Authorities. tablets), uncoated 1mg. USFDA approved.
Me-too status
GMP status
evaluated.
DML
• The firm was asked to add blistering and packing
steps to the manufacturing outlines along with
submission of applicable fee as per notification 7-
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021. The firm did not comply
• The firm was asked to submit stability data as per
zone IV-A. The firm informed that they will submit
the data.
• The firm was asked to revise tacrolimus to tacrolimus
monohydrate in the master formula and adjust its
weight in master formula based on salt factor along
with submission of applicable fee as per
07.05.2021 and 13.07.2021. The firm did not
comply.
Decision: Deferred for submission of stability study data as data as per the guidelines approved
in 293rd meeting of Registration Board.
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Talim ER Tablet 0.75mg
Composition Each extended release tablet contains:
Tacrolimus …………………………… 0.75mg
Rs.50,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference ENVARSUS XR® (tacrolimus extended-release
Regulatory Authorities. tablets), uncoated 0.75mg. USFDA approved.
Me-too status
GMP status
evaluated.
DML
11/2012-B&A/DRAP dated 07.05.2021 and
• The firm was asked to submit stability data as per
zone IV-A. The firm informed that they will submit
the data.
• The firm was asked to revise tacrolimus to tacrolimus
monohydrate in the master formula and adjust its
weight in master formula based on salt factor along
comply
Pakistan, Pakistan
Brand Name +Dosage Form + Strength APRANT 125mg Capsule
Composition Each Hard Capsule Contains:
Aprepitant ……………………………….. 125mg
Rs.20,000/- dated 06.03.2019
Pharmacological Group Antiemtic
Type of Form Form 5
Approval status of product in Reference Aprepitant 125 mg hard capsules. MHRA approved.
Me-too status Aprant 125 mg Capsule. Reg. No. 82251
GMP status
evaluated.
DML
14771025235)
• Revised the quanitity of API in the master formula
based on label claim and batch size.
Pakistan, Pakistan
Brand Name +Dosage Form + Strength APRANT 40mg Capsule
Composition Each Hard Capsule Contains:
Aprepitant …………………………..….. 40mg
Rs.20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference Emend 40mg hard capsules. USFDA “Federal Register
Regulatory Authorities. determined that product was not discontinued or
withdrawn for safety or effectiveness reasons”.
Me-too status Apritus 40mg Capsule. Reg. No. 74885
GMP status
evaluated.
DML
0912079527)
Pakistan, Pakistan
Brand Name +Dosage Form + Strength APRANT 125mg Sachet (powder for oral suspension)
Composition Each sachet contains:
Aprepitant …………………….. 125mg
Rs.20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference EMEND for oral suspension 125mg per pouch.
Regulatory Authorities. USFDA approved
Me-too status
GMP status
evaluated.
DML
• The firm was asked to clarify the 206kg batch size in
terms of number of sachets and calculations of API
and excipients thereof, and in case of revision,
revise the manufacturing outlines along with
11/2012-B&A/DRAP dated 07.05.2021 and
• The firm was asked to add sachet filling, sealing and
packing steps to the manufacturing outlines along
comply
• The firm submitted that stability studies are under
process
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Piram 400mg Capsule
Piracetam …………………………….…. 400mg
Rs.20,000/- dated 06.03.2019
Pharmacological Group Nootropic agent
Type of Form Form 5
GMP status
evaluated.
DML
• The firm was asked to provide proof of international
availability of same formulation and same strength
in reference regulatory authorities as defined in
275th meeting of the registration board. The firm
did not comply
11/2012-B&A/DRAP dated 07.05.2021 and
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Piram 1000mg/5ml injection (IV)
Composition Each ml Contains:
Piracetam ……………………….…. 200mg
Rs.20,000/- dated 06.03.2019
Type of Form Form 5
Me-too status Neurotam Injection 1000mg/5ml. Reg. No. 73480
GMP status
evaluated.
DML
availability of same formulation, same filled
volume and same strength in reference regulatory
authorities as defined in 275th meeting of the
registration board. The firm did not comply
• The firm was asked to provide add packing step to the
manufacturing outlines along with submission of
applicable fee as per notification 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
The firm did not comply
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Piram 800mg Tablet
Piracetam ……………………………. 800mg
Rs.20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference Piracetam 800mg film-coated tablet. MHRA approved
Me-too status Nootropil Tablet 800mg. Reg. No. 82277
GMP status GMP inspection was conducted on 12-02-2020 and
concluded as, “Based on the area inspected, the people
met and the document reviewed and considering the
findings of the inspection including the observation
listed above M/s Genix Pharma Private Limited Located
at Plot No.44-45-B Korangi, Creek Road Karachi,
Pakistan was considered to be operating at a good level
of compliance with cGMP guideline as of today.”
evaluated.
DML
• Had mentioned the dosage form as capsule in
enclosure of Form 5. The label claim was “each
tablet contains”. Had mentioned the coating
composition in the master formula. The firm
revised the label claim to:
Each film-coated tablet Contains:
Piracetam …. 800mg
06206784120).
Decision: Approved with innovator’s specifications and following label claim;
Each film-coated tablet Contains:
Piracetam ………………….…. 800mg
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Citolin 1g/4ml Injection
Composition Each 4ml Injection Contains:
Citicoline sodium Eq. to Citicoline …. 1g
Rs.20,000/- dated 06.03.2019
Pharmacological Group Psychoanaleptic
Type of Form Form 5
Finished Product Specification The firm has claimed Innovator’s specs.
Me-too status Coleen Injection 1000mg/4ml. Reg. No. 46760
evaluated.
DML
registration board. The firm did not comply
• The firm was asked to clarify the 10L batch size for
5,000 ampule (4ml) and calculations of API and
excipients thereof. In case of revision, revise the
B&A/DRAP dated 07.05.2021 and 13.07.2021.
• The firm was asked to add packing step to the
B&A/DRAP dated 07.05.2021 and 13.07.2021.
• Evidence of approval of applied formulation in reference regulatory
• Addition of packing step to the manufacturing outlines along with submission of
applicable fee as per notification 7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Citolin 250mg/2ml Injection
Composition Each 2ml Injection Contains:
Citicoline sodium Eq. to Citicoline …. 250mg
Rs.20,000/- dated 06.03.2019
Pharmacological Group Psychoanaleptic
Type of Form Form 5
Finished Product Specification The firm has claimed Innovator’s specs.
Me-too status Citograin Injection 250mg/2ml. Reg. No. 50042
evaluated.
DML
registration board. The firm did not comply.
• The firm was asked to provide add packing step to the
B&A/DRAP dated 07.05.2021 and 13.07.2021.
• Addition of packing step to the manufacturing outlines along with submission of
13.07.2021.
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Medop Tablet
Methyldopa Equivalent To Anhydrous Methyldopa …
250mg
Rs.20,000/- dated 06.03.2019
Pharmacological Group Antihypretensive
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, 20’s, 30’s, 100’s; As per SRO
Approval status of product in Reference Aldomet film-caoted tablets 250mg. MHRA approved
Me-too status Aldomet by OBS Pakistan.
evaluated.
DML.
• The firm has mentioned Cilostazole instead of
Cilostazol.
• The provided label claim is “Methyldopa Equivalent
To Anhydrous Methyldopa … 250mg”. the firm
was asked to mention the hydrate form of the API
along with adjustment of its weight based on
equivalency factor in master formula with
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021. The firm mentioned sesquihydrate (1.5
H2O) form in justification and revised weight of
API based on equivalency factor in master formula,
but it is still anhydrous in the master formula.
• The firm added blistering and packing steps to the
manufacturing outlines.
10296563229)
Decision: Approved. Registration letter will be issued after submission of differential fee of Rs.
20,000/- for correction/pre-approval change, as per notification No.F.7-11/2012-
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Siltaz 100mg Tablet
Cilostazole ……………………..….. 100mg
Rs.20,000/- dated 06.03.2019
Pharmacological Group Antiplatelet agent
Type of Form Form 5
Finished Product Specification The firm has claimed In-house specs.
Approval status of product in Reference Cilostazol Tablets 100 mg. PMDA approved
Me-too status Kladica Tablet 100 mg. Reg. No. 76638
evaluated.
DML.
• The firm has mentioned Cilostazole instead of
Cilostazol.
• Added blistering and packings step to the
7691744945).
Decision: Approved with USP specifications.
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Velzib 10mg Tablet
Composition Each film-coated tablet Contains:
Valdecoxib …………………….… 10mg
Rs.20,000/- dated 06.03.2019
Pharmacological Group Antiinflamatory
Type of Form Form 5
Finished Product Specification The firm has claimed In-house specs.
Pack size & Demanded Price 2’s, 5’s, 10’s, 20’s 30’s, 50’s, 100’s; As per SRO
Me-too status Ulxib 10Mg Tablets. Reg. No. 37069
evaluated.
DML.
availability of same formulation and same strength
in reference regulatory authorities as defined in
275th meeting of the registration board. The firm
provide reference which was discontinued in
USFDA.
1728314772
Decision: Deferred for Evidence of approval of applied formulation in reference regulatory
Pakistan, Pakistan
Brand Name +Dosage Form + Strength D-40000 Capsules
Cholecalciferol …. 1mg (40,000IU)
Rs.50,000/- dated 06.03.2019
Pharmacological Group Vitamins
Type of Form Form 5D
Finished Product Specification The firm has claimed innovator’s specs. Available in
USP
Approval status of product in Reference Plenachol D3 40 000 IU (equivalent to 1.0 mg vitamin
Regulatory Authorities. D3) hard Capsules. MHRA approved
Me-too status Could not be confirmed
evaluated.
DML.
• The firm has applied for hard gelatin capsule, while
the reference product is hypromelluse hard capsule.
The firm shall revise the formulation in line with
the reference product along with submission of
B&A/DRAP dated 07.05.2021 and 13.07.2021.
• The firm shall add blistering and packings step to the
B&A/DRAP dated 07.05.2021 and 13.07.2021.
• The firm shall submit stability data as per zone IV-A.
• Provide evidence of approval of applied formulation already approved by the
Registration Board with brand name & registration number or elsewise applied on the
prescribed form i.e. Form 5D along with applicable fee.
• Submission of stability data as per guidelines of 293rd meeting of Registration Board.
• latest GMP certificate/last inspection report conducted within last three years.
Pakistan, Pakistan
Brand Name +Dosage Form + Strength Hypin 10mg Tablet
Composition Each Film-Coated Tablet Contains:
Lercanidipine Hydrochloride………. …. 10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antihypertensive
Type of Form Form 5
Approval status of product in Reference Lercanidipine Hydrochloride10 mg film-coated tablet.
Me-too status Karman-10 Tablets (Lercanidipine HCl eq. to
Lercanidipine… 10mg). Reg. No. 38010
evaluated.
DML.
9131359212)
Decision: Approved with innovator’s specifications.
94. Name and address of manufacturer / Genix Pharma (Pvt) Ltd, 44-45-B, Korangi Creek Road,
Applicant Karachi 75190, Pakistan, Pakistan
Brand Name +Dosage Form + Strength Meclan 6.25/25 mcg Capsule
Umeclidinium Bromide Eq. To Umeclidinium …
62.5Mcg
Vlinaterol Trifenatate Eq. To Vilanterol …. 25Mcg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
st
125
Approval status of product in Reference Lercanidipine Hydrochloride10 mg film-coated tablet.
evaluated.
DML.
• The firm has applied for hard gelatin capsule, while
the reference product is ANORO ELLIPTA is a
light grey and red plastic inhaler containing 2 foil
blister strips. Each blister on one strip contains a
white powder mix of micronized umeclidinium
bromide (74.2 mcg equivalent to 62.5 mcg of
umeclidinium), magnesium stearate (75 mcg), and
lactose monohydrate (to 12.5 mg), and each blister
on the other strip contains a white powder mix of
micronized vilanterol trifenatate (40 mcg
equivalent to 25 mcg of vilanterol), magnesium
stearate (125 mcg), and lactose monohydrate (to
12.5 mg). After the inhaler is activated, the powder
within both blisters is exposed and ready for
dispersion into the airstream created by the patient
inhaling through the mouthpiece. The firm shall
revise the formulation in line with the reference
product. The firm revised the formulation.
• Revised the quantity of vilanterol trifenatate based on
the salt factor / equivalency in the master formula.
5382568405)
• The firm was asked to provide proof of me-too
product approved by DRAP; otherwise, submit
stability data as per zone IV-A on Form 5D and
differential fee. The firm did not comply.
Registration Board with brand name & registration number or elsewise applied on the
prescribed form i.e. Form 5D along with applicable fee.
• Latest GMP certificate/last inspection report conducted within last three years.
95. Name and address of manufacturer / M/s Welmed Pharmaceuticals Industries (Pvt) Ltd.
Applicant Plot # 108, R-2, Industrial Estate Gadoon, Swabi
Brand Name +Dosage Form + Strength Acyclowel 200mg/5ml oral suspension
Composition Each 5ml Contains:
Acyclovir ……………………………200mg
Rs. 20,000/- dated 04.03.2019
Type of Form Form 5
Available in USP
Approval status of product in Reference Zovirax 200 mg/5 mL oral suspension. HPRA
Me-too status Acovir Dry Suspension. Reg. No. 84093.
GMP status The firm M/s Welmed Pharmaceutical Industries was
inspected on 17-09-2020 and conclusion of inspection
was: Based on the area inspected, the people met and
documentation reviewed and considering the findings
of inspection, M/s Welmed Pharmaceutical Industries
(Pvt.) Ltd. Gadoon-Swabi is considered to be operating
at fair level of compliance with GMP guidelines as per
Drug Act, 1976 and rules framed thereunder.
evaluated.
• Revised the pharmacological group to antivirals.
• Added filling and packing process in the
• Submitted Rs. 7500/- fee. (Challan-82115071359)
Decision: Approved.
Brand Name +Dosage Form + Strength Acyclowel 400mg tablet
Composition Each film-coated tablet Contains:
Acyclovir………………………………400mg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Antiviral
Type of Form Form 5
Pack size & Demanded Price As per SRO
Approval status of product in Reference Aciclovir 400mg tablets, uncoated. MHRA Approved
Me-too status Virocil 400mg Tablet. Reg. No. 83709
evaluated.
• Revised the formulation (label, composition and
manufacturing outlines) from film-coated tablet
to uncoated tablet.
• Submitted Rs. 7500/ (Challan- 983111551
Revised formulation is as under:
Each tablet Contains:
Acyclovir………………………………400mg
Decision: Approved.
Brand Name +Dosage Form + Strength Tenzex 20mg Tablet
st
127
Escitalopram as oxalate eq. to escitalopram…20mg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group SSRIs
Type of Form Form 5
Approval status of product in Reference Escitalopram 20 mg film-coated tablets. MHRA
Me-too status Neolexa 20mg Tablet . Reg. No. 66978
evaluated.
• Had adjusted the weight of the API in master
formulation.
• Revised Escitalopram as oxalate to Escitalopram
oxalate in master formulation.
Decision: Approved.
Brand Name +Dosage Form + Strength Tenzex 5mg Tablet
Escitalopram as oxalate eq. to escitalopram…5mg
Rs. 20,000/- dated 04.03.2019
Type of Form Form 5
Me-too status Dipgo Tablet 5mg. Reg. No. 85714
evaluated.
formulation.
• Revised Escitalopram as oxalate to Escitalopram
oxalate in master formulation.
Decision: Approved.
Brand Name +Dosage Form + Strength Mopin 2% Cream
Mupirocin Calcium Eq. To Mupirocin …………2%
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Other antibiotics for topical use
Type of Form Form 5
Pack size & Demanded Price 10g; As per SRO
Approval status of product in Reference SOUL PATTINSON ANTIFUNGAL
Regulatory Authorities. CLOTRIMAZOLE WOMEN'S TREATMENT 2%
w/w vaginal cream tube. TGA approved
Me-too status Upirox Cream 2%. Reg. No. 82540
evaluated.
antibiotics to Other antibiotics for topical use.
formulation. Revised it from 21.36mg to 21.5mg
and revised “Mupirocin Calcium Eq To
Mupirocin” to Mupirocin Calcium in master
formulation.
• Did not add filling and packing process in the
• Submitted Rs. 7500 (Challan-45284768140).
Decision: Approved. Firm will also provide revised manufacturing outlines with revision of
filling and packing process with applicable pre-registration variation fee as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Strength Welpro 800mg/15ml Syrup
Iron protein succinylate 800mg eq. to elemental
iron…………………………………40mg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Antianemic
Type of Form Form 5
Approval status of product in Reference FERPLEX 40 mg Oral Solution (Each vial of 15
Regulatory Authorities. ml of oral solution contains: Iron protein succinylate
800 mg (contains milk protein), equivalent to 40 mg
of Fe 3+ ). CIMA approved
Me-too status Hemiplex Syrup. Reg. No. 057283
evaluated.
• Added packing process in the manufacturing
outlines.
• In the revised document the label claim is elemental
Iron 40mg and protein succinylate 800mg/15ml.
The frim once again submitted that the initially
submitted label claim may be considered.
• Submitted Rs. 7500 (Challan-1375516780)
Decision: Deferred for review of applied formulation in line with innovator drug product and
generic product.
101. Name and address of manufacturer / M/s Welmed Pharmaceuticals Industries (Pvt.) Ltd.
Brand Name +Dosage Form + Strength Welzin 20mg/5ml oral syrup
Composition Each 5ml Syrup Contains:
Zinc Sulphate Monohydrate ……………..…20mg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Other mineral supplements
Type of Form Form 5
Approval status of product in Reference Available in IP as solution (Available strengths: 10
Regulatory Authorities. mg or 20 mg of zinc per 5 mL)
Me-too status Zevro Syrup 10mg. Reg. No. 77058
evaluated.
• Revised the pharmacological group from trace
elements to Other mineral supplements.
• Revised the label claim from Zinc Sulphate
Monohydrate…20mg to Zinc Sulphate
Monohydrate eq to zinc …20mg and adjusted its
weight as per salt factor in the master formula.
• Submitted Rs. 7500 (challan-122735245).
Revised label claim is as under:
Each 5ml Syrup Contains:
Zinc Sulphate Monohydrate eq. to elemental Zinc
……………..…20mg
Decision: Approved. Registration letter will be issued after submission of differential fee of
22,500/- /- for correction/pre-approval change, as per notification No.F.7-11/2012-
Brand Name +Dosage Form + Strength Onised 4mg/5ml Syrup
Composition Each 5ml Syrup Contains:
Ondansetron as HCl Dihydrate ………………4mg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Serotonin (5HT3) antagonists
Type of Form Form 5
Approval status of product in Reference Ondansetron (as the hydrochloride dihydrate)
Regulatory Authorities. 4mg/5ml Syrup. MHRA Approved
Me-too status Ondan syrup 4mg/5ml, Bio-mark pharmaceutical,
Reg. No. 082628.
evaluated.
• Revised the pharmacological group from selective
Serotonin (5HT3) receptor antagonists to
Serotonin (5HT3) antagonists.
formulation. Revised Ondansetron as HCl
dihydrate to Ondansetron HCl dihydrate in
master formulation.
• Submitted Rs. 7500/- fee. (Challan-6223047112)
Decision: Approved.
103. Name and address of M/s Safe Pharmaceuticals Pvt Ltd. Plot No. C.I-20, Sector 6-
manufacturer / Applicant B, North Karachi Industrial Area, Karachi
Brand Name +Dosage Form + Fast D Tablet 60/120mg
Strength
Fexofenadine HCl…………………..…60mg
Pseudoophedrine HCl……………..…120mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Nasal decongestants for systemic use
Type of Form Form 5
Pack size & Demanded Price 1x10’s, 2x10’s, 3x10’s; As per SRO
Approval status of product in ALLEGRA-D 12 HOUR Extended-Release Tablets. USFDA
Reference Regulatory Authorities. approved
Me-too status Fexet-D 60Mg/120Mg film-coated Tablets. Reg No. 39099
(data does not depict two layer tablet)
GMP status The firm was inspected on 24.03.2021, wherein GMP was
rated as GOOD
Remarks of the Evaluator. • Revised the pharmacological group from antihistamine to
antihistamine, Nasal decongestants for systemic use.
• Revised the term capsule in the manufacturing outlines to
tablet.
• Revised each film-caoted tablet to Each extended release
tablet.
• The manufacturing outlines contained alogliptn and
pioglitazone, and capsule. Revised it.
• Submitted Rs. 7500/- (Challan- 5244429795)
• The reference product is in the form of two-layer extended
release tablet. Revise the formulation accordingly.
• Provide proof of availability of manufacturing facility.
• Revise the pseudoephedrine to pseudoephedrine HCl in the
recently submitted master formulation.
• Revision of formulation as per reference product as the reference product is in the form
of two-layer extended release tablet.
• Revision of label claim from each film-caoted tablet to Each extended release tablet shall
be accompanied with full fee instead of 7500/-.
• Evidence of availability of bilayerd tablet machine.
• Revision of pseudoephedrine to pseudoephedrine HCl in the recently submitted master
formulation.
Brand Name +Dosage Form + Linzox Tablet 400mg
Strength
Linezolid ……………………….…400mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Other antibacterials
Type of Form Form 5
Finished Product Specification The firm has claimed innovator’s specifications.
Pack size & Demanded Price 1x12’s,; As per SRO
Approval status of product in ZYVOX® (linezolid) tablets (film-coated) for oral use by
Reference Regulatory Authorities. Pharmacia and Upjohn. not discontinued or withdrawn by US-
FDA for safety or efficacy reasons
Me-too status Enliv 400mg Tablet by PharmEvo (Pvt.) Ltd. Reg No. 58096
(does not depict coating)
rated as GOOD
Remarks of the Evaluator. • Revised the pharmacological group from antibiotics to
antibacterials.
tablet.
• Did not mention coating composition and coating process.
Revised it accordingly.
• For revision, submit applicable fee as per notifications 7-
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Decision: Approved. Registration letter will be issued after submission of 7500/- fee for
dated 13-07-2021.
Brand Name +Dosage Form + Linzox Tablet 600mg
Strength
Linezolid …………………………….…600mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Other antibacterials
Type of Form Form 5
Approval status of product in ZYVOX® (linezolid) 600mg tablets (film-coated) for oral use
Reference Regulatory Authorities. by Pharmacia and Upjohn. US-FDA approved
Me-too status Ozlin 600 mg Tablet by Linta Pharmaceuticals. Reg No.
78179
GMP status The firm was inspected on 24.03.2021, wherein GMP was rated
as GOOD
Remarks of the Evaluator. • Revised the pharmacological group from antibiotics to
antibacterials.
tablet.
• Did not mention coating composition and coating process.
Revised it accordingly.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Decision: Approved. Registration letter will be issued after submission of 7500/- fee for
dated 13-07-2021.
Brand Name +Dosage Form + S Vant 4mg Tablet
Strength
Candesartan Cilexetil …………………….…4mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Angiotensin II receptor blockers (ARBs) and diuretics
Type of Form Form 5
Approval status of product in ATACAND® (candesartan cilexetil) non-film-coated tablets,
Reference Regulatory Authorities. for oral use. USFDA approved
Me-too status Ozlin 600 mg Tablet by Linta Pharmaceuticals. Reg No.
78179
rated as GOOD
Remarks of the Evaluator. • Revised the pharmacological group from Angiotensin II
receptor antagonist to Angiotensin II receptor blockers
(ARBs) and diuretics.
tablet.
• Had applied for film-coated tablet without providing coating
composition and process. The firm was asked to provide
proof of international availability in the reference
regulatory agencies as defined by the registration board in
its 275th meeting, or revise the formulation to uncoated
tablet. The firm did not comply.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
submission of 7500/- fee for correction/pre-approval change, as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Firm will also submit revised form 5, its annexures and label claim as uncoated tablets
as per reference product and submission of pre-registration variation fee.
Brand Name +Dosage Form + Savantazide Tablet 16mg/12.5mg
Strength
Candesartan Cilexetil…16mg
Hydrochlorothiazide…12.5mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Candesartan and Hydrochlorothiazide 16 mg/12.5 mg Tablets,
Reference Regulatory Authorities. uncoated. MHRA approved
Me-too status Carac-H Tablet 16/12.5mg. Reg No. 55803
rated as GOOD
Remarks of the Evaluator. • Revised the pharmacological group from angiotensin
receptor blockers to Angiotensin II receptor blockers
tablet.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Savantazide Tablet 32mg/25mg
Strength
Candesartan Cilexetil……………………….…32mg
Hydrochlorothiazide………………………..…25mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Candesartan and Hydrochlorothiazide 32 mg/25 mg Tablets,
Reference Regulatory Authorities. uncoated. MHRA approved
Me-too status Cansaar Forte Tablets (film-coated). Reg No. 39581
rated as GOOD
Remarks of the Evaluator. • Revised the pharmacological group from angiotensin
receptor blockers to Angiotensin II receptor blockers
tablet.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
st
134
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Tranic Injection 1gm/5ml
Strength
Tranexamic Acid…1g
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Antihaemorrhagic
Type of Form Form 5
Finished Product Specification The firm has claimed innovator’s specifications. available in
BP and JP
Pack size & Demanded Price 1x10’s (5ml); As per SRO
Approval status of product in Could not be confirmed.
Reference Regulatory Authorities.
Me-too status Trasolide Injection 1gm/5ml. Reg No. 68820
rated as GOOD
Remarks of the Evaluator. • There was no initial sterilization of the ampules and terminal
sterilization in the manufacturing outlines. The frim
revised it.
• Added filling, sealing and packing process in the
• Mentioned the oral route of administration. Then, revised it.
• Submitted Rs. 7500/- fee (challan-07880832)
• Proof of international availability of same formulation and
same strength with filled volume of 5ml in reference
regulatory authorities as defined in 275th meeting of the
registration board is required
Brand Name +Dosage Form + Tranic Injection 500mg/5ml
Strength
Tranexamic Acid…500mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Antihaemorrhagic
Type of Form Form 5
Finished Product Specification The firm has claimed innovator’s specifications. available in
BP and JP
Pack size & Demanded Price 1x10’s (5ml); As per SRO
Approval status of product in Tranexamic acid 100mg/ml Solution for Injection (5ml,
Reference Regulatory Authorities. 10ml). MHRA approved
Me-too status Dravix 500mg/5ml Injection. Reg No. 76447
rated as GOOD
Remarks of the Evaluator. • There was no initial sterilization of the ampules and terminal
sterilization in the manufacturing outlines. The frim
revised it.
• Mentioned the oral route of administration. Then, revised it.
• Submitted Rs. 7500/- fee (challan-0663624757)
Decision: Approved with BP specifications.
111. Name and address of manufacturer / M/s Swan Pharmaceuticals pvt Ltd 11-E, Industrial
Applicant Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Lansodex 30mg Capsule
Dexlansoprazole Enteric Coated Pellets Eq To
Dexlansoprazole …………………………30mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference Dexilant capsule, delayed release. USFDA approved.
Me-too status
GMP status swngmp
evaluated.
• Form 5 has not been signed by the applicant, i.e.,
CEO.
• You have mentioned the demanded price as per
requirement of the importing country. Clarify.
• Justify the addition of 3% overage in the
composition.
• Specify the capsule shell material and other
excipients used in pellets in the master formula.
sheets of three batches of the pellets.
• For above revision, submit applicable fee as per
07.05.2021 and 13.07.2021.
• Submit stability data of three batches conducted in
Zone IV-A.
• Submit latest GMP inspection report.
Decision: Deferred for the following;
• Justify the addition of 3% overage in the composition.
• Specify the capsule shell material and other excipients used in pellets in the master
formula.
summary sheets of three batches of the pellets. In case of imported pellets, differential
fee shall also be submitted.
• Stability study data as per guidelines provided in 293rd meeting of Registration Board.
Brand Name +Dosage Form + Strength Lansodex 60mg Capsule
Dexlansoprazole Enteric Coated Pellets Eq To
Dexlansoprazole ………………………..…60mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference Dexilant capsule, delayed release. USFDA approved.
Me-too status
GMP status swngmp
evaluated.
CEO.
• You have demanded the price as per SRO and have
mentioned the demanded price as per requirement
of the importing country. Clarify.
• Justify the addition of 3% overage in the
composition.
• Specify the capsule shell material and other
excipients used in pellets in the master formula.
sheets of three batches of the pellets.
07.05.2021 and 13.07.2021.
• Submit stability data of three batches conducted in
Zone IV-A.
• Justify the addition of 3% overage in the composition.
• Specify the capsule shell material and other excipients used in pellets in the master
formula.
summary sheets of three batches of the pellets. In case of imported pellets, differential
fee shall also be submitted.
• Stability study data as per guidelines provided in 293rd meeting of Registration Board.
Brand Name +Dosage Form + Strength Oxazol 600mg/300ml Infusion
Composition Each Vial Of 300ml Contains:
Linezolid ……………………600mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group other antibacterials
Type of Form Form 5
Pack size & Demanded Price 1 vial (300ml); As per SRO
Approval status of product in Reference ZYVOX® (Linezolid) Injection, for Intravenous Use
Regulatory Authorities. 200mg/100ml, 600mg/300ml. USFDA approved
ZYVOX® (Linezolid) Injection, for Intravenous Use
400mg/200ml,. discontinued in USFDA not for safety /
efficacy reasons.
Me-too status Linzol Infusion 600mg. Reg No. 81999
GMP status swngmp
evaluated.
CEO. Signed Form submitted.
• Revisde the pharmacological group from antibiotics
to “other antibacterials”.
• Demanded the price as per SRO and have mentioned
the demanded price as per requirement of the
importing country. Revised the price as per SRO.
• The firm removed 3% overage in the composition.
• Submitted Rs. 10000 fee (challan-2336766029)
detail of the product not provided.
Brand Name +Dosage Form + Strength Moxiwan 400mg/250ml Infusion
Moxifloxacin as HCl …………………….…400mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Fluoroquinolone
Type of Form Form 5
Approval status of product in Reference Moxifloxacin 400 mg/250 ml solution for infusion.
Regulatory Authorities. MHRA approved.
Me-too status X-Lox 400mg Infusion. Reg No. 76970
GMP status swngmp
evaluated.
• Already adjusted the weight of API as per
equivalency factor Revised Moxifloxacin as HCl to
Moxifloxacin HCl in the master formula.
detail of the product not provided
Brand Name +Dosage Form + Strength Race 500mg/5ml IV Injection
Composition Each Ampoule Contains:
Levetiracetam …………………..…500mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group antiepileptics
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specs. Available in USP
Pack size & Demanded Price 1 ampule (5ml); As per SRO
Approval status of product in Reference Levetiracetam Wockhardt 100mg/ml concentrate for
Regulatory Authorities. solution for infusion. MHRA approved.
Me-too status Epicetam Injection 500mg Reg No. 78922
GMP status swngmp
evaluated.
• Submitted Rs. 10000 fee (challan-74345098) detail
of the product not provided
of latest GMP certificate/last inspection report conducted within last three years.
Brand Name +Dosage Form + Strength Moxafil Infusion 100mg/50ml
Fluconazole ………………………100mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Triazole and tetrazole derivatives
Type of Form Form 5
Finished Product Specification The firm has mentioned NaCl in excipients and claimed
in-house specs. Available in USP (as Fluconazole in
dextrose, and Fluconazole in NaCl), BP (Fluconazole
infusion is sterile solution), IP (as Fluconazole in Water
for injections) and JP (an aqueous injection, pH specified
separately when the drug is granted approval based on
the Law)
Approval status of product in Reference Fluconazole 2mg/ml solution for infusion (with NaCl)
Regulatory Authorities. (50ml. 100ml, 200ml) in LDPE bottles or polyolefine
bags. MHRA approved.
Me-too status Cozil I.V Infusion (50ml). Reg No. 77581
GMP status swngmp
evaluated.
• Revised the pharmacological group from Triazole
antifungal to Triazole and tetrazole derivatives.
• Submitted Rs. 10000 fee (challan-34358762) detail
of the product not provided
Brand Name +Dosage Form + Strength Sitamet 50/500 mg Tablet
Sitagliptin Phosphate ………………..…50mg
Metformin HCl ………………………500mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference JANUMET® (sitagliptin and metformin HCl) tablet,
Regulatory Authorities. 50/500mg film-coated. USFDA approved
Me-too status Neoglip 50/500mg Tablets. Reg. No. 53099 (does not
depict hydrate form).
GMP status swngmp
evaluated.
• Revised the pharmacological group to Combinations
of oral blood glucose lowering drugs.
• Revised Sitagliptin Phosphate to Sitagliptin as
phosphate monohydrate in the label claim and to
Sitagliptin phosphate monohydrate in master
formula and adjusted its weight in master formula
as per equivalency factor.
Sitagliptin as Phosphate monohydrate ..…50mg
submission of submission of 20,000/- fee for correction/pre-approval change, as per
notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Firm will also submit latest GMP certificate/last inspection report conducted within
last three years.
Brand Name +Dosage Form + Strength Sitamet DS 50/1000 mg Tablet
Sitagliptin Phosphate…50mg
Metformin HCl…1000mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference JANUMET® (sitagliptin and metformin HCl) tablet,
Regulatory Authorities. 50/1000mg film-coated. USFDA approved
Me-too status Neoglip 50/1000mg Tablets. Reg. No. 53100 (does not
depict hydrate form).
GMP status swngmp
evaluated.
• Revised the pharmacological group to Combinations
of oral blood glucose lowering drugs.
• Revised Sitagliptin Phosphate to Sitagliptin as
phosphate monohydrate in the label claim and to
Sitagliptin phosphate monohydrate in master
formula and adjusted its weight in master formula
as per equivalency factor.
Sitagliptin as Phosphate monohydrate ..…50mg
submission of 20,000/- fee for correction/pre-approval change, as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
last three years.
119. Name and address of manufacturer / M/s Swan Pharmaceuticals Pvt Ltd 11-E, Industrial
Brand Name +Dosage Form + Strength Tamisol 0.4mg Capsule
Tamsulosin HCl Modified Release Pellets Eq. To
Tamsulosin………………………..…0.4mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Alpha-adrenoreceptor antagonists
Type of Form Form 5
Approval status of product in Reference FLOMAX® (tamsulosin hydrochloride, USP) Capsules,
Regulatory Authorities. for oral use. USFDA approved
Me-too status Tamsolin 0.4mg Capsule. Reg. No. 50392
GMP status swngmp
evaluated.
• Revised the pharmacological group from selective
apha-1 blockers to Alpha-adrenoreceptor
antagonists
• The firm was asked to provide the source of pellets
along with GMP certificate of the firm, COA and
stability summary sheets of three batches of the
pellets. The firm submitted the source as M/s vision
pharmaceutical, Islamabad.
• You have adjusted the weight of pellets as per
strength of the pellets. Revise the weight
considering the equivalency factor as well, because
the pellets assay is in terms of Tamsulosin HCl.
material. Specified as gelatin.
of revised master formula with adjusting the weight of pellets as per strength of the
pellets. Also revise the weight considering the equivalency factor as well, because the
pellets assay is in terms of Tamsulosin HCl.
last three years.
120. Name and address of manufacturer / M/s Safe Pharmaceuticals Pvt Ltd. Plot No. C.I-20,
Applicant Sector 6-B, North Karachi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Leveron Oral Solution 100mg/ml
Levetiracetam …………………..…100mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specs. available in USP
Pack size & Demanded Price 30ml, 60ml, 120ml; As per SRO
Approval status of product in Reference KEPPRA (levetiracetam) oral solution 100mg/ml.
Me-too status Evic Solution 100mg/ml. Reg. No. 82629
GMP status GMP certificate issued on 13.08.2022
evaluated.
• Claimed levetricetam 100mg per ml. while it is
levetricetam 100mg per 5ml in the master formula.
Revised it to 100mg per ml.
of 20,000/- fee for correction/pre-approval change, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Strength Savantazide Tablet 32mg/12.5mg
Candesartan Cilexetil ……………..…32mg
Hydrochlorothiazide …………….…12.5mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Angiotensin II receptor blockers (ARBs) and diuretics.
Type of Form Form 5
Finished Product Specification The firm has claimed innovator’s specs. available in
USP
Approval status of product in Reference Candesartan/Hydrochlorothiazide 32 mg/12.5 mg
Regulatory Authorities. tablets. MHRA approved
Me-too status Advantec Tablet 32/12.5mg. Reg. No. 80270
evaluated.
group from Angiotensin II receptor antagonist to
Angiotensin II receptor blockers (ARBs) and
diuretics. The firm did not comply.
• Revised the term capsule in the manufacturing
outlines to tablet.
• Added blistering and packing process in
themanufacturing outlines.
• Applied for film-coated tablet. Revised the
formulation to uncoated tablet.
Each Tablet Contains:
Hydrochlorothiazide …………….…12.5mg
Decision: Approved with USP specifications. Registration letter will be issued after revision of
the pharmacological group from Angiotensin II receptor antagonist to Angiotensin
II receptor blockers (ARBs) and diuretics.
Brand Name +Dosage Form + Strength S Vant 32mg Tablet
Candesartan Cilexetil ……………….…32mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Angiotensin II receptor blockers
Type of Form Form 5
Approval status of product in Reference Candesartan 32 mg tablets. MHRA approved
Me-too status Skygen Neo Tablet. Reg. No. 67268
evaluated.
Angiotensin II receptor antagonist to Angiotensin
II receptor blockers (ARBs).
outlines to tablet.
• Added blistering and packing process in the
• Applied for film-coated tablet without providing
coating composition and process. Revised the
formulation to uncoated tablet.
Decision: Approved.
123. sName and address of manufacturer / M/s Safe Pharmaceuticals Pvt Ltd. Plot No. C.I-20,
Brand Name +Dosage Form + Strength Riloxban Tablet 10mg
Rivaroxaban ………………………10mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Direct factor Xa inhibitors
Type of Form Form 5
Finished Product Specification The firm has claimed USP specs. Not available in USP
Pack size & Demanded Price 2x10’s, 5x10’s; As per SRO
Approval status of product in Reference Rivaroxaban 10 mg film-coated tablets by Milpharm
Regulatory Authorities. Limited. MHRA approved
Me-too status Xaroban 10mg Tablet. Reg. No. 76284
evaluated.
• Revised the pharmacological group from sedative &
hypnotics to Direct factor Xa inhibitors.
outlines to tablet.
composition and manufacturing outlines for film-
coated tablet.
Rivaroxaban……………………….…15mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Me-too status Roxaban 15mg Tablet. Reg. No. 85165
evaluated.
outlines to tablet.
coated tablet.
Rivaroxaban………………………….…20mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Me-too status Roxaban 20mg Tablet. Reg. No. 85164
evaluated.
outlines to tablet.
coated tablet.
Brand Name +Dosage Form + Strength Lorex plus 5/120mg Tablet
Loratadine…………………….……..…5mg
Pseudoephadrine………………………120mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group other antihistamines for systemic use with
sympathomimetics.
Type of Form Form 5
Pack size & Demanded Price 1x10’s, 2x10’s, 3x10’s; As per SRO
Approval status of product in Reference
Me-too status
Decision: evaluated.
antihistamines to antihistamines,
sympathomimetics.
• Applied for film coated tablet, added coating
excipients and coating process in composition and
• Submitted fee Rs. 7500 (challan-8422359415)
• Provide proof of international availability in the
reference regulatory agencies as defined by the
registration board in its 275th meeting.
• Proof of me-too product (name and registration
number) already approved by DRAP is required.
Deferred for following:
• Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
along with registration number, brand name and name of firm.
• Evidence of approval of applied formulation in reference regulatory authorities/agencies
which were declared/approved by the Registration Board.
Brand Name +Dosage Form + Strength Tranic 250mg Capsule
Tranexamic Acid …………………..…250mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Antihemorrhagics
Type of Form Form 5
Finished Product Specification The firm has claimed innovator’s specs. available in JP
Approval status of product in Reference TRANEX 250mg capsule. AIFA approved
Me-too status Tranza 250mg capsules. Reg No. 85769
evaluated.
• Specified the capsule shell material in the
composition.
• Revised the term tablet in the manufacturing outlines
to capsule.
• Removed the compression process from the
07.05.2021 and 13.07.2021.
Decision: Approved with JP specifications. Registration letter will be issued after submission
of 7500/- fee for correction/pre-approval change, as per notification No.F.7-11/2012-
Brand Name +Dosage Form + Strength Tranic 500mg Capsule
Tranexamic Acid…500mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Finished Product Specification The firm has claimed innovator’s specs. available in JP
Approval status of product in Reference TRANEX 500mg capsule. AIFA approved
Me-too status Sotran 500 Capsule. Reg No. 80350
evaluated.
• Specified the capsule shell material in the
composition.
• Revised the term tablet in the manufacturing outlines
to capsule.
• Removed the compression process from the
07.05.2021 and 13.07.2021.
of 7500/- fee for correction/pre-approval change, as per notification No.F.7-11/2012-
Brand Name +Dosage Form + Strength Tranic Injection 250mg/5ml
Tranexamic Acid…………………….…250mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Finished Product Specification The firm has claimed innovator’s specs. available in BP
and JP
Pack size & Demanded Price 1x10’s (5ml ampule); As per SRO
Me-too status Dravix 250mg/5ml Injection. Reg No. 76446
evaluated.
• Added initial sterilization of the ampules and
terminal sterilization in the manufacturing outlines.
Justify.
• Mentioned the oral route of administration. Revised
it to injectable.
• Submitted fee Rs. 7500 (challan-29857311484)
• Proof of international availability of same
formulation and same strength with filled volume
of 5ml in reference regulatory authorities as
defined in 275th meeting of the registration board
is required
Brand Name +Dosage Form + Strength Linzox Infusion 200mg/100ml
Composition Each 100ml vial Contains:
Linezolid ………………………..…200mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Antibacterials
Type of Form Form 5
Pack size & Demanded Price 100ml vial; As per SRO
efficacy reasons.
evaluated.
• Revised the pharmacological group from antibiotics
to “antibacterials, oxazolidinone”.
• Applied for 200mg/100ml, while it is 200mg/5ml in
the master formula. Revised it to 200mg/100ml.
• Added initial sterilization of the vials and terminal
sterilization in the manufacturing outlines.
• Mentioned injection as the route of administration.
Revised it to infusion. They did not mention IV
route.
Linezolid …………………………..…400mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group antibacterials, oxazolidinone
Type of Form Form 5
efficacy reasons.
evaluated.
route.
Linezolid…600mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
efficacy reasons.
evaluated.
route.
Brand Name +Dosage Form + Strength Linzox Suspension 100mg/5ml
Linezolid …………………………100mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Pack size & Demanded Price 60ml, 120ml; As per SRO
Approval status of product in Reference ZYVOX for Oral Suspension (granule/powder). USFDA
Me-too status Nezolid 100mg Suspension. Reg No. 50326
evaluated.
• Applied for suspension, and have mentioned various
liquids in the excipients. Moreover, the
manufacturing outlines also depict that the product
is liquid suspension. The reference product is dry
suspension for reconstitution. Revised the applied
product, the excipients and manufacturing outlines
meant for dry suspension.
Brand Name +Dosage Form + Strength Sericalm Suspension 2mg/ml
Haloperidol Decanoate……………………..2mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Butyrophenone derivatives
Type of Form Form 5
Finished Product Specification The firm has claimed innovator’s specs. Available in
USP and BP
Approval status of product in Reference Haloperidol Oral Solution BP 10mg/5 ml. MHRA
Serenace 2mg/ml liquid solution. TGA approved (export
only medicine).
evaluated.
tranquilizers to “Butyrophenone derivatives”.
• Applied for suspension, while you have mentioned
syrup in the international reference. Revised oral
suspension to oral solution.
• Revised Haloperidol Decanoate…2mg to
Haloperidol…2mg.
• Add filling and packing process in the manufacturing
outlines.
07.05.2021 and 13.07.2021.
Registration Board with brand name, manufacturer name & registration number or
elsewise applied on the prescribed form i.e. Form 5D along with applicable fee.
• latest GMP certificate/last inspection report conducted within last three years.
Brand Name +Dosage Form + Strength Montesafe Sachet 4mg
Composition Each Sachet Contains:
Montelukast sodium …………………….…4mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Leukotriene receptor antagonists
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specs. Available in USP
Approval status of product in Reference SINGULAIR® (montelukast as sodium 4mg) oral
Regulatory Authorities. granules. USFDA approved
Me-too status Inspra Oral Granules 4mg. Reg. No. 73781
evaluated.
bronchodialtor to “Leukotriene receptor
antagonists”.
• Revised montelukast sodium to montelukast as
sodium in the label claim only, and adjusted its
weight as per salt factor in the master formula.
• You have mentioned filled weight of 60ml in the
manufacturing outlines. Clarify/ revise.
of 22,500/- fee for correction/pre-approval change, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
• Firm will also revise their manufacturing outlines to remove 60ml fill volume and
submission of pre-registration variation fee.
Brand Name +Dosage Form + Strength Zolcarb 20/1680 sachet
Omeprazole …………………..…20mg
Sodium Bicarbonate ………….…1680mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Finished Product Specification Not submitted. Available in USP
Approval status of product in Reference Omeprazole and sodium bicarbonate (Packet) for oral
Regulatory Authorities. suspension. approved by US-FDA
Me-too status Risek Insta Sachet by Getz Pharma (Pvt.) Ltd., Karachi
Reg. No. 58547
evaluated.
• Applied for omeprazole 20mg and sodium
bicarbonate 1680mg sachet.
• Later, submitted properly filled enclosure of Form 5.
• Later, submitted undertaking at the end of form 5.
• Later, submitted the exact label claim, composition
with list of excipients and manufacturing outlines.
07.05.2021 and 13.07.2021.
submission of fee for correction/pre-approval change, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Strength Zolcarb forte 40/1680 sachet
Omeprazole ……………………………….…40mg
Sodium Bicarbonate ………………………1680mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Proton pump inhibitor.
Type of Form Form 5
Approval status of product in Reference Omeprazole and sodium bicarbonate (Packet) for oral
Regulatory Authorities. suspension. approved by US-FDA
Me-too status Risek Insta Sachet by Getz Pharma (Pvt.) Ltd., Karachi
Reg. No. 58548
evaluated.
• Applied for omeprazole 40mg and sodium
bicarbonate 1680mg sachet.
• Later, submitted properly filled enclosure of Form 5.
• Later, submitted undertaking at the end of form 5.
• Later, submitted the exact label claim, composition
with list of excipients and manufacturing outlines.
07.05.2021 and 13.07.2021.
submission of fee for correction/pre-approval change, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
138. Name and address of manufacturer / M/s Usawa Pharmaceuticals. 146 S.I.Z. Risalpur,
Applicant KPK, Pakistan
By
M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle,
Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Awacol 11MU IV Injection
Colistimethate Sodium (Lyophilized Powder)
………………………………………1MIU
Rs. 50,000/- dated 05.03.2019
Pharmacological Group Antibiotic (polymyxin)
Type of Form Form 5
Approval status of product in Reference Colistimethate Sodium 1 Million I.U. Powder for
Regulatory Authorities. Solution for Injection (lyophilized powder in glass
vial). Approved by MHRA
Me-too status Colistat powder for Injection. Reg. No. 76160
GMP status M/s Usawa Pharmaceuticals was inspected on
08.01.2019, wherein satisfactory level of GMP was
reported
M/s Usawa Pharmaceuticals was inspected on
08.07.2021, 15.07.2021, 30.07.2021 and 03.08.2021
wherein renewal of DML / regularization of layout
plan, grant of additional section as well as change in
section was recommended
evaluated.
• Did not provide chemical name of the API at serial
No. 03. Later on, submitted it.
• Had mentioned Colistimethate Sodium eq. to
Colistimethate and mentioned its weight as
85.68mg in master formula. Then, mentioned
Colistimethate Sodium…1MIU and revised
85.68mg to 90mg (for 7% water contents and
4%overage). Then, revised Colistimethate
Sodium…90mg (for 7% water contents and
4%overage to Colistimethate Sodium…80mg.
But the label claim in the revised documents is
Colistimethate Sodium eq. to
Colistimethate….1MIU. Then, once again
submitted the label claim “Each Vial Contains:
Colistimethate Sodium (Lyophilized
Powder)…1MIU” shall be considered.
• Also mentioned water for injection, and
lyophilization process.
• Added packing process to the manufacturing
outlines.
• Revised brand Awacol 11MU to Awacol 1MIU.
Decision: Registration Board deferred the case for submission of batch manufacturing details
of most recent commercial batch from M/s Bio Labs Pvt Ltd., for applied
formulation to confirm the fact whether Colistimethate injection is formulated
from pre-lyophilised drug substance or otherwise.
By
Brand Name +Dosage Form + Strength Usven 500mg Injection
Vancomycin as HCl …………………500mg
Rs. 50,000/- dated 05.03.2019
Pharmacological Group Tricyclic Glycopeptide
Type of Form Form 5
Approval status of product in Reference VANCOCIN CP vancomycin 500mg (as
Regulatory Authorities. hydrochloride) powder for injection vial. TGA
approved
Me-too status Vanzy 500mg Injection. Reg. No. 81901
reported
M/s Bio-lab was inspected on 08.07.2021,
15.07.2021, 30.07.2021 and 03.08.2021 wherein
renewal of DML / regularization of layout plan, grant
of additional section as well as change in section was
recommended
evaluated.
• Had adjusted the weight of API as per salt factor in
the master formula. Revised Vancomycin as HCl
to Vancomycin HCl in the master formula.
• Mentioned the excipients in the master formula/
composition.
• Submitted complete manufacturing outlines.
• Enclosure of Form 5 from point 16 onwards was
missing. Submitted it.
• Confirmation of manufacturing method for the applied formulation whether through
lyophilization process or otherwise.
• Latest GMP certificate/last inspection report conducted within last three years for
contract acceptor.
By
Brand Name +Dosage Form + Strength Usven 1g Injection
Vancomycin as HCl ………………………..…1g
Rs. 50,000/- dated 05.03.2019
Pharmacological Group Tricyclic Glycopeptide
Type of Form Form 5
Approval status of product in Reference VANCOCIN CP vancomycin 1g (1,000,000IU as
Regulatory Authorities. hydrochloride) powder for injection vial. TGA
approved
Me-too status Vanzy 1g Injection. Reg. No. 81902
reported
M/s M/s Bio-lab was inspected on 08.07.2021,
15.07.2021, 30.07.2021 and 03.08.2021 wherein
recommended
evaluated.
• Had adjusted the weight of API as per salt factor in
the master formula. Revised Vancomycin as HCl
to Vancomycin HCl in the master formula.
• Mentioned the excipients in the master formula/
composition.
• Confirmation of manufacturing method for the applied formulation whether through
lyophilization process or otherwise.
• Latest GMP certificate/last inspection report conducted within last three years for
contract acceptor.
By
Brand Name +Dosage Form + Strength Ketoride 30mg Ampoule
Ketorolac Tromethamine ………………..…30mg
Rs. 50,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Reference TORADOL ketorolac trometamol 30mg/1mL
Regulatory Authorities. (ketorolac trometamol 30mg without equivalency)
injection ampoule. TGA approved.
Me-too status Syntor 30 mg Injection IV/IM. Reg. No. 83365
reported
M/s M/s Bio-lab was inspected on 08.07.2021,
15.07.2021, 30.07.2021 and 03.08.2021 wherein
recommended
evaluated.
• Submitted complete manufacturing outlines.
• Enclosure of Form 5 from point 16 onwards was
missing. Submitted it.
07.05.2021 and 13.07.2021.
Decision: Registration Board deferred the case for further deliberation regarding the
sterilization method of the applied formulation whether by way of terminal sterilization or
otherwise.
142. Name and address of manufacturer / M/s High-Q Pharmaceuticals
Applicant B-64, KDA, Scheme No. 1, Main Karsaz Road,
Karachi, Pakistan
By
M/s Aries Pharmaceuticals.
1-W, Industrial Estate, Hayatabad, Peshawar, KPK,
Pakistan
Brand Name +Dosage Form + Strength Dupagest Tablet 10mg
Dydrogesterone ………………….…10mg
Rs. 50,000/- dated 06.03.2019
Pharmacological Group Progestogen
Type of Form Form 5
Pack size & Demanded Price As per SRO; Rs 600/-
Approval status of product in Reference Duphaston 10 mg film-coated tablets. Approved in
Regulatory Authorities. Belgium
Me-too status D-Gest 10mg Tablets. Reg. No. 77100
GMP status
evaluated.
• The firm has claimed tran isomer of the drug
substance.
• The address of manufacturer in Form 5 is M/s Aries
Pharmaceuticals, 1-W, Industrial Estate,
Hayatabad, Peshawar, KPK, Pakistan, while it is
M/s Aries Pharmaceuticals (Pvt.) Ltd., 1-W,
Industrial Estate, Hayatabad, Peshawar in the
DML.
• Form 5 shall be submitted by the applicant, not
manufacturer along with submission of applicable
fee as per notification 7-11/2012-B&A/DRAP
dated 07.05.2021 and 13.07.2021.
• Submit copy of the DML of the applicant.
• Submit undertaking at the end of Form 5.
• Submit valid GMP inspection reports of both the
firms.
of Form 5 by the applicant, not manufacturer along with submission of applicable fee
as per notification 7-11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
• Latest GMP certificate/last inspection report conducted within last three years of
both the contact acceptor and giver shall be submitted.
Karachi, Pakistan
By
Pakistan
Brand Name +Dosage Form + Strength Estrop Tablet 2/2/0.5mg
Composition Each 11 White Sugar Coated Tablet Contains:
Estradiol Valerate ……………………….…2mg
Each 10 Light Brown Sugar Coated Tablet Contains:
Estadiol Valerate …………………….…2mg
Norgestrel …………………………..…0.5mg
Rs. 50,000/- dated 06.03.2019
Pharmacological Group Oestrogen agonist / Progestogen
Type of Form Form 5
Pack size & Demanded Price 21’s; Rs 300/-
Approval status of product in Reference Cyclo-Progynova® 2mg Sugar-coated tablets. MHRA
Me-too status Nexate Tablets. Reg. No. 71222
GMP status High-Q: Copy of inspection report dated 10-8-2022
concludes good level of compliance
Aries: cGMP certificate on the basis of Evaluation
conducted on 06-04-2022
evaluated.
M/s Aries Pharmaceuticals (Pvt) Ltd., 1-W,
DML.
dated 07.05.2021 and 13.07.2021.
• You have submitted same coating process for both
the brown and white tablets. Clarify.
firms.
of Form 5 by the applicant, not manufacturer along with submission of applicable fee
as per notification 7-11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Karachi, Pakistan
By
Pakistan
Brand Name +Dosage Form + Strength Noreta 2mg/35mcg Tablet

Cyproterone Acetate ………………..…2mg
Ethinylestradiol ……………………..…35mcg
Rs. 50,000/- dated 06.03.2019
Pharmacological Group Anti-androgen / Oestrogen
Type of Form Form 5
Pack size & Demanded Price 21’s; Rs 300/-
Approval status of product in Reference Co-cyprindiol 2000/35 Tablets film-coated. MHRA
Me-too status Acne-Heal Tablet. Reg. No. 73476
evaluated.
DML.
dated 07.05.2021 and 13.07.2021.
firms.
Decision: Approved. Registration letter will be issued after submission of Form 5 by the
applicant, not manufacturer along with submission of applicable fee as per
notification 7-11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Karachi, Pakistan
By
Pakistan
Brand Name +Dosage Form + Strength Primela Tablet 5mg
Norethisterone ……………………..…5mg
Rs. 50,000/- dated 06.03.2019
Pharmacological Group Progestogen
Type of Form Form 5
Pack size & Demanded Price As per SRO; Rs 200/-
Approval status of product in Reference Norethisterone 5mg Tablets, uncoated. MHRA
Me-too status Postpon-M Tablet 5mg. 73532
evaluated.
The address of manufacturer in Form 5 is M/s Aries
DML.
dated 07.05.2021 and 13.07.2021.
firms.
Decision: Approved. Registration letter will be issued after submission of Form 5 by the
applicant, not manufacturer along with submission of applicable fee as per
146. Name and address of manufacturer / Goodman Laboratories (Pvt) Ltd., Plot No. 05, Street
Applicant No. S-05, National Industrial Zone, Rawat, Islamabad,
Pakistan
Brand Name +Dosage Form + Strength Aprent Capsules 80mg
Composition Each Hard Gelatin Capsule Contains:
Aprepitant …………………………..…80mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Antimetic agent
Type of Form Form 5
Approval status of product in Reference Emend 80mg hard capsules. USFDA approved.
GMP status
evaluated.
• Stamped signatures of the QCM and PM are placed
in the file.
• The firm mentioned the address as “Goodman
Laboratories (Pvt) Ltd., Plot No. 05, Street No. S-
05, National Industrial Zone, Rawat, Islamabad,
Pakistan” while it is “Goodman Laboratories (Pvt)
Ltd., Plot No. 05, S-05, National Industrial Zone,
Rawat, Islamabad”.
• You have submitted the manufacturing method
mentioning granules and tubes; revise it along with
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
• Verification of validity staus of DML from Licensing Divison.
• Submission of Manufacturing method /outline of applied product with applicable fee as per
notification 7-11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021
Pakistan
Brand Name +Dosage Form + Strength Artho K Tablet 50mg
Diclofenac Potassium ……………………….…50mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Reference Diclofenac Potassium 50 mg Tablets, film-coated.
Me-too status Arnil-P 50mg Tablet. Reg. No. 82129
GMP status
evaluated.
in the file.
mentioning granules and tubes; revise it.
• You have mentioned the quantity of API as 55.85mg
per tablet. Revise the composition / master formula
as per label claim.
• Submit fee for above revisions as per notification 7-
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
Pakistan
Brand Name +Dosage Form + Strength Erycin Tablet 250mg
Erythromycin stearate eq. to erythromycin ….…250mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Macrolide group of antibiotics
Type of Form Form 5
Approval status of product in Reference Erythromycin 250mg film-coated tablets. MHRA
Me-too status Erobicin 250mg Tablet. Reg. No. 73812
GMP status
evaluated.
in the file.
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
• Submission of Manufacturing method /outline of applied product with applicable fee
as per notification 7-11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021
Pakistan
Brand Name +Dosage Form + Strength Erycin Tablet 500mg
Erythromycin stearate eq to erythrmycin…500mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Macrolide group of antibiotics
Type of Form Form 5
Approval status of product in Reference Erythromycin 500mg film-coated tablets. MHRA
Me-too status Erobicin 500mg Tablet. Reg. No. 73813
GMP status
evaluated.
in the file.
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
Pakistan
Brand Name +Dosage Form + Strength Bet Tablet 150mg
Irbesartan ……………………………150mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Angiotensin II Receptor Blockers (ARBs), Plain.
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, 60’s,; As per SRO
Approval status of product in Reference Irbesartan 150 mg film-coated tablets. MHRA
Me-too status Arbista 150mg Tablet. Reg. No. 83013
GMP status
evaluated.
in the file.
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
Pakistan
Brand Name +Dosage Form + Strength Lamid 150mg Tablet
Lacosamide ……………………….…150mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Funcitional aminoacid
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s, 30’s, 60’s; As per SRO
Approval status of product in Reference Lacosamide Accord 150 mg film-coated tablets.
Me-too status Lacolep 150mg Tablet . Reg. No. 73859
GMP status
evaluated.
in the file.
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
• Revise the pharmacological group.
• Correction of pharmacological group
Pakistan
Lacosamide …………………………….…100mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
GMP status
evaluated.
in the file.
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
• Submission of Manufacturing method /outline and correct pharmacological group of
applied product with applicable fee as per notification 7-11/2012-B&A/DRAP dated
07.05.2021 and 13.07.2021
Pakistan
Lacosamide……………………..…50mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Reference Lacosamide Accord 50 mg film-coated tablets. MHRA
GMP status
evaluated.
in the file.
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
07.05.2021 and 13.07.2021
Pakistan
Brand Name +Dosage Form + Strength Zapine Tablet 30mg
Mirtazapine …………………………..…30mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Reference Mirtazapine 30mg tablets. MHRA Approved
Me-too status Jeta 30mg Tablets. Reg. No. 77035
GMP status
evaluated.
in the file.
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
07.05.2021 and 13.07.2021
Pakistan
Brand Name +Dosage Form + Strength Zapine Tablet 15mg
Mirtazapine ……………………….…15mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Reference Mirtazapine 15mg tablets. MHRA Approved
Me-too status Jeta 15mg Tablets. Reg. No. 77034
GMP status
evaluated.
in the file.
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
07.05.2021 and 13.07.2021
Pakistan
Brand Name +Dosage Form + Strength Roxet Tablet 20mg
Paroxetine as HCl ………………………20mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group SSRI
Type of Form Form 5
Approval status of product in Reference Paroxetine 20mg Film-coated Tablets (as hydrochloride
Regulatory Authorities. anhydrous). MHRA Approved
Me-too status P-OX 20mg Tablets. Reg. No. 78013
GMP status
evaluated.
in the file.
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
• Revise Paroxetine as HCl to Paroxetine HCl in the
master formula only.
07.05.2021 and 13.07.2021
Pakistan
Brand Name +Dosage Form + Strength Roxet CR Tablet 25mg
Composition Each Control Release Tablet Contains:
Paroxetine as HCl …………………..…25mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Reference Paxil CR Tablet 25mg. USFDA approved.
Me-too status Impika CR Tablet. Reg. No. 84447
GMP status
evaluated.
in the file.
• You have submitted the reference wherein it is stated
that:
➢ Each extended-release tablet contains 12.5 mg,
25 mg, or 37.5 mg paroxetine equivalent to 14.25
mg, 28.51 mg, or 42.76 mg of paroxetine
hydrochloride, respectively. The factor used is
meant for hemihydrate form.
➢ One layer of the tablet consists of a degradable
barrier layer and the other contains the active
material in a hydrophilic matrix.
➢ In addition to controlling the rate of drug release
in vivo, an enteric coat delays the start of drug
release until tablets of PAXIL CR have left the
stomach.
Revise your composition, master formula, and
manufacturing method in line with the above-
mentioned facts.
07.05.2021 and 13.07.2021.
• Submission of Manufacturing method /outline and correct label claim as per
innovator product with applicable fee as per notification 7-11/2012-B&A/DRAP
dated 07.05.2021 and 13.07.2021
Pakistan
Brand Name +Dosage Form + Strength Roxet CR Tablet 37.5mg
Composition Each Control Release Tablet Contains:
Paroxetine As HCl ………………….…37.5mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Reference Paxil CR Tablet 37.5mg. USFDA approved.
Me-too status Peroxa CR 37.5 mg Tablet. Reg. No. 82118
GMP status
evaluated.
in the file.
• You have submitted the reference wherein it is stated
that:
➢ Each extended-release tablet contains 12.5 mg,
25 mg, or 37.5 mg paroxetine equivalent to 14.25
mg, 28.51 mg, or 42.76 mg of paroxetine
hydrochloride, respectively. The factor used is
meant for hemihydrate form.
➢ One layer of the tablet consists of a degradable
barrier layer and the other contains the active
material in a hydrophilic matrix.
➢ In addition to controlling the rate of drug release
in vivo, an enteric coat delays the start of drug
release until tablets of PAXIL CR have left the
stomach.
Revise the composition, master formula, and
manufacturing method in line with the above-
mentioned facts.
07.05.2021 and 13.07.2021.
• Submission of Manufacturing method /outline and correct label claim as per
innovator product with applicable fee as per notification 7-11/2012-B&A/DRAP
dated 07.05.2021 and 13.07.2021
Pakistan
Brand Name +Dosage Form + Strength Pine XR Tablet 300mg
Composition Each Extended Release Tablet Contains:
Quetiapine as fumarate ……………………300mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group atypical antipsychotic
Type of Form Form 5
Approval status of product in Reference SEROQUEL® XR (quetiapine fumarate) 300mg
Regulatory Authorities. tablets. USFDA approved
Me-too status Angepine XR Tablets . Reg. No. 78826
GMP status
evaluated.
in the file.
• You have mentioned the weight of API as
345mg/tablet. Revise it as per salt factor.
07.05.2021 and 13.07.2021.
Pakistan
Brand Name +Dosage Form + Strength Pin Tablet 1mg
Ropinirole HCl ……………………1mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Dopamine agonist
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, 20’s, 21’s, 28’s, 30’s, 50’s; As per SRO
Approval status of product in Reference Ropinirole 1 mg film-coated tablets (as hydrochloride)
Regulatory Authorities. 1mg. MHRA approved.
Me-too status Zeque Tablets 1mg. 52636
GMP status
evaluated.
in the file.
• Revise ropinirole as HCl to ropinirole HCl in the
07.05.2021 and 13.07.2021.
• Revise the pharmacological group to dopamine
agonists.
07.05.2021 and 13.07.2021
Pakistan
Brand Name +Dosage Form + Strength Pin Tablet 2mg
Ropinirole HCl ……………………………2mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Dopamine agonist
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, 20’s, 21’s, 28’s, 30’s, 50’s; As per SRO
Approval status of product in Reference Ropinirole 2 mg film-coated tablets (as hydrochloride)
Regulatory Authorities. 1mg. MHRA approved.
Me-too status Zeque Tablets 2mg. 52637
GMP status
evaluated.
in the file.
• Revise ropinirole as HCl to ropinirole HCl in the
07.05.2021 and 13.07.2021.
• Revise the pharmacological group to dopamine
agonists.
07.05.2021 and 13.07.2021
Pakistan
Brand Name +Dosage Form + Strength A Sart Tablet 80mg/5mg
Telmisartan …………………………80mg
Amlodipine as besylate ………………5mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Angiotensin II antagonists and dihydropyridine calcium
channel blocker
Type of Form Form 5
Approval status of product in Reference TWYNSTA® (telmisartan/amlodipine) tablets, for oral
Regulatory Authorities. use (5/80mg). TGA approved
Me-too status Ezitab-AM Tablet. Reg. No. 082044
GMP status
evaluated.
in the file.
• Revise amlodipine as besylate to amlodipine besylate
in the master formula only.
• You have mentioned the weight of besylate to
amlodipine 7mg/tablet. Reivse it as per salt factor.
• The reference product in USFDA and TGA is bilayer
tablet. You have applied for plain / single layer
tablet. Justifications is required.
07.05.2021 and 13.07.2021.
• Submission of Manufacturing method /outline of applied product for bilayer tablet with
applicable fee as per notification 7-11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
• Evidence of availability of bilayer compression machine shall also be submitted.
Pakistan
Telmisartan …………………..…80mg
Amlodipine as besylate …………10mg
Rs. 20,000/- dated 05.03.2019
channel blocker
Type of Form Form 5
Me-too status AM-Telsan 10/ 80 tablet. Reg. Np. 67434
GMP status
evaluated.
in the file.
07.05.2021 and 13.07.2021.
Pakistan
Telmisartan …………………………..…40mg
Amlodipine as besylate ……………….…5mg
Rs. 20,000/- dated 05.03.2019
channel blocker
Type of Form Form 5
GMP status
evaluated.
in the file.
07.05.2021 and 13.07.2021.
Pakistan
Telmisartan ………………………..…40mg
Amlodipine as besylate ………………10mg
Rs. 20,000/- dated 05.03.2019
channel blocker
Type of Form Form 5
GMP status
evaluated.
in the file.
07.05.2021 and 13.07.2021.
Pakistan
Brand Name +Dosage Form + Strength Zomid Capsules 100mg
Composition Each Hard Gelatin Capsule Contains:
Zonisamide ………………………100mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Reference ZONEGRAN® (zonisamide) capsules 100mg.
Regulatory Authorities. Approved in USFDA.
Me-too status Zonisa 100mg Capsule. Reg. No. 58505
GMP status
evaluated.
in the file.
• The firm mentioned the address as “M/s Goodman
Laboratories. No.5, Street No. S-5, National
Industrial Zone, Rawat, Rawalpindi” while it is
“M/s Goodman Laboratories.
(Pvt) Ltd., Plot No. 05, S-05, National Industrial
Zone, Rawat, Islamabad”.
hydrogenated vegetable oil (from soyabean) and
sodium laurilsulfate. Justification is required for
not mentioning the same in the applied product.
• You have submitted the composition / master formula
for fenofibrate; revise it along with submission of
B&A/DRAP dated 07.05.2021 and 13.07.2021.
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
• Submission of Manufacturing method /outline of applied product as per innovator product
with applicable fee as per notification 7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021
167. Name and address of manufacturer / M/s Global Pharmaceuticals Pvt Ltd Plot # 204-205,
Brand Name +Dosage Form + Strength Moximox 400mg Tablet
Moxifloxacin as HCl ……………………..…400mg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Quinolone antibiotics
Type of Form Form 5
Approval status of product in Reference Moxifloxacin 400 mg film-coated tablets. Approved in
Regulatory Authorities. MHRA.
Me-too status Navilox 400mg Tablet. Reg. No. 85166
GMP status Firm has submitted copy of GMP certificate dated 04-
01-2022.
evaluated.
• Form 5 has not been submitted.
• Submit copy of the DML.
• The reference product in MHRA contains
Moxifloxacin HCl…400mg, you have applied for
Moxifloxacin as HCl…400mg. Revise the label
claim, and quantity of API in the master formula
without equivalency along with submission of
B&A/DRAP dated 07.05.2021 and 13.07.2021.
of 7500/- fee for pre-approval changes/correction in the specifications as per
168. Name and address of manufacturer / Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Applicant Estate, Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Tacrim Capsule 0.5mg
Tacrolimus ……………………..…0.5mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Immunosuppresant
Type of Form Form 5
Approval status of product in Reference PROGRAF 0.5mg, 1mg, 5mg capsule. USFDA
Me-too status Tacgraf Capsule 0.5mg. Reg. No. 68114
GMP status Firm has submitted copy of GMP certificate No.
140/2022-DRAP (AD-084433115014) dated 26-08-
2022 on the basis of inspection conducted on 22-08-
2022.
evaluated.
• Add blistering and packing process to the
• Revise the pharmacological group to Calcineurin
inhibitors.
• In USFDA, PROGRAF is available for oral
administration as capsules (tacrolimus capsules
USP) containing the equivalent of 0.5 mg, 1 mg or
5 mg of anhydrous tacrolimus USP Revise
tacrolimus to tacrolimus monohydrate in the
master formula and adjust its weight in master
formula based on salt factor
• For above revisions, submit the applicable fee as per
07.05.2021 and 13.07.2021.
Decision: Approved.
Brand Name +Dosage Form + Strength Tacrim Capsule 5mg
Tacrolimus ……………………..…5mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in ReferencePROGRAF 0.5mg, 1mg, 5mg capsule. USFDA
Me-too status Tacgraf Capsule 5mg. Reg. No. 68116
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
• Revise the pharmacological group to Calcineurin
inhibitors.
• In USFDA, PROGRAF is available for oral
administration as capsules (tacrolimus capsules
USP) containing the equivalent of 0.5 mg, 1 mg or
5 mg of anhydrous tacrolimus USP Revise
tacrolimus to tacrolimus monohydrate in the
master formula and adjust its weight in master
formula based on salt factor
st
173
07.05.2021 and 13.07.2021.
Decision: Approved.
Brand Name +Dosage Form + Strength Tazomil Cream 0.1% w/w
Composition Each Gram of Cream Contains:
Tazarotene …………………………….…1mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antipsoriasis
Type of Form Form 5
Approval status of product in Reference AVAGE ® (tazarotene) cream, 0.1%, for topical use.
Me-too status Taz 0.1% cream. Reg. No. 81185
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
• Add packing process to the manufacturing outlines.
• Revise the pharmacological group to Other
antipsoriatics for topical use.
07.05.2021 and 13.07.2021.
submission of 7500/- fee for pre-approval changes/correction in the specifications as
per notification 7-11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Tazomil Gel 0.1% w/w
Composition Each Gram of gel Contains:
Tazarotene …………………………..…1mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antipsoriasis
Type of Form Form 5
Approval status of product in Reference ZORAC 0.1%, gel. MHRA approved
Me-too status Trazene 0.1% Gel. Reg. No. 57747
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
• You have added emulsifying agent in the gel. Calrify.
• You have added any gelling agent to the gel
composition. Clarify.
• Revise the pharmacological group to Other
07.05.2021 and 13.07.2021.
submission of 7500/- fee for pre-approval changes/correction in the specifications as
Brand Name +Dosage Form + Strength TM Soliten Tablet 0.4/6mg
Tamsulosin HCl…………………..…0.4mg
Solifenacin Succinate……………….…6mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference Vesomni 6 mg/0.4 mg modified release film-coated
Regulatory Authorities. tablets (bilayer). MHRA approved.
Vesomni 6 mg/0.4 mg is a modified-release tablet
composed of one layer containing 6 mg solifenacin
succinate (immediate release) and a second layer
containing 0.4 mg tamsulosin hydrochloride (Oral
Controlled Absorption System/modified release)
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
• The reference product contains modified release
pellets of solifenacin succinate. Revise the label
claim, composition and manufacturing outlines.
07.05.2021 and 13.07.2021.
• Submit stability data as per zone IV-A.
• The reference product contains modified release pellets of solifenacin succinate. Revise
the label claim, composition and manufacturing outlines as per reference product with
applicable fee.
Registration Board with brand name & registration number or elsewise applied on
the prescribed form i.e. Form 5D along with applicable fee.
• Add blistering and packing process to the manufacturing outlines.
Brand Name +Dosage Form + Strength Biscord H Tablet 10/6.25mg
Bisoprolol Fumarate …………………….…10mg
Hydrochlorothiazide ………………….…6.25mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Pack size & Demanded Price 10’s;, 14’s, 20’s, 28’s, 30’s; As per SRO
Approval status of product in Reference ZIAC® (Bisoprolol Fumarate and
Regulatory Authorities. Hydrochlorothiazide) Tablets10/6.25mg. USFDA
approved
Me-too status Valvozid-10 Plus Tablets.. Reg. No. 47718
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
• Revise the Pharmacological group.
07.05.2021 and 13.07.2021.
Decision: Approved. Registration letter will be issued after submission revised manufacturing
outlines, revised pharmacological group with 7500/- fee for pre-approval
changes/correction in the specifications as per notification 7-11/2012-B&A/DRAP
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Ecrim Tablet 0.25mg
Everolimus ………………………….…0.25mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Mammalian target of rapamycin (mTOR) kinase
inhibitors
Type of Form Form 5
Approval status of product in Reference Certican 0.25 mg tablets, uncoated. MHRA approved.
Me-too status Afitor 0.25mg tablet of M/s Safe Pharma
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
07.05.2021 and 13.07.2021.
• Submit proof of me-too product (name and
registration number) already registered by DRAP.
• Decision: Approved with Innovator’s specifications against the available section of “Tablet
(Anti-cancer”). The firm shall submit fee of Rs. 7500/- for correction/pre-approval change
in product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Strength Ecrim Tablet 0.75mg
Everolimus …………………………..…0.75mg
Rs. 20,000/- dated 06.03.2019
inhibitors
Type of Form Form 5
Approval status of product in Reference Zortress tablets for oral administration 0.25 mg, 0.5
Regulatory Authorities. mg, and 0.75 mg. USFDA approved.
Me-too status Primus 0.75mg tablet of M/s Rotex Pharma Reg.#
101693
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
07.05.2021 and 13.07.2021.
• Submit proof of me-too product (name and
registration number) already registered by DRAP.
• Decision: Approved with Innovator’s specifications against the available section of “Tablet
(Anti-cancer”). The firm shall submit fee of Rs. 7500/- for correction/pre-approval change
in product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Strength Ecrim Tablet 5mg
Everolimus …………………………5mg
Rs. 20,000/- dated 06.03.2019
inhibitors
Type of Form Form 5
Approval status of product in Reference AFINITOR® (everolimus) tablets, for oral use 2.5 mg,
Regulatory Authorities. 5 mg, 7.5 mg, or 10 mg. USFDA approved.
Me-too status AFINITOR 5MG TABLETS. Reg. No. 69519
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
07.05.2021 and 13.07.2021.
Decision: Approved with Innovator’s specifications against the available section of “Tablet
(Anti-cancer”). The firm shall submit fee of Rs. 7500/- for correction/pre-approval change in
product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Strength Ecrim Tablet 10mg
Everolimus ………………………..…10mg
Rs. 20,000/- dated 06.03.2019
inhibitors
Type of Form Form 5
Approval status of product in Reference AFINITOR® (everolimus) tablets, for oral use 2.5 mg,
Regulatory Authorities. 5 mg, 7.5 mg, or 10 mg. USFDA approved.
Me-too status AFINITOR 10MG TABLETS. Reg. No. 69520
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Roxonib Tablet 20mg
Ruxolitinib As Phosphate …………………..…20mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Janus-associated kinase (JAK) inhibitors
Type of Form Form 5
Approval status of product in Reference JAKAFI® (ruxolitinib) uncoated tablets, for oral use 5
Regulatory Authorities. mg, 10 mg, 15 mg, 20 mg. USFDA approved.
Me-too status JAKAVI 20MG TABLETS. Reg. No. 78121 (does not
depict the salt form)
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
• You have adjusted the weight of API as per salt
factor; revise Ruxolitinib As Phospate to
Ruxolitinib Phospate in the master formula.
07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Vortix Tablet 10mg
Vortioxetine Hydro bromide Eq. To Vortioxetine
……………………………………10mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference JAKAFI® (ruxolitinib) uncoated tablets, for oral use 5
Regulatory Authorities. mg, 10 mg, 15 mg, 20 mg. USFDA approved.
Me-too status JAKAVI 20MG TABLET. Reg. No. 78121 (does not
depict the salt form)
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
factor; revise Vortioxetine as Hydrobromide to
Vortioxetine Hydrobromide in the master formula.
07.05.2021 and 13.07.2021.
Decision: Deferred for the followings;
• Add blistering and packing process to the manufacturing outlines.
• You have adjusted the weight of API as per salt factor; revise Vortioxetine as Hydro
bromide to Vortioxetine Hydro bromide in the master formula.
• For above revisions, submit the applicable fee as per notification 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
• Stability study data as per guidelines approved in 293rd meeting of Registration Board.
Brand Name +Dosage Form + Strength Tamodex Tablet 10mg
Tamoxifen as Citrate ……………………10mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference TAMOXIFEN SANDOZ tamoxifen 10mg and 20mg
Regulatory Authorities. (as citrate) tablet film-coated. USFDA approved.
Me-too status TAMOXIFEN-SANDOZ 10MG TABLETS. Reg. No.
47670 (does not depict the salt form)
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
factor; revise Tamoxifen as Citrate to Tamoxifen
Citrate in the master formula.
• Revise the pharmacological group to Anti-estrogens.
07.05.2021 and 13.07.2021.
manufacturing outline with addition of blistering and packing process, revised
pharmacological group to Anti-estrogens along with submission of applicable fee as
Brand Name +Dosage Form + Strength Tamodex Tablet 20mg
Tamoxifen as Citrate …………………….…20mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference TAMOXIFEN SANDOZ tamoxifen 10mg and 20mg
Regulatory Authorities. (as citrate) tablet film-coated. USFDA approved.
Me-too status TAMOXIFEN-SANDOZ 20MG TABLETS. Reg. No.
47671 (does not depict the salt form)
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
factor; revise Tamoxifen as Citrate to Tamoxifen
Citrate in the master formula.
• Revise the pharmacological group to Anti-estrogens.
07.05.2021 and 13.07.2021.
•
manufacturing outline with addition of blistering and packing process, revised
pharmacological group to Anti-estrogens along with submission of applicable fee as
Brand Name +Dosage Form + Strength Migxen Tablet 85/500mg
Sumatriptan as succinate……………..…85mg
Naproxen Sodium ……………….….…500mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference TREXIMET (sumatriptan and naproxen sodium)
Regulatory Authorities. tablets, film-coated. USFDA approved.
Me-too status Reprox 500+85mg Tablet film-coated. Reg. No. 83089
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
07.05.2021 and 13.07.2021.
submission of revised manufacturing outline with addition of blistering and packing
process, revised pharmacological group along with submission of applicable fee as
Brand Name +Dosage Form + Strength Cyclovir Cream 5%
Acyclovir …………………………….…50mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Pack size & Demanded Price 5g, 10g; As per SRO
Approval status of product in Reference ZOVIRAX® (acyclovir) cream, for topical use 5%.
Me-too status Ciavir 5% Cream. Reg. No. 85089
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
• Revise the pharmacological group to antivirals.
07.05.2021 and 13.07.2021.
manufacturing outline with addition of packing process, revised pharmacological
group along with submission of applicable fee as per notification 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Cyclovir ointment 5%
Acyclovir ……………………………………50mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in ReferenceZOVIRAX® (acyclovir) ointment, for topical use 5%.
Me-too status Ciavir 5% Ointment. Reg. No. 85088
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
• Revise the pharmacological group to antivirals.
07.05.2021 and 13.07.2021.
manufacturing outline with addition of packing process, revised pharmacological
group along with submission of applicable fee as per notification 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Soquin Cream 4% w/w
Hydroquinone ……………………………4gm
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference Corrector 4% Cream by M/s VIVIER CANADA
Regulatory Authorities. INCORPORATED (Health Canada approved)
Status of the product on the website of Health Canada
is “Cancelled Post Market”
Me-too status Hydrofair Cream 4% by M/s Scotmann (Reg#028278)
140/2022-DRAP (AD-084433115014) dated 26-08-
2022.
evaluated.
• Revise the label claim from Hydroquinone…4gm to
Hydroquinone…40mg.
• You have not mentioned any emulsifying agent.
Clarify.
07.05.2021 and 13.07.2021.
Decision. Deferred for followings;
• Revision of the label claim from Hydroquinone 4gm to Hydroquinone 40mg with
13.07.2021.
• Justification for not mentioning any emulsifying agent.
• Revision of the manufacturing outlines with adding packing process.
186. Name and address of manufacturer / M/s Reign Pharmaceuticals PCSIR-KLC Pvt Ltd.
Applicant TBIC Building-1, PCSIR Laboratories Complex,
Shahrahe Dr. Salim-us-Zaman Siddiqui, Off University
Road, Karachi by
M/s Global Pharmaceuticals (Pvt.) Ltd., Plot # 204-
205, Industrial Triangle Kahuta Road Islamabad
Brand Name +Dosage Form + Strength Sucren Injection
Iron as Iron Sucrose ………………..…100mg
Rs. 50,000/- dated 05.03.2019
Type of Form Form 5
Finished Product Specification Not submitted.
Approval status of product in Reference VENOFER iron 100mg/5mL (as iron(III) hydroxide
Regulatory Authorities. sucrose complex) injection ampoule. TGA approved
Me-too status Orsec Injection 100mg/5ml. Reg. No.82559
GMP status Global: Firm has submitted copy of GMP certificate
dated 04-01-2022.
evaluated.
• The address in application is M/s Reign
Pharmaceuticals PCSIR-KLC Pvt Ltd. TBIC
Building-1, PCSIR Laboratories Complex,
Shahrahe Dr. Salim-us-Zaman Siddiqui, Off
University Road,Karachi, while it M/s Reign
Pharmaceuticals PCSIR-KLC Pvt Ltd. TIBC
Karachi in the DML.
• Did not provide the name of contract receiver
(manufacturer). Revised the name of manufacturer
Form 5. The firm also submitted Form 5 from the
manufacturer, which is not required.
• Revised the label claim from Iron as Iron
Sucrose…100mg to Iron Sucrose complex eq to.
Elemental iron…100mg.
• Undertaking at the end of Form has not been signed.
Submitted signed undertaking.
• Had only submitted Form 5. Submitted all the
document as per enclosure of the Form along with
copy of contract manufacturing agreement.
• Claimed 5’s pack size in the revised documents.
• Justify 72.727 kg of iron sucrose for 40,000 ampules
with label claim of Iron Sucrose complex eq to.
Elemental iron…100mg.
07.05.2021 and 13.07.2021.
Decision: Approved with USP specifications and as per following label claim:
“Each 5ml contains:
Iron sucrose (iron(III)-hydroxide sucrose complex) eq. to elemental Iron ……... 100mg”
• Firm shall submit fee of Rs. 75,000 for standardization of label claim, as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Registration Board decided that registration letter will be issued after submission of
valid GMP certificates of both the contract giver and contract acceptor. Moreover, firm
shall submit evidence of performance of assay test on atomic absorption
spectrophotometry, as recommended by USP monograph, by M/s Global
Pharmaceuticals.
• Registration Board further Authorized its Chairman for issuance of registration letter
upon capacity assessment of manufacturing and testing facility of M/s Global
Pharmaceuticals (Pvt) Ltd. Plot No. 204-205, Industrial Triangle Kahuta Road
Islamabad.
Road, Karachi by
M/s Global Pharmaceuticals (Pvt.) Ltd., Plot # 204-
205, Industrial Triangle Kahuta Road Islamabad
Brand Name +Dosage Form + Strength Cepime 2g Injection
Cefepime as HCl With L Arginine…….…2000mg
Rs. 50,000/- dated 05.03.2019
Pharmacological Group Cephalosporins
Type of Form Form 5
Finished Product Specification Not submitted. Then submitted USP specs
Approval status of product in Reference Renapime 2g Powder for solution for injection/infusion.
Me-too status Could not be confirmed.
GMP status regngmp
evaluated.
Karachi in the DML.
• Justify 1% overage in the master formula.
• Did not specify the excipients in the master formula.
07.05.2021 and 13.07.2021.
• Latest GMP certificate/last inspection report conducted within last three years of both
the applicant and manufacturer.
• The firm shall submit fee of Rs. 75000/- for correction/pre-approval change in product
specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021
Road,Karachi by
M/s Global Pharamceuticals (Pvt.) Ltd., Plt # 204-205,
Industrial Triangle Kahuta Road Islamabad
Brand Name +Dosage Form + Strength Iro Plus 500mg Injection
Deferoxamine Mesylate Lyophilized Powder
…………………………………….…500mg
Rs. 50,000/- dated 05.03.2019
Pharmacological Group Iron chelating agent
Type of Form Form 5
Finished Product Specification Not submitted initially; then claimed in-house specs.
Available in USP
Approval status of product in Reference Desferal® deferoxamine mesylate for injection vial
Regulatory Authorities. 500mg. USFDA approved
GMP status regngmp
evaluated.
Karachi in the DML.
• Did not mention the excipients in the formulation.
• The proposed route of administration is injection.
• Revision of “Deferoxamine Mesylate eq. to
Deferoxamine…500mg” in the label claim to
“Deferoxamine Mesylate…500mg” is required.
07.05.2021 and 13.07.2021.
• Revision of “Deferoxamine Mesylate eq. to Deferoxamine…500mg” in the label claim
to “Deferoxamine Mesylate…500mg” is required with submission of applicable fee as
Road,Karachi by
Brand Name +Dosage Form + Strength Ertaren IV 1gm Injection
Ertapenem as sodium ……………………..…1g
Rs. 50,000/- dated 05.03.2019
Pharmacological Group Carbapenems
Type of Form Form 5
Finished Product Specification Not submitted. Then claimed innovator’s specs.
Approval status of product in Reference INVANZ® (ertapenem for injection), for intravenous or
Regulatory Authorities. intramuscular (lyophilized powder in vial). USFDA
approved
Me-too status Ernem Injection 1g (vial). Reg. No. 81179
GMP status Firm has submitted copy of GMP certificate dated 04-
01-2022.
evaluated.
University Road, Karachi, while it M/s Reign
Karachi in the DML.
Form 5.
The firm submitted signed undertaking.
• In the master formula, justify the quantity of
Ertapenem sodium eq. to Ertapenem…1.046 and
1% overage.
07.05.2021 and 13.07.2021.
Decision: Approved with innovator’s specifications. The firm shall submit fee of Rs. 75000/-
for correction/pre-approval change in product specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021
Registration Board Authorized its Chairman for issuance of registration letter upon capacity
assessment of manufacturing and testing facility of M/s Global Pharmaceuticals (Pvt) Ltd.
Plot No. 204-205, Industrial Triangle Kahuta Road Islamabad.
Road,Karachi by
Brand Name +Dosage Form + Strength Teinin Injection 200mg
Teicoplanin Powder Sterile ………………….…200mg
Rs. 50,000/- dated 05.03.2019
Type of Form Form 5
Finished Product Specification Not submitted. Then claimed innovator’s specifications.
Approval status of product in Reference Targocid 200mg powder for solution for
Regulatory Authorities. injection/infusion or oral solution (lyophilized). MHRA
approved
Me-too status Planin 200mg Injection (vial). Reg. No. 55188
GMP status regngmp
evaluated.
Karachi in the DML.
• Undertaking at the end of Form was not signed.
• Revised the label claim from Teicoplanin Powder
Sterile…200mg to Teicoplanin sodium eq. to
Teicoplanin…200mg. while it is “Each vial
contains 200 mg teicoplanin equivalent to not less
than 200,000 IU” in the reference product.
• Revise the pharmacological group from glycopeptide
antibiotic to Glycopeptide antibacterials
• Did not specify the excipients in the master formula.
07.05.2021 and 13.07.2021.
• Revision of label claim as per reference product with submission of full fee as per
• Confirmation of manufacturing facility of “Dry powder injection (Lyophilisation)”
section required for the applied formulation.
• Justification of 1% overage in the master formula.
• specify the excipients in the master formula.
Road,Karachi by
Brand Name +Dosage Form + Strength Cefavi Injection 2gm
Ceftazidime pentahydrate Eq To Ceftazidime…..…2g
Avibactam sodium Eq To Avibactam Ceftazidime
……………………………………..…0.5g
Rs. 50,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Reference AVYCAZ (ceftazidime and avibactam) for injection, for
Regulatory Authorities. intravenous us. MHRA approved
Me-too status Not confirmed.
GMP status regngmp
evaluated.
Karachi in the DML.
• Had not provided the name of contract receiver
in Form 5.
• Undertaking at the end of Form was not signed.
document as per enclosure of Form 5 along with
Cephalosporins to third generation cephalosporins.
• Revised the route of administration from parentertal
to intra venous.
• Revised Avibactam sodium Eq To Avibactam
Ceftazidime…0.5g to Avibactam sodium Eq To
Avibactam…0.5g
• Submit your application on Form 5D along with
stability studies as per zone IV-A.
07.05.2021 and 13.07.2021.
• Submission of Finished Product Specification.
• Submission of full fee for correction in the label claim as per notification 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
Road,Karachi by
M/s Vision Pharmaceuticals, Plot # 22-23, Industrial
Triangle Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Vancoren 1gm Injection
Vancomycin as HCl…………………..…1g
Rs. 50,000/- dated 05.03.2019
Pharmacological Group Antibiotics
Type of Form Form 5
Finished Product Specification Not submitted. Then claimed USP specs.
Regulatory Authorities. hydrochloride) powder for injection vial. TGA approved
GMP status regngmp
evaluated.
Karachi in the DML.
The firm submitted signed undertaking.
document as per enclosure of Form 5 (meant for
500mg) of the Form along with copy of contract
manufacturing agreement. Did not adjust the
weight of API as per salt factor in the master
formula.
• Claimed a pack size of 1x1’s in the revised
documents.
07.05.2021 and 13.07.2021.
• Confirmation of manufacturing facility required for the applied formulation.
• Adjust the weight of API as per salt factor in the master formula.
• Excipients in the formulation.
• Submission of the applicable fee for correction/changes as per notification 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
193. Name and address of manufacturer / M/s Reko Pharmacal Pvt Ltd. 13-Km, Multan Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Dexanil 30mg Capsule
Dexlansoprazole Dual Delayed Released Pellets
Enteric Coated Eq To Dexlansoprazole …….….30mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Regulatory Authorities. hydrochloride) powder for injection vial. TGA approved
GMP status regngmp
evaluated.
University Road, Karachi, while it M/s Reign
Building-1, PCSIR Laboratories Complex, Karachi
in the DML.
• The firm submitted Rs. 10,000/- fee (challan No.
7896172330).
• The applied brand name is Dexanil 60mg Capsule.
Clarify.
• Specify the capsule shell material in the composition.
• Specify the source of pellets.
07.05.2021 and 13.07.2021.
• Submit stability studies as per zone IV-A.
• The firm replied that they have submitted the stability
data. The matter was referred to PEC for evaluation
of stability data on its turn.
• Specify the capsule shell material in the composition.
• Source of pellets along with stability studies data, GMP certificate of supplier and
differential fee in case of import of pellets.
• Submission of stability study data as per the guidelines approved in 293rd meeting of
Registration Board.
Brand Name +Dosage Form + Strength Jovin 500mg/400mg Tablet
Glucosamine HCl ………………….…500mg
Chondroitin Sulphate …………………400mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Glucoaminoglycan
Type of Form Form 5
Approval status of product in Reference Could not be confirmed.
Me-too status Glucotin Tablets. Reg. No. 64400 (corrected in 271-M
of RB from glucosamine sulfate to glucosamine HCl).
The matter of sodium chloride still remains unclear.
12.08.2020.
evaluated.
• Undertaking at the end of Form 5 is missing.
• Revise the pharmacological group to Factor Xa
inhibitor.
• Provide proof of reference product (brand name and
market authorization holder, with same strength
and formulation) in reference regulatory agencies
as defined in 275th meeting of the registration
Board.
• Provide proof of me-too product (name and
registration number with same salt form) already
approved by DRAP.
• You have claimed USP specifications for the drug
product. Provide proof that the product monograph
is available in the latest edition of USP.
07.05.2021 and 13.07.2021.
authorities/agencies which were adopted by the Registration Board in its 275 th
meeting.
• Evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) along with registration number, brand name and name of firm.
Brand Name +Dosage Form + Strength Zolpro forte 20mg
Omeprazole ………………………….…20mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Finished Product Specification Not submitted. Available in USP old edition, not in latest
Me-too status
GMP status sfephmgmp
evaluated.
• You have applied for omeprazole 20mg sachet.
Submit properly filled enclosure of Form 5.
• Submit the composition with list of excipients and
• Submit drug product specifications.
07.05.2021 and 13.07.2021.
Decision: Deferred for following;
authorities/agencies which were declared/approved by the Registration Board.
• Submission of Pharmacological Group for the applied formulation.
• Submission of composition with list of excipients and manufacturing outlines.
• Submission of finished drug product specifications.
Brand Name +Dosage Form + Strength Zolpro forte 40mg
Omeprazole…40mg
Rs. 20,000/- dated 05.03.2019
Type of Form Form 5
Finished Product Specification Not submitted. Available in USP old edition, not in latest
Me-too status
evaluated.
• You have applied for omeprazole 40mg sachet.
Submit properly filled enclosure of Form 5.
• Submit the composition with list of excipients and
07.05.2021 and 13.07.2021.
authorities/agencies which were declared/approved by the Registration Board.
• Submission of composition with list of excipients and manufacturing outlines.
• Submission of Pharmacological Group for the applied formulation.
• Submission of finished drug product specifications.
197. Name and address of manufacturer / M/s Genome Pharmaceuticals Pvt Ltd.
Applicant Plot # 16/I-Phase IV, Industrial Estate, Hattar, KPK
By
M/s EG Pharmaceuticals. Plot. No. 13-A, Industrial
Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Gennifer P Injection 100mg/5ml (IV)
Iron As III hydroxide polymaltose complex…100mg
Rs. 50,000/- dated 06.03.2019
Pharmacological Group Iron parenteral preparations
Type of Form Form 5
Approval status of product in Reference FERROSIG INJECTION iron 100mg/2mL (as
Regulatory Authorities. polymaltose)
injection ampoule, TGA Approved
GMP status
evaluated.
• Revise the pharmacological group from Iron
supplement to Iron, parenteral preparations.
• You have applied for Iron as III Hydroxide
Polymaltose Complex…100mg. Revise the label
claim in line with the reference product and adjust
the weight of API as per salt factor in master
formula.
• Specify the excipients for the pH adjustment.
07.05.2021 and 13.07.2021.
• You have claimed USp specifications. Provide proof
that the drug product is available in USP.
• Submit latest GMP inspection reports of both the
firms.
• Submit copy of DMLs of both the firms.
alongwith registration number, brand name and name of firm.
• Reference of drug product specifications.
By
Brand Name +Dosage Form + Strength Gennifer Injection 100mg/5ml (IV)
iron as sucrose …………………100mg
Eq. to iron…………………..…100mg
Rs. 50,000/- dated 06.03.2019
Pharmacological Group Iron parenteral preparations
Type of Form Form 5
Pack size & Demanded Price 5’s (5ml); As per SRO
Approval status of product in Reference VENOFER iron 100mg/5mL (as iron(III) hydroxide
Regulatory Authorities. sucrose complex) injection ampoule, TGA Approved
Me-too status Ferrodin Injection 100mg/5ml. reg. No. 84670
GMP status genomgmp
evaluated.
• The TGA has used the term Iron sucrose for the
iron(III) hydroxide sucrose complex.
• Revised the pharmacological group from Iron
supplement to Iron, parenteral preparations.
• Applied for Each 5ml Ampoule Contains: iron as
sucrose…100mg Eq. to iron…100mg. Revised the
label claim to iron as iron sucrose…100mg in line
with the reference product and adjust the weight of
API as per salt factor in master formula.
• No excipients were mentioned. Specified the
excipients for the pH adjustment.
07.05.2021 and 13.07.2021.
• Registration Board in its 288th meeting upon

detailed deliberation of capacity assessment report
and considering the measures taken by the firm for
upgradation of QC lab decided to allow contract
manufacturing by M/s EG Pharmaceuticals,
Industrial Triangle Kahuta Road, Islamabad
Decision: Approved. Registration letter will be issued upon submission of following:
• Revised label claim as per innovator product alongwith submission of 75,000/- fee as
per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Latest GMP certificate/last inspection report conducted within last three years for both
applicant and manufacturer.
By
Brand Name +Dosage Form + Strength Citonome 1g/4ml Injection
Citicoline As Sodium eq to Citicoline …….. …1g
Rs. 50,000/- dated 06.03.2019
Pharmacological Group Other psychostimulants and nootropics
Type of Form Form 5
Approval status of product in Reference CITICOLINA GIT 1000mg / 4ml solution for injection
Regulatory Authorities. (vial 4ml), AIFA approved
Me-too status Coleen Injection.1000mg/4ml. Reg. No. 46760
GMP status genomgmp
evaluated.
neurotonic/nootropic to “Other psychostimulants
and nootropics”.
• Applied for Each 4ml Ampoule Contains:
Citicoline As Sodium eq to Citicoline …1g.
Revised the label claim to Each 4ml Ampoule
Contains:
Citicoline As Sodium ……………1g.
07.05.2021 and 13.07.2021.
• Registration Board in its 288th meeting upon detailed
deliberation of capacity assessment report and
considering the measures taken by the firm for
manufacturing by M/s EG Pharmaceuticals,
Industrial Triangle Kahuta Road, Islamabad
Registration letter will be issued upon submission of latest GMP certificate/last inspection
report conducted within last three years for both applicant and manufacturer.
By M/s EG Pharmaceuticals. Plot. No. 13-A, Industrial
Brand Name +Dosage Form + Strength Piranome 1g/5ml Injection
Piracetam ……………………..…1g
Rs. 50,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference DIZZITAM 200 mg / ml oral and injectable solution
Regulatory Authorities. for intravenous use (5ml, 10ml ampoule), AIFA
approved
Me-too status Neurotam Injection. Reg. No. 7348
GMP status genomgmp
evaluated.
• The firm revised the pharmacological group from
anticonvulsant to “Other psychostimulants and
nootropics”.
07.05.2021 and 13.07.2021.
Registration Board in its 288th meeting upon detailed
deliberation of capacity assessment report and
considering the measures taken by the firm for
manufacturing by M/s EG Pharmaceuticals, Industrial
Triangle Kahuta Road, Islamabad
submission of 7500/- fee for pre-registration correction/change as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Firm will also submit latest GMP inspection report conducted within last three years
for both applicant and manufacturer.
By
Brand Name +Dosage Form + Strength Lacgen 30mg/ml Injection
Composition Each ml Ampoule Contains:
Ketoralac Tromethamine eq to Ketoralac
Tromethamine ………………………...…30mg
Rs. 50,000/- dated 06.03.2019
Pharmacological Group Acetic acid derivatives and related substances
Type of Form Form 5
Pack size & Demanded Price 5’s (1ml ampoule); As per SRO
Approval status of product in Reference TORADOL ketorolac trometamol 30mg/1mL
Regulatory Authorities. (ketorolac trometamol 30mg without equivalency)
injection ampoule. TGA approved.
Me-too status Syntor 30 mg Injection IV/IM. Reg. No. 83365
GMP status genomgmp
evaluated.
• Applied for Ketorolac Tromethamine eq to Ketorolac
Tromethamine…30mg. Revised the label claim to
Ketorolac Tromethamine…30mg.
• Revise the pharmacological group from NSAIDs to
“Acetic acid derivatives and related substances”.
07.05.2021 and 13.07.2021.
Each ml Ampoule Contains:
Ketorolac Tromethamine ……………...…30mg
Decision: Registration Board deferred the case for further deliberation regarding the
sterilization method of the applied formulation whether by way of terminal sterilization or
otherwise.
202. Name and address of manufacturer / M/s Remington Pharmaceuticals Industries Pvt Ltd. 18
Applicant km, Multan Road, Lahore
Brand Name +Dosage Form + Strength Redicort cream 1%, 1% w/w
Clotrimazole …………………..…10mg
11.2 mg Hydrocortisone Acetate eq. to 10mg
hydrocortisone
Rs. 20,000/- dated 06.03.2019
Pharmacological Group hydrocortisone, combinations
Type of Form Form 5
Finished Product Specification Not submitted. available in BP.
Pack size & Demanded Price 10g; Leader price
Approval status of product in Reference Canesten Hydrocortisone Canesten Hydrocortisone
Regulatory Authorities. (with salt equivalent) Athlete’s Foot 1%, 1% w/w
Cream. MHRA approved
Me-too status Aquazole Cream 10gm (without salt equivalent).
(Reg#067931)
GMP status rmggmp
evaluated.
• Revise the pharmacological group from antifungal to
hydrocortisone, combinations.
• You have mentioned eye ointment form in the
manufacturing outlines. Justify.
• You have mentioned NLT 5G filling, but the applied
pack size is 10g. Clarify.
• For revision, submit applicable fee as per
07.05.2021 and 13.07.2021.
of revised pharmacological group, revised manufacturing outlines with fee of 7500/-
for pre-registration correction/changes as per notifications 7-11/2012-B&A/DRAP
dated 07.05.2021 and 13.07.2021.
• Firm shall also submit latest GMP certificate/last inspection report conducted within
last three years.
Brand Name +Dosage Form + Strength Fusirem Cream 2%

Fusidic Acid ………………………………20mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Other antibiotics for topical use
Type of Form Form 5
Finished Product Specification The firm has submitted copy of BP specs. available in
BP.
Pack size & Demanded Price 5g, 10g; Leader price
Approval status of product in Reference Fucidin 20 mg/g Cream. MHRA Approved
Me-too status FUCIDIN CREAM 20mg. Reg. No. 15539
GMP status rmggmp
evaluated.
• You have mentioned NLT 5G filling, but the applied
pack size is 10g. Clarify.
manufacturing outlines. Justify.
07.05.2021 and 13.07.2021.
of revised manufacturing outlines with fee of 7500/- for pre-registration
correction/changes as per notifications 7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
• Firm shall also submit latest GMP certificate/last inspection report conducted within
last three years.
Brand Name +Dosage Form + Strength Retaval cream 0.1%
Betamethasone as Valerate …………………1mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Corticosteroids
Type of Form Form 5
BP.
Approval status of product in Reference Betamethasone (as) Valerate 0.1%w/w Cream. MHRA
Me-too status Beason Cream 0.1%. Reg. No. 80082
GMP status rmggmp
evaluated.
• Mentioned NLT 15g filling, but the applied pack size
is 5g and 15g. then, revised it.
• Submitted Rs. 7500/- fee challan- 208859634230.
Brand Name +Dosage Form + Strength Retaval Lotion 0.1%
1% lotion contains 1.2mg of Betamethasone Valerate
(eq. to 1mg Betamethasone)
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
BP.
Pack size & Demanded Price 60ml; Leader price
Approval status of product in Reference Betnovate Lotion (Betamethasone Valerate 0.122%
Regulatory Authorities. w/w). MHRA Approved
Me-too status B.M.T Lotion 0.1%/gm. Reg. No. 72710
GMP status rmggmp
evaluated.
• Applied for w/w, however, the master formula and
pack size were mentioned in ml. then, revised it to
grams.
• Submitted Rs. 7500/- fee challan- 27671491529
206. Name and address of manufacturer / M/s Remington Pharmaceuticals Industries Pvt Ltd.
Applicant 18 km, Multan Road, Lahore
Brand Name +Dosage Form + Strength Tacilus Ointment 0.1%
Tacrolimus as Monohydrate …………….…0.1%
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Calcipotriol, Combinations
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specs. available in BP.
Approval status of product in Reference Tacrolimus Accord 0.1 % ointment. MHRA approved
Me-too status Limus 0.1% Ointment. Reg. No. 45215
GMP status rmggmp
evaluated.
• Revise the pharmacological group from
dermatologicals to “Agents for dermatitis,
excluding corticosteroids”.
• You have mentioned NLT 5g filling, but the applied
pack size is 10g and 30g. Clarify.
manufacturing outlines. Justify
07.05.2021 and 13.07.2021.
Decision: Registration Board approved registration of product with innovator’s specifications
in general manufacturing areas with condition that manufacturer shall provide safety
and protective measures for workers and personnel which remain in direct contact
or are involved in close handling of these drugs.
• Registration letter will be issued after submission of revised the pharmacological
group from dermatological to “Agents for dermatitis, excluding corticosteroids,
revised manufacturing outlines with submission of fee of 7500/- for pre-registration
13.07.2021.
last three years.
207. Name and address of manufacturer / M/s Sapient Pharma 123/S, Quaid e Azam Industrial
Applicant Estate, Kot Lakhpat, Lahore
Brand Name +Dosage Form + Strength Lsprd 50mg Tablet
Levosulpiride ………………………….…50mg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Benzamides
Type of Form Form 5
Pack size & Demanded Price 1x10’s, 3x10’s, 6x10’s, 10x10’s; As per SRO
Approval status of product in Reference LEVOPRAID® 50 mg Tablets by TEOFARMA Srl.
Regulatory Authorities. Approved by AIFA
Me-too status Sulvo Tablets 50mg. Reg. No. 31748
GMP status Copy of GMP certificate No. 80/2020-DRAP (AD-
199285-703) dated 22-04-2020 issued on the basis of
inspection conducted on 18-11-2019 is submitted.
evaluated.
• Submitted form 5 and its enclosures are for Itopride
HCL instead of Levosulpiride.
Decision: Deferred for submission of all the enclosures of Form 5 for the applied formulation
along with submission of apllicable fee as per notifications 7-11/2012-B&A/DRAP dated
07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Mosmd 100mg Tablet
Lacosamide …………………………..…100mg
Rs. 20,000/- dated 04.03.2019
Type of Form Form 5
Approval status of product in Reference Lacosamide Aspire 100 mg film-coated tablets by
Regulatory Authorities. Aspire Pharma Limited. MHRA Approved
Me-too status Lalap 100mg Tablet by Genix Pharma (Pvt.) Ltd.
Reg. No. 70471
evaluated.
• Firm has submitted all the enclosures of form 5.
However, specifications for the finished drug
product are not provided.
submission of 7500/- fee for pre-registration correction/changes as per notifications
7-11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Lacosamide ………………….…50mg
Rs. 20,000/- dated 04.03.2019
Type of Form Form 5
Approval status of product in Reference Lacosamide Aspire 50 mg film-coated tablets by
Regulatory Authorities. Aspire Pharma Limited. MHRA Approved
Me-too status Lalap 50mg Tablet by Genix Pharma (Pvt.) Ltd. Reg.
No. 70470
evaluated.
submission of 7500/- fee for pre-registration correction/changes as per notifications
7-11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Lacosamide……………………………..…150mg
Rs. 20,000/- dated 04.03.2019
Type of Form Form 5
Me-too status Lacolep 150mg Tablet Reg. No. 73859
evaluated.
• Form has not been signed.
submission of 7500/- fee for pre-registration correction/changes as per notifications 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Ondan 8mg Tablet
Ondansetron as Ondansetron HCl dihydrate……8mg
Rs. 20,000/- dated 04.03.2019
Type of Form Form 5
Finished Product Specification Not submitted. Available in USP and BP
Approval status of product in Reference Ondansetron 8 mg Film-coated Tablets. MHRA
Me-too status Ondan Tablet film-coated 8mg. Reg No. 82657
evaluated.
• The firm mentioned the pharmacological group as
selective Serotonin (5HT3) antagonists.
However, form 5 is unsigned.
submission of 7500/- fee for pre-registration correction/changes as per notifications 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Pelip 3mg Tablet
Composition Each Sustained Release Tablet Contains:
Paliperidone…………………………..…3mg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Antipsychotic
Type of Form Form 5
Approval status of product in Reference INVEGA (1.5mg, 3mg, 6mg, 9mg) Extended-Release
Regulatory Authorities. Tablets USFDA approved
Me-too status Vegadon SR 3mg Tablets. Reg. No. 080371
evaluated.
• The reference product Invega, approved by USFDA
is Extended release tablet manufactured by
OROS Push-Pull Technology and the public
assessment report describes that osmotic pressure
delivers paliperidone from the dosage form at a
controlled rate. Provide evidence of required
manufacturing technology as per reference
product, and revise the manufacturing outlines
accordingly.
• Firm has submitted signed form 5 along with all the
enclosures of form 5.
• Provide evidence of required manufacturing technology (OROS Push-Pull
Technology) as per reference product.
Brand Name +Dosage Form + Strength Pelip 6mg Tablet
Composition Each Sustained Release Tablet Contains:
Paliperidone………………………………6mg
Rs. 20,000/- dated 04.03.2019
Type of Form Form 5
evaluated.
is Extended release tablet manufactured by
OROS Push-Pull Technology and the public
assessment report describes that osmotic pressure
delivers paliperidone from the dosage form at a
controlled rate. Provide evidence of required
manufacturing technology as per reference
product.
Brand Name +Dosage Form + Strength Moprostl 200mcg
Misoprostol……………………..…200mcg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Prostaglandins.
Type of Form Form 5
Finished Product Specification Not submitted. Available in IP and BP
Approval status of product in Reference CYTOTEC Misoprostol 200 microgram tablet,
Regulatory Authorities. uncoated. TGA approved
Me-too status Misoclear Tablets 200mcg. Reg. No. 84191
evaluated.
Prostaglandin analogues to Prostaglandins.
submission of submission of 75,00/- fee for pre-registration correction/change as per
• Firm will also submit revised pharmacological group with pre-registration variation
fee.
Brand Name +Dosage Form + Strength Sapride 50mg
Itopride HCl…………………………..…50mg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Antiemetics, Prokinetics
Type of Form Form 5
Approval status of product in Reference Itopride hydrochloride tablet 50 mg. PMDA approved
Me-too status Itoride Tablet by Lexicon Pharmaceutical. Reg No.
42040
evaluated.
Prostaglandin analogues to Prostaglandins.
• Revise the label claim from Each Tablet Contains:
Itorpide Hcl…50mg to Each film-coated Tablet
Contains:
Itorpide Hcl…50mg.
enclosures of form 5. Firm has revised their label
claim from each tablet contains Itorpide
HCl…50mg to each tablet contains Itorpide as
Itopride HCl…50mg without submission of any
fee. Furthermore, no finished product
specifications are submitted.
Decision: Approved with innovator’s specifications and following label claim;
Itopride as HCl………………50mg
• Registration letter will be issued after submission of submission of 30,000/- fee for pre
registration correction/change as per notification No.F.7-11/2012-B&A/DRAP dated
13-07-2021.
Brand Name +Dosage Form + Strength SDOLP 37.5mg/325mg Tablet
Tramadol HCl…………………………..37.5mg
Paracetamol………………………………325mg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Opioids in combination with non-opioid analgesics
Type of Form Form 5
Approval status of product in Reference ULTRACET (tramadol hydrochloride and
Regulatory Authorities. acetaminophen) tablets, for oral use by Janssen Pharms
US-FDA approved
Me-too status Tril-P Tablet by Linta Pharmaceuticals. Reg. No.
78181
evaluated.
• Revise the pharmacological group to Opioids in
combination with non-opioid analgesics.
• Revise the label claim to film-coated tablet.
• Firm has submitted form 5 along with all the
enclosures of form 5. However, firm has neither
revised the pharmacological group the label
claim of the applied formulation.
of submission of 7500/- fee for pre registration correction/change as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Firm will also submit revised label claim from uncoated tablets to film coated tablet
and revised the pharmacological group for the applied formulation with pre-
registration variation fee.
Brand Name +Dosage Form + Strength Telam tablet 5/40mg

Amlodipine As Besylate……………………5mg
Telmisartan………………………………….40mg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Angiotensin II antagonists and calcium channel
blocker
Type of Form Form 5
Approval status of product in Reference TWYNSTA® (telmisartan/amlodipine) tablets, for
Regulatory Authorities. oral use (5/40mg). TGA approved
evaluated.
• Submit all the requirements /documents as per
enclosure of Form 5 along with submission of
applicable fee as per notifications 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
Decision: Deferred for submission of all the requirements /documents as per enclosure of Form
5 along with submission of applicable fee as per notifications 7-11/2012-B&A/DRAP dated
07.05.2021 and 13.07.2021.

Amlodipine As Besylate………………5mg
Telmisartan…………………………..80mg
Rs. 20,000/- dated 04.03.2019
blocker
Type of Form Form 5
evaluated.
B&A/DRAP dated 07.05.2021 and 13.07.2021.
07.05.2021 and 13.07.2021.
Amlodipine As Besylate…10mg
Telmisartan…40mg
Rs. 20,000/- dated 04.03.2019
blocker
Type of Form Form 5
evaluated.
B&A/DRAP dated 07.05.2021 and 13.07.2021.
07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Smval 10/160mg Tablets
Amlodipine Besylate…………………………10mg
Valsartan…………………………………160mg
Rs. 20,000/- dated 04.03.2019
blocker
Type of Form Form 5
Approval status of product in Reference Amlodipine/Valsartan 10 mg/160 mg film-coated
Regulatory Authorities. tablets, MHRA approved.
Me-too status Exforge 10/160mg tablet, Novartis Pharma (Import),
Reg. No. 047571.
evaluated.
• Revise the formulation from tablet to film-coated
tablet.
• Revise Amlodipine Besylate…10mg to
Amlodipine as Besylate…10mg.
enclosures of form 5. However, no change is
made in the label claim and coated tablets.
of submission of 30,000/- fee for pre-registration correction/change as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Firm will also submit revised label claim as per reference product from Amlodipine
Besylate…10mg to Amlodipine as Besylate…10mg and revision of formulation from
uncoated to film coated tablets.
Brand Name +Dosage Form + Strength Sinita 1mg Tablet
Cinitapride Hydrogen Tartrate…………………1mg
Rs. 20,000/- dated 04.03.2019
Type of Form Form 5
Approval status of product in Reference Cinitapride Cinfa 1 mg uncoated tablets (Spain
Regulatory Authorities. Approved)
Me-too status Cidine 1mg tablet by highnoon laboratories
evaluated.
• Revise Cinitapride Hydrogen Tartrate…1mg to
Cinitapride as Hydrogen Tartrate…1mg.
enclosures of form 5. Firm has also revised their
label claim as per reference product without
submission of applicable fee. However,
specifications for the finished product are not
submitted.
Cinitapride as Hydrogen Tartrate…………1mg
submission of submission of 30,000/- fee for pre-registration correction/change as per
Brand Name +Dosage Form + Strength Slrnx 8mg
Lornoxicam……………………….…8mg
Rs. 20,000/- dated 04.03.2019
Type of Form Form 5
Approval status of product in Reference Xefo 8 mg Film tabletten. Swiss Medic Approved
Me-too status Lornoxi DS 8mg Tablet. Reg. No. 74933
evaluated.
• Revise the formulation from tablet to film-coated
tablet.
enclosures of form 5. However, specifications for
the finished product are not submitted.
submission of submission of 7500/- fee for pre-registration correction/change as per
Brand Name +Dosage Form + Strength Mapdon 4mg/5ml Syrup
Ondansetron HCl Dihydrate…………………….4mg
Rs. 20,000/- dated 04.03.2019
Type of Form Form 5
Approval status of product in Reference Ondansetron (as the hydrochloride dihydrate)
Regulatory Authorities. 4mg/5ml Syrup. MHRA Approved
Me-too status Ondan syrup 4mg/5ml, Bio-mark pharmaceutical,
Reg. No. 082628.
evaluated.
enclosures of form 5. Firm has also revised their
label claim as per reference product without
submission of applicable fee. However,
specifications for the finished product are not
submitted.
Each 5ml Contains:
Ondansetron as hydrochloride Dihydrate….4mg
of submission of 30,000/- fee for pre-registration correction/change as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Strength Saprofen 200mg/5ml
Ibuprofen…………………..…200mg
Rs. 20,000/- dated 04.03.2019
Pharmacological Group Non-selective COX inhibitors
Type of Form Form 5
Approval status of product in Reference Ibuprofen 100mg/5ml Suspension, MHRA approved.
Me-too status Tercica 100mg/5ml Suspension, Sami, Karachi, Reg.
No. 061206
evaluated.
• In initially submitted dossier firm has claimed each
5ml contains 200mg of Ibuprofen. However, in
newly submitted enclosures of Form 5 they
revised their label claim to each 5ml contains
100mg of Ibuprofen.
• They have claimed BP specs.
Decision: Deferred for clarification of the label claim for the applied formuation.
Brand Name +Dosage Form + Strength Sinita 2mg/ml syrup
Cinitapride Hydrogen Tartrate……………..…2mg
Rs. 20,000/- dated 04.03.2019
Type of Form Form 5
Approval status of product in Reference Cidine 1 mg/5 ml Oral solution, CIMA approved.
Me-too status Gutt oral solution. Reg. No. 75278
evaluated.
• The pharmacological group has not been provided.
Mention it as Propulsives.
• Revise Each ml Contains: Cinitapride Hydrogen
Tartrate…2mg to Each 5ml Contains: Cinitapride
as Hydrogen Tartrate…1mg, and fill serial No. 04
of the enclosure accordingly.
• You have provided the pack size as 1x14’s tablet.
Jsutify/revise.
B&A/DRAP dated 07.05.2021 and 13.07.2021.
• Pharmacological group for the applied formulation.
• Revision of label claim as per reference product along with submission of full fee.
• Revision of pack size from tablet to syruo formulation.
• Submission of all the requirements /documents as per enclosure of Form 5.
226. Name and address of manufacturer / M/s Highnoon Laboratories Ltd. 17.5 km, Multan
Applicant Road, Lahore By
M/s Shahzeb Pharmaceuticals Hazara Trunk Road,
Sarai Gadaee
Haripur. KPK
Brand Name +Dosage Form + Strength Dee Injection 5mg IM / oral
Cholecalciferol (Vitamin D3)…5mg (200,000 IU)
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Vitamin D
Type of Form Form 5
Pack size & Demanded Price 1’s (HDPE ampule) 1ml; As per SRO
Approval status of product in Reference VITAMINE D3 BON 200 000 U.I. / 1 ml, solution
Regulatory Authorities. injectable IM en ampoule (glass). ANSM approved
Me-too status Accu-D Injection. Reg. No. 79755
GMP status srqgmp
evaluated.
• The provided reference product is packed in glass
ampoule. You have applied for HDPE ampoule.
Justify.
• You have not provided the strength of the product.
• Submit compostion (with list of excipients), master
formula and manufacturing outlines.
• Submit contract manufacturing agreement.
• Manufacturer in enclosure of Form 5 is Highnoon
Laboratories. Revise it.
07.05.2021 and 13.07.2021.
• Justification for using HDPE ampoule while the reference product is packed in glass
ampoule.
• Submission of complete compostion (with list of excipients), master formula and
• Copy of the contract agreement.
• Revision of manufacturer in the enclosure of Form 5 where M/s Highnoon Laboratories
is mentioned as manufacturer
• submission of stability study data as per the guidelines approved in 293rd meeting of
Registration Board.
• Latest GMP certificate/ last inspection report conducted within last three years of both
Brand Name +Dosage Form + Strength Colin Injection 1MIU
Colistimethate Sodium………………….…1MIU
Rs. 50,000/- dated 05.03.2019
Pharmacological Group Antibacterials
Type of Form Form 5
Approval status of product in Reference Colistimethate Sodium 1 Million I.U. Powder for
Regulatory Authorities. Solution for Injection (lyophilized powder in glass
vial). Approved by MHRA
Me-too status Colistat powder for Injection. Reg. No. 76160
GMP status The firm was inspected on 12.12.2018, GMP was
reported at satisfactory level.
GMP certificate issued on the basis of inspection
dated 12.08.2020.
evaluated.
manufacturer.
• Specify the applicant as well as manufacturer in
enclosure of Form 5.
• The reference product is lyophilized powder. The
submitted documents does not depict the same.
Clarification is required.
07.05.2021 and 13.07.2021.
• Latest GMP certificate/ last inspection report conducted within last three years.
• Form 5 shall be submitted by the applicant, not manufacturer.
• Clarification regarding the manufacturing method of the applied formulation as
reference product is lyophilized powder.
• Deferred for confirmation of required manufacturing facility / section from Licensing
Division.
By
M/s Rotex Pharma Pvt Ltd. Plot No. 206 & 207.
Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Deson 4mg/ml Injection
Dexamethasone Phosphate (as sodium)….…4.4mg
Rs. 50,000/- dated 05.03.2019
Pharmacological Group Glucocorticoids
Type of Form Form 5
Pack size & Demanded Price 25’sx1ml; As per SRO
Approval status of product in Reference DBL DEXAMETHASONE SODIUM PHOSPHATE
Regulatory Authorities. INJECTION 4mg/1mL (as sodium) injection
ampoule. TGA approved
Me-too status Histopak Injection. Reg. No. 57655
dated 12.08.2020.
evaluated.
manufacturer.
• Revise Dexamethasone Phosphate (as sodium)
4.4mg to Dexamethasone Phosphate (as
sodium)…4mg in the label claim.
• Revise Dexamethasone Phosphate as
sodium…4.4mg to Dexamethasone Phosphate
sodium…4.37mg in the master formula.
07.05.2021 and 13.07.2021.
• Submit GMP inspection reports of both the firms.
• Confirmation of approval of required manufacturing facility Licensing Division.
• Revision of label claim as per innovator product along with submission of applicable
fee as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
• Capacity assessment of M/s Rotex Pharma Pvt. Ltd.
By
Brand Name +Dosage Form + Strength Drocort 100mg Injection
Hydrocortisone Sodium Succinate eq. to
Hydrocortisone…………………..…100mg
Rs. 50,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Reference HYDROCORTISONE PANPHARMA
Regulatory Authorities. hydrocortisone as sodium succinate 100 mg powder
for injection vial. TGA approved
Me-too status Cortizone 100mg Injection. Reg. No. 81898
dated 12.08.2020.
evaluated.
manufacturer.
• Revise “Hydrocortisone Sodium Succinate eq. to
Hydrocortisone” to Hydrocortisone Sodium
Succinate” in the composition master formula
only.
• Mentioned the excipients in the composition.
• The reference product is a freeze-dried cake. You
have not submitted the lyophilization procedure
and provision of facility thereof.
07.05.2021 and 13.07.2021.
• Specify the applicant as well as manufacturer in enclosure of Form 5.
• Revise salt form as per innovator drug product.
• Approval of Licensing Division for lyophilization facility.
dated 07.05.2021 and 13.07.2021
By
Brand Name +Dosage Form + Strength Drocort 250mg Injection
Hydrocortisone Sodium Succinate eq. to
Hydrocortisone…250mg
Rs. 50,000/- dated 05.03.2019
Type of Form Form 5
Approval status of product in Reference HYDROCORTISONE PANPHARMA
Regulatory Authorities. hydrocortisone as sodium succinate 250 mg powder
for injection vial. TGA approved
Me-too status Cortizone 250mg Injection. Reg. No. 81899
dated 12.08.2020.
evaluated.
manufacturer.
• Revise “Hydrocortisone Sodium Succinate eq. to
Hydrocortisone” to Hydrocortisone Sodium
Succinate” in the composition master formula
only.
• Mentioned the excipients in the composition.
• The reference product is a freeze-dried cake. You
have not submitted the lyophilization procedure
and provision of facility thereof.
07.05.2021 and 13.07.2021.
• Specify the applicant as well as manufacturer in enclosure of Form 5.
• Revise salt form as per innovator drug product.
• Approval of Licensing Division for lyophilization facility.
dated 07.05.2021 and 13.07.2021
231. Name and address of manufacturer / M/s Semos Pharmaceuticals Pvt Ltd. Plot No. 11,
Applicant Sector 12-A, North Karachi, Krachi-75850, Pakistan
Brand Name +Dosage Form + Strength Bical 50mg Tablet
Bicalutamide……………………….…50mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Anti-androgens
Type of Form Form 5
Approval status of product in Reference Bicalutamide 50mg filmcoated tablets. MHRA
Me-too status Calutide-50 Tablet. Reg. No. 45650
GMP status semsgmp
evaluated.
• The structure does not contain steroid nucleus.
•
Decision: Registration Board rejected the application of the firm since the firm does not have
the required manufacturing facility for the applied formulation.
232. Name and address of manufacturer / M/s Semos Pharmaceuticals Pvt Ltd. Plot No. 11,
Applicant Sector 12-A, North Karachi, Krachi-75850, Pakistan
Brand Name +Dosage Form + Strength Besol 2mg Tablet
Chlorambucil…………………2mg
Rs. 20,000/- dated 05.03.2019
Pharmacological Group Anticancer
Type of Form Form 5
Approval status of product in Reference Chlorambucil 2 mg filmcoated tablets. MHRA
Me-too status Leukeran tablets 2mg. Reg. No. 11511
GMP status semsgmp
evaluated.
•
Decision: Registration Board rejected the application of the firm since the firm does not have
the required manufacturing facility for the applied formulation.
233. Name and address of manufacturer / M/s Wimits Pharmaceuticals (Pvt.) Ltd. Plot No. 129,
Applicant Sundar Industrial Estate, Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Triwim Cream
Fluocinolone Acetonide …. 0.1mg
Hydroquinone ……………… 40mg
Tretinoin ……………….… 0.5mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Corticosteroids, potent (group III) in combination
with other dermatological and retinoids for topical
use.
Type of Form Form 5
Pack size & Demanded Price 10g, 15g, 30g, 45g; As per SRO
Approval status of product in Reference TRI-LUMA® (fluocinolone acetonide,
Regulatory Authorities. hydroquinone, and tretinoin) cream, 0.01%, 4%,
0.05% for topical use by Galderma Labs LP. USFDA
approved
Me-too status Trimelasin Cream by Valor Pharmaceuticals. Reg.
No. 31104
GMP status cGMP certificate on the basis of evaluation
evaluated.
• Revise pharmacological group to Corticosteroids,
potent (group III) in combination with other
dermatological and retinoids for topical use.
07.05.2021 and 13.07.2021.
Firm has submitted Form 5 with corrected
pharmacological group as Corticosteroids, potent
(group III) in combination with other dermatological
and retinoids for topical use along with submission of
fee of Rs. 7,500/- vide deposit slip# 91777507459
Brand Name +Dosage Form + Strength Fuci-Mit 2% w/w Ointment
Sodium Fusidate ……………………… 20mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference FUCIDIN sodium fusidate 20mg/g ointment tube.
Regulatory Authorities. TGA Approved
Me-too status Fusiderm Ointment 2%. Reg. No. 26749
evaluated.
• You have applied for ointment, however, the
submitted composition are meant for o/w
emulsion. Clarify.
07.05.2021 and 13.07.2021.
• Firm has submitted master formulation with
submission of fee of Rs. 7,500/- vide deposit
slip# 075033962
Decision: Approved.
Brand Name +Dosage Form + Strength Betawit C ointment
Betamethasone (as dipropionate) … 0.5mg
Calcipotriol (as monohydrate)… 50mcg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Corticosteroids + Antibiotics
Type of Form Form 5
Approval status of product in Reference Calcipotriol (as monohydrate) /Betamethasone (as
Regulatory Authorities. dipropionate) Sandoz 50 micrograms per g / 500
micrograms per g ointment. MHRA approved.
Me-too status Calbet Ointment. Reg. No. 84025
evaluated.
Corticosteroids + Antibiotics to Other
07.05.2021 and 13.07.2021.
• Firm has submitted Form 5 with corrected
pharmacological group as Corticosteroids, potent
(group III) in combination with other
dermatological and retinoids for topical use along
with submission of fee of Rs. 7,500/- vide deposit
slip# 9106510579
236. Name and address of manufacturer / M/s Zephyr Pharmatec Pvt Ltd. Plot No. A-39, S.I.T.E
Applicant II, Super Highway, Karachi.
Brand Name +Dosage Form + Strength Detellix 10mg Tablet
Vortioxetine…………………………10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antidepressant
Type of Form Form 5
in USP
Approval status of product in Reference Trintellix 10mg Tablet of Takeda Pharms USFDA
Me-too status
GMP status The firm was rated Good as per GMp inspection dated
19.01.2022.
Remarks of the Evaluator. • Revise the pharmacological group from antipsychotic
to antidepressants.
• You have already adjusted the of weight of
vortioxetine hydrobromide in master formula as
per salt factor. Revise the label claim from
vortioxetine..10mg to vortioxetine as
hydrobromide..10mg.
• Add blistering and packing process in the
• For revision, submit applicable fee as per notification
7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
• Revision of the pharmacological group from antipsychotic to antidepressants.
• Revision of the label claim as per reference product along with submission of applicable
fee.
• Addition of blistering and packing process in the manufacturing outlines.
• Submission of stability study data as per the guidelines approved in 293rd meeting of
Registration Board.
237. Name and address of manufacturer / M/s Zephyr Pharmatec Pvt Ltd. Plot No. A-39, S.I.T.E
Applicant II, Super Highway, Karachi.
Brand Name +Dosage Form + Strength Etexin CR 25mg Tablet
Paroxetine HCl eq to paroxetine………………25mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
in USP
Approval status of product in Reference Paxil CR Tablet 25mg. USFDA approved.
GMP status The firm was rated Good as per GMp inspection dated
19.01.2022.
Remarks of the Evaluator. • Revised the pharmacological group from
antipsychotic to antidepressants.
• The firm was asked to revise the composition, master
formula, and manufacturing method in line with
the submitted reference:.
Reference Action Action required
product taken
Each extended- The firm Revision to
release tablet revised the 28.51mg is
contains 12.5 mg, quantity of required.
25 mg, or 37.5 API to Revise paroxetine
mg paroxetine 28.41mg. as HCl to
equivalent to Paroxetine as HCl
14.25 mg, 28.51 hemihydrate in the
mg, or 42.76 mg label claim.
of paroxetine Revise paroxetine
hydrochloride, as HCl to
respectively. The Paroxetine HCl
factor used is hemihydrate in
meant for the master
hemihydrate formula.
form
.
One layer of the NIL Revise the

tablet consists of composition and
a degradable manufacturing
barrier layer and outlines.
the other contains
the active
material in a
hydrophilic
matrix
In addition to NIL Add enteric
controlling the coating
rate of drug
release in vivo, an
enteric coat
delays the start of
drug release until
tablets of PAXIL
CR have left the
stomach.
• Added blistering and packing process in the
• Submitted Rs. 7500 fee (challan-9237480294).
of revised label claim as per reference product along with submission of differential
fee of 22,500/- fee for pre-registration correction/changes fee as per notification 7-
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
238. Name and address of manufacturer / M/s Zafa Pharmaceuticals Laboratories Private
Applicant Limited. L1/B Block-22, Federal B industrial Area,
Karachi
Brand Name +Dosage Form + Strength Alfa-Zaf 0.5mcg Tablet
Alfacalcidol ……………………..…0.5mcg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Vitamin D analogue
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specifications
Approval status of product in Reference one alpha tablet 0.5 μg. PMDA Japan Approved
Me-too status Bon One Tablet 0.5mcg
GMP status GMP certificate was issued based on inspection

conducted on 29 october 2020.
Remarks of the Evaluator. • The total weight of the tablet does not correspond to
630mg; however, it has been mentioned 630mg in
the manufacturing outlines. Justification is
required.
7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
submission of fee of 7500/- fee for pre-registration correction/changes fee as per
Karachi
Brand Name +Dosage Form + Strength Amisul 50mg Tablet
Amisulpride…………………….…50mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antipsycotic
Type of Form Form 5
in BP
Approval status of product in Reference SOLIAN 50 amisulpride 50 mg uncoated tablet. TGA
Me-too status Ampisol 50mg Tablet. Reg No. 76060
Remarks of the Evaluator. • The total weight of the tablet does not correspond to
630mg; however, it has been mentioned 630mg in
the manufacturing outlines. Justification is
required.
7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
of fee of 7500/- fee for pre-registration correction/changes fee as per notification 7-
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Karachi
Brand Name +Dosage Form + Strength Lipizaf 200mg Capsule
Fenofibrate (micronized)……………………200mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group lipid modifying agents
Type of Form Form 5
in USP
Approval status of product in Reference Fenofibrate 200 mg capsules (micronized). MHRA
Me-too status Elmc 200mg Capsule. Reg No. 53499
Remarks of the Evaluator. • Revise the pharmacological group to lipid modifying
agents.
7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
of fee of 7500/- fee for pre-registration for observed corrections/changes fee as per
Karachi
Brand Name +Dosage Form + Strength Olanzaf 10mg Tablet
Olanzapine…………………10mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
in USP
Approval status of product in Reference Olanzapine 10mg Film-coated tablets. MHRA approved
Me-too status Olanzpine 10mg tablets. Reg. No. 81661
Remarks of the Evaluator. • Revise the pharmacological group to antipsychotics.
• Revise the label claim from each tablet contains to
• Revise 1.25kg of olanzapine to 0.25kg per 50,000
tablets as per exact calculation.
• Add coating excipients in the composition and
coating process in the manufacturing outlines.
7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
of revised label claim as per reference product along with fee of 7500/- fee for pre-
registration correction/changes fee as per notification 7-11/2012-B&A/DRAP dated
07.05.2021 and 13.07.2021.
Karachi
Brand Name +Dosage Form + Strength Olanzaf 5mg Tablet
Olanzapine……………………….…5mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
in USP
Approval status of product in Reference Olanzapine 5mg Film-coated tablets. MHRA approved
Remarks of the Evaluator. • Revise the pharmacological group to antipsychotics.

• Revise the label claim from each tablet contains to
• Revise 2.5kg per 50,000 tablets as per exact
calculation.
• Add coating excipients in the composition and
coating process in the manufacturing outlines.
7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
of revised label claim as per reference product along with fee of 7500/- fee for pre-
07.05.2021 and 13.07.2021.
Karachi
Brand Name +Dosage Form + Strength Palidon 50mg Tablet
Composition Each Extended Released Film Coated Tablet Contains:
Paliperidone……………………………6mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Remarks of the Evaluator. • Add blistering and packing process in the

is Extended release tablet manufactured by OROS
Push-Pull Technology and the public assessment
report describes that osmotic pressure delivers
paliperidone from the dosage form at a controlled
rate. Provide evidence of required manufacturing
technology as per reference product, and revise the
manufacturing outlines accordingly.
7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
• Submit latest GMP certificate/last inspection report conducted within last three years.
• Add blistering and packing process in the manufacturing outlines along with
submission of applicable fee as per notification 7-11/2012-B&A/DRAP dated
07.05.2021 and 13.07.2021.
Karachi
Brand Name +Dosage Form + Strength Venlazaf 50mg Tablet
Desvenlafaxine Succinate Eq. To Desvenlafaxine
……………………..…50mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
in USP
Approval status of product in Reference Pristiq extended release tablets 50mg (film-coated).
Me-too status Denla XR 50mg Tablet. Reg. No. 70433 (Does not
depict coating)
zfagmp
Remarks of the Evaluator. • You have claimed extended release film-coated tablet
in the dosage form and specifications. Revise the
label claim from “Each Tablet Contains” to
extended release film-coated tablet contains”.
7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
Decision: Approved with innovator’s specification. Registration letter will be issued after
submission of revised label claim as per reference product from “Each Tablet
Contains” to extended release film-coated tablet contains along with full fee for pre-
07.05.2021 and 13.07.2021.
Karachi
Brand Name +Dosage Form + Strength Zafnil 16mg Tablet
Betahistine as dihydrochloride……………..…16mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
in BP
Approval status of product in Reference Betahistine uncoated tablet 16mg. MHRA approved
Remarks of the Evaluator. • Revise the pharmacological group to Antivertigo

preparations
• Revise Betahistine as dihydrochloride…16mg to
Betahistine dihydrochloride…16mg in the label
claim.
7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
Decision: Approved with BP specification. Registration letter will be issued after submission of
revised label claim, pharmacological group, manufacturing outlines as per reference
product along with full fee for pre-registration correction/changes fee as per
Karachi
Brand Name +Dosage Form + Strength Zafpram 20mg Tablet
Escitalopram as oxalate………………20mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antidepressant of SSRI class
Type of Form Form 5
in USP
Me-too status Neolexa 20mg Tablet Reg. No. 66978
Remarks of the Evaluator. • Adjust the weight of API in the master formula as per
salt factor.
7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
Decision: Approved with USP specification. Registration letter will be issued after submission
of revised label claim, pharmacological group, manufacturing outlines as per reference
product along with full fee for pre-registration correction/changes fee as per notification 7-
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Karachi
Brand Name +Dosage Form + Strength Zafta 1mg Tablet
Cinitapride hydrogen tartrate eq. to cinitapride…1mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Reference Cinitapride Cinfa 1 mg uncoated tablets (Spain
Regulatory Authorities. Approved)
Me-too status Cidine 1mg tablet by highnoon laboratories
GMP status zfagmp
Remarks of the Evaluator. • Revise the pharmacological group to propulsives.
7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
Decision: Approved with innovator’s specification. Registration letter will be issued after
submission of revised label claim, pharmacological group, manufacturing outlines as per
reference product along with full fee for pre-registration correction/changes fee as per
Karachi
Brand Name +Dosage Form + Strength Z-Loft 50mg Tablet
Sertraline as HCl……………………..…50mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
in USP
Approval status of product in Reference Lustral 50mg film coated tablets (MHRA Approved)
Me-too status Serglad Tablets 50mg. Reg. No. 30852
GMP status zfagmp
Remarks of the Evaluator. • Add blistering and packing process in the
7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021.
Decision: Approved with USP specification. Registration letter will be issued after submission
of revised label claim, pharmacological group, manufacturing outlines as per reference
product along with full fee for pre-registration correction/changes fee as per notification 7-
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
249. Name and address of M/s Ameer Pharma 23 KM-Sheikhupura Road, Lahore
manufacturer / Applicant
Brand Name +Dosage Form + Ameset 8mg Tablet
Strength
Ondansetron as HCl dihydrate…………….…8mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antiemetics and antinauseants
Type of Form Form 5
Approval status of product in Ondansetron 8 mg Film-coated Tablets. MHRA approved
Me-too status Ondan Tablet film-coated 8mg. Reg No. 82657
Remarks of the Evaluator. • You have already adjusted the weight of API in the master
formulation. Then, revised “Ondansetron as
hydrochloride dihydrate” to Ondansetron hydrochloride
dihydrate in master formulation.
• For revision, submit applicable fee as per notification 7-
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Pharma Pvt. Ltd.” decided to approve the product. Firm shall submit applicable fee
for pre-approval change/correction of label claim as per notification 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Estapram 10mg Tablet
Strength
Composition Each film coated tablet Contains:
Escitalopram as oxalate…………………..…10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antidepressant (SSRI)
Type of Form Form 5
Approval status of product in Escitalopram 10 mg film-coated Tablets. MHRA approved
Me-too status Atcopram 10mg Tablets. Reg No. 48555
Remarks of the Evaluator. • You have already mentioned film-coated tablet in the
compostion. Revise the label claim in Form 5 to each film-
coated tablet contains.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Fexofed 180mg Tablet
Strength
Fexofenadine HCl…………………..…180mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antihistaminic agent
Type of Form Form 5
Approval status of product in Fexofenadine Hydrochloride 180 mg Film-coated tablets.
Reference Regulatory Authorities. MHRA approved
Me-too status Tilast Tablets 180mg. Reg No. 50251
Remarks of the Evaluator. • You have already mentioned film-coated tablet in the
compostion. Revise the label claim in Form 5 to each film-
coated tablet contains.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Histamer 16mg Tablet
Strength
Betahistine Dihydrochloride…………………..…16mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antivertigo
Type of Form Form 5
Approval status of product in Betahistine uncoated tablet 8mg. MHRA approved
Remarks of the Evaluator.
decided to approve the product.
Brand Name +Dosage Form + Livamo 2mg Tablet
Strength
Pitavastatin as calcium………………………..…2mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specifications. Available in JP
Approval status of product in Alipza▼ 2mg film-coated tablets. MHRA approved
Me-too status Astin 2mg Tablet. Reg. No. 70448
to approve the product. Firm shall submit the fee of Rs. 7,500/- for correction/pre-approval
change/ in product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-
2021.
Brand Name +Dosage Form + Montac 10mg tablet
Strength
Composition Each Film-coated Tablet Contains:
Montelukast as sodium………………..…10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antihistamininc (Leukotriene receptor antagonist)
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specifications. Available in
USP
Approval status of product in SINGULAIR® (montelukast sodium) film-coated tablets.
Reference Regulatory Authorities. USFDA approved
Me-too status Singulair Tablets 10mg. Reg. No. 25259
Remarks of the Evaluator. • You have submitted the quantity of API for 300,000 tablets
as
Raw Role Specs Quantity / Quantity /
material tablet (mg) batch (kg)
Montelukast API BP 10.00 3.114
(as sodium)
Revise the last column to 3kg.
to approve the product. Firm shall submit the fee of Rs. 7,500/- for correction/pre-approval
change/ in product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-
2021.
Brand Name +Dosage Form + N Card 10mg Tablet
Strength
Nebivolol as HCl …………………….…10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Betablockers
Type of Form Form 5
Approval status of product in Nebivolol 10 mg tablets. MHRA approved
Me-too status Byscard-10 Tablet. Reg. No. 71102
Remarks of the Evaluator. Submit GMP inspection report/ certificate.
Pharma Pvt. Ltd.” decided to approve the product with Innovator’s specifications.
Firm shall submit the fee of Rs. 7,500/- for correction/pre-approval change/ in
product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-
2021.
Brand Name +Dosage Form + Pantrop 40mg Tablet
Strength
Pantoprazole as sodium sesquihydrate……….…40mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Proton pump inhibitors
Type of Form Form 5
USP
Approval status of product in PROTONIX (pantoprazole sodium) delayed-release tablets
Reference Regulatory Authorities. 40mg, for oral use. USFDA approved
Me-too status Qtum Tablet 40mg. Reg. No. 82648
to approve the product with USP specifcations. Firm shall submit the fee of Rs. 7,500/- for
Brand Name +Dosage Form + Paratram 37.5/325mg Tablet
Strength
Tramadol HCl………………………37.5mg
Paracetamol…………………………325mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Opioids in combination with non-opioid analgesics
Type of Form Form 5
USP
Approval status of product in ULTRACET (tramadol hydrochloride and acetaminophen)
Reference Regulatory Authorities. tablets, for oral use by Janssen Pharms US-FDA approved
Me-too status Tril-P Tablet by Linta Pharmaceuticals. Reg. No. 78181
Remarks of the Evaluator. • Revise the pharmacological group to Opioids in combination
with non-opioid analgesics.
to approve the product with USP specifcations. Firm shall submit the fee of Rs. 7,500/- for
Brand Name +Dosage Form + Ribamer 400mg Tablet
Strength
Ribavirin……………………….…400mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antivirals for treatment of HCV infections
Type of Form Form 5
Approval status of product in Ribavirin 400 mg film-coated tablets. MHRA approved
Me-too status Orilan 400mg Tablet. Reg. No. 83292
Remarks of the Evaluator. • Revise the pharmacological group from antiviral to
Antivirals for treatment of HCV infections.
Pharma Pvt. Ltd.” decided to approve the product.
Brand Name +Dosage Form + Sitamer 50/1000mg Tablet
Strength
Metformin HCl……………………………1000mg
Sitagliptin as phosphate monohydrate…….…50mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in JANUMET® (sitagliptin and metformin HCl) tablet,
Reference Regulatory Authorities. 50/1000mg film-coated. USFDA approved
Me-too status Neoglip 50/1000mg Tablets. Reg. No. 53100 (does not depict
hydrate form).
Remarks of the Evaluator. • Revise the pharmacological group to Combinations of oral
• You have already adjusted theweight of API in the master
formula as per salt factor. Revise Sitagliptin as phosphate
monohydrate to Sitagliptin phosphate monohydrate in
master formula.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
submission of revised pharmacological group for the applied formulation along with
submission of 7500/- fee for pre-registration correction/changes fee as per notification 7-
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Spasmer Tablet 80/80mg
Strength
Phlorglucinol hydrate………………………..…80mg
Trimethylphloroglucinol…………………….…80mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in PHLOROGLUCINOL / TRIMETHYLPHLOROGLUCINOL
Reference Regulatory Authorities. ACINO 62.233 mg / 80 mg, coated tablet. Approved by
ANSM
Me-too status Despasm Tablet by Irza Pharmaceuticals. Reg. No. 85210
Remarks of the Evaluator. • Revise the pharmacological group to Drugs for functional
gastrointestinal disorders
• You have already mentioned Phlorglucinol hydrate in the
label claim. Revise Phlorglucinol to Phlorglucinol hydrate
in the composition / master formula
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
to approve the product with Innovator’s specifcations. Firm shall submit the fee of Rs. 7,500/-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Vastamer 20mg Tablet
Strength
Atorvastatin as Calcium…………………………20mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Hypo;ipidemic (HMG-CoA reductase inhibitor)
Type of Form Form 5
Approval status of product in ACH-ATORVASTATIN CALCIUM (film-coated) by Accord
Reference Regulatory Authorities. Healthcare Inc. Health Canada approved
Me-too status LIPITOR TABLETS 20MG. Reg. No. 23621
Remarks of the Evaluator. • You have already adjusted the weight of API as per salt
factor. The reference product in Health Canada contains
Atorvastatin as calcium trihydrate. Revise the label claim
from Atorvastatin as calcium to Atorvastatin as calcium
trihydrate, and Atorvastatin calcium to Atorvastatin
calcium trihydrate in the master formula.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
to approve the product as per following label claim:
“Each film coated tablet contains:

Atorvastatin as Calcium ………… 20mg”
Registration letter will be issued after submission of revised label claim as per reference
product along with submission of full fee for pre-registration correction/changes fee as per
Brand Name +Dosage Form + Vilmet 50/500mg Tablet
Strength
Vildagliptin……………………..…50mg
Metformin HCl……………………500mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in GALVUMET 50/500 vildagliptin 50 mg/metformin
Reference Regulatory Authorities. hydrochloride 500 mg film coated tablet by Novartis
Pharmaceuticals Australia Pty Ltd. TGA approved
Me-too status Galmet 50mg/500mg Tablet by Vision Pharma. Reg No.
81905
Remarks of the Evaluator. • The approved shelf-life of the product in 18 months in TGA
Australia. You have claimed it as 2 years. Justify.
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Ameerocaine Injection 5mg
Strength
Composition Each ml of 10ml and 20ml Contains:
Bupivacaine ………………5mg as Bupivacaine HCl
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Local anaesthetics
Type of Form Form 5
Finished Product Specification The firm has claimed USP specifications
Pack size & Demanded Price 5’s (10ml), 5’s (20ml); As per SRO
Approval status of product in Bupivacaine 5 mg / mL Solution for injection (5ml, 10ml,
Reference Regulatory Authorities. 20ml). TGA approved
Me-too status Bucain Injection, 5mg/ml (20ml). Reg No. 39141
Bucan 0.5% Injection (10ml). Reg No. 39196
Remarks of the Evaluator. • Revise the label claim from “Each ml Of 10ml and 20ml
Contains: Bupivacaine …5mg as Bupivacaine HCl” to
“Each ml contains: Bupivacaine HCl as monohydrate
…5mg”.
• You have applied for 10ml and 20ml. choose one filled
volume.
• Specify the ampoule material.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
“Each ml contains:
Bupivacaine HCl as monohydrate …. 5mg”
Registration letter will be issued after submission of full fee for pre-registration
correction/changes of label claim as per notification 7-11/2012-B&A/DRAP dated 07.05.2021
and 13.07.2021.
Registration Board further decided that firm shall choose one fill voume before issuance of
registration letter.
Brand Name +Dosage Form + Atrameer Injection 25mg
Strength
Composition Each 2.5ml Ampoule Contains:
Atracurium Besylate…25mg (eq. to atracurium 7.5mg/ml)
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Non-depolarising neuromuscular blocking agent
Type of Form Form 5
Pack size & Demanded Price 5’s (2.5ml); As per SRO
Approval status of product in Atracurium Besilate 10 mg/ml Solution for Injection (2.5ml.
Reference Regulatory Authorities. 5ml, 25ml). MHRA approved
Me-too status Tracur Injection (2.5ml). Reg. No. 27350
Atramed Injection (2.5ml, 5ml). Reg. No. 28826
Remarks of the Evaluator. • Revise benzene sulfonic to benzene sulfonic acid in the
composition.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Dopamer 4% Injection
Strength
Dopamine hydrochloric acid……………………...200mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Adrenergic and dopaminergic agents
Type of Form Form 5
Approval status of product in Dopamine 40 mg/ml Sterile Concentrate. (5ml). MHRA
Me-too status Dopna 200mg/5ml IV solution for infusion. Reg. No. 81455
Remarks of the Evaluator. • Revise the pharmacological group from beta-adrenergic
agonist to Adrenergic and dopaminergic agents
• In the label claim, revise the API from Dopamine
hydrochloric acid to Dopamine hydrochloride.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
“Each 5ml Ampoule Contains:

Dopamine hydrochloric ……... 200mg”
Registration letter will be issued after submission of full fee for pre-registration
correction/changes of salt form of drug substace as per notification 7-11/2012-B&A/DRAP
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Fenatmer Injection 50ug
Strength
Fentanyl……………………….50 mcg (as Fentanyl citrate)
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Opioid anesthetics
Type of Form Form 5
Pack size & Demanded Price 25’s (2ml), 10’s (10ml); As per SRO
Approval status of product in Fentanyl 50 micrograms/ml Solution for injection/Infusion
Reference Regulatory Authorities. (2ml,10ml). MHRA approved
Me-too status Fantol 100ug / 2ml Injection. Reg. No. 61050
Fantol 500ug / 10ml Injection. Reg. No. 61051
Remarks of the Evaluator. • Specify the ampoule material.
• You have applied for 2ml and 10ml. Choose one filled
volume.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
• Submit approval of manufacturing facility for the applied
drug product.
• Evidence of approval of required manufacturing facility of “Liquid injection
(Psychotropic section) from CLB.
• Firm shall choose single fill volume along with submnission of applicable fee as per
notifications 7-11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Ltine Injection 1g
Strength
Composition Each 5ml Vial Contains:
Levocarnitine…………………………………1g
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Aminoacid
Type of Form Form 5
Approval status of product in Carnitor 1 g Solution for Injection (5ml). MHRA approved
Me-too status KEFEI INJECTION (Each vial contains: levocarnitine for
injection...1.0g (amino-acid).. Reg. No. 59054; filled volume
not specified
Remarks of the Evaluator. • The international reference product is filled in 5 ml glass
ampoule; you have applied for vial. Clarify.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Decision: Deferred for evidence of approval of required manufacturing facility of “Liquid
Injectable vial” from CLB.
Brand Name +Dosage Form + Meerocaine Injection 20mg
Strength
Lidocaine HCl……………………….…20mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Pack size & Demanded Price 50’s, 100’s (2ml); As per SRO
Approval status of product in Lidocaine 1% w/v injection (2ml, 5ml, 10ml, 20ml). MHRA
Me-too status L.A. Neutro Injection 20mg/2ml. Reg. No. 60495
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
decided to approve the product.
Brand Name +Dosage Form + Muscomer Injection 4mg
Strength
Thiocolchicoside…………………………4mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Pack size & Demanded Price 1X5’s, (2ml); As per SRO
Approval status of product in MIOREL 4 mg/2 ml, solution injectable (IM) en ampoule.
Reference Regulatory Authorities. ANSM approved
Me-too status Thiolax Injection 4mg/2ml. Reg. No. 61919
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Promer Injection 200mg/20ml
Strength
Propofol………………………200mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Pack size & Demanded Price 1x5’s, (2ml); As per SRO
Approval status of product in Propofol 1 % (10 mg/1 ml) Fresenius emulsion for injection or
Reference Regulatory Authorities. infusion (20ml ampoule, 50ml vial, 100ml vial). MHRA
approved
Me-too status Thiolax Injection 4mg/2ml. Reg. No. 61919
• The firm has mentioned emulsifier and oil phase in the
composition.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
to approve the product with BP specifcations. Firm shall submit the fee of Rs. 7,500/- for
271. Name and address of M/s Perfect Pharma Pvt Ltd. 5-Km, Manga Road, Raiwind,
manufacturer / Applicant Lahore, Pakistan
Brand Name +Dosage Form + Anzapine 10mg Tablet
Strength
Olanzapine …………………………….…10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antipsychotics
Type of Form Form 5
Approval status of product in Olanzapine 10mg Film-coated tablets. MHRA approved
GMP status The firm was inspected on 22.09.2021 and 08.10.2021, where
satisfactory level of GMP compliance was reported.
Remarks of the Evaluator. • Not submitted the composition with list and quantity of
excipients. Revised it.
• Coating composition still missing, but mentioned in the
coating process.
Decision: Approved with USP specifications. The firm shall submit fee of Rs. 7500/- for
correction/pre-approval change in product specifications as per notification No.F.7-11/2012-
Brand Name +Dosage Form + Anzapine 5mg Tablet
Strength
Olanzapine …………………………………5mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antipsychotics
Type of Form Form 5
Approval status of product in Olanzapine 10mg Film-coated tablets. MHRA approved
coating process.
Brand Name +Dosage Form + Azepam 1mg Tablet
Strength
Clonazepam ……………………………….…1mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Benzodiazepine derivatives
Type of Form Form 5
Finished Product Specification Not submitted. Available in USP, BP and JP
Approval status of product in Clonazepam Neuraxpharm 1 mg tablets. MHRA approved
Me-too status Curo 1mg Tablets. Reg. No. 65700
• Submit proof of approval of manufacturing facility for the
applied drug product.
• Firm has provided letter No. F. 1-15/98-Lic (Vol-II) dated
26-06-2018 wherein additional section of Tablet
Psychotropic section has been granted to M/s Perfect
Pharma (Pvt.) Ltd. 5-Km, Manga Road, Raiwind, Lahore.
Brand Name +Dosage Form + Azepam 2mg Tablet
Strength
Clonazepam ………………………………2mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Benzodiazepine derivatives
Type of Form Form 5
Finished Product Specification Not submitted. Available in USP, BP and JP
Approval status of product in Clonazepam Neuraxpharm 2 mg tablets. MHRA approved
Me-too status Curo 1mg Tablets. Reg. No. 65698
applied drug product
• Firm has provided letter No. F. 1-15/98-Lic (Vol-II) dated
26-06-2018 wherein additional section of Tablet
Psychotropic section has been granted to M/s Perfect
Pharma (Pvt.) Ltd. 5-Km, Manga Road, Raiwind, Lahore.
Brand Name +Dosage Form + Cloze 100mg Tablet
Strength
Clozapine ……………………….…100mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Diazepines, oxazepines, thiazepines and oxepines
Type of Form Form 5
Approval status of product in Denzapine ®100 mg Tablets. MHRA approved
Me-too status Clozcare Tablets 100mg. Reg. No. 84243
Remarks of the Evaluator. • The firm was asked revise the pharmacological group from
dibenzodiazepine to Diazepines, oxazepines, thiazepines
and oxepines. The firm revised it to diazapines.
• Not submitted the composition with list and quantity of
• Revised the formulation from film-coated tablet to uncoated
tablet.
applied drug product.
Decision: Approved with USP specifications as per following label claim:
Clozapine ……………….…100mg.
Brand Name +Dosage Form + Cloze 25mg Tablet
Strength
Clozapine ………………………..…25mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Diazepines, oxazepines, thiazepines and oxepines
Type of Form Form 5
Approval status of product in Denzapine ®25 mg Tablets. MHRA approved
Me-too status Clozcare Tablets 25mg. Reg. No. 84242
Remarks of the Evaluator. • The firm was asked revise the pharmacological group from
dibenzodiazepine to Diazepines, oxazepines, thiazepines
and oxepines. The firm revised it to diazapines.
• Revised the formulation from film-coated tablet to uncoated
tablet.
applied drug product
• Each Tablet Contains:
Clozapine ……………….…25mg.
Brand Name +Dosage Form + Factoline 500mg Tablet
Strength
Citicoline Sodium eq to Citicoline ………………..…500mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Could be confirmed
Me-too status Cercolin Tablets 500mg. Reg. No. 48984
Remarks of the Evaluator. • Revised the pharmacological group from central stimulants
to psychostimulants.
• Mentioned ciprofloxacin HCl in the manufacturing outlines.
Revised it.
• Revised the formulation from uncoated tablet to film-coated
tablet.
coating process.
• The provided international reference product could not be
verified. Provide proof international availability of same
formulation and same strength in reference regulatory
authorities as defined in 275th meeting of the registration
board.
Brand Name +Dosage Form + Kaldine 5mg Tablet
Strength
Desloratadine …………………………..…5mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Histamine H1 receptor antagonist
Type of Form Form 5
Approval status of product in Desloratadine 5 mg Film-Coated Tablets. MHRA approved
Me-too status E-Din 5mg Tablets. Reg. No. 67986
tablet.
coating process.
Desloratadine …………………………..…5mg
Decision: Approved with USP specifications with relevant fee for specification.
Brand Name +Dosage Form + Kalgil 50mg Tablet
Strength
Sitagliptin Phosphate Monohydrate Eq. To Sitagliptin…50mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Dipeptidyl peptidase-4 (DPP-4) inhibitor
Type of Form Form 5
Approval status of product in Sitagliptin 50 mg Film-coated Tablets. MHRA approved
Me-too status Bounty Tablets 50mg. Reg. No. 70189
Remarks of the Evaluator. • You have not submitted the composition with list and
quantity of excipients.
• You have applied for uncoated tablet, and have mentioned
coating process in the manufacturing outlines. Clarify in
line with the reference product.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of revised label claim from uncoated tablet to coated tablets, complete composition with list
and quantity of excipients with submission of 7500/- for pre-registration correction/changes as
per notifications 7-11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Kalgil 50mg/1000mg Tablet
Strength
Sitagliptin Phosphate Monohydrate Eq To Sitagliptin…50mg
Metformin ……………………………..…1000mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
hydrate form).
coating process.
st
238
• Revised Metformin to Metformin HCl in the label claim and
composition.
Sitagliptin Phosphate Monohydrate Eq. To
Sitagliptin……………………………50mg
Metformin HCl……………………………..…1000mg.
submission of differential fee of 22,500/- for pre-registration correction/changes as per
notifications 7-11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021
Brand Name +Dosage Form + Kalgil 50mg/500mg Tablet
Strength
Sitagliptin Phosphate Monohydrate Eq To Sitagliptin…50mg
Metformin………………………………..…500mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
hydrate form).
coating process.
• Revised Metformin to Metformin HCl in the label claim and
composition.
Sitagliptin Phosphate Monohydrate Eq. To
Sitagliptin……………………………50mg
Metformin HCl……………………………..…500mg.
submission of differential fee of 22,500/- for pre-registration correction/changes as per
Brand Name +Dosage Form + Kalnor 4mg Tablet
Strength
Lornoxicam ……………………….…4mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Finished Product Specification Not submitted. Available in BP
Approval status of product in Xefo 4 mg Film tabletten. Swiss Medic Approved
Me-too status Xoni-F 4mg Tablet. Reg. No. 76707
tablet.
coating process.
Decision: Approved with BP specifications with relevant fee for specification as per following
label claim:
Brand Name +Dosage Form + Kalnor 8mg Tablet
Strength
Lornoxicam ……………………………..…8mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Finished Product Specification Not submitted. Available in BP
Approval status of product in Xefo 8 mg Film tabletten. Swiss Medic Approved
Me-too status Lornoxi 8mg Tablet. Reg. No. 74933
tablet.
coating process.
Decision: Approved with BP specifications with relevant fee for specification as per following
label claim:
Brand Name +Dosage Form + Kalpride 150mg Capsule
Strength
Itopride HCl ……………………150mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Prokinetics
Type of Form Form 5
st
240
Approval status of product in Could not be confirmed
Me-too status Itoguard tablet 150mg. Reg. No. 076122
excipients.
same strength in reference regulatory authorities as
defined in 275th meeting of the registration board is
required.
Brand Name +Dosage Form + Kalsart AVH Tablet 80/10/25mg
Strength
Valsartan ………………………80mg
Amlodipine as besylate……………….…10mg
Hydrochlorothiazide…………………..…25mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Could not be confirmed.
Remarks of the Evaluator. • Had not submitted the composition with list and quantity of
coating process.
• In the BMR, mentioned amlodipine besiylate 10mg. then
rivsed it to amlodipine as besylate…10mg, and
amlodipine as besylate…. 1.38 kg.
same strength in reference regulatory authorities as
defined in 275th meeting of the registration board is
required.
• Proof of me-too product (same formulation and same
strength) already registered in DRAP is required
Strength
Valsartan …………………………….…160mg
Amlodipine as besylate………….…….…10mg
Hydrochlorothiazide………………………25mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in EXFORGE HCT® Tablets by Novartis Pharmaceuticals
Reference Regulatory Authorities. Corporation. US-FDA approved
Me-too status Exforge HCT 10/160/25MG film coated tablets by Novatris
Pharma. Reg. No. 69551
coating process.
rivsed it to amlodipine as besylate…10mg,, and
amlodipine as besylate…. 1.38 kg.
Brand Name +Dosage Form + Kalsart AVH Tablet 160/5/12.5mg
Strength
Valsartan …………………………..…160mg
Amlodipine as besylate…………………5mg
Hydrochlorothiazide…………………12.5mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in EXFORGE HCT® Tablets. US-FDA approved
Me-too status Exforge HCT 5/160/12.5MG film coated tablets. Reg. No.
69548
coating process.
rivsed it to amlodipine as besylate…5mg,, and amlodipine
as besylate…. 0.69 kg.
Strength
Valsartan………………………………….…160mg
Amlodipine as besylate…………………………5mg
Hydrochlorothiazide………………………..…25mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in EXFORGE HCT® Tablets by Novartis Pharmaceuticals
Reference Regulatory Authorities. Corporation. US-FDA approved
Me-too status Exforge HCT 5/160/25MG film coated tablets by Novatris
Pharma. Reg. No. 69549
coating process.
rivsed it to amlodipine as besylate…5mg, and amlodipine
as besylate…. 0.69 kg.
Brand Name +Dosage Form + Kart M 40/240mg Tablet
Strength
Artemether………………………………40mg
Lumefantrine………………………..…240mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antimalarial
Type of Form Form 5
Finished Product Specification Not submitted. Available in IP
Approval status of product in WHO Approved formulation.
Me-too status Malavel Tablets. Reg. No. 69818
coating process.
• Revised from uncoated tablet to film-coated tablet.
Decision: Approved with IP specifications with relevant fee for specification.

Brand Name +Dosage Form + Kart M 80/480mg Tablet
Strength
Artemether……………………………80mg
Lumefantrine…………………….…480mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Finished Product Specification Not submitted. Available in IP
Approval status of product in WHO Approved formulation
Me-too status Eptrim-X 80/480mg Tablets. Reg. No. 75828
Decision: Approved with IP specifications with relevant fee for specification.
Brand Name +Dosage Form + Kast 5mg Tablet
Strength
Composition Each Chewable Tablet Contains:
Montelukast Sodium Eq. To Montelukast ……………5mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Montelukat sodium chewable tablet. USFDA approved.
Me-too status Montekast 5mg Tablets. Reg. No. 79785
• Removed coating process in the manufacturing outlines.
Decision: Approved with USP Specifications and correction in pharmacological group. The
firm shall submit fee of Rs. 7500/- for correction/pre-approval change in product specifications
and pharmacological group as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021
Brand Name +Dosage Form + Katine 30mg Capsule
Strength
Duloxetine as HCl……………………………30mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Dutor 30 mg gastro-resistant capsules, hard. MHRA approved
Me-too status Oxcym DR 30 mg Capsule. Reg. No. 53101
Remarks of the Evaluator. • Revise the pharmacological group from SSRI antidepressant
to antidepressant.
• Revise the label claim from “each capsule contains;
Duloxetine as HCl…………60mg” to “Each gastro-
resistant capsule contains: duloxetine hydrochloride
enteric coated pellets eq. to duloxetine….30mg.
• In the composition, you have mentioned Duloxetine
HCl…6mg. Revise the quantity of API as per salt factor
and strength of pellets in the master formula.
• You have not submitted the list and quantity of excipients.
• Provide the source of pellets along with GMP certificate of
the firm, COA and stability summary sheets of three
batches of the pellets.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
revise label claim as per reference product and differential fee of 30,000/- for pre-
registration correction/changes as per notifications 7-11/2012-B&A/DRAP dated
07.05.2021 and 13.07.2021.
• Firm will also submit revised master formula.
• Firm will also submit source of pellets along with GMP certificate of the firm, COA
and stability summary sheets of three batches of the pellets. In case of imported
source for the pellets, full fee for import registration shall also be submitted.
Brand Name +Dosage Form + Katine 60mg Capsule
Strength
Duloxetine as HCl………………………..…60mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Duloxetine 60 mg hard gastro-resistant capsules. MHRA
Me-too status Oxcym DR 60 mg Capsule. Reg. No. 53102
Remarks of the Evaluator. • Revised the pharmacological group from SSRI
antidepressant to antidepressant.
• Revised the label claim from “each capsule contains:
Duloxetine as Hcl…30mg” to “Each gastro-resistant
capsule contains: duloxetine hydrochloride enteric coated
pellets eq. to duloxetine….30mg.
• Revise the quantity of API as per salt factor and strength of
pellets in the master formula.
• Provide the source of pellets along with GMP certificate of
the firm, COA and stability summary sheets of three
batches of the pellets.
Each gastro-resistant capsule contains:
Duloxetine hydrochloride enteric coated pellets eq. to
duloxetine……………………F….60mg
of differential fee of 22,500/- for pre-registration correction/changes as per
• Firm will also submit revised master formula.
• Firm will also submit source of pellets along with GMP certificate of the firm, COA
and stability summary sheets of three batches of the pellets. In case of imported
source for the pellets, full fee for import registration shall also be submitted.
Brand Name +Dosage Form + Kestec 20mg Tablet
Strength
Ebastine …………………………………….…20mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Finished Product Specification Not submitted. Available in JP
Approval status of product in Bactil Forte 20 mg film-coated tablets. CIMA Approved.
Me-too status Ebist 20mg Tablets. Reg. No. 77854
coating process.
Each film coated tablet contains:
Ebastine …………………………………….…20mg
Decision: Approved with JP Specifications with relevant fee for specification as per following
albel claim.
Ebastine …………………………………….…20mg
Brand Name +Dosage Form + Misart 20mg Tablet
Strength
Telmisartan …………………………20mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Angiotension receptor antagonists
Type of Form Form 5
Finished Product Specification Not submitted. Available in USP and JP
Approval status of product in Telmisartan 20 mg tablets. MHRA Approved.
Me-too status Tecardic Tablets 20mg. Reg. No. 84799
Strength
Telmisartan ………………………………40mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Strength
Telmisartan …………………………..…80mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Brand Name +Dosage Form + Misart-A 40/5 mg Tablet
Strength
Amlodipine as Amlodipine Besylate…....…5mg
Telmisartan……………………………….40mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antihypertensives
Type of Form Form 5
Approval status of product in TELMISARTAN/AMLO 40/5 telmisartan/amlodipine (as
Reference Regulatory Authorities. besilate) 40/5 mg tablet blister pack. TGA Approved.
Me-too status Ezitab-AM 4/5mg Tablet. Reg. No. 82041
• Revised from film-coated tablet to uncoated tablet.
Amlodipine as Amlodipine Besylate…....…5mg
Telmisartan……………………………….40mg
Decision: Deferred for evidence of availability of bilayer compression machine along with
revision of manufacturing outlone as per innovator product..
Brand Name +Dosage Form + Moxcal 400mg Tablet
Strength
Moxifloxacin HCl ……………………..…400mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Fluoroquinolone antibiotic
Type of Form Form 5
Approval status of product in Moxifloxacin 400 mg film-coated tablets. Approved in
Reference Regulatory Authorities. MHRA.
Remarks of the Evaluator. • You have not submitted the list and quantity of excipients.
• The reference product in MHRA is film-coated tablet. You
have applied for uncoated tablet. Clarify.
• Revise Moxifloxacin HCl…400mg to Moxifloxacin as
HCl…400mg, and adjust its weight in the master formula
as per salt factor.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of revised label claim as per reference product with fee of 30,000/- for pre-registration
13.07.2021.
Brand Name +Dosage Form + Oxin 500mg Tablet
Strength
Levofloxacin ……………………..…500mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Levofloxacin (as hemihydrate) 500mg Film-coated Tablets.
Reference Regulatory Authorities. Approved in MHRA.
coating process.
• The firm applied for levofloxacin….500mg and mentioned
levofloxacin hemihydrate in the manufacturing outlines.
Revised the label claim to levofloxacin as
hemihydrate…………500mg.
Levofloxacin as hemihydrate ………………500mg
of differential fee of 22,500/- for pre-registration correction/changes as per notifications 7-
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Oxycam 15mg Tablet
Strength
Meloxicam………………………….…15mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Meloxicam 15mg uncoated tablets. MHRA approved
Me-too status Melflam 15mg Tablets. Reg. No. 84266
• You have applied for uncoated tablet. Remove the coating
process form the manufacturing outlines.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of 7500/- for pre-registration correction/changes as per notifications 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
• Firm will also submit revised manufacturing outlines with pre-registration variation
fee.
Brand Name +Dosage Form + Percip 250mg Tablet
Strength
Ciprofloxacin HCl……………………….…250mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Ciprofloxacin 250 mg, film coated tablets. MHRA approved
Me-too status Decip Tablet 250mg. Reg. No. 84085
• The reference product in MHRA is film-coated tablet. You
have applied for uncoated tablet. Clarify.
• Revise Ciprofloxacin Hcl…250mg to Ciprofloxacin as
Hcl…250mg, and adjust its weight in the master formula
as per salt factor.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of revised label claim as per reference product and fee of 30,000/- for pre-registration
13.07.2021.
Brand Name +Dosage Form + Percip 500mg Tablet
Strength
Ciprofloxacin HCl…………………………500mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Ciprofloxacin 500 mg, film coated tablets. MHRA approved
Me-too status Decip Tablet 500mg. Reg. No. 84086
coating process.
• Revised Ciprofloxacin Hcl…500mg to Ciprofloxacin as
Hcl…500mg.
Ciprofloxacin as HCl…………………………500mg
of differential fee of 22,500/- for pre-registration correction/changes as per notifications 7-
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Perfectine 10mg Tablet
Strength
Memantine HCl……………………10mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Memantine hydrochloride 10 mg film-coated tablets. MHRA
Me-too status Cara-Tine 10 mg Tablets. Reg. No. 68529
coating process.
Strength
Memantine HCl……………………….…20mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Me-too status Rement 20mg Tablet. Reg. No. 73884
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Strength
Memantine HCl ………………………………5mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Me-too status Afdol 5mg Tablets. Reg. No. 47166
coating process.
Brand Name +Dosage Form + Perfrizine 10mg Tablet
Strength
Cetirizine HCl……………………………..…10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Antihistamines for systemic use
Type of Form Form 5
Approval status of product in Cetirizine Hydrochloride 10 mg film-coated tablets. MHRA
Me-too status Actilix-CTZ Tablets. Reg. No. 48644
Remarks of the Evaluator. • The reference porudct has mentioned Cetirizine
Hydrochloride in the brand and Cetirizine diydrochloride
in the composition. The USP monograph for the drug
substance has used formula cetirizine 2HCl and name as
Cetirizine Hydrochloride. The same has been adopted by
sigma-aldrich with CAS No, 83881-52-1.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of revised label claim as per reference product with submission of full fee for pre-registration
13.07.2021and of list and quantity of excipients.
Brand Name +Dosage Form + Peride 50mg Tablet
Strength
Levosulpride …………………….…50mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in LEVOPRAID® 50 mg Tablets by TEOFARMA Srl. Approved
Reference Regulatory Authorities. by AIFA
Me-too status Sulvo Tablets 50mg. Reg. No. 31748
Remarks of the Evaluator. • Application for the same product has already been submitted
and processed vide Dy. No. 11891 dated 06.03.2019.
• Had not submitted the composition with list and quantity of
Decision: Registration Board disposed of the application since same formulation has been
approved in the name of firm in 317th meeting of Regsitration Board.
Brand Name +Dosage Form + Permitine 100mg Tablet
Strength
Lacosamide………………………………100mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Other antiepileptics
Type of Form Form 5
Approval status of product in Lacosamide Accord 100 mg film-coated tablets. MHRA
Reference Regulatory Authorities. approved.
Me-too status Lacolep 100mg Tablet. Reg. No. 73858
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
submission of fee of Rs. 7,500 for correction/pre-approval change/ in product specifications, as
Strength
Lacosamide ……………………….…150mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Strength
Lacosamide ……………………..…50mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Paroxetine 25mg Tablet
Strength
Composition Each Enteric Film Coated controlled release Tablet Contains:
Paroxetine As HCl………………………..…25mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group selective serotonin reuptake inhibitor
Type of Form Form 5
Approval status of product in Paxil CR Tablet 25mg. USFDA approved.
Remarks of the Evaluator. • Revise the pharmacological group from selective serotonin
and norepinephrine reuptake inhibitor to selective
serotonin reuptake inhibitor.
• You have submitted the reference wherein it is stated that:
➢ Each extended-release tablet contains 12.5 mg, 25 mg,
or 37.5 mg paroxetine equivalent to 14.25 mg, 28.51 mg,
or 42.76 mg of paroxetine hydrochloride, respectively.
The factor used is meant for hemihydrate form.
➢ One layer of the tablet consists of a degradable barrier
layer and the other contains the active material in a
hydrophilic matrix.
➢ In addition to controlling the rate of drug release in vivo,
an enteric coat delays the start of drug release until
tablets of PAXIL CR have left the stomach.
• Revise your composition, master formula, and
manufacturing method in line with the above-mentioned
facts.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
submission of fee of Rs. 7,500 for correction/pre-approval change as per notification No.F.7-
11/2021-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Paroxetine 37.5mg Tablet
Strength
Composition Each Enteric Film Coated controlled release Tablet Contains:
Paroxetine As Hcl…37.5mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group selective serotonin reuptake inhibitor
Type of Form Form 5
Approval status of product in Paxil CR Tablet 37.5mg. USFDA approved.
Me-too status Peroxa CR 37.5 mg Tablet. Reg. No. 82148
Remarks of the Evaluator. • Revise the pharmacological group from selective serotonin
and norepinephrine reuptake inhibitor to selective
serotonin reuptake inhibitor.
• You have submitted incomplete manufacturing outlines.
• You have submitted the reference wherein it is stated that:
➢ Each extended-release tablet contains 12.5 mg, 25 mg,
or 37.5 mg paroxetine equivalent to 14.25 mg, 28.51 mg,
or 42.76 mg of paroxetine hydrochloride, respectively.
The factor used is meant for hemihydrate form.
➢ One layer of the tablet consists of a degradable barrier
layer and the other contains the active material in a
hydrophilic matrix.
➢ In addition to controlling the rate of drug release in vivo,
an enteric coat delays the start of drug release until
tablets of PAXIL CR have left the stomach.
• Revise your composition, master formula, and
manufacturing method in line with the above-mentioned
facts.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
submission of fee of Rs. 7,500 for correction/pre-approval change as per notification No.F.7-
11/2021-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Plexine 20mg Capsule
Strength
Fluoxetine as HCl…………………………….…20mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Fluoxetine 20 mg capsules, hard. MHRA approved.
Me-too status Welflux 20mg Capsules. Reg. No. 64384
• Had submitted itopride HCl in the composition. Revised it.
Brand Name +Dosage Form + Plexine 40mg Capsule
Strength
Fluoxetine as HCl………………………..…40mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Fluoxetine 40 mg capsules, hard. MHRA approved.
Me-too status Not confirmed
Brand Name +Dosage Form + Pramper 10mg Tablet
Strength
Escitalopram As Oxalate ……………………10mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Escitalopram 10 mg film-coated tablets. MHRA approved
Me-too status Globoset 10mg Tablets. Reg. No. 36344
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of fee of Rs. 7,500 for correction/pre-approval change as per notification No.F.7-11/2021-
Brand Name +Dosage Form + Pramper 5mg Tablet
Strength
Escitalopram As Oxalate ……………………….…5mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Escitalopram 5 mg film-coated tablets. MHRA approved
Me-too status Promital Tablet 5mg. Reg. No. 67846
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of fee of Rs. 7,500 for correction/pre-approval change as per notification No.F.7-11/2021-
Brand Name +Dosage Form + Pre Cyc 20mg Tablet
Strength
Piroxicam Beta cyclodextrin ………………………20mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in CYCLADOL 20 mg scored tablet. ANSM approved
Me-too status Utrahit-beta Tablet. Reg. No. 81355
• Revise Piroxicam Beta cyclodextrin…20mg to Piroxicam as
beta cyclodextrin…20mg and adjust its weight in master
formula as per equivalency factor.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
submission of revised label claim as per reference product along with fee of Rs. 30,000 for
correction/pre-approval change as per notification No.F.7-11/2021-B&A/DRAP dated 13-07-
2021.
Brand Name +Dosage Form + Prococal 500mcg Tablet
Strength
Composition Each Sugar Coated Tablet Contains:
Mecobalamin …………………………..…500mcg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Vitamin B12 (cyanocobalamin and analogues)
Type of Form Form 5
Finished Product Specification Not submitted. Available in JP
Approval status of product in Methicobide tablet 500 mcg sugar-coated, by Daito
Reference Regulatory Authorities. Corporation. Approved by PMDA Japan
Me-too status Balin 500mcg Tablet (sugar-coated) by Cibex Pharma
Karachi. Reg. No. 74877
• In the manufacturing outlines, you have mentioned
risperidone… 50g, while at another place,
clonazepam…0.2kg. revise it.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of revised manufacturing outlines along with fee of Rs. 7500/- for correction/pre-approval
change as per notification No.F.7-11/2021-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Quine 100mg Tablet
Strength
Quetiapine Fumarate Eq. To Quetiapine….…100mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Anti-psychotic
Type of Form Form 5
Approval status of product in Quetiapine 100mg film-coated tablets. MHRA Approved
Me-too status Qupixan Tablet 100 mg. Reg. No. 81961
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Quine 25mg Tablet
Strength
Quetiapine Fumarate Eq To Quetiapine ……………25mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Quetiapine 25 mg film-coated tablets. MHRA approved
Me-too status Qupixan Tablet 25 mg. Reg. No. 81960
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Quine XR 200mg Tablet
Strength
Quetiapine as fumarate……………….…200mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Alaquet XL 200 MG prolonged-release tablets. MHRA
Reference Regulatory Authorities. Approved
Me-too status Ziapine XR 200mg Oral Tablets. Reg. No. 78754
Please mention the sustained release polymer /
excipient(s) as well.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of fee of Rs. 7500/- for correction/pre-approval change as per notification No.F.7-
11/2021-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Quine XR 150mg Tablet
Strength
Composition Each Extended Relase Tablet Contains:
Quetiapine as fumarate ……………………150mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Alaquet XL 150 MG prolonged-release tablets. MHRA
Reference Regulatory Authorities. Approved
Me-too status Ziapine XR 150mg Oral Tablets. Reg. No. 78755
Please mention the sustained release polymer /
excipient(s) as well.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of fee of Rs. 7500/- for correction/pre-approval change in the master formulation of
excipients as per notification No.F.7-11/2021-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Ristol 1mg Tablet
Strength
Risperidone…………………………….…1mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Risperdal® 1mg film coated Tablets. MHRA approved
Me-too status Neo-Risp Tablet 1mg, film-coated. Reg No. 85184
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of fee of Rs. 7500/- for correction/pre-approval change as per notification No.F.7-
11/2021-B&A/DRAP dated 13-07-2021.
Strength
Risperidone…………………………3mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of fee of Rs. 7500/- for correction/pre-approval change as per notification No.F.7-11/2021-
Strength
Risperidone………………………..…3mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Remarks of the Evaluator. • The firm has mentioned ristol 3mg in the bank challan, but
corrected to ristol 4mg later. A separate challan has been
provided for 3mg strength.
• You have applied for risperidone…4mg on the cover letter,
however, you have mentioned risperidone…3mg in the
label claim and composition. Clarify.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of revised label claim for Risperidone 4mg along with fee of Rs. 30,000/- for correction/pre-
approval change as per notification No.F.7-11/2021-B&A/DRAP dated 13-07-2021.
Brand Name +Dosage Form + Sart 160mg Tablet
Strength
Valsartan ………………………….…160mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Diovan tablets for oral administration (40 mg, 80 mg, 160 mg
Reference Regulatory Authorities. or 320 mg). USFDA approved
Diovan film-coated tablets for oral administration (40 mg, 80
mg, 160 mg or 320 mg). TGA approved
Me-too status Nobel 160mg film-coated Tablets. Reg No. 71835
Remarks of the Evaluator. • Revise the pharmacological group from Angiotensin II
receptor antagonists to Angiotensin II receptor blockers.
• You have mentioned uncoated tablet, but mention the
coating process in the manufacturing outlines. The
reference / innovator product in TGA is film-coated.
Revise the label claim and submit coating composition.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of revised label claim as per reference product, revised pharmacological group along with fee
of Rs. 7500/- for correction/pre-approval change as per notification No.F.7-11/2021-
Brand Name +Dosage Form + Sart 80mg Tablet
Strength
Valsartan………………………..…80mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Diovan tablets for oral administration (40 mg, 80 mg, 160 mg
Reference Regulatory Authorities. or 320 mg). USFDA approved
Diovan film-coated tablets for oral administration (40 mg, 80
mg, 160 mg or 320 mg). TGA approved
Me-too status Nobel 80mg film-coated Tablets. Reg No. 71834
Remarks of the Evaluator. • Revise the pharmacological group from Angiotensin II
receptor antagonists to Angiotensin II receptor blockers.
• You have mentioned uncoated tablet, but mention the
coating process in the manufacturing outlines. The
reference / innovator product in TGA is film-coated.
Revise the label claim and submit coating composition.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of revised label claim as per reference product, revised pharmacological group along with fee
of Rs. 7500/- for correction/pre-approval change as per notification No.F.7-11/2021-
Brand Name +Dosage Form + Sart A 160/10mg Tablet
Strength
Amlodipine Besylate As Amlodipine ………..…10mg
Valsartan……………………..…160mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Angiotensin II receptor blockers (ARBs) and calcium channel
blockers
Type of Form Form 5
Approval status of product in Exforge tablets, film-coated (5/160 mg, 10/160 mg, 5/320 mg,
Reference Regulatory Authorities. and 10/320 mg). USFDA approved
Exforge® 5 mg/80 mg film-coated tablets. MHRA approved.
Me-too status Amsart 10/160mg Tablet. Reg No. 84097
Remarks of the Evaluator. • Revise the pharmacological group from Antihypertensives
to Angiotensin II receptor blockers (ARBs) and calcium
channel blockers.
• Revise “Amlodipine Besylate As Amlodipine” in the label
claim and compostion to “Amlodipine Besylate eq. to
Amlodipine”.
• You have mentioned amlodipine in the manufacturing
outlines. Revise it to amlodipine besylate and adjust its
weight as per salt factor.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of revised label claim as per reference product, revised pharmacological group and
manufacturing outlines along with fee of Rs. 30000/- for correction/pre-approval change as per
Strength
Amlodipine Besylate As Amlodipine ……………………5mg
Valsartan…………………………………………160mg
Rs. 20,000/- dated 06.03.2019
blockers
Type of Form Form 5
channel blockers.
Amlodipine”.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Strength
Amlodipine Besylate As Amlodipine………………5mg
Valsartan…………………………………80mg
Rs. 20,000/- dated 06.03.2019
blockers
Type of Form Form 5
channel blockers.
Amlodipine”.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Sova 20mg Tablet
Strength
Rosuvastatin Calcium…………. …20mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Lipid lowering agent
Type of Form Form 5
Approval status of product in Rosuvastatin 20 mg film-coated tablets. MHRA approved
Me-too status Rostor 20mg tablet. Reg. No. 74400
Remarks of the Evaluator. • Revise the label claim to film-coated tablet.
• Revise rosuvastatin to rosuvastain calcium in the master
formula and adjust its weight as per salt factor.
• Revise rosuvastatin calcium to rosuvastain as calcium in the
label claim.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Rosuvastatin as Calcium…………. …20mg.
product, revised master formula with adjustment of weight as per salt factor along with fee of
Rs. 30,000/- for correction/pre-approval change as per notification No.F.7-11/2021-
Brand Name +Dosage Form + Sova 5mg Tablet
Strength
Rosuvastatin Calcium ……………….…5mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Lipid lowering agent
Type of Form Form 5
Approval status of product in Rosuvastatin 5 mg film-coated tablets. MHRA approved
Me-too status Rostor 5mg tablet. Reg. No. 71183
Remarks of the Evaluator. • Revise the label claim to film-coated tablet.
• Revise rosuvastatin to rosuvastatin calcium in the master
formula and adjust its weight as per salt factor.
• Revise rosuvastatin calcium to rosuvastatin as calcium in the
label claim.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
Rosuvastatin as Calcium…………. …5mg.
product, revised master formula with adjustment of weight as per salt factor along with fee of
Rs. 30,000/- for correction/pre-approval change as per notification No.F.7-11/2021-
Brand Name +Dosage Form + Vol 10mg Tablet
Strength
Nebivolol (hydrochloride)………………10mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Betablocker
Type of Form Form 5
Finished Product Specification Not submitted. Available in USP.
Remarks of the Evaluator. • Revise Nebivolol (hydrochloride) to Nebivolol (as
hydrochloride) in the label claim.
• You have mentioned Nebivolol (hydrochloride) in the
master formula; adjust its weight as per salt factor.
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of revised label claim as per reference product, revised master formula with adjustment of
weight as per salt factor along with fee of Rs. 30,000/- for correction/pre-approval change as
Brand Name +Dosage Form + Vol 2.5mg Tablet
Strength
Nebivolol (hydrochloride)………………2.5mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
Approval status of product in Nebivolol 2.5 mg tablets. MHRA approved
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of revised label claim as per reference product, revised master formula along with fee of Rs.
30,000/- for correction/pre-approval change as per notification No.F.7-11/2021-B&A/DRAP
dated 13-07-2021.
Brand Name +Dosage Form + Vol 5mg Tablet
Strength
Nebivolol (hydrochloride)……………..…5mg
Rs. 20,000/- dated 06.03.2019
Type of Form Form 5
11/2012-B&A/DRAP dated 07.05.2021 and 13.07.2021.
of revised label claim as per reference product, revised master formula along with fee of Rs.
30,000/- for correction/pre-approval change as per notification No.F.7-11/2021-B&A/DRAP
dated 13-07-2021.
b. Deferred cases
The following cases were deferred by the registration Board in its 296th meeting to be considered on its turn.
337. Name and address of manufacturer/ M/s Maxitech Pharma Pvt Ltd. Plot No. E-178,
Applicant S.I.T.E. Super Highway, Phase II, Karachi
Brand Name + Dosage Form + Strength Lowvat-A 10/10 mg Tablet
Atorvastatin as calcium trihydrate………..…10mg
Amlodipine as besylate…………………….…10mg
Diary No. Date of R & I & fee Dy. No. 13527; 07.03.2019
PKR. 20,000/-; 06.03.2019
Pharmacological Group HMG CoA reductase inhibitors, other combinations
Type of Form Form 5
Finished product Specification The firm has claimed manufacturer’s specifications
Pack size & Demanded Price as per SRO
Approval status of product in Reference CADUET® (amlodipine as besylate and atorvastatin
Regulatory Authorities. as calcium) tablets, film-coated. USFDA approved
Me-too status Corsafe AT 10/10 Tablets. Reg No. 68320

Remarks of the Evaluator The case was evaluated before notifications 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021,
without considering the changes for fee as per the said
notifications.
Decision: Approved with Innovator’s specifications. Registration letter will be issued after
submission of fee of Rs. 7500/- for correction/pre-approval change in the
specifications as per notification No.F.7-11/2021-B&A/DRAP dated 13-07-2021.
Atorvastatin as calcium
trihydrate……………….…20mg
Amlodipine as besylate……………….…10mg
PKR. 20,000/-; 06.03.2019
Type of Form Form 5
Me-too status Corsafe AT 10/20 Tablets. Reg No. 68321

B&A/DRAP dated 07.05.2021 and 13.07.2021,
notifications.
Atorvastatin as calcium
trihydrate……………..…20mg
Amlodipine as
besylate……………………………5mg
PKR. 20,000/-; 06.03.2019
Type of Form Form 5
Me-too status Zodip Plus 20 Tablet. Reg No. 83294

B&A/DRAP dated 07.05.2021 and 13.07.2021,
st
267
notifications.
Brand Name + Dosage Form + Strength Fetrex 0.025% Cream
Fluocinolone Acetonide……………….…0.25mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Corticosteroids, potent (group III)
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 15g, 30g; as per SRO
Approval status of product in Reference Synlar Cream 0.025%. USFDA approved
Me-too status Dermolone Cream 0.025%. Reg. No. 41891
B&A/DRAP dated 07.05.2021 and 13.07.2021,
notifications.
Brand Name + Dosage Form + Strength Fetrex C Cream
Fluocinolone Acetonide…………….…0.25mg
Clioquinol…………………………3mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Clioquinol, combinations
Type of Form Form 5
Approval status of product in Reference Synalar C Cream 0.025/3%. MHRA approved
Me-too status Synalar C Cream. Reg. No. 30866
B&A/DRAP dated 07.05.2021 and 13.07.2021,
notifications.
Brand Name + Dosage Form + Strength Fetrex C Ointment
Composition Each Gram of Ointment Contains:
Fluocinolone Acetonide………………………0.25mg
Clioquinol……………………………………..…3mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Clioquinol, combinations
st
268
Type of Form Form 5
Approval status of product in Reference Synalar C Ointment 0.025/3%. MHRA approved
Me-too status Synalar C Ointment. Reg. No. 30865
B&A/DRAP dated 07.05.2021 and 13.07.2021,
notifications.
Brand Name + Dosage Form + Strength Univate 0.05% Cream
Halobetasol Propionate………………..…0.5mg
PKR. 20,000/-; 06.03.2019
Type of Form Form 5
Pack size & Demanded Price 10g, 15g, 30g; as per SRO
Approval status of product in Reference Ultravate® (halobetasol propionate) Cream, 0.05%.
Me-too status Halovate Cream 0.05%. Reg. No. 46990.
B&A/DRAP dated 07.05.2021 and 13.07.2021,
notifications.
Brand Name + Dosage Form + Strength Univate 0.05% Ointment
Halobetasol Propionate…………………0.5mg
PKR. 20,000/-; 06.03.2019
Type of Form Form 5
Pack size & Demanded Price 10g, 15g, 30g; as per SRO
Approval status of product in Reference Ultravate® (halobetasol propionate) Ointment, 0.05%.
Me-too status Halovate Ointment 0.05%. Reg. No. 46989
B&A/DRAP dated 07.05.2021 and 13.07.2021,
notifications.
Brand Name + Dosage Form + Strength Laxolol Sachet
Macrogol………………………………….13.125g
Sodium Chloride……….…………………0.3507g
Sodium Hydrogen Carbonate………….…0.1785g
Potassium Chloride…………………….…0.0466g
PKR. 20,000/-; 06.03.2019
Pharmacological Group Osmotic laxative
Type of Form Form 5
Approval status of product in Reference Movicol 13.8g sachet, powder for oral solution.
Regulatory Authorities. Approved by MHRA
Me-too status Forlax Sachet. Reg. No. 82099
Remarks of the Evaluator The case was evaluated before notifications 7-
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021, without considering the changes for fee
as per the said notifications.
Brand Name + Dosage Form + Strength Mebis Sachet
Mebevirine as HCl…………….…135mg
Ispaghula Husk………………..…3.5mg
PKR. 20,000/-; 06.03.2019
Type of Form Form 5
Approval status of product in Reference Fybogel Mebeverine Granules for oral suspension
Regulatory Authorities. Reckitt Benckiser Healthcare (UK) Limited, approved
by MHRA, The firm has mentioned powder
Me-too status Mebsyl Sachet by Neutro Pharma (Pvt) Ltd., Lahore
Reg. No. 74307
Remarks of the Evaluator • Submit complete manufacturing outlines from
dispensing to blistering.
The case was evaluated before notifications 7-
11/2012-B&A/DRAP dated 07.05.2021 and
submission of revised label claim as per reference product along with fee of Rs.
30,000/- for correction/pre-approval change in the specifications as per notification
No.F.7-11/2021-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength Maltomax-F Syrup
Iron (III) Hydroxide Polymaltose Eq. to Elemental
Iron…………………………………….…50mg
Folic Acid………………………………0.35mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Iron in combination with folic acid
Type of Form Form 5
Me-too status Poly-F Syrup. Reg. No. 64045
B&A/DRAP dated 07.05.2021 and 13.07.2021,
notifications.
Brand Name + Dosage Form + Strength Clospo 100mg Soft Gelatin Capsule
Composition Each Soft Gelatin Capsule Contains:
Cyclosporine…………………………..…100mg
PKR. 20,000/-; 06.03.2019
Type of Form Form 5
Approval status of product in Reference NEORAL® Soft Gelatin 100mg Capsule. USFDA
Me-too status SANDIMMUN CAPSULES 100MG. Reg, No. 12176
B&A/DRAP dated 07.05.2021 and 13.07.2021,
notifications.
Decision: Registration Board approved registration of product in general manufacturing
areas with condition that manufacturer shall provide safety and protective measures for
workers and personnel which remain in direct contact or are involved in close handling of
these drugs.
Brand Name + Dosage Form + Strength Clospo 50mg Soft Gelatin Capsule
Cyclosporine……………………….…50mg
PKR. 20,000/-; 06.03.2019
Type of Form Form 5
Approval status of product in Reference NEORAL® Soft Gelatin 50mg Capsule. USFDA not
Regulatory Authorities. discontinued or withdrawn for safety or efficacy
reasons
Me-too status CYSPINRAL CAPSULES 50MG. Reg, No. 18272
11/2012-B&A/DRAP dated 07.05.2021 and
Decision: Registration Board approved registration of product in general manufacturing areas
with condition that manufacturer shall provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of these drugs.
Brand Name + Dosage Form + Strength Nidin 10mg Soft Gelatin Capsule
Nifedipine………………………10mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Dihydropyridine derivatives
Type of Form Form 5
Pack size & Demanded Price ; as per SRO
Approval status of product in Reference Nifedipine soft capsules 10 mg. MHRA approved
Me-too status Nifedil Sg Capsule 10mg. Reg. No. 31291
B&A/DRAP dated 07.05.2021 and 13.07.2021,
notifications.
Brand Name + Dosage Form + Strength Co-Ibtan 150/12.5 mg Tablet
Irbesartan………………………….…150mg
Hydrochlorothiazide…………………12.5mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Irbesartan and diuretics
Type of Form Form 5
Approval status of product in Reference Avalide tablet 150mg/12.5mg, film-coated. USFDA
Me-too status Co- Irbisaff Tablet 150/12.5. Reg. No. 77191
B&A/DRAP dated 07.05.2021 and 13.07.2021,
notifications.
Brand Name + Dosage Form + Strength Mefintin-EZ 80/480 mg Tablet
Artemether……………….…80mg
Lumefantrine………………..…480mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Artemisinin and derivatives, combinations
Type of Form Form 5
Finished product Specification IP
Approval status of product in Reference WHO Approved formulation
Me-too status Eptrim-X 80/480mg Tablets. Reg. No. 75828
B&A/DRAP dated 07.05.2021 and 13.07.2021,
notifications.
Brand Name + Dosage Form + Strength V Artan-S 97/103 mg Tablet
Sacubitril………………………..…97mg
Valsartan……………………….…103mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Angiotensin II receptor blockers (ARBs), other
combinations
Type of Form Form 5
Approval status of product in Reference ENTRESTO™ (sacubitril and valsartan) 97/103mg
Regulatory Authorities. tablets, film-coated. USFDA approved (with box
warning)
GMP status The firm was inspected on 21.02.2019 with the
following conclusion: Based on above observations
and keeping in view the attitude of the management of
the firm towards constant improvement their current
GMP compliance level is rated as Good.
Remarks of the Evaluator • Submit all the legal requirements meant for
the product that requires the stability studies as
per zone IV-A.
• The case was evaluated before notifications 7-
11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021, without considering the changes
for fee as per the said notifications.
Decision; Deferred for submission of stability study data as per the guidelines approved in 293rd
meeting of Registration Board.
354. Name and address of manufacturer/ M/s Shrooq Pharmaceuticals Pvt Ltd. 21-km
Applicant Ferozpur Road, Lahore, Pakistan
Brand Name + Dosage Form + Strength Irosid Injection (5ml)
Iron (III) Isomaltoside eq. to elemental Iron…100mg
PKR. 20,000/-; 07.03.2019
Pharmacological Group Iron, parenteral preparations
Type of Form Form 5
Finished product Specification The firm has claimed manufacturer’s specifications.
Pack size & Demanded Price 5’s; as per SRO
Approval status of product in Reference Monofer 100 mg/ml solution for injection/infusion
Regulatory Authorities. (1ml, 2ml, 3ml, 5ml, 10ml ampule/vial). MHRA
approved
Me-too status Wisofer Injection. Reg. No. 78521
GMP status
11/2012-B&A/DRAP dated 07.05.2021 and
submission of revised label claim as per reference product along with fee of Rs.
30,000/- for correction/pre-approval change in the specifications as per
• Firm will also submit latest GMP certificate/last inspection report conducted
within last three years.
Brand Name + Dosage Form + Strength Fonic Injection
Composition Each 2ml contains:
Folinic acid (as calcium folinate)…15mg
PKR. 20,000/-; 07.03.2019
Pharmacological Group Folic acid analogs (not in ATC)
Type of Form Form 5
Approval status of product in Reference Calcium Folinate (eq to folinic acid) 7.5 mg/mL
Regulatory Authorities. Injection (15mg/2ml). MHRA approved
GMP status The firm has been issued GMP certificate on the basis
of inspection dated 19.01.2019
11/2012-B&A/DRAP dated 07.05.2021 and
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) along with registration number, brand name and name of firm.
Brand Name + Dosage Form + Strength Ronium Injection 50mg/5ml
Rocuronium Bromide…50mg
PKR. 20,000/-; 07.03.2019
Pharmacological Group Other quaternary ammonium compounds
Type of Form Form 5
Approval status of product in Reference Rocuronium bromide 10 mg/ml solution for
Regulatory Authorities. injection/infusion (vial). MHRA approved
Me-too status ESMERON INJECTION 50MG/5ML. Reg. No.
21154
Remarks of the Evaluator • The firm has claimed ampule packing.
11/2012-B&A/DRAP dated 07.05.2021 and
Brand Name + Dosage Form + Strength Saprin tablet
Composition Each film coated tablet contain:
Amlodipine as besilate……………….…5mg
Valsartan…………………………..…160mg
PKR. 20,000/-; 07.03.2019
Type of Form Form-5
Approval status of product in Reference Exforge film-coated tablet 5/160. USFDA approved
Me-too status VALTAN -M 165 PLUS TABLET. Reg. No. 77206
11/2012-B&A/DRAP dated 07.05.2021 and
Decision: Approved. Registration letter will be issued after submission latest GMP
Brand Name + Dosage Form + Strength Flunide Lotion 0.01% w/v
Composition Each ml of Lotion contains:
Fluocinolone Acetonide…0.1%W/v
PKR. 20,000/-; 07.03.2019
Pharmacological Group Corticosteroids, potent (group III)
Type of Form Form 5
(available in USP as topical solution)
Pack size & Demanded Price 60ml, 120ml; as per SRO
Remarks of the Evaluator • Had applied for lotion, but the composition in
master formula are API in oily base. Justify
• The firm submitted Derma-Smoothe/FS®
fluocinolone acetonide Topical Oil, 0.01% approved
in USFDA as reference product.
11/2012-B&A/DRAP dated 07.05.2021 and
Brand Name + Dosage Form + Strength Mebewin MR Capsule
Composition Each extended release capsule contains:
Mebeverine HCl (pellets)………………200mg
st
275
PKR. 20,000/-; 07.03.2019
Pharmacological Group Synthetic anticholinergics, esters with tertiary amino
group
Type of Form Form 5
Finished product Specification The firm has claimed manufacturer’s specifications.
Approval status of product in Reference COLOFAC® MR 200mg Capsules. MHRA
Me-too status Mebrest-200 Capsule. Reg. No. 80547
Remarks of the Evaluator • The firm revised Mebeverine as HCl to Mebeverine
HCl in the dossier.
• The source of pellets is Vision Pharmaceuticals,
Islamabad.
11/2012-B&A/DRAP dated 07.05.2021 and
submission of fee of Rs. 30,000/- for correction/pre-approval change in the
Brand Name + Dosage Form + Strength Hepa-Zerm Sachet
Composition Each Sachet contains:
L-Ornithine-L-Asperate………………….…3g
PKR. 20,000/-; 07.03.2019
Pharmacological Group Liver therapy mentioned as ornithine oxoglurate salt
Type of Form Form 5
Approval status of product in Reference Hepa-Merz Sachet containing ornithine aspartate
Regulatory Authorities. (granules for solution). AGES approved
Me-too status Lolar Sachet. Reg. No. 76499
Remarks of the Evaluator • The firm applied for powder for solution. The
reference product is granules for solution. The firm
revised the manufacturing outlines to granules.
The case was evaluated before notifications 7-
11/2012-B&A/DRAP dated 07.05.2021 and
361. Name and address of manufacturer / M/s Iqra Pharmaceuticals. Plot No. 02, Street No. S-
Applicant 9, National Industrial Zone, Rawat, Islamabad,
Pakistan
Brand Name + Dosage Form + Strength Opidol 100mg/2ml Injection
Composition Each 2ml ampule contains:
Tramadol hydrochloride……………….….100mg
Diary No. Date of R & I & Fee Dy No. 15610: 07.03.2019
Rs. 20,000/-: 07.03.2019
Pharmacological Group Other opioids
Type of Form Form-5
Pack Size & Demanded Price 2mlx10’s;, 2mlx30’s; as per SRO
Approval Status of product in Reference Tramadol 50mg/ml Solution for Injection or Infusion
Regulatory Authorities (2ml). MHRA approved
Me-too Status Welmadol Injection (2ml). Reg. No. 52629 (deos not
show ampule or vial)
GMP Status The firm was inspected on 22.06.2020 with the
following conclusion:
In light of above the firm can be rated as complying
GMP standards as per Schedule B-II of Drugs
(LR&A) Rules, 1976. However, cGMP is a continual
process of improvement for which the above stated
points of improvement have been agreed upon by the
management.
Remarks of the Evaluator •
Pervious decision The Board in its 289th meeting deferred the case for
consideration on its turn as neither Narcotic or
Psychotropic as per INCB
Evaluation by PEC The case was evaluated before notifications 7-
11/2012-B&A/DRAP dated 07.05.2021 and
last three years.
362. Name and address of manufacturer / M/s Iqra Pharmaceuticals. Plot No. 02, Street No. S-
Applicant 9, National Industrial Zone, Rawat, Islamabad,
Pakistan
Brand Name + Dosage Form + Strength Nilbo 10mg/ml Injection
Nalbuphine hydrochloride………………….….10mg
Diary No. Date of R & I & Fee Dy No. 15609: 07.03.2019
Rs. 20,000/-: 07.03.2019
Pharmacological Group Morphinan derivatives
Type of Form Form-5
Finished Product Specification The firm has claimed manufacture’s specifications.
Pack Size & Demanded Price 2x5 ampule PVC contour cellular package 1 contour
cellular in a carton box.
Approval Status of product in Reference NUBAIN (Nalbuphine Hydrochloride) Injection, 10
Regulatory Authorities mg/mL (1ml ampule). Health Canada approved
Me-too Status Nalburax Injection. Reg. No. 28830 (deos not show
ampule or vial)
GMP Status The firm was inspected on 22.06.2020 with the
following conclusion:
In light of above the firm can be rated as complying
GMP standards as per Schedule B-II of Drugs
(LR&A) Rules, 1976. However, cGMP is a continual
process of improvement for which the above stated
points of improvement have been agreed upon by the
management.
Remarks of the Evaluator • Clarification is required about the pack size.
Pervious decision The Board in its 289th meeting deferred the case for
consideration on its turn as neither Narcotic or
Psychotropic as per INCB
Evaluation by PEC The case was evaluated before notifications 7-
11/2012-B&A/DRAP dated 07.05.2021 and
Case no. 02 Registration applications for local manufacturing of (veterinary) drugs

a. New Cases
363. Name and address of manufacturer / M/s Selmore Pharmaceuticals Pvt Ltd. 36-Km,
Applicant Multan Road Lahore.
Brand Name +Dosage Form + Oxy LA 30% Injection IM
Strength
Oxytetracycline HCl Eq. To
Oxytetracycline…………………..300mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Tetracyclines
Type of Form Form 5
Pack size & Demanded Price 100ml; decontrolled.
Reference / Me-too status Alamycin LA 300 mg/ml (as dihydrate) Solution for
Injection (100ml, 250ml, 500ml amber color glass).
HRPE approved.
GMP status The firm was inspected on 05-03-2018,17-08-2018 &
16-10-2018, where renewal of DML was
recommended.
evaluated.
• The reference product contains Magnesium Oxide,
Dimethylacetamide, Sodium formaldehyde
Sulphoxylate, Water for Injections
• Revised the pharmacological group to
Tetracyclines.
• The mentioned excipients were not as per the
reference product. Revised them.
• As per the reference product mentioned above, the
firm was asked to revise “Oxytetracycline HCl
Eq. To Oxytetracycline…300mg” to
“Oxytetracycline …300mg” The firm revised it
to tetracycline and adjusted its weight in master
formula. The firm submitted the reference (Reg.
No. 52310) with label claim of Each ml contains
Oxytetracycline as HCl…300mg
• Lidocaine HCl is an API, which is not present in
the reference product. The firm added it in the
excipients. Removed it.
• Submitted Rs. 30000 (challan-20699544116).
11/2012-B&A/DRAP dated 07-05-2021
Brand Name +Dosage Form + Oxy LA 30% Injection IM
Strength
Oxytetracycline HCl Eq. To
Oxytetracycline…………………..…300mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Tetracyclines
Type of Form Form 5
Pack size & Demanded Price 50ml; decontrolled.
Reference / Me-too status Alamycin LA 300 mg/ml (as dihydrate) Solution for
Injection (100ml, 250ml, 500ml amber color glass).
HRPE approved.
recommended.
evaluated.
• The reference product contains Magnesium Oxide,
Dimethylacetamide, Sodium formaldehyde
Sulphoxylate, Water for Injections.
• Revised the pharmacological group to
Tetracyclines.
• The mentioned excipients are not as per the
reference product. Revised them.
• As per the reference product mentioned above, the
firm was asked to revise “Oxytetracycline HCl
Eq. To Oxytetracycline…300mg” to
“Oxytetracycline …300mg” The firm revised it
to tetracycline and adjusted its weight in master
formula. The firm submitted the reference (Reg.
No. 88833) with label claim of Each ml contains
Oxytetracycline as Hcl…300mg (50ml)
• Lidocaine HCl is an API, which is not present in
the reference product. The firm added it in the
excipients. Removed it.
11/2012-B&A/DRAP dated 07-05-2021
Brand Name +Dosage Form + Vital 4 Solution
Strength
Vitamin A…………………….…30,000,000 IU
Vitamin D3…………………….…1,000,000 IU
Vitamin E…………………………..…5,000mg
Vitamin K3……………………………6,000mg
Rs. 20,000/- dated 06.03.2019
Pharmacological Group Multivitamins
Type of Form Form 5
Pack size & Demanded Price 500ml, 1000ml, 5000ml; decontrolled.
Reference / Me-too status Adekbar Oral Liquid. Reg. No. 73950
recommended.
evaluated.
• Justify the capacity of one-liter water to
accommodate Vitamin A…30,000,000 IU,
Vitamin D3…1,000,000 IU, Vitamin
E…5,000mg and Vitamin K3…6,000mg. the
firm submitted the quantity to be Vitamin
A…17.64g, Vitamin D3…25mg, Vitamin
E…5,000mg and Vitamin K3…6,000mg
• You have applied for solution. Justify the solubility
of water insoluble vitamins in water. The firm
submitted that these are emulsified with tween-
80.
• The quantity of APIs in master formula are not in
line with the label claim. The firm revised the
master formula accordingly.
• Submitted Rs. (challan-70559611534)
• Justification of applied strength of formulation considering the solubility of each
drug substance in terms of mg/ml.
• Justification for the proposing formulation of water insoluble vitamins in water.
Case no. 06 Registration applications of drugs submitted on Form 5F

a. Deferred cases
366. Name, address of Applicant / Marketing M/s Cure Laboratories (Pvt.) Ltd. Plot # 11-12, Street
Authorization Holder # NS-2, National Industrial Estate, Rawat, Islamabad.
Name, address of Manufacturing site. M/s Cure Laboratories (Pvt.) Ltd. Plot # 11-12, Street
# NS-2, National Industrial Estate, Rawat, Islamabad.
Status of the applicant ☒Manufacturer
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 29080 Dated: 01/09/2021
Details of fee submitted PKR 30,000/- Dated: 05/07/2021
The proposed proprietary name / brand name CURAW 100MG SR CAPSULES
Strength / concentration of drug of Active Each capsule Contains:
Pharmaceutical ingredient (API) per unit Diclofenac sodium (as enteric coated pellets
32%)………………………….100mg
Pharmaceutical form of applied drug Oral Capsules

Pharmacotherapeutic Group of (API) NSAIDS (Non-Steroidal Anti-Inflammatory Drugs)
Proposed Pack size 1x10’s & 1x20’s
The status in reference regulatory authorities DICLOMAX RETARD®
(Diclofenac Sodium) 100mg Capsules
MHRA APPROVED.
Manufacturers:
Almac Pharma Services Limited
Almac House 20, Seagoe Industrial Estate,
Craigavon, BT63, 5QD, UK
Mipharm SpA
Via Bernardo Quaranta, 12 20141-Milan, Italy.
For generic drugs (me-too status)
Visodic SR 100mg Capsules
Vision Pharmaceuticals (Pvt.) Ltd.
(Reg.# 078171)
GMP status of the Finished product Two additional sections granted by Licensing
manufacturer Division by Letter No. F-1-13/2017-Lic. Dated: 08th
October 2020.
Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt.) Ltd. Plot # 22-23,
Industrial Triangle, Kahutta Road, Islamabad,
Pakistan.
its Validation/verification, batch analysis and
Module III (Drug Substance) Official monograph of Diclofenac Sodium is present
in BP. The firm as submitted detail of nomenclature,
process and controls, tests for impurities & related
substances specifications, analytical procedures and
Stability Batches: (DE-322, DE-325, DE-329)
impurities, specifications, analytical procedures as
per BP and its verification studies, batch analysis and
product.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence has been established
dissolution profile against the brand leader that is Visodic 100mg SR
Capsules by Vision Pharmaceuticals (Pvt.) Ltd. by
performing quality tests (Description, Identification,
Avg. Weight, Dissolution, and Assay, as per BP
Monograph).
CDP is with the Same Brand Visodic 100mg SR
Capsules by Vision Pharmaceuticals (Pvt.) Ltd. at
three pH Acid (1.2), Acetate Buffer (4.5) &
Phosphate Buffer (6.8). and also the similarity factor
(f2) is calculated
Manufacturer of API M/s Vision Pharmaceuticals (Pvt.) Ltd. Plot # 22-23, Industrial Triangle,
Kahutta Road, Islamabad, Pakistan.
API Lot No. DE703ER
Description of Pack White to off white colored, spherical, sustained release pellets filled in
(Container closure system) Natural/ Natural capsule shells of Size# 1.
Real Time: 0, 3, 6, 9,12 (Months)
Batch No. C-013 C-014 C-015
Batch Size 720 Capsules 720 Capsules 720 Capsules
No. of Batches 03
1. Reference of previous approval of Seven Products are approved in 307th Meeting of
applications with stability study data of the Registration Board with stability Data. Loxiten 20mg
firm (if any) Capsules, Loxiten 30mg Capsules, Loxiten 60mg
Capsules, Omexa 20mg Capsules, Omexa 40mg
Capsules, Lansasure 15mg Capusles and Lansasure
30mg Capsules.
2. Approval of API/ DML/GMP certificate of Vision Pharmaceuticals (Pvt.) Ltd. Semi Basic
API manufacturer issued by concerned (000816) has a GMP Certificate No. 3-26/2019-
regulatory authority of country of origin. Adl.Dir.(QA & LT-I) Dated: 25th February 2019.
Valid Till: 10th February 2022.
3. Documents for the procurement of API with The Material is locally purchased from Vision
approval from DRAP (in case of import). Pharmaceuticals (Pvt.) Ltd. Islamabad, Pakistan.
4. Data of stability batches will be supported by Submitted.
chromatograms,
etc.
5. Compliance Record of HPLC software 21CFR Not Submitted.
6. Record of Digital data logger for temperature Submitted.
Shortcomings Reply of the firm
2.3.P.1 • You have claimed in-house This was a typo mistake. It should be BP
specifications and have mentioned specifications. Correction is attached
BP specifications in the stability
summary sheets. Justification is
required. This was a typo mistake. It should be BP
• You have mentioned the quantity specifications. Correction is attached
per tablet. Justification is required.
• The quantity of pellets per unit has
been mentioned as 319mg. against The firm submitted that the calculation was
312.5mg. Justification is required. based on 3% water content with potency
• You have not adjusted the potency adjustment. However, the water content in the
of the pellets in the BMR. COA of the firm is 4.1%.
Justification is required.
The dissolution testing method for The firm submitted the dissolution testing
pellets is not clear and not legible. method of the pellets manufacturer, which does
Clarification is required. not contain acid resistance test as mentioned in
the earlier submitted method.
3.2.S.4.3 • The drug product manufacturer Not submitted.
shall submit their method validation
protocol for the drug substance in
section 3.2.S.4.3.
• The specificity in the absence of It is true that specificity in the absence of
impurity(es) shall be justified. impurities could not be justified.
• The drug substance (pellets)
contains excipients. The ICH Q2
guidelines states that”:
“Several methods for determining
accuracy are available:
a) application of the analytical
procedure to synthetic mixtures of
the drug product components to
which known quantities of the
drug substance to be analysed
have been added;
b) in cases where it is impossible
to obtain samples of all drug
product components, it may be
acceptable either to add known
quantities of the analyte to the
drug product or to compare the
results obtained from a second,
well characterized procedure, the
accuracy of which is stated and/or
defined.”
• Justify the samples for accuracy Mistakenly written as placebo, what I have
(recovery) studies in the light of the done is crushed the pellets and added a known
above statement. The drug product amount of API. Protocol/method of spiking is
manufacturer shall also clarify the missing.
term “placebo of diclofenac sodium
capsules” used.
• Moreover, the ICH Q2 guidelines The firm could not justify the same.
states that “the range of an
analytical procedure is the interval
between the upper and lower
concentration (amounts) of analyte
in the sample (including these
concentrations) for which it has
been demonstrated that the
analytical procedure has a suitable
level of precision, accuracy and
linearity”. You have used different
extremes for the precision, accuracy
and linearity parameters.
• The ICH Q2 guidelines states “the The firm used UV method, but did not test the
robustness of an analytical effect of change of wavelength.
procedure is a measure of its
capacity to remain unaffected by
small, but deliberate variations in
method parameters and provides an
indication of its reliability during
normal usage”. Such variations
include:
- influence of variations of pH in a
mobile phase;
- influence of variations in mobile
phase composition;
- different columns (different lots
and/or suppliers);
- temperature;
- flow rate;
- change in wavelength of the
detector
You have tested six samples (each)
of filtered and centrifuged
solutions. Justification is required. Variation of equipment could not be followed
• Typical variations to be studied for as only single UV spectrophotometer is
intermediate precision include days, available.
analysts, equipment, etc. The use of
an experimental design (matrix) is
encouraged. The firm has submitted
data of two analysts without
considering other variations.
3.2.S.4.5 Justifications of specifications for We have claimed in-house specs and followed
dissolution test for the drug substance the method of pellets manufacturer.
shall be submitted.
3.2.P.2.2.1 • Submit the proof of procurement of No data is available because it is a local
the innovator product, i.e., Visodic purchase.
100mg capsules for CDP studies,
and approval status of the product.
• You have performed CDP on 06 We will be careful next time.
capsules justification is required.
• The acid retain test in dissolution
test shall be clarified.
• The WHO annexure 7 specifies that
“For extended-release FPPs the The release at acid stage is almost negligible.
time-points should be set to cover
the entire duration of expected
release, e.g. in addition to earlier
time-points: samples at 1, 2, 3, 5 and we have used timepoint as adopted by pellets
8 hours should be collected for a 12- manufacturer.
hour release. You have conducted
CDP for 2 h in phosphate buffer.
• You have not mentioned the
potency of the working standard in 100% potency was mentioned. Consider it as
the calculation formula of percent typo mistake.
drug release.
• Submit the calculated similarity
factor and all calculation thereof. Not submitted.
• The buffer has pH value of 7.2 in the It is typo mistake consider it as 6.8
CDP method, while it 6.8 in the
results, Justification is required.
3.2.P.3.3 • The selection and optimization of Not submitted.
the manufacturing process
described in 3.2.P.3.3, in particular
its critical aspects, shall be
explained.
• A flow diagram shall be presented
giving the steps of the process and Not submitted
showing where materials enter the
process. The critical steps and
points at which process controls,
intermediate tests or final product
controls are conducted shall be
identified.
3.2.P.3.4 Tests and acceptance criteria shall be Not submitted
provided (with justification, including
experimental data) performed at the
critical steps identified in 3.2.P.3.3 of the
manufacturing process, to ensure that the
process is controlled.
3.2.P.4.2 Copies of analytical procedures of non- We did not use any excipient.
compendial excipient shall be submitted. The firm did not consider gelatin capsule as
excipient.
3.2.P.4.3 Validation information for the analytical In-house standard excipients were used.
procedures for in-house standard
excipients shall be submitted
3.2.P.4.4 Justification of specifications of the The firm submitted the justification for
gelatin capsules is required. specification as in-house.
3.2.P.4.5 For excipients of human or animal No animal or human origin excipients were
origin, a certificate shall be provided, used, the firm did not confirm the source of
confirming that the excipient(s) are free gelatin.
from BSE and TSE.
3.2.P.5.2 • The formula of assay and The firm did not justify the same.
dissolution in terms of dilutions
is not in line with the testing
method. Clarification is
required. This is an un-official test.
• Water content test has not been
performed. This is an un-official test
• The method for weight variation
test has not been included in the
testing method of the drug We performed the testing as per BP
product. specifications, which allows to adopt any
• The method for dissolution test suitable method. The dissolution test was
has not been included in the performed as per pellets manufacturer
testing method of the drug specification.
product
3.2.P.5.6 • Justifications of specifications We performed the testing as per BP
for dissolution test shall be specifications, which allows to adopt any
submitted. suitable method. The dissolution test was
performed as per pellets manufacturer
specification.
3.2.P.8 • Moreover, some values have The firm again submitted the calculation, which
been mentioned in the could not be understood. It is pertinent to
calculations, which are not clear mention that the firm has used 900ml of
w.r.t. the calculation formula. dissolution medium, which is depicted in the
Clarification is required. calculation.
• The potency of the working
standard is 99.4%. Justify the Not justified.
100% potency of the reference
standard (having water content)
used in the analyses.
• You have not performed the We were unable to arrange the impurity
impurity testing. You shall standards. We requested the pellets
provide a discussion and manufacturer to arrange the same, who told
justification for incomplete they are working impurities and once it is
analyses of the drug product.complete they will provide all the data and
standards.
Submit audit trail report and record of The firm submitted the record of temperature
digital data loggers and humidity but did not submit audit trail
report.
The dissolution testing method has not been validated.
S. No Explanation / background Previous decision (M-316): Reply submitted

The case was deferred for:
The quantity of pellets per unit has Clarification of water contentInitially we have
been mentioned as 319mg. against in the COA of the drug performed Water
312.5mg. and potency of the pellets substance. Content Test on Karl
not adjusted in the BMR. Upon Fisher at that time Karl
justification, the firm submitted that Fisher was not
the calculation was based on 3% performing well due to
water content with potency some technical error.
adjustment. However, the water Then we have sent the
content in the COA of the firm is Karl Fisher for
4.1%. repairing to the
supplier. When we
I. received Karl Fisher
after repairing we again
performed Water
Content test on 24-03-
2020 before dispensing
of Trial Batches for
potency adjustment and
we have adjusted
potency of active
material on the basis of
this report. The copy of
report is attached.
Submission of calculation Submitted
i.
sheets.
Submission of audit trail We have BP
record. Monograph (Diclofenac
Sodium Prolonged
Release Capsules) for
Testing of Curaw
(Diclofenac Sodium)
100mg SR Capsules.
II. The method for Assay
and Dissolution
mentioned in BP
Monograph is on UV
Spectrophotometer (BP
Monograph attached).
Therefore, there is no
audit trail option
available on our UV
Spectrophotometer.
Validation studies of Submitted with the
dissolution testing method same diffeicnecy as
III.
mentioned for assay
validation.
The potency of the working standard Justification of 100% We have standardized
used in all calculations is 99.4%. potency of the working the working standard
The firm was previously asked to standard against 99.4% supplied by the API
justify the 100% potency of the (having water content). Manufacturer internally
reference standard (having water and adjusted the
content) used in the analyses. potency of working
IV. Moreover, in a query related to standard as 100%.
dissolution method (as adopted from
pellets manufacturer) for not
mentioning the potency factor, the
firm submitted for dissolution data
100% potency was mentioned.
Consider it as typo mistake.
V. The water content test for drug Justification for not We have applied BP
product is not mentioned in the BP performing the Water content monograph for the
specification; however, it is a part of test finished product
the pellet testing. Therefore, the firm (Curaw) analysis and
was asked for this test for the the BP monograph does
capsules. not show any water
content test for the
finished product. That’s
why we haven’t
performed water
content test.
VI. Method was not submitted The method for weight Submitted
previously variation test.
VII. The specificity in the absence of Justification for specificity in We are unable to
impurity(es) shall be justified. The the absence of impurities. arrange Impurity
firm previously submitted that It is Standards form API
true that specificity in the absence of Supplier. We have
impurities could not be justified. intimated Vision
Pharmaceuticals to
provide us impurity
standards but they
didn’t provide the
standards.
Therefore, we have
performed specificity
without any impurity
standards. We are
requesting you to kindly
consider this time we
will be careful in future.
VIII. The firm has used gelatin capsules Certificate, confirming that The capsule shell
the excipient(s) are free from manufacturer did not
BSE and TSE. provide the same. We
will submit it before
manufacturing of
commercial batches,
IX. The firm has used gelatin capsules Halal certificate for gelatin. Submitted
X. Submission of details and We are unable to
proof of procurement of the arrange innovator
product for Curaw
innovator product for CDP 100mg SR Capsules
studies. therefore we have
performed CDP and
Pharmaceutical
Equivalence with Local
Brand in Pakistan i.e.
Visodic 100mg
Capsules Manufactured
by Vision
Pharmaceuticals
Islamabad.
This product (Visodic
100mg Capsules)
Registration # 078171,
and is being
manufactured by Vision
Pharmaceuticals (Pvt.)
Ltd. Model town
Humak Islamabad.
No procurement data
available because it is a
local purchase.
XI. The firm did not submit clear calculations for CDP and the submitted data depicts that they
did not perform CDP studies as per the ICH guidelines. They have tested the capsules
separately at:
i. pH 1.2 for 1 h;
ii. pH 4.5 for 2 h and 8 h, and
iii. pH 6.8 for 2 h and 8 h,
and has applied formula for similarity factor on the combined data.
Decision. Approved. Registration letter will be issued after submission of CDP results with the
innovator drug product.
• Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months as per the
commitment submitted in the registration application.
• Manufacturer will perform process validation of first three batches as per the
Agenda of Evaluator PEC-XI
Case No. 01: Routine Registration applications of Human Drugs on Form 5F (Local)
367. Name, address of Applicant / Marketing The Searle Company Limited., F-319, S.I.T.E.,
Authorization Holder Karachi, Pakistan.
Name, address of Manufacturing site. The Searle Company Limited., F-319, S.I.T.E.,
Karachi, Pakistan.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Bacetam 25mg Tablet
Strength / concentration of drug of Active Each film-coated tablet contains:
Pharmaceutical ingredient (API) per unit Brivaracetam……….…………25 mg
Pharmaceutical form of applied drug Tablets
Pharmacotherapeutic Group of (API) Anti-Epileptic
Reference to Finished product specifications In house
Proposed Pack size As per DPC
The status in reference regulatory authorities BRIVIACT (10mg, 25mg, 50mg, 75mg, 100mg)
tablets USFDA Approved
For generic drugs (me-too status) Brivatam 25mg tablet by M/s CCL Pharmaceuticals
(Reg#109738)
GMP status of the Finished product The firm has submitted GMP certificate issued on
manufacturer 13th august 2020 based on inspection conducted on
11th July 2019
Name and address of API manufacturer. Chengda Pharmaceuticals Co., Ltd., No. 36, Huanghe
Road, Huimin Subdistrict, Jiashan, Zhejiang, China.
Batches: (NP1713-1907002, NP1713-1908003,
NP1713-1909004)

its verification studies, batch analysis and
product.
dissolution profile against the innovator product BRIVIACT 25mg
Tablet of M/s UCB Pharma Ltd., 208 bath road,
Slough, Berkshire, SL13WE, United Kingdom by
is BRIVIACT 25mg Tablet in Acid media (pH 1.2),
Acetate Buffer (pH 4.5) & Phosphate Buffer (pH 6.8).
The CDP of Bacetam 25mg Tablet and BRIVIACT
25mg Tablet Show Equivalence. The % release of
API in 15 minutes in all three mediums is more than
85%. Hence the drug product is categorized as very
rapidly dissolving drug and there is no need to
calculate F2 value.
Analytical method validation/verification of Firm have submitted method validation studies
specificity.
Manufacturer of API Chengda Pharmaceuticals Co., Ltd., No. 36, Huanghe Road, Huimin
Subdistrict, Jiashan, Zhejiang, China.
API Lot No. NP1713-1908003
Description of Pack
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 20PD-205 20PD-206 20PD-207
Manufacturing Date Aug-2020 Aug-2020 Aug-2020
Date of Initiation Sep-2020 Sep-2020 Sep-2020
No. of Batches 03
1. Reference of previous approval of applications The firm has referred to previous inspection of
with stability study data of the firm (if any) stability data of the same dosage form on the basis of
which Registration Board in 289th meeting decided to
approve registration of Tapendol tablets 50mg,
Tapendol tablets 75mg and Tapendol tablets 100mg.
Inspection date: 11th March, 2019
The report shows that:
The HPLC software is 21 CFR compliant.
The firm has software for monitoring of stability
chambers.
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate No.
manufacturer issued by concerned regulatory 388b/17 issued by National Pharmaceutical
authority of country of origin. Regulatory Agency, Ministry of Health Malaysia
issued on 17/Oct/2017 based on inspection conducted
on 18-20 July 2017. (Validity three years)
Firm has also submitted copy of DML
No#Zhe20100526 of M/s Chengda Pharmaceuticals
Co., Ltd., issued by Zhejiang Provincial Drug
Administration.
3. Documents for the procurement of API with Firm has submitted copy of Form 6 i.e. License to
approval from DRAP (in case of import). import Raw material for manufacturing Trial
Examination, test or Analysis for 2.5kg of drug
substance Brivaracetam attested by AD (I&E) DRAP
Karachi
4. Data of stability batches will be supported by Firm has submitted data of stability batches supported
attested respective documents like by attested respective documents like
chromatograms, Raw data sheets, COA, chromatograms, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR Firm has submitted compliance Record of HPLC
& audit trail reports on product testing software 21CFR & audit trail reports on product
testing
6. Record of Digital data logger for temperature Firm has submitted record of digital data logger for
and humidity monitoring of stability chambers temperature and humidity monitoring of stability
XI
Remarks of Evaluator :
Section Observations Response
1.3.4 Submit latest GMP inspection report The firm has submitted latest GMP inspection
conducted with in last three years report. The firm was inspected on 07-05-2020
and conclusion of inspection was:
Based on the area visited, documents/SOPs and
system reviewed, commitment of the firm for
continuous improvement and people met, it is
concluded that the firm is operating at a Good
1.6.5 Submit valid GMP certificate / Drug The firm have submitted written confirmation for
Manufacturing License of the Drug active substance exported to EU to M/s Chengda
Substance manufacturer issued by Pharmaceuticals Co., Ltd., No. 36, Huanghe
relevant regulatory authority of Road, Huimin Subdistrict, Jiashan, Zhejiang,
country of origin China for Active substance Brivaracetam issued
by Zhejiang Food and Drug Administration
China confirming that the manufacturing plant
complies with requirement of Chinese Good
Manufacturing practices.
3.2.S.4.2 The ratio of mobile phase used for The firm submitted that we have used the same
assay of drug substance by drug method as provided and used by the drug
product manufacturer (Mobile phase substance manufacturer but the way of writing is
A; Phosphate Buffer 95: Acetonitrile tabular form and mistakenly marked as gradient
05 and mobile phase B; ACN) is elution instead of isocratic elution. However, the
different than that used by drug ratio of mobile phase is different from the drug
substance manufacturer (Phosphate substance manufacturer.
Buffer 80: Acetonitrile 20), clarify?
Furthermore, the drug substance
manufacturer has followed isocratic
elution while drug product
manufacturer has followed gradient
elution, clarify?
Time Mobile Mobile
phase A phase B
(%) (%)
0 80 20
• 15 80 20
3.2.P.6 Submit readable copy of COA of The firm have submitted certificate of analysis of
primary / secondary reference reference standard from M/s Chengda
standard including source and lot Pharmaceuticals Co., Ltd., China.
number shall be provided.
3.2.P.8 • Stability study at initial time point is • The firm have submitted stability study at
not submitted initial time point
• Submit Raw data sheets & analytical • The firm have submitted submit Raw data
record for both assay & dissolution sheets for both assay & dissolution test
test containing detail of sample containing detail of sample preparation,
preparation, standard preparation standard preparation and calculation formula
and calculation formula for various for various performance parameters.
performance parameters. • The firm submitted that we have imported and
• COA of API batch no. NP1713- used only one batch of API Brivaracetam
1908003 is provided in batch having Batch No. NP1713-1908003 in the
analysis while in stability study manufacturing of stability batches. It was a
batch no. NP1713-1908005 of API is typographical error in stability protocol.
mentioned, clarify which API was • Firm has submitted readable copy of
used in stability study Commercial Invoice No: C05S05ZEP191224
• Submit readable copy of commercial Date: JAN 22, 2020 for 2.5kg of drug substance
invoice Brivaracetam attested by AD (I&E) DRAP
Karachi on 28-02-2020
Decision: Approved with innovators specifications.
• Firm shall submit the fee of Rs. 7,500/- for correction/pre-approval change/ in product specifications,
as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Karachi, Pakistan.
☐ Importer
☐ Export sale
(Reg#109739)
11th July 2019
Batches: (NP1713-1907002, NP1713-1908003,
NP1713-1909004)

product.
calculate F2 value.
specificity.
API Lot No. NP1713-1908003
Description of Pack
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 20PD-221 20PD-222 20PD-223
Manufacturing Date Sep-2020 Sep-2020 Sep-2020
No. of Batches 03
chambers.
Administration.
Karachi.
testing
XI
1.6.5 Submit valid GMP certificate / Drug The firm have submitted written confirmation
Manufacturing License of the Drug for active substance exported to EU to M/s
Substance manufacturer issued by Chengda Pharmaceuticals Co., Ltd., No. 36,
relevant regulatory authority of country Huanghe Road, Huimin Subdistrict, Jiashan,
of origin Zhejiang, China for Active substance
Brivaracetam issued by Zhejiang Food and
Drug Administration China confirming that the
manufacturing plant complies with requirement
of Chinese Good Manufacturing practices.
product manufacturer (Mobile phase A; substance manufacturer but the way of writing
Phosphate Buffer 95: Acetonitrile 05 is tabular form and mistakenly marked as
and mobile phase B; ACN) is different gradient elution instead of isocratic elution.
than that used by drug substance However, the ratio of mobile phase is different
manufacturer (Phosphate Buffer 80: from the drug substance manufacturer.
Acetonitrile 20), clarify? Furthermore,
the drug substance manufacturer has
followed isocratic elution while drug
product manufacturer has followed
gradient elution, clarify?
Time Mobile Mobile

phase A phase B
(%) (%)
0 80 20
• 15 80 20
3.2.P.6 • Submit readable copy of COA of The firm have submitted certificate of analysis
primary / secondary reference of reference standard from M/s Chengda
• Submit Raw data sheets & analytical • The firm have submitted Raw data sheets for
record for both assay & dissolution both assay & dissolution test containing detail
test containing detail of sample of sample preparation, standard preparation
preparation, standard preparation and and calculation formula for various
calculation formula for various performance parameters.
1908003 is provided in batch analysis having Batch No. NP1713-1908003 in the
while in stability study batch no. manufacturing of stability batches. It was a
NP1713-1908005 of API is typographical error in stability protocol.
• Submit readable copy of commercial Date: JAN 22, 2020 for 2.5kg of drug
invoice substance Brivaracetam attested by AD (I&E)
DRAP Karachi on 28-02-2020
Karachi, Pakistan.
☐ Importer
☐ Export sale
(Reg#109740)
11th July 2019
Batches: (NP1713-1907002, NP1713-1908003,
NP1713-1909004)

product.
calculate F2 value.
specificity.
API Lot No. NP1713-1908003
Description of Pack
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 20PD-208 20PD-209 20PD-210
Manufacturing Date Aug-2020 Aug-2020 Aug-2020
No. of Batches 03
chambers.
Administration.
Karachi.
testing
XI
Karachi, Pakistan.
☐ Importer
☐ Export sale
(Reg#109741)
11th July 2019
Batches: (NP1713-1907002, NP1713-1908003,
NP1713-1909004)

product.
calculate F2 value.
specificity.
API Lot No. NP1713-1908003
Description of Pack
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 20PD-218 20PD-219 20PD-220
No. of Batches 03
st th nd
chambers.
Administration.
Karachi.
testing
XI
1.6.5 Submit valid Good Manufacturing The firm have submitted written confirmation for
Practice (GMP) certificate / Drug active substance exported to EU to M/s Chengda
Manufacturing License of the Drug Pharmaceuticals Co., Ltd., No. 36, Huanghe
Substance manufacturer issued by Road, Huimin Subdistrict, Jiashan, Zhejiang,
relevant regulatory authority of China for Active substance Brivaracetam issued
country of origin by Zhejiang Food and Drug Administration
China confirming that the manufacturing plant
complies with requirement of Chinese Good
Manufacturing practices.
product manufacturer (Mobile phase substance manufacturer but the way of writing is
A; Phosphate Buffer 95: Acetonitrile tabular form and mistakenly marked as gradient
05 and mobile phase B; ACN) is elution instead of isocratic elution. However, the
different than that used by drug ratio of mobile phase is different from the drug
substance manufacturer (Phosphate substance manufacturer.
Buffer 80: Acetonitrile 20), clarify?
Furthermore, the drug substance
manufacturer has followed isocratic
elution while drug product
manufacturer has followed gradient
elution, clarify?
Time Mobile Mobile

phase A phase B
(%) (%)
0 80 20
15 80 20
3.2.P.6 Submit readable copy of COA of The firm have submitted certificate of analysis of
primary / secondary reference reference standard from M/s Chengda
test containing detail of sample of sample preparation, standard preparation and
preparation, standard preparation calculation formula for various performance
and calculation formula for various parameters.
1908003 is provided in batch having Batch No. NP1713-1908003 in the
analysis while in stability study manufacturing of stability batches. It was a
batch no. NP1713-1908005 of API is typographical error in stability protocol.
• Submit readable copy of commercial Date: JAN 22, 2020 for 2.5kg of drug substance
invoice Brivaracetam attested by AD (I&E) DRAP
Karachi on 28-02-2020
371. Name, address of Applicant / Marketing M/s Axis Pharmaceuticals., 3-B Value Addition
Authorization Holder City, 1.5 Km Khurrianwala – Sahianwala Road,
Faisalabad – Pakistan
Name, address of Manufacturing site. M/s Axis Pharmaceuticals., 3-B Value Addition
City, 1.5 Km Khurrianwala – Sahianwala Road,
Faisalabad – Pakistan
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 25932 dated: 17-09-2021
Details of fee submitted PKR 30,000/-: 02-09-2021 (deposit slip #
977318003814)
The proposed proprietary name / brand name Monticel Sachet 4mg
Strength / concentration of drug of Active Each sachet contains:
Pharmaceutical ingredient (API) per unit Montelukast (as Sodium)……………4mg
Pharmaceutical form of applied drug Powder for Oral use
Pharmacotherapeutic Group of (API) Leukotriene receptor antagonist
Reference to Finished product specifications BP specification
Proposed Pack size 14’s and 28’s
The status in reference regulatory authorities Singulair (4mg) oral granules USFDA Approved
For generic drugs (me-too status) Myteka 4mg Sachet by M/s Hilton Pharma
(Reg#039695)
GMP status of the Finished product Firm has submitted GMP certificate issued on 06-07-
manufacturer 2020, based on inspection conducted on 09-06-2020
Name and address of API manufacturer. Zhejiang Tianyu Pharmaceutical Co., Ltd., No.15,
Donghai 5th Avenue, Zhejiang Provincial Chemical
and Medical Raw Materials Base Linhai Zone,
Taizhou City, Zhejiang Province, China 317016
drug product.
Module III (Drug Substance) Firm has submitted detailed drug substance data
procedures and its verification, batch analysis and
substance.
Stability studies Firm has submitted stability study data of 3 batches
of API as per zone IV-A conditions
Stability study conditions:
Batches: (11001-161001, 11001-161002, 11001-
161003)
product.
Pharmaceutical equivalence and comparative Firm has submitted results of pharmaceutical
dissolution profile equivalence and comparative dissolution study
against the comparator product i.e. Myteka Sachet
4mg by M/s Hilton Pharma.
Pharmaceutical Equivalence have been conducted by
performing quality tests (Assay, Dissolution and
Results of CDP studies have been submitted against
the same brand in Pharmacopoeial Media (0.5%
SLS) only. Release of both the test and reference
product is more than 85% in hence no calculation of
f2 factor is required.
Analytical method validation/verification of Firm has submitted report of verification of
product analytical method for the drug product including
specificity, accuracy, and precision.
Manufacturer of API Zhejiang Tianyu Pharmaceutical Co., Ltd., No.15, Donghai 5th Avenue,
Zhejiang Provincial Chemical and Medical Raw Materials Base Linhai Zone,
Taizhou City, Zhejiang Province, China 317016
API Lot No. 11001-201005
Description of Pack Alu – Foil Sachet, packed in carton
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. T-002 T-003 T-004
Batch Size 300 Sachet 500 Sachet 500 Sachet
No. of Batches 03
1. Reference of previous approval of applications Not submitted
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP Certificate of
API manufacturer issued by concerned M/s Zhejiang Tianyu Pharmaceutical Co., Ltd.,
regulatory authority of country of origin. issued by China Food and Drug Administration valid
till 14-03-2023
3. Documents for the procurement of API with The firm has submitted copy of commercial invoice
approval from DRAP (in case of import). No#TYI21009 dated 29-12-2020 for import of 60kg
of Montelukast Sodium attested by AD (I&E) DRAP
Lahore.
attested respective documents like supported by attested respective documents like
chromatograms, Raw data sheets, COA, chromatograms, Raw data sheets, COA, summary
summary data sheets etc. data sheets etc.
5. Compliance Record of HPLC software 21CFR Firm has submitted audit trail reports on product
& audit trail reports on product testing testing
(real time and accelerated) chambers (real time)
XI
3.2.S.4 • Drug substance manufacturer has • Analytical method and specifications of
stated USP specifications while drug montelukast sodium in both pharmacopeia
product manufacturer has stated (BP/USP) are same, therefore both standards are
USP/BP specifications, clarify? mentioned on COA. Evidence is submitted.
• Analytical procedure of drug • Firm has submitted analytical procedure of drug
substance by drug substance substance by provided drug substance
manufacturer shall be submitted manufacturer
• You have mentioned the use of • The firm submitted that montelukast sodium is
Montelukast sodium working standard readily available as raw material and used as
in analytical procedure during working standard in routine testing after
preparation of standard solution while standardization against montelukast
pharmacopeia states the use of dicyclohexylamine (reference standard).
montelukast dicyclohexylamine
reference standard, clarify?
3.2.S.5 Reference standard is montelukast Montelukast sodium (working standard) is used
dicyclohexylamine while working in routine testing, which is standardized against
standard is montelukast sodium, clarify? montelukast dicyclohexylamine (reference
standard).
3.2.P.2.1 • Clarification is required since the • The firm submitted that magnesium stearate is
innovator product contain routinely used as lubricant in oral solid dosage
magnesium stearate in addition to form to improve flow characteristics of the
other excipients while the applied product. The drug product is fine granular
product does not contain magnesium powder having satisfactory flow
stearate. characteristics without the use of magnesium
• Justify why Pharmaceutical stearate. Moreover, addition of magnesium
equivalence of the applied product stearate causes haziness in solution prepared
has not been performed against the after reconstitution as observed in product
innovator product? development phase. That is why, the said
• The results of comparative dissolution excipient was not used.
profile conducted in three BCS media • Firm submitted that Pharmaceutical equivalence
across the physiological pH range of the applied product has been performed
along with calculation of similarity against comparator product as per DRAP’s
factor f2 shall be submitted and guidance document (FAQs about form 5F)
discussed dated 28-01-21.
• The firm submitted that comparative dissolution
profile has been conducted in three BCS media
(pH 1.2, 4.5 &6.8) and already submitted
pharmacopeial method (0.5% SLS) & already
submitted. Montelukast sodium did not show
any response in the stated BCS media across
physiological range (pH 1.2, 4.5 & 6.8)
therefore it was not applicable to calculate
similarity factor in those media (firm has
submitted a few chromatograms for evidence).
However, in pharmacopeial method both
products showed more than 85% dissolution,
therefore no calculation was required.
3.2.P.3.2 The reference formulation states The firm submitted that the applied formulation is
granules for oral suspension for applied free flowing granular powder and is completely
formulation. soluble after reconstitution for use. API is
Clarification is required in geometrically mixed with other excipients.
manufacturing process and process
control whether granules will be
prepared in-house or otherwise.
3.2.P.5 • You have mentioned the use of The firm submitted that montelukast sodium is
Montelukast sodium working standard readily available as raw material and used as
in analytical procedure during working standard in routine testing after
preparation of standard solution while standardization against montelukast
pharmacopeia states the use of dicyclohexylamine (reference standard).
montelukast dicyclohexylamine
reference standard, clarify?
3.2.P.6 Reference standard is montelukast Montelukast sodium (working standard) is used
dicyclohexylamine while working in routine testing, which is standardized against
standard is montelukast sodium, clarify? montelukast dicyclohexylamine (reference
standard).
3.2.P.8 • Submit 6th month stability study data • Firm has submitted 6th month stability study
at both real time and accelerated data at both real time and accelerated conditions
conditions • Firm has submitted readable copy of
• Submit readable copy of commercial commercial invoice
invoice • The firm has submitted Compliance Record of
• Compliance Record of HPLC HPLC software 21CFR
software 21CFR shall be submitted • Firm has submitted Record of Digital data
• Submit Record of Digital data logger logger for temperature and humidity monitoring
for temperature and humidity of stability chambers (accelerated conditions)
monitoring of stability chambers
(accelerated conditions)
Decision: Deferred for Scientific justification for use of Montelukast sodium as reference standard in
analytical procedures instead of Montelukast dicyclohexylamine specified by BP monograph.
1.6.5 Submit valid GMP certificate / Drug The firm have submitted written confirmation
Manufacturing License of the Drug for active substance exported to EU to M/s
Substance manufacturer issued by Chengda Pharmaceuticals Co., Ltd., No. 36,
relevant regulatory authority of country Huanghe Road, Huimin Subdistrict, Jiashan,
of origin Zhejiang, China for Active substance
Brivaracetam issued by Zhejiang Food and
Drug Administration China confirming that the
manufacturing plant complies with requirement
of Chinese Good Manufacturing practices.
product manufacturer (Mobile phase A; substance manufacturer but the way of writing
Phosphate Buffer 95: Acetonitrile 05 is tabular form and mistakenly marked as
and mobile phase B; ACN) is different gradient elution instead of isocratic elution.
than that used by drug substance However, the ratio of mobile phase is different
manufacturer (Phosphate Buffer 80: from the drug substance manufacturer.
Acetonitrile 20), clarify? Furthermore,
the drug substance manufacturer has
followed isocratic elution while drug
product manufacturer has followed
gradient elution, clarify?
Time Mobile Mobile

phase A phase B
(%) (%)
0 80 20
• 15 80 20
3.2.P.6 Submit readable copy of COA of The firm have submitted certificate of analysis
primary / secondary reference standard of reference standard from M/s Chengda
including source and lot number shall Pharmaceuticals Co., Ltd., China.
be provided.
test containing detail of sample of sample preparation, standard preparation
preparation, standard preparation and and calculation formula for various
calculation formula for various performance parameters.
1908003 is provided in batch analysis having Batch No. NP1713-1908003 in the
while in stability study batch no. manufacturing of stability batches. It was a
NP1713-1908005 of API is typographical error in stability protocol.
• Submit readable copy of commercial Date: JAN 22, 2020 for 2.5kg of drug
invoice substance Brivaracetam attested by AD (I&E)
DRAP Karachi on 28-02-2020
372. Name, address of Applicant / Marketing Magns Pharmaceuticals Plot No. 7 B Value Addition City
Authorization Holder Sahianwala Road Khurrianwala Faisalabad.
Name, address of Manufacturing site. Magns Pharmaceuticals Plot No. 7 B Value Addition City
Sahianwala Road Khurrianwala Faisalabad.
☐ Importer
☐ Export sale
PKR 10,000/-: dated 09/06/2021
The proposed proprietary name / brand Dexopra Capsule 30mg
name
Pharmaceutical ingredient (API) per unit Dexlansoprazole (as dual delayed release pellets)
…………….……. 30 mg
Pharmaceutical form of applied drug Capsule
Pharmacotherapeutic Group of (API) Proton pump inhibitors
Reference to Finished product specifications Innovator’s Specifications”
Proposed Pack size 3x10, s capsules
Proposed unit price MRP Rs. 540/-
The status in reference regulatory authorities DEXILANT (30mg, 60mg) delayed-release capsules
USFDA Approved
For generic drugs (me-too status) Dextop Capsule 30 mg by M/s The Searle Company Ltd.
(Reg#086978)
GMP status of the Finished product The firm have submitted cGMP certificate issued on 22-03-
manufacturer 2019 based on inspection conducted on 01-03-2019
Name and address of API manufacturer. Source of Pellets:
Vision Pharmaceuticals Pvt. Ltd. Plot No. 22-23, Industrial
Triangle, Kahuta Road, Islamabad Pakistan.
Tel : + 92-51-4493587-90
Fax : + 92-51-4493591
E-mail: [email protected]
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template.
Summarized information related to nomenclature,
structure, general properties, solubilities, physical form,
manufacturers, description of manufacturing process and
controls, impurities, specifications, analytical procedures,
batch analysis and justification of specification, reference
standard, container closure system and stability studies of
drug substance and drug product is submitted.
Module III (Drug Substance) The firm has submitted detail of manufacturers, description
of manufacturing process and controls, impurities,
specifications, analytical procedure, batch analysis and
justification of specification, reference standard, container
closure system and stability studies of drug substance.
Batches: (DLP125T, DLP124T, DLP123T)
Module-III (Drug Product): The firm has submitted detail of manufacturers, description
specifications, analytical procedure and its verification
studies, batch analysis and justification of specification,
reference standard, container closure system and stability
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been established against
dissolution profile the Dextop 30mg capsule by M/s The Searle Company Ltd
Karachi by performing quality tests (Assay, Dissolution).
Analytical method validation/verification of Firm have submitted method verification studies including
product linearity, range, accuracy, precision.
Manufacturer of API Source of Pellets:
Vision Pharmaceuticals Pvt. Ltd. Plot No. 22-23, Industrial Triangle, Kahuta Road,
Islamabad Pakistan.
Tel : + 92-51-4493587-90
Fax : + 92-51-4493591
API Lot No. DLP 420
Description of Pack
Alu-alu Blisters, packed in unit carton
Real Time: 0,3,6,9,12,18,24 (Months)
Batch No. T-003 T-004 T-005
Batch Size 5000 caps 3000 caps 3000 caps
st th nd
Manufacturing Date 06-2019 12/10/2021 15/10/2021
Date of Initiation 27-06-2019
No. of Batches 03
1. Reference of previous approval of Not submitted
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm have submitted cGMP certificate of Vision
API manufacturer issued by concerned Pharmaceuticals issued on 31-07-2019 based on inspection
regulatory authority of country of origin. conducted on 11-02-2019
3. Documents for the procurement of API with The firm has submitted copy of invoice #502094 dated 19-
approval from DRAP (in case of import). 02-2019 for 1.2kg of Dexlansoprazole DDR Pellets 22.5%
batch # DLP420 from Vision Pharmaceuticals Islamabad.
4. Data of stability batches will be supported by Firm has submitted record of testing of one batch only along
attested respective documents like with chromatograms, COA and summary data sheets.
5. Compliance Record of HPLC software Firm has submitted Compliance Record of HPLC software
21CFR & audit trail reports on product testing 21CFR & audit trail reports on product testing
6. Record of Digital data logger for temperature Firm has submitted record of data logger for temperature
and humidity monitoring of stability and humidity monitoring of real time.
Remarks of Evaluator XI:
• Submit valid DML as the submitted • The firm have submitted valid copy of DML
DML has been expired on 24-11-2021 issued in name of M/s Magns Pharmaceuticals on
• Submit latest GMP inspection report 06/06/2022
conducted with in last three years • The firm have submitted GMP certificate issued
• Submit valid GMP certificate of drug on 13-04-2022 based on inspection conducted on
substance manufacturer 11-03-2022.
• The firm have submitted cGMP certificate of
Vision Pharmaceuticals issued on 25-03-2022
based on inspection conducted on 11-02-2019 and
further extended till 09-05-2022.
2.3.R.1 • Provide copy of Batch Manufacturing Firm has submitted Batch Manufacturing Record
Record (BMR) for all the batches of (BMR) for all the batches (T-003, T-004, T-005) of
drug product for which stability drug product for which stability studies data is
studies data is provided in Module 3 provided in Module 3 section 3.2.P.8.3>.
section 3.2.P.8.3> Two more batches, Batch T-004 and T-005 was
manufactured on 12/10/2021 and 15/10/2021
respectively while batch T-003 was manufactured
on23/06/2019. The details of these two batches are
incorporated in above table.
3.2.S.4 • Copies of the Drug substance • Copies of the Drug substance specifications and
specifications and analytical analytical procedures used for routine testing of
procedures used for routine testing of the Drug substance /Active Pharmaceutical
the Drug substance /Active Ingredient by Drug Product manufacturer is not
Pharmaceutical Ingredient by Drug submitted.
Product manufacturer is required. • Analytical Method Verification studies including
• Analytical Method Verification specificity, accuracy and repeatability (method
studies including specificity, accuracy precision) performed by the Drug Product
and repeatability (method precision) manufacturer for drug substance(s) is not
performed by the Drug Product submitted.
manufacturer for drug substance(s)
shall be submitted.
3.2.P.2.2.1 • Justify why the pharmaceutical • No clarification is submitted. However
equivalence study does not include pharmaceutical equivalence is again submitted.
complete testing of the drug product Test like content uniformity, loss on drying and
and the comparator product including identification are not performed.
the tests recommended by innovator • The firm submitted that we have performed
product. comparative study for assay and dissolution
• Comparative dissolution profile hence Comparative dissolution profile is not
against the innovator product shall be required
submitted
3.2.P.4 • Justify the use of gelatine capsule • The firm submitted that hard gelatine capsules are
shell in dexlansoprazole capsule since easily available and having same dissolving time
innovator product has specified and behaviour and other competitors are also using
hypromellose capsule shells. gelatine capsule shell.
• For excipients of human or animal • No clarification submitted
origin, a certificate shall be provided, • The firm have submitted Halal certificate for
confirming that the excipient(s) are gelatin shall
free from BSE and TSE.
• Halal certificate for gelatin shall be
provided
3.2.P.5 • You have mentioned innovator • The firm submitted that we have followed
specifications under section 1.5.6 innovator’s specifications.
while you have followed • The firm submitted that content uniformity test is
manufacturer specifications for recommended for dosage form which have API
applied product, justify? 25mg or less than 25mg in all pharmacopeia
• The tests of content uniformity and reference, so we have not performed.
loss on drying were not included in • Results of specificity test in method validation is
the submitted specifications as not submitted
recommended by literature of • Firm have submitted copies of complete analysis
innovator product, justify? of two batches
• Results of specificity test in method
validation is not submitted
• The copies of complete analysis of at
least two batches shall be provided
while you have provided batch
analysis of only one batch, justify?
3.2.P.8 • Submit latest inspection report for • Inspection report for exemption conducted by the
exemption conducted by the panel for panel for authenticity of stability data (PSI) is not
authenticity of stability data (PSI) submitted
• Submit Raw data sheets & analytical • Firm has not submitted stability study data
record of stability studies containing including summary data sheets, COA, raw data
calculation formula for both assay & sheet and attested respective chromatogram as
dissolution test per requirement.
• Justify why you have submitted • Record of Digital data logger for temperature
stability study data of only one batch and humidity monitoring of stability chambers
while it is required to submit stability (accelerated conditions) is not submitted
study data of three batches as per zone
IV-A conditions
• Submit Record of Digital data logger
for temperature and humidity
• Submission of Copies of the Drug substance specifications and analytical procedures used for routine testing
of the Drug substance /Active Pharmaceutical Ingredient by Drug Product manufacturer
• Submission of Analytical Method Verification studies including specificity, accuracy and repeatability
(method precision) performed by the Drug Product manufacturer for drug substance(s)
• Submission of Comparative dissolution profile against the innovator product
• Submission of results of specificity test in method validation studies of drug product
• Submission of stability study data including summary data sheets, COA, raw data sheet and attested
respective chromatogram as per requirement.
• Submission of Record of Digital data logger for temperature and humidity monitoring of stability chambers
373. Name, address of Applicant / Marketing Magns Pharmaceuticals Plot No. 7 B Value Addition City
Authorization Holder Sahianwala Road Khurrianwala Faisalabad.
Name, address of Manufacturing site. Magns Pharmaceuticals Plot No. 7 B Value Addition City
Sahianwala Road Khurrianwala Faisalabad.
☐ Importer
☐ Export sale
PKR 10,000/-: dated 09/06/2021
The proposed proprietary name / brand name Dexopra Capsule 60mg
Pharmaceutical ingredient (API) per unit Dexlansoprazole (as dual delayed release pellets)
…………….……. 60 mg
Reference to Finished product specifications Innovator’s Specifications”
Proposed Pack size 3x10, s capsules
Proposed unit price MRP Rs. 840/-
USFDA Approved
For generic drugs (me-too status) Dextop Capsule 60 mg by M/s The Searle Company Ltd.
(Reg#086979)
GMP status of the Finished product The firm have submitted cGMP certificate issued on 22-03-
manufacturer 2019 based on inspection conducted on 01-03-2019
Vision Pharmaceuticals Pvt. Ltd. Plot No. 22-23, Industrial
Triangle, Kahuta Road, Islamabad Pakistan.
Tel : + 92-51-4493587-90
Fax : + 92-51-4493591
Module III (Drug Substance) The firm has submitted detail of manufacturers, description
specifications, analytical procedure, batch analysis and
Batches: (DLP125T, DLP124T, DLP123T)
specifications, analytical procedure and its verification
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been established against
dissolution profile the Dextop 60mg capsule by M/s The Searle Company Ltd
Karachi by performing quality tests (Assay, Dissolution).
Analytical method validation/verification of Firm have submitted method verification studies including
product linearity, range, accuracy, precision.
Islamabad Pakistan.
Tel : + 92-51-4493587-90
Fax : + 92-51-4493591
API Lot No. DLP 420
Description of Pack Alu-alu Blisters, packed in unit carton
Real Time: 0,3,6,9,12,18,24 (Months)
Batch No. T-003 T-004 T-005
Manufacturing Date 06-2019 12/10/2021 15/10/2021
Date of Initiation 27-06-2019
No. of Batches 03
1. Reference of previous approval of Not submitted
firm (if any)
3. Documents for the procurement of API with Not submitted
4. Data of stability batches will be supported by Firm has submitted record of testing of one batch only along
attested respective documents like with chromatograms, COA and summary data sheets.
5. Compliance Record of HPLC software Firm has submitted Compliance Record of HPLC software
21CFR & audit trail reports on product testing 21CFR & audit trail reports on product testing
and humidity monitoring of stability and humidity monitoring of real time.
• Submit valid DML as the submitted • The firm have submitted valid copy of DML
DML has been expired on 24-11-2021 issued in name of M/s Magns Pharmaceuticals
• Submit latest GMP inspection report on 06/06/2022
conducted with in last three years • The firm have submitted GMP certificate issued
• Submit valid GMP certificate of drug on 13-04-2022 based on inspection conducted
substance manufacturer on 11-03-2022.
• The firm have submitted cGMP certificate of
Vision Pharmaceuticals issued on 25-03-2022
based on inspection conducted on 11-02-2019
and further extended till 09-05-2022.
2.3.R.1 • Provide copy of Batch Manufacturing Firm has submitted Batch Manufacturing Record
Record (BMR) for all the batches of (BMR) for all the batches (T-003, T-004, T-005)
drug product for which stability studies of drug product for which stability studies data is
data is provided in Module 3 section provided in Module 3 section 3.2.P.8.3>.
3.2.P.8.3> Two more batches, Batch T-004 and T-005 was
manufactured on 12/10/2021 and 15/10/2021
respectively while batch T-003 was
manufactured on23/06/2019. The details of
these two batches are incorporated in above
table.
3.2.S.4 • Copies of the Drug substance • Copies of the Drug substance specifications
specifications and analytical procedures and analytical procedures used for routine
used for routine testing of the Drug testing of the Drug substance /Active
substance /Active Pharmaceutical Pharmaceutical Ingredient by Drug Product
Ingredient by Drug Product manufacturer is not submitted.
manufacturer is required. • Analytical Method Verification studies
• Analytical Method Verification studies including specificity, accuracy and
including specificity, accuracy and repeatability (method precision) performed by
repeatability (method precision) the Drug Product manufacturer for drug
performed by the Drug Product substance(s) is not submitted.
manufacturer for drug substance(s) shall
be submitted.
3.2.P.2.2.1 • Justify why the pharmaceutical • No clarification is submitted. However
equivalence study does not include pharmaceutical equivalence is again
complete testing of the drug product and submitted. Test like content uniformity, loss on
the comparator product including the drying and identification are not performed.
tests recommended by innovator • The firm submitted that we have performed
product. comparative study for assay and dissolution
• Comparative dissolution profile against hence Comparative dissolution profile is not
the innovator product shall be submitted required
3.2.P.4 • Justify the use of gelatine capsule shell • The firm submitted that hard gelatine capsules
in dexlansoprazole capsule since are easily available and having same dissolving
innovator product has specified time and behaviour and other competitors are
hypromellose capsule shells. also using gelatine capsule shell.
• For excipients of human or animal • No clarification submitted
origin, a certificate shall be provided, • The firm have submitted Halal certificate for
confirming that the excipient(s) are free gelatin shall
from BSE and TSE.
• Halal certificate for gelatin shall be
provided
3.2.P.5 • You have mentioned innovator • The firm submitted that we have followed
specifications under section 1.5.6 while innovator’s specifications.
you have followed manufacturer • The firm submitted that content uniformity test
specifications for applied product, is recommended for dosage form which have
justify? API 25mg or less than 25mg in all
• The tests of content uniformity and loss pharmacopeia reference, so we have not
on drying were not included in the performed.
submitted specifications as • Results of specificity test in method validation
recommended by literature of innovator is not submitted
product, justify? • Firm have submitted copies of complete
• Results of specificity test in method analysis of two batches
validation is not submitted
• The copies of complete analysis of at
least two batches shall be provided
while you have provided batch analysis
of only one batch, justify?
3.2.P.8 • Submit latest inspection report for • Inspection report for exemption conducted by
exemption conducted by the panel for the panel for authenticity of stability data (PSI)
authenticity of stability data (PSI) is not submitted
• Submit Raw data sheets & analytical • Firm has not submitted stability study data
record of stability studies containing including summary data sheets, COA, raw data
calculation formula for both assay & sheet and attested respective chromatogram as
dissolution test per requirement.
• Justify why you have submitted stability • Record of Digital data logger for temperature
study data of only one batch while it is and humidity monitoring of stability chambers
required to submit stability study data of (accelerated conditions) is not submitted
three batches as per zone IV-A • The firm has submitted copy of invoice
conditions #800742 dated 23-09-2021 for 2.5kg of
• Submit Record of Digital data logger Dexlansoprazole DDR Pellets 22.5% batch #
for temperature and humidity DLP775 from Vision Pharmaceuticals
monitoring of stability chambers Islamabad.
• Submit documents for the procurement
of API
• Submission of Copies of the Drug substance specifications and analytical procedures used for routine testing
of the Drug substance /Active Pharmaceutical Ingredient by Drug Product manufacturer
(method precision) performed by the Drug Product manufacturer for drug substance(s)
• Submission of Comparative dissolution profile against the innovator product
• Submission of results of specificity test in method validation studies of drug product
• Submission of stability study data including summary data sheets, COA, raw data sheet and attested
respective chromatogram as per requirement.
• Submission of Record of Digital data logger for temperature and humidity monitoring of stability chambers
374. Name, address of Applicant / Marketing M/s Jaskan Pharmaceuticals (Pvt.) Ltd., Plot No. 50
Authorization Holder Sunder Industrial Estate Lahore
Name, address of Manufacturing site. M/s Jaskan Pharmaceuticals (Pvt.) Ltd., Plot No. 50
Sunder Industrial Estate Lahore
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 24360 dated: 03-09-2021
Details of fee submitted PKR 30,000/-: 18-06-2021 (deposit slip # 85552371641)
The proposed proprietary name / brand name Clarkan Dry Suspension 250mg/5ml
Strength / concentration of drug of Active Each 5ml of reconstituted suspension contains:
Pharmaceutical ingredient (API) per unit Clarithromycin ………. 250mg
Pharmaceutical form of applied drug Dry powder for oral suspension
Reference to Finished product specifications USP specification
Proposed Pack size As per SRO
The status in reference regulatory authorities Klaricid Paediatric Suspension 250mg/5ml MHRA
Approved
For generic drugs (me-too status) Klaricid DS Granules by M/s Abbot Laboratories
Limited (Reg#076148)
GMP status of the Finished product Firm has submitted GMP certificate issued on 18-02-2021,
manufacturer based on inspection conducted on 26-10-2020
Name and address of API manufacturer. Source of Micro-Pellets:
Vision Pharmaceuticals Pvt. Ltd. Plot No. 22-23,
Industrial Triangle, Kahuta Road, Islamabad Pakistan.
Tel : + 92-51-4493587-90
Fax : + 92-51-4493591
controls, impurities, specifications, analytical procedures
and its verification, batch analysis and justification of
specification, reference standard, container closure system
and stability studies of drug substance and drug product.
Module III (Drug Substance) Firm has submitted detailed drug substance data related to
specifications, analytical procedures and its verification,
drug substance.
Stability studies Firm has submitted stability study data of 3 batches of API
as per zone IV-A conditions
Batches: (CTM0511, CTM0510, CTM0513)
impurities, specifications, analytical procedure and its
verification studies, batch analysis and justification of
and stability studies of drug product.
Pharmaceutical equivalence and comparative Firm has submitted results of pharmaceutical equivalence
dissolution profile against the Klaricid DS 250mg/5ml by M/s Abbot
Laboratories by performing quality tests (Appearance,
Identification, pH, Assay).
Analytical method validation/verification of Firm has submitted report of verification of analytical
product method for the drug product including specificity,
accuracy and precision.
Manufacturer of API Source of Micro-Pellets:
Islamabad Pakistan.
Tel : + 92-51-4493587-90
Fax : + 92-51-4493591
API Lot No. CTM-0645
Description of Pack Glass bottle 90ml packed in paper board U/C box
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. CJ-01 CJ-02 CJ-03
Batch Size 33 bottles 33 bottles
Manufacturing Date 04-03-2020 04-03-2020 04-03-2020
No. of Batches 03
1. Reference of previous approval of Not Submitted
firm (if any)
3. Documents for the procurement of API with Not required as local source was used.
4. Data of stability batches will be supported by Firm has submitted data of stability batches supported by
attested respective documents like attested respective documents like chromatograms, Raw
chromatograms, Raw data sheets, COA, data sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software Not submitted
21CFR & audit trail reports on product testing
and humidity monitoring of stability chambers temperature and humidity monitoring of stability chambers
(real time and accelerated) (real time and accelerated)
XI
1.6.5 Submit valid GMP certificate of drug The firm have submitted cGMP certificate of Vision
substance manufacturer Pharmaceuticals issued on 25-03-2022 based on
inspection conducted on 11-02-2019 and further
extended till 09-05-2022.
3.2.S.4 • Copies of the Drug substance • The firm have submitted Copies of the Drug
specifications and analytical substance specifications and analytical procedures
procedures used for routine testing used for routine testing of the Drug substance /
of the Drug substance / Active Active Pharmaceutical ingredient by Drug Product
Pharmaceutical ingredient by Drug manufacturer according to USP monograph.
Product manufacturer is required. However, the number and limits of tests and
• Analytical Method Verification analytical procedure are different from the drug
studies including specificity, substance manufacturer as monograph for
accuracy and repeatability (method clarithromycin EC Taste Mask Pellets are not
precision) performed by the Drug available in USP.
Product manufacturer for drug • Firm have submitted Analytical Method
substance(s) shall be submitted. Verification studies including accuracy and
repeatability (method precision) performed by the
Drug Product manufacturer. However, results of
specificity is not submitted.
3.2.P.2 • Justification is required why • The firm submitted that we have used these three
Antimicrobial Preservatives were preservatives (Sodium benzoate, Methyl
included in composition of applied parabene sodium, Propyl parabene sodium) in
product although no antimicrobial very small quantity to get their synergistic
preservative is included in preservative effect. They further sated that they
composition of innovator product may omit parabens from formulation for
• Justify why the pharmaceutical commercial batches.
equivalence study does not include • The firm submitted that comparative study along
complete testing of the drug product with uniformity of dosage unit, deliverable volume
and the comparator product and loss on drying has been performed and
including the tests recommended by submitted
USP monograph (uniformity of
dosage unit, deliverable volume,
loss on drying)
3.2.P.4 No data / document is submitted in this Relevant data / document is submitted in this section
section
3.2.P.5 • Justification is required why • The firm submitted that complete testing as
specification does not include recommended by USP monograph (uniformity of
complete testing as recommended dosage unit, deliverable volume, loss on drying)
by USP monograph (uniformity of has been done
dosage unit, deliverable volume,
loss on drying)
3.2.P.6 No data / document is submitted in this COA’s of Drug substance has been submitted instead
section of primary / secondary reference standard
3.2.P.8 • Preservative content and efficacy • Preservative content and efficacy test has been
test not performed during stability performed and submitted
study, clarify? • In use stability study of reconstitution suspension
• In use stability study of has been performed and submitted. However, the
reconstitution suspension shall be limits of pH test are not within recommended limit
submitted range after 14 days. (Limit 4---5.4……result 3.81)
• Submit documents for the • The firm has submitted copy of invoice #602776
procurement of API dated 02-03-2020 for 10kg of Clarithromycin Taste
• Compliance record of HPLC Masked Micro Pellets 27.5% batch # CTM0645
software 21CFR & audit trail reports from Vision Pharmaceuticals Islamabad.
on product testing is required. • The firm submitted that EZ Chrom software is 21
CFR compliant and submit audit trail reports on
product testing
Decision: Approved.
• Registration Board further decided that registration letter will be issued upon submission of
following:
a. Specification, Analytical procedure & Analytical record for drug substance analysis by Jaskan
Pharmaceuticals (Pvt.) Ltd., Plot No. 50 Sunder Industrial Estate Lahore along with for the drug
substance analysis.
b. Performance of specificity parameter for analytical method verification studies of drug substance
shall be submitted.
c. Results of specificity test in analytical method verification studies for drug substance.
d. Submission of In use stability study of 14 days for reconstituted suspension
375. Name, address of Applicant / Marketing M/s Atco Laboratories Ltd, B-18, S.I.T.E, Karachi.
Name, address of Manufacturing site. M/s Atco Laboratories Ltd, B-18, S.I.T.E, Karachi.
☐ Importer
☐ Export sale
PKR 120,000/-: dated 26/07/2021 (balance fee)
Total PKR 150,000/-: (Imported Pellets Fee)
The proposed proprietary name / brand name Dexlansoprazole DR Capsule 30mg
Strength / concentration of drug of Active Each capsule contains:
Pharmaceutical ingredient (API) per unit Dexlansoprazole MS 30mg
(as enteric coated pellets)
Proposed Pack size 7s, 10s, 14s, 20s, 28s & 30s.
USFDA Approved
For generic drugs (me-too status) Delanzo DR Capsule 30mg by M/s SAMI
Pharmaceuticals (Reg# 089145)
GMP status of the Finished product The firm was inspected on 28-02-2017 for renewal of
manufacturer DML and conclusion of inspection was:
Keeping in view good facilities provided for
manufacturing and quality control of pharmaceutical
products registered in the name of firm being produced at
site the overall good maintenance of plant and the required
documentation and standards operating procedures were
also found to be in place, the panel recommended the
grant of renewal of Drug Manufacturing License No.
000188 (Formulation) of the firm.
Alphamed Formulations Pvt., Limited
Survey No.225, Sampanbole Village, Shamirpet Mandal,
Medchal Malkajgiri District Telangana - 500 101, India
Module III (Drug Substance) The firm has submitted detail of manufacturers,
impurities, specifications, analytical procedure, batch
drug substance.
Batches: (AJ2A7004, AJ2A7005, AJ2A7006)
system and stability studies of drug product.
dissolution profile against the innovator product that is Dexilant 30mg
Capsule by Takeda Pharmaceuticals America, Inc by
Alphamed Formulations Pvt., Limited., Survey No.225, Sampanbole Village,
Shamirpet Mandal, Medchal Malkajgiri District Telangana - 500 101, India
API Lot No. AJ4A0003/B, RD-0050-023, RD-0050-024
Description of Pack
Alu-alu Blisters, packed in printed carton
Real Time: 0,3,6,9,12,18,24 (Months)
Batch No. AU231B AU232B AU233B
No. of Batches 03
1. Reference of previous approval of applications The firm has referred to previous inspection for
with stability study data of the firm (if any) authenticity of stability data of Rofl 500mcg tablet on the
basis of which Registration Board in its 277th meeting
dated 27-29 December, 2017 decided to approve
registration of Rofl 500mcg tablet.
Inspection date: 10-10-2017
Adequate monitoring and control are available for stability
chambers
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP issued by Drug
API manufacturer issued by concerned Control Administration, Government of Telangana India
regulatory authority of country of origin. valid till 29/08/2022.
3. Documents for the procurement of API with The firm has submitted two copies of invoice confirming
approval from DRAP (in case of import). the import of 6kg and 9kg dexlansoprazole dual delayed
release pellets respectively attested by AD (I&E) DRAP
Karachi. Invoice # and date, supplier and receiver details
are not clearly readable
Firm has submitted record of testing of all batches along
with chromatograms, raw data sheets, COA and summary
chromatograms, Raw data sheets, COA, data sheets.
5. Compliance Record of HPLC software 21CFR Firm has submitted Compliance Record of HPLC software
& audit trail reports on product testing 21CFR & audit trail reports on product testing
and humidity monitoring of stability chambers and humidity monitoring of real time and accelerated
(real time and accelerated) stability chambers.
XI
Submit latest GMP inspection report The firm has submitted cGMP certificate issued on
conducted with in last three years 24-12-2020 base on inspection conducted on 06th
November 2020
1.5.2 Strength / concentration of drug of The have submitted label claim as under:
Active Pharmaceutical ingredient Each capsule contains:
(API) per unit shall be clearly Dexlansoprazole Dual Delayed Release Pellets
mentioned indicating the type and 22.5% w/w eq. to Dexlansoprazole: 30mg
concentration of pellets
3.2.S.4 • Justification is required for not • Enantiomer is the process related impurity of pure
including the test for Percentage of API manufacturing of Dexlansoprazole and well
enantiomer in specification by drug controlled in drug substance specification by both
substance manufacturer and drug drug substance manufacturer of Dexlansoprazole
product manufacturer although stated (M/s. Enal Drugs Private Limited) and drug
by the innovator product? (drug is product (bulk) manufacturer of Dexlansoprazole
racemic mixture) pellets 22.5% (M/s. Alphamed Formulations
• Justify the dissolution specification Private Limited) as per requirement of innovator
set by the drug substance specification. One typical batch comparative
manufacturer (0.1N HCl, Buffer pH results from both drug substance manufacturer and
6 and Buffer pH 7.4) since they are drug product manufacturer has been submitted.
different from the innovator • The firm submitted that Dissolution specification
dissolution specifications (0.1N HCl, set by the drug substance manufacturer are adopted
pH 5.5 and pH 6.75). from FDA website of Dissolution.
• Analytical Method Verification • Analytical method verification studies including
studies including specificity, specificity, accuracy and repeatability (method
accuracy and repeatability (method precision) performed by drug product manufacturer
precision) performed by the Drug for drug substance is attached.
Product manufacturer for drug
substance(s) shall be submitted.
3.2.S.4.4 Provide results of analysis of relevant Firm has submitted results of analysis of relevant
batch(es) of Drug Substance batches of Drug Substance performed by Drug
performed by Drug Product Product manufacturer used during product
manufacturer used during product development and stability studies, along with
development and stability studies, Certificate of Analysis (CoA) of the same batch from
(CoA) of the same batch from Drug drug substance/ Active Pharmaceutical Ingredient
Substance / /Active Pharmaceutical manufacturer
Ingredient manufacture. (batch
number of both supplier and
manufacturer are different)
3.2.P.2 The applied product is 30mg capsule The firm have submitted Comparative dissolution
while the submitted CDP is for 60mg profile of Dexlansoprazole 30mg DR Capsules
caps, clarify conducted against innovator product Dexilant
capsule 30mg, in 0.1N HCl, Phosphate Buffer pH 5.5
and Phosphate buffer of pH 7.0 with SLS. The results
of f2 factor are in acceptable range.
3.2.P.4 • Justify the use of gelatine capsule We have performed compatibility studies of
shell in dexlansoprazole capsule Dexlansoprazole pellets 22.5% with hard gelatine
since innovator product has specified capsule shells and found compatible for
hypromellose capsule shells. Dexlansoprazole pellets.
3.2.P.5 • Justify the dissolution specification • The firm submitted that Dissolution specification
set by the drug product manufacturer set by the drug product manufacturer are
(0.1N HCl, Buffer pH 5.5 and Buffer harmonized with the Dissolution Methods on FDA
pH 7) since they are different from website which is “Acid stage: 0.1N Hydrochloric
the innovator dissolution acid, Buffer stage: pH 7.0 Phosphate Buffer with
specifications (0.1N HCl, pH 5.5 and 5mM Sodium Lauryl Sulphate”. Besides, for dual
pH 6.75). delayed release effect determination, with
• The tests of loss on drying was not reference to DRB 278th Meeting as advised to M/s.
included in the submitted Weatherfolds Pharmaceuticals, Hattar, we have
specifications as recommended by included pH 5.5 buffer stage dissolution.
literature of innovator product. Furthermore, the specifications has also validated
through comparative dissolution profile studies as
per requirement of innovator’s specification and
found both products pharmaceutical equivalent.
• The firm submitted that We are including the test
of water content in the specifications as
recommended by literature of innovator product.
Proposed specifications are submitted
3.2P.8 • The results of batch analysis and • The stability specification has been established in-
stability data reflect that tests of line with ICH Q 1A – 1F. Stability studies should
content uniformity have not been include testing of those attributes of the drug
performed throughout stability product that are susceptible to change during
studies. Justify your stability study storage and are likely to influence quality, safety,
data without performance of this and/or efficacy. The testing should cover, as
tests. appropriate, the physical, chemical, biological, and
• Submit readable copy of both the microbiological attributes. Furthermore,
commercial invoice for evidence of Uniformity of dosage units (content uniformity) is
purchase of pellets an in-process control test and it is well controlled
during release of drug product. Q1F Stability
Guideline WHO 2018 is being submitted
• The firm has submitted two copies of invoice No#
GE2020/177 dated 30-11-202 and invoice
No#GS2020/8 dated 17-06-2020 confirming the
import of 6kg and 9kg dexlansoprazole dual
delayed release pellets 22.5% w/w respectively
attested by AD (I&E) DRAP Karachi.
• Manufacturer will place first three production batches on long term stability studies throughout proposed
shelf life and on accelerated studies for six months as per the commitment submitted in the registration
application.
• Manufacturer will perform process validation of first three batches as per the commitment submitted in
• Firm shall submit the fee of Rs. 7,500/- for correction/pre-approval change/ in product specifications, as
per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021
376. Name, address of Applicant / Marketing M/s Atco Laboratories Ltd, B-18, S.I.T.E, Karachi.
Name, address of Manufacturing site. M/s Atco Laboratories Ltd, B-18, S.I.T.E, Karachi.
☐ Importer
☐ Export sale
PKR 120,000/-: dated 26/07/2021 (balance fee)
Total PKR 150,000/-: (Imported Pellets Fee)
The proposed proprietary name / brand name Dexlansoprazole DR Capsule 60mg
Pharmaceutical ingredient (API) per unit Dexlansoprazole MS 60mg
(as enteric coated pellets)
Proposed Pack size 7s, 10s, 14s, 20s, 28s & 30s.
USFDA Approved
For generic drugs (me-too status) Delanzo DR Capsule 60mg by M/s SAMI
Pharmaceuticals (Reg# 089146)
GMP status of the Finished product The firm was inspected on 28-02-2017 for renewal of
manufacturer DML and conclusion of inspection was:
Keeping in view good facilities provided for
manufacturing and quality control of pharmaceutical
products registered in the name of firm being produced
at site the overall good maintenance of plant and the
required documentation and standards operating
procedures were also found to be in place, the panel
recommended the grant of renewal of Drug
Manufacturing License No. 000188 (Formulation) of the
firm.
Alphamed Formulations Pvt., Limited
Survey No.225, Sampanbole Village, Shamirpet
Mandal, Medchal Malkajgiri District Telangana - 500
101, India
specifications, analytical procedures, batch analysis and
impurities, specifications, analytical procedure, batch
standard, container closure system and stability studies
of drug substance.
Batches: (AJ2A7004, AJ2A7005, AJ2A7006)
dissolution profile against the innovator product that is Dexilant 60mg
Capsule by Takeda Pharmaceuticals America, Inc by
CDP has been performed against the same brand that is
Dexilant 60mg Capsule by Takeda Pharmaceuticals
America, Inc in Acid media (pH 1.0-1.2), Phosphate
Buffer (pH 5.5) & Phosphate Buffer (pH 7 with SLS).
The values for f2 is in the acceptable range
Alphamed Formulations Pvt., Limited., Survey No.225, Sampanbole Village,
Shamirpet Mandal, Medchal Malkajgiri District Telangana - 500 101, India
API Lot No. AJ4A0003/B, RD-0050-023, RD-0050-024
Description of Pack
Alu-alu Blisters, packed in printed carton
Real Time: 0,3,6,9,12,18,24 (Months)
Batch No. AU228B AU229B AU230B
No. of Batches 03
1. Reference of previous approval of applications The firm has referred to previous inspection for
with stability study data of the firm (if any) authenticity of stability data of Rofl 500mcg tablet on the
st
323
basis of which Registration Board in its 277th meeting
dated 27-29 December, 2017 decided to approve
registration of Rofl 500mcg tablet.
Inspection date: 10-10-2017
Adequate monitoring and control are available for
stability chambers
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP issued by Drug
manufacturer issued by concerned regulatory Control Administration, Government of Telangana India
3. Documents for the procurement of API with The firm has submitted two copies of invoice confirming
approval from DRAP (in case of import). the import of 6kg and 9kg dexlansoprazole dual delayed
release pellets respectively attested by AD (I&E) DRAP
Karachi. Invoice # and date, supplier and receiver details
are not clearly readable
4. Data of stability batches will be supported by Firm has submitted record of testing of all batches along
with chromatograms, raw data sheets, COA and
chromatograms, Raw data sheets, COA, summary data sheets.
5. Compliance Record of HPLC software 21CFR Firm has submitted Compliance Record of HPLC
& audit trail reports on product testing software 21CFR & audit trail reports on product testing
(real time and accelerated) stability chambers.
XI
• Submit latest GMP inspection report The firm has submitted cGMP certificate issued on
conducted with in last three years 24-12-2020 base on inspection conducted on 06th
November 2020
1.5.2 • Strength / concentration of drug of The have submitted label claim as under:
Active Pharmaceutical ingredient Each capsule contains:
(API) per unit shall be clearly Dexlansoprazole Dual Delayed Release Pellets
mentioned indicating the type and 22.5% w/w eq. to Dexlansoprazole: 60mg
concentration of pellets
3.2.S.4 • Justification is required for not • Enantiomer is the process related impurity of pure
including the test for Percentage of API manufacturing of Dexlansoprazole and well
enantiomer in specification by drug controlled in drug substance specification by both
substance manufacturer and drug drug substance manufacturer of Dexlansoprazole
product manufacturer although stated (M/s. Enal Drugs Private Limited) and drug
by the innovator product? (drug is product (bulk) manufacturer of Dexlansoprazole
racemic mixture) pellets 22.5% (M/s. Alphamed Formulations
• Justify the dissolution specification Private Limited) as per requirement of innovator
set by the drug substance specification. One typical batch comparative
manufacturer (0.1N HCl, Buffer pH 6 results from both drug substance manufacturer and
and Buffer pH 7.4) since they are drug product manufacturer has been submitted.
different from the innovator • The firm submitted that Dissolution specification
dissolution specifications (0.1N HCl, set by the drug substance manufacturer are
pH 5.5 and pH 6.75). adopted from FDA website of Dissolution.
• Analytical Method Verification • Analytical method verification studies including
studies including specificity, accuracy specificity, accuracy and repeatability (method
and repeatability (method precision) precision) performed by drug product
performed by the Drug Product manufacturer for drug substance is submitted.
shall be submitted.
3.2.S.4.4 • Provide results of analysis of relevant Firm has submitted results of analysis of relevant
batch(es) of Drug Substance batches of Drug Substance performed by Drug
performed by Drug Product Product manufacturer used during product
manufacturer used during product development and stability studies, along with
development and stability studies, Certificate of Analysis (CoA) of the same batch
along with Certificate of Analysis from drug substance/ Active Pharmaceutical
(CoA) of the same batch from Drug Ingredient manufacturer
Substance / /Active Pharmaceutical
Ingredient manufacture.
3.2.P.2 • As per WHO guideline surfactants The firm submitted Surfactant should be avoided in
should be avoided in comparative comparative dissolution testing as the use of
dissolution testing while you have surfactants results in loss of discriminatory power
used surfactant in CDP, clarify? of dissolution method. In this case, drug is not
released in uniform pattern without surfactant due
to solubility issue of Dexlansoprazole while release
profile is the mandatory for comparative dissolution
testing. Furthermore, the use of surfactant did not
disturbed the release profile and the Active
Pharmaceutical Ingredient releases gradually from
the dual delayed release pellets and the
discriminatory power of dissolution method is not
loss as these pellets are dual delayed release,
designed to release till large intestine in vivo.
Results of Comparative dissolution profile of
Dexlansoprazole pellets without surfactant in pH
7.0 buffer medium is submitted for reference.
3.2.P.4 • Justify the use of gelatine capsule We have performed compatibility studies of
shell in dexlansoprazole capsule since Dexlansoprazole pellets 22.5% with hard gelatine
innovator product has specified capsule shells and found compatible for
hypromellose capsule shells. Dexlansoprazole pellets.
3.2.P.5 • Justify the dissolution specification • The firm submitted that Dissolution specification
set by the drug product manufacturer set by the drug product manufacturer are
(0.1N HCl, Buffer pH 5.5 and Buffer harmonized with the Dissolution Methods on FDA
pH 7) since they are different from the website which is “Acid stage: 0.1N Hydrochloric
innovator dissolution specifications acid, Buffer stage: pH 7.0 Phosphate Buffer with
(pH 5.5 and pH 6.75). 5mM Sodium Lauryl Sulphate”. Besides, for dual
• The tests of loss on drying was not delayed release effect determination, with
included in the submitted reference to DRB 278th Meeting as advised to M/s.
specifications as recommended by Weatherfolds Pharmaceuticals, Hattar, we have
literature of innovator product. included pH 5.5 buffer stage dissolution.
Furthermore, the specifications has also validated
through comparative dissolution profile studies as
per requirement of innovator’s specification and
found both products pharmaceutical equivalent.
• The firm submitted that We are including the test
of water content in the specifications as
recommended by literature of innovator product.
Proposed specifications are submitted
3.2P.8 • The results of batch analysis and • The stability specification has been established in-
stability data reflect that tests of line with ICH Q 1A – 1F. Stability studies should
content uniformity have not been include testing of those attributes of the drug
performed throughout stability product that are susceptible to change during
studies. Justify your stability study storage and are likely to influence quality, safety,
data without performance of this test. and/or efficacy. The testing should cover, as
• Submit readable copy of both the appropriate, the physical, chemical, biological,
commercial invoice for evidence of and microbiological attributes. Furthermore,
purchase of pellets Uniformity of dosage units (content uniformity) is
• The quantity of imported drug an in-process control test and it is well controlled
substance as per submitted invoice is during release of drug product. Q1F Stability
15kg and three batches of 30mg Guideline WHO 2018 is being submitted
dexlansoprazole capsule each of • The firm has submitted two copies of invoice No#
22500 caps and 60mg GE2020/177 dated 30-11-202 and invoice
dexlansoprazole capsule each of No#GS2020/8 dated 17-06-2020 confirming the
11200 caps were manufactured from import of 6kg and 9kg dexlansoprazole dual
it. Justification is required as how the delayed release pellets 22.5% w/w respectively
imported drug substance was attested by AD (I&E) DRAP Karachi.
sufficient enough to manufacture • The firm submitted that initially, during
three batches of each strength. development stage, we have also received 6Kg
pellets received from two lots of pellets (3Kg from
each lot) for development and trial purpose as
FOC. The total quantity received is 21Kg while
approx. 18Kg pellets has been consumed in
preparation of three batches of 30mg
Dexlansoprazole capsules each of 22500 caps and
three batches of 60mg Dexlansoprazole capsules
each of 11200 caps
• Manufacturer will place first three production batches on long term stability studies throughout proposed
shelf life and on accelerated studies for six months as per the commitment submitted in the registration
application.
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product specifications, as per
notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021
Case No. 02: Registration applications of New Section of human drugs

a. M/s Quaper (Pvt) Ltd. 26-A, Small Industrial Estate, Lahore Road, Sargodha (New Sections).
The Central Licensing Board in its 276th meeting held on 3rd September, 2020 has considered and approved the
following additional section of M/s Quaper (Pvt) Ltd. 26-A, Small Industrial Estate, Lahore Road, Sargodha.
under Drug Manufacturing License No. 000609 (Formulation) vide approval letter No. F. 1-37/2003-Lic (Vol-I)
dated 29th September 2020.
S No. Section
1. Capsule (General) Section (New)
2. Sachet (General) Section (New)
Following applications have been submitted for registration by the firm.
377. Name, address of Applicant / Marketing M/s Quaper (Pvt) Ltd. 26-A, Small Industrial Estate,
Authorization Holder Lahore Road, Sargodha.
Name, address of Manufacturing site. M/s Quaper (Pvt) Ltd. 26-A, Small Industrial Estate,
Lahore Road, Sargodha.
☐ Importer
☐ Is involved in none of the above
(contract giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 3134 dated 01-02-2022
The proposed proprietary name / brand name Diclomax SR 100 mg Capsule
Diclofenac Sodium SR Pellets 32% eq. to Diclofenac
Sodium………..100 mg
Pharmacotherapeutic Group of (API) NSAID (Non-steroidal anti-inflammatory drugs)
Reference to Finished product specifications BP specifications
The status in reference regulatory authorities Rhumalgan XL 100mg modified-release capsules,
MHRA Approved.
For generic drugs (me-too status) Phlogin-100 capsule by M/s Brookes
Pharmaceuticals (Reg#009129 )
GMP status of the Finished product New sections
manufacturer
Name and address of API manufacturer. M/s Vision Pharmaceuticals, Plot No.22-23,
Industrial Triangle Kahuta Road Islamabad.
Module III (Drug Substance) The firm has submitted detail of nomenclature,
Stability studies Long-term stability studies were performed at a
storage temperature of 30°C±2°C/65%±5% RH for
36 months.
Accelerated stability studies were performed at a
temperature of 40±2°C/75%±5% RH for 6 months.
Batches: (DE062ER, DE230ER, DE160ER)
product.
dissolution profile against the brand Phlogen SR 100mg Capsule by M/s
Brooks Pharmaceuticals by performing quality tests
Phlogen SR 100mg Capsule by M/s Brooks
Pharmaceuticals in Acid media 0.1N HCl (pH 1.2),
acetate buffer (pH 4.5) & phosphate Buffer (pH 6.8).
The values are in the acceptable range.
Analytical method validation/verification of Method verification studies have been submitted
product including linearity, specificity, accuracy, precision.
Manufacturer of API M/s Vision Pharmaceuticals, Plot No.22-23, Industrial Triangle Kahuta Road
Islamabad.
API Lot No. DE812ER
Description of Pack
Alu-PVC blister packed in unit carton
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. T1/21 T2/21 T3/21
Batch Size 2000 Cap 2000 Cap 2000 Cap
No. of Batches 03
1. Reference of previous approval of applications The firm submitted that Quaper Pvt. Ltd is a new
with stability study data of the firm (if any) license facility hence no such inspection has been
conducted
2. Approval of API/ DML/GMP certificate of The firm submitted copy of GMP certificate No.F.3-
API manufacturer issued by concerned 26/2019-Addl. Dir. (QA &LT-I) dated 31st July 2019
regulatory authority of country of origin. of M/s Vision Pharmaceuticals valid up to
10/02/2022
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice for
approval from DRAP (in case of import). 2kg of Diclofenac Sodium SR pellets 32% from
Vision Pharmaceuticals (Pvt.) Ltd
4. Data of stability batches will be supported by The firm have submitted data of stability batches
attested respective documents like along with respective documents like Raw data
chromatograms, Raw data sheets, COA, sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR Not required as Assay and dissolution performed on
& audit trail reports on product testing UV
6. Record of Digital data logger for temperature The firm have submitted record of Digital data logger
and humidity monitoring of stability chambers for temperature and humidity monitoring of stability
XI
• Submit valid GMP certificate of drug Firm has submitted copy of application and fee
substance manufacturer i.e. Vision deposit slip submitted to DRAP for issuance of
Pharma new GMP certificate to Vision Pharma
1.5.15- • Commitments not submitted as per Firm has submitted commitments as per the
1.5.20 the CTD guidance document CTD guidance document
3.2.S.4. • Copies of the analytical procedures Firm has submitted copies of the analytical
used for routine testing of the Drug procedures used for routine testing of the Drug
substance /Active Pharmaceutical substance /Active Pharmaceutical Ingredient
by Drug substance manufacturer is required.
Ingredient by Drug substance
manufacturer is required.
3.2.P.2.2.1 • Justification is required since Due to non-availability of innovator product in
pharmaceutical equivalence and the market, available brand of well reputed
CDP studies have not been conducted company was used for pharmaceutical
against the innovator product. equivalence and CDP studies.
3.2.P.4.5 • For excipients of human or animal The firm have submitted statement regarding
origin, a certificate shall be provided, TSE/BSE/GMO from M/s Multicaps capsule
confirming that the excipient(s) are for quality product Karachi. It is certified that
free from BSE and TSE. we manufacturer Empty Hard capsules from
• Halal certificate for gelatin shall be halal gelatin. It is derived form the bovine
provided bones of halal animals. We hereby declare that
our product is free from Transmissible
Spongiform Encephalopathy (TSE), Bovine
Spongiform Encephalophathy and also free
from Genetically Modified Organism (GMO).
3.2.P.5 • Justification shall be submitted for • Copy of IR spectrum for identification of
applying UV spectrum for diclofenac sodium as per BP specification is
identification of the diclofenac submitted
sustained released capsule while BP • Limit for Q NLT 70% in buffer pH 7.2 after
specifies identification of diclofenac 8 hr is selected as per drug substance
sodium prolonged release capsule by manufacturer specifications
IR method.
• Justification shall be submitted for
selecting Q NLT 70% in buffer pH
7.2 after 8 hr?
3.2.P.8 • You have mentioned the batch size The firm submitted that there was a
1600caps in batch T1/21 in stability typographical error. In actual the batch size for
summary sheet while 2000caps in all three stability batches was 2000 capsule.
two other batches, clarify as the batch The firm have submitted corrected summary
size should be same for all batches sheet
manufactured?
Decision: Approved.
b. M/s Invictus Pharmaceuticals Plot No. 21 & 26, Street No. NS-2, RCCI, Industrial Estate, Rawat”.
The Central Licensing Board in its 273rd meeting held on 15th January, 2020 has considered and approved the
following three (03) sections of “M/s Invictus Pharmaceuticals Plot No. 21 & 26, Street No. NS-2, RCCI,
Industrial Estate, Rawat” under Drug Manufacturing License No. 000892 (Formulation) vide approval letter
No. F. 1-37/2016-Lic (Vol-I) dated 18th February 2020.
S No. Section
1. Dry Powder Injection Section (Cephalosporine)
2. Dry Powder for suspension Section (Cephalosporine))
3. Capsule Section (Cephalosporine)
378. Name, address of Invictus Pharmaceuticals., NS2, Rawalpindi, Rawat Industrial Estate,
Applicant / Marketing Islamabad, Rawalpindi, Islamabad Capital Territory
Name, address of Invictus Pharmaceuticals., NS2, Rawalpindi, Rawat Industrial Estate,
Manufacturing site. Islamabad, Rawalpindi, Islamabad Capital Territory
☐ Importer
☐Is involved in none of the above (contract giver)
Intended use of ☐ Domestic sale
pharmaceutical product ☐ Export sale
Dy. No. and date of Dy. No. 23341 dated 26-08-2021
submission
The proposed Cef-Vic 400mg capsule
proprietary name /
brand name
Strength / concentration Each Capsule contains:
of drug of Active Cefixime as Trihydrate…….400mg
Pharmaceutical
ingredient (API) per
unit
Pharmaceutical form of White to off white powder filled in Size “0” Shell and packed in Alu-
applied drug Alu pack of 5’s.
Pharmacotherapeutic Cephalosporin Antibiotic
Group of (API)
Reference to Finished Innovator specifications
product specifications
Proposed Pack size Alu/Alu of Pack size of 5’s.
The status in reference Cefixime 400mg Capsule by M/s Alkem Labs Ltd USFDA approved
regulatory authorities
For generic drugs (me- Cebosh 400mg Capsule by M/s Bosch Pharmaceuticals (Reg# 027160)
too status)
GMP status of the New section
Finished product
manufacturer
Name and address of Pharmagen Limited., Kot Nabi Bukshwala, 34 Km Ferozepur Road,
API manufacturer. Lahore.
Tel: +92 (042) 5935261-68
Fax: +92 (042) 5935269
Web: www.pharmagen.com.pk
Module-II (Quality Firm has submitted QOS as per WHO QOS-PD template.
Overall Summary) Firm has summarized information related to nomenclature, structure,
general properties, solubilities, physical form, manufacturers,
Characterization, specifications, analytical procedures and its
validation, batch analysis and justification of specification, reference
standard, container closure system and stability studies of drug
substance. The firm has summarized information of drug product
including its description, composition, pharmaceutical development,
manufacture, manufacturing process and process control, process
validation protocols, control of excipients, control of drug product,
specifications, analytical procedures, validation/verification of
analytical procedures, batch analysis, justification of specifications,
reference standard or materials, container closure system and stability.
Module III (Drug Firm has submitted detailed data for both drug substance data related to
Substance) nomenclature, structure, general properties, solubilities, physical form,
manufacturers, description of manufacturing process and controls,
impurities, specifications, analytical procedures and its validation,
batch analysis and justification of specification, reference standard,
container closure system and stability studies of drug substance.
Stability studies Firm has submitted stability study data of 3 batches of drug substance
at both accelerated as well as real time conditions. The accelerated
stability data is conducted at 40 O ± 2 O C /75% ± 5% RH for 6 months.
The real time stability data is conducted at 30OC ± 2 O C / 65% ± 5%
RH for 36 months.
Module-III (Drug The firm has submitted detail of manufacturers, description of
Product): manufacturing process and controls, impurities, specifications,
analytical procedure batch analysis and justification of specification,
reference standard, container closure system and stability studies of
drug product.
Pharmaceutical Firm has performed pharmaceutical equivalence and comparative
equivalence and dissolution profile against the product Cefspan Capsule 400mg by M/s
comparative dissolution Barrett Hodgson (Pvt) Ltd
profile
Analytical method Not submitted
validation/verification
of product
Manufacturer of API Pharmagen Limited., Kot Nabi Bukshwala, 34 Km Ferozepur Road, Lahore.
manufacturer Tel: +92 (042) 5935261-68
Fax: +92 (042) 5935269
Web: www.pharmagen.com.pk
API Lot No. 00243/078/2020
Description of Pack The granular dry powder for capsule will be filled in a Size “0” Empty Hard
(Container closure Gelatin Shell and blistered in Alu/Alu of Pack size of 5’s.
system)
Stability Storage Real time: 30°C ± 2°C / 65% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. Tc-001 Tc-002 Tc-003
Batch Size 2500 2500 2500
No. of Batches 03
1. Reference of previous approval NA
of applications with stability
study data of the firm (if any)
2. Approval of API/ DML/GMP GMP certificate of M/s Pharmagen Limited issued on
certificate of API manufacturer 11.01.2019 based on inspection conducted on 08.01.2019
issued by concerned regulatory
3. Documents for the procurement Not Applicable
of API with approval from
DRAP (in case of import).
4. Data of stability batches will be Firm has submitted record of testing of all batches along with
supported by attested respective chromatograms, and summary data sheets.
documents like chromatograms,
Raw data sheets, COA, summary
data sheets etc.
5. Compliance Record of HPLC N/A
software 21CFR & audit trail
reports on product testing
6. Record of Digital data logger for Firm has submitted record of data logger for temperature and
temperature and humidity humidity monitoring of real time and accelerated stability
monitoring of stability chambers chambers.
Evaluation by PEC XI:
1.3.3 Specify the status of applicant as you have The firm have submitted revised form 5-F and
submitted that applicant “Is involved in specified the status of applicant as
none of the above (contract giver)” in “manufacturer”
module 1 of form 5F
1.3.1.- The address mentioned in submitted The firm have submitted revised form 5-F and
1.3.2 application is different from the address corrected the address as per DML
mentioned on DML, clarify?
1.5.6 In Form 5F you have mentioned The firm have revised the specifications to JP
innovator’s specifications for the product specifications
under section 1.5.6. while the monograph
of applied product is available in JP,
clarify?
2.3. Submit module 2 as per WHO QOS-PD Firm have submitted module 2 as per WHO
template without referring to any QOS-PD template
annexure of Module III.
3.2.S.4.1. As per the drug substance specifications The firm have submitted certificate of analysis
of the drug substance manufacturer i.e. of drug substance in which the drug substance
M/s Pharmagen Limited, the firm follows USP specifications
submitted that material complies BP, USP
and in-house specifications, justification
is required as how the drug substance
follow all the specifications
3.2.S.4.1. Copies of the Drug substance Drug substance specification and analytical
-3.2.S.4.2 specifications and analytical procedures procedure of Invictus Pharmaceuticals is
used for routine testing of the Drug provided. However, the analytical procedure
substance /Active Pharmaceutical does not contain procedure for identification
Ingredient by Drug Product manufacturer test (IR), pH, water content and specific
is required. rotation as recommended by USP and
contain only procedure for assay test.
3.2.S.4.3 Analytical Method Verification studies No reply submitted
including specificity, accuracy and
repeatability (method precision)
performed by the Drug Product
manufacturer drug substance(s) shall be
submitted.
3.2.S.4.4 The Batch No. mentioned in batch The firm submitted that batch No. of the drug
analysis by drug substance manufacturer substance cefixime used is 00243/078/2020
is 00243/078/2020 while the Batch No. and submitted COA of drug substance from
mentioned in batch analysis by drug drug substance manufacturer and drug product
product manufacturer 00243/264/2020, manufacturer. The firm further stated that
clarify? compacted cefixime is used in formulation of
Furthermore, COA submitted by the drug cefixime capsule as depicted in COA.
substance manufacturer and drug product However, COA of same batch number of API
manufacturer shows that micronized was submitted for micronized form of
cefixime was used in formulation of cefixime previously.
cefixime capsule, clarify?
3.2.P.1 • The composition of applied product is • The response is submitted in subsection
not as per innovator’s product, clarify 3.2.P.2.1.1
Applied product SUPRAX • Quantity of cefixime per unit dose and per
400mg batch have been explained and justified
capsules based upon the salt factor calculation and
Cefixime trihydrate Cefixime assay results. The justification is submitted.
trihydrate • Firm has used the theoretical factor for
Colloidal silicon Colloidal adjustment of water content while
dioxide silicon dioxide dispensing, instead of the actual results of
“water content test” reported in the drug
Crospovidone substance analysis.
• The firm submitted that we have used no
Microcrystalline Low overages in our formulation
cellulose 102 Substituted
Hydroxy
Propyl
Cellulose,
Magnesium Stearate, Magnesium
Stearate,
EHG Capsule shell Mannitol
‘0’ size
• Quantity of cefixime per unit dose shall

be justified with equivalency factor for
cefixime trihydrate.
• You have mentioned the use of
overages in your formulation to
compensate the potency of the product
during process loss, justify?
3.2.P.2.2.1 • Firm has performed pharmaceutical • Firm has again submitted pharmaceutical
equivalence against the product Cefspan equivalence of applied product against the
Capsule 400mg by M/s Barrett Hodgson product Cefspan Capsule 400mg by M/s
(Pvt) Ltd. Justification is required as Barrett Hodgson (Pvt) Ltd and the results of
comparator product fails the dissolution tests are within range.
test, then how product is pharmaceutical • No reply submitted
equivalent. (Limit NLT 80%, test result
69.82%.)
• Time point for CDP conducted is 30, 45,
60min. 15 min time point is not
considered being necessary as per WHO
guidelines.
3.2.P.2.1.1 Compatibility studies of the Drug The firm have submitted that applied
Substance(s) with excipients shall be formulation contains colloidal silicon dioxide,
provided as the qualitative composition of
magnesium stearate and microcrystalline
the formulation is not similar to innovator
cellulose as per reference formulation. The
/ reference product. stability studies of the product show that all the
test, physical appearance dissolution and assay
are within limits and there are no changes
developed during stability.
3.2.P.5.2 • Provide signed copy of analytical • The firm submitted that product complies JP
methods used for applied product specifications and analytical method and JP
• Justification for proposed analytical monograph is submitted. However, JP
procedure is required as the official monograph for applied product was not
monograph is available in JP
• The firm have proposed UV submitted and analytical was submitted
spectrophotometric method for assay of only for assay test and dissolution test.
drug product while the JP monograph • The firm submitted that there was a
recommends HPLC for assay analysis typographical mistake we have use the
submitted method and HPLC
chromatograms are attached. However, no
chromatograms were submitted
3.2.P.5.4 • In finished product specifications under The firm submitted that product complies JP
section 3.2.P.5.1 you have applied in specifications and stated that JP monograph is
house specifications while in Batch attached. However, no JP monograph was
Analyses you confirmed that product submitted
complies with USP specifications,
clarify?
3.2.P.6 • The working standard used during • The firm have submitted valid COA of
analysis states that it should be used working standard.
before July 2020 while 3rd month • The firm have submitted COA of primary
stability study performed in august 2020 reference standard and standardization of
and 6th month stability study performed working standard has been performed
at November 2020 using the same against the same primary reference standard.
working standard
• The firm have provided COA of
primary reference standard for drug
substance analysis and COA of working
standard. However, the standardization
of working standard is performed with
other Reference Standards, the COA of
which is not provided
3.2.P.8 • Submit Raw data sheets, COA & • Firm have submitted Raw data sheets,
analytical record for both assay & including actual details of sample solution
dissolution test containing detail of preparation & standard preparation, weight
sample preparation, standard of standard & calculation formula applied for
preparation for various performance assay test only. Raw data sheets and COA
parameters. for dissolution test containing detail of
• The date of initiation mentioned in sample preparation, standard preparation
stability study is 13.05.2020 while the for various performance parameters is not
date of manufacturing mentioned in submitted.
BMR is 18.05.2021. Clarify how • The firm submitted that there was a
stability study started before the typographic mistake. The initiation date is
manufacturing of batch. 18-05-2021 as mentioned in BMR
• Submission of analytical procedures & analytical record for testing of the Drug substance by Drug
Product manufacturer as per USP monograph.
(method precision) for drug substance performed by the Drug Product manufacturer
• Justification how same batch of drug substance (Batch No. 00243/078/2020) is used both as compacted
and micronized.
• Submission of CDP as per WHO guidelines against innovator product
• Revision of specification as approved by Registration Board in its 313th meeting and notified vide letter
No. F.14-I/2022-PEC dated 14th March 2022.
• Performance of batch analysis as per the monograph approved by Registration Board in its 313 th
meeting and notified vide letter No. F.14-I/2022-PEC dated 14th March 2022.
c. M/s Titlis Pharma (Private) Limited, Plot No. 528-A, Sundar Industrial Estate, Raiwand Road,
Lahore
The Central Licensing Board in its 285th meeting held on 17th & 18th March, 2022 has considered and
approved the grant of following sections of M/s Titlis Pharma (Private) Limited, Plot No. 528-A,
Sundar Industrial Estate, Raiwand Road, Lahore under Drug Manufacturing License No. 000779
(Formulation) vide approval letter No. F. 1-11/2009-Lic (Vol-I) dated 10th May, 2022.
S No. Section
1. Tablet Section II (General) New
2. Dry Powder Suspension Section. New
3. Dry Powder Sachet Section (General). New

379. Name, address of Applicant M/s Titlis Pharma (Private) Limited, Plot No. 528-A, Sundar
/ Marketing Authorization Industrial Estate, Raiwand Road, Lahore
Holder
Name, address of M/s Titlis Pharma (Private) Limited, Plot No. 528-A, Sundar
Manufacturing site. Industrial Estate, Raiwand Road, Lahore
☐ Importer
Status of application ☒ New Drug Product (NDP)
☐ Generic Drug Product (GDP)
Intended use of ☒ Domestic sale
Dy. No. and date of Dy. No. 17860 dated 20/06/2022
submission
(slip No#392967182013)
The proposed proprietary Azipos 200mg /5ml Dry Powder Suspension
name / brand name
Strength / concentration of Each 5ml contains:
drug of Active Azithromycin as dihydrate………..200mg
Pharmaceutical ingredient
(API) per unit
Pharmaceutical form of Dry Powder suspension (Azithromycin dihydrate 35% Taste masked
applied drug micropellets)
Pharmacotherapeutic Group Macrolides
of (API)
Reference to Finished USP Specifications
Proposed Pack size 15ml, 25ml
The status in reference Zithromax for oral suspension 200mg/5ml USFDA Approved
For generic drugs (me-too Azomax 200mg Oral Suspension by M/s Sandoz (Pakistan) Ltd
status) (Reg#022201)
GMP status of the Finished New section granted on 17th & 18th March, 2022 and letter issued on
product manufacturer 10th May, 2022
Name and address of API Vision Pharmaceuticals (Pvt.) Ltd. Plot No. 22-23, Industrial
manufacturer. Triangle, Kahuta Road, Islamabad Pakistan.
Tel : + 92-51-4493587-90
Fax : + 92-51-4493591
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD template.
Summary) Summarized information related to nomenclature, structure, general
properties, solubilities, physical form, manufacturers, impurities,
specifications, analytical procedures and its verification, batch
analysis and justification of specification, reference standard,
container closure system and stability studies of drug substance and
Module III (Drug The firm has submitted detail of nomenclature, structure, general
Substance) properties, solubilities, physical form, manufacturers, description of
manufacturing process and controls, tests for impurity,
specifications, analytical procedures, batch analysis and justification
of specification, reference standard, container closure system and
stability studies of drug substance
Batches: (AZI 112, AZI 111, AZI 115)
Module-III (Drug Product): The firm has submitted detail of manufacturers, description of
manufacturing process and controls, specifications, analytical
procedure and its verification studies, batch analysis and justification
Pharmaceutical equivalence Firm has performed Pharmaceutical Equivalence of their product
and comparative dissolution Azipos 200mg dry powder suspension against the Azomax dry
profile powder suspension 200mg/5ml by M/s Novartis Pharma and found
that both products are equivalent to each other.
Analytical method Firm has submitted method verification report for the applied
validation/verification of product
product
Manufacturer of API Vision Pharmaceuticals (Pvt.) Ltd. Plot No. 22-23, Industrial Triangle, Kahuta
Road, Islamabad Pakistan.
Tel : + 92-51-4493587-90
Fax : + 92-51-4493591
API Lot No. AZI 154
Description of Pack Amber colored glass bottle with Aluminium P.P caps printed with company logo
(Container closure
system)
Batch No. AZ-02 AZ-03 AZ-04
Batch Size 100 bottles 100 bottles 100 bottles
No. of Batches 03
1. Reference of previous The firm has referred to previous inspection for authenticity of
approval of applications with stability data of their product on the basis of which Registration
stability study data of the Board in its 289th meeting held on 14-16th May, 2019 decided to
firm (if any) approve registration of Delanso 30mg capsule and Delanso 60mg
capsule.
Inspection date: 02nd May, 2019
• The firm have quaternary gradient HPLC (Shimadzu; Model;
LC20AT); with time and date locked but it is not 21 CFR
compliant.
• Power backup by UPS and 200kv generator was available. Digital
data logger was not installed for continuous monitoring and control
of stability chambers. Storage conditions were being recorded
thrice daily manually.
2. Approval of API/ The firm have submitted cGMP certificate of Vision Pharmaceuticals
DML/GMP certificate of issued on 25-03-2022 based on inspection conducted on 11-02-2019
API manufacturer issued by and further extended till 09-05-2022.
concerned regulatory
authority of country of
origin.
3. Documents for the Not submitted
procurement of API with
approval from DRAP (in
case of import).
4. Data of stability batches will Firm has submitted stability study data of all three batches supported
be supported by attested by attested respective documents like chromatograms, Raw data
respective documents like sheets, COA, summary data sheets etc.
chromatograms, Raw data
sheets, COA, summary data
sheets etc.
5. Compliance Record of Not submitted
HPLC software 21CFR &
audit trail reports on product
testing
6. Record of Digital data logger Not submitted
for temperature and
humidity monitoring of
stability chambers (real time
and accelerated)
Firm has stated that they have R&D
section as date of manufacturing of
batches is November 2021 and grant of
additional section is March 2022
1.4.1 You have stated that the submitted The firm submitted that we have applied for
application is for registration of New generic drug product but typographic error it
Drug Product while the applied product was highlighted as new drug molecule
is Generic drug product, clarify?
1.6.5 Submit valid GMP certificate of drug The firm have submitted cGMP certificate of
substance manufacturer Vision Pharmaceuticals issued on 25-03-2022
and further extended till 09-05-2022. The
firm further submitted that vision pharma has
already submitted request for cGMP
inspection on 22-12-2021 along with requisite
fee.
3.2.S.4 • Analytical Method Verification Firm has submitted Analytical Method
studies including specificity, accuracy Verification studies including specificity,
and repeatability (method precision) accuracy and repeatability (method precision)
performed by the Drug Product performed by the Drug Product manufacturer
manufacturer for drug substance(s) for drug substance
shall be submitted.
3.2.P.5 • Time for dissolution test is not • The firm have revised specification and
specified in submitted specifications mentioned time for dissolution test in
of applied product specifications.
• The limits of pH test (8.5-11) in • The firm submitted that acceptance criteria
submitted specification is different of pH for multiple unit containers is 8.5-11
from that recommended by USP (9- as per USP.
11) • The firm submitted that We used
• The calculation formula used for convention equation for the calculation
assay calculation is different from that of Assay now we have updated our
recommended by USP clarify? testing method as per USP. It’s notable
• The injection volume mentioned in that the results are same by applying both
chromatographic conditions of assay calculations.
(applied 20ul and USP 50ul) and • The firm submitted that Sample and
dissolution test (applied 20ul and USP standard were analyzed under same
100ul) in submitted analytical chromatographic conditions (including the
procedure is different from that same injection volume) and found that the
recommended by USP. results were closely comparable.
• The calculation formula used for • USP <621> states that injection volume can
dissolution is different from that be adjusted as it is consistent with
recommended by USP clarify? acceptable precision (evidence submitted
herewith).
• It is remarkable that we have performed
analytical method validation in which we
did extensive testing taking different
concentrations under heading of Limit of
Detection, Limit of Quantification,
Linearity, Accuracy and Recovery. Results
of above said validation parameters
complied with the Relative Standard
Deviation limits.
• The firm submitted that We used
convention equation for the calculation
of Dissolution now we have updated our
testing method as per USP. It’s notable
that the result are same by applying both
calculations
3.2.P.8 • Tests for antimicrobial preservative • The firm have submitted Tests for
content and efficacy of preservative as antimicrobial preservative content and
recommended by ICH Q1 (R2) efficacy of preservative for only one batch.
guidelines and USP chapter <51> • Firm have submitted protocol for in use
should be performed for finished stability study of reconstitution suspension.
product However, firm have not submitted result of
• In use stability study of reconstitution in use stability study of reconstitution
suspension shall be submitted suspension
• Submit documents for the • The firm has submitted copy of invoice No#
procurement of API 60008 dated 29-10-2021 from vision
• Submit Record of Digital data logger pharmaceutical confirming the purchase of
for temperature and humidity 550gm azithromycin Diydrate T.M
monitoring of stability chambers Micropellets 35% batch No#AZI154 in
(accelerated conditions) name of Titlis Pharma
• Compliance record of HPLC software • We have performed the stability study of
21CFR & audit trail reports on Azipos 200mg/5ml Dry powder
product testing is required. suspension on our HPLC (QC-HPLC-
001) SHIMAZDZU Model No. LC-20
AT, which is not 21CFR Compliant.
• However, it is certified that date and
time of this HPLC (QC-HPLC-001) is
locked and data alteration/editing is
strictly restricted. Moreover this HPLC
(QC-HPLC-001) has access control and
only two authorized QC analysts have
authorization to access and operate this
HPLC (QC-HPLC-001).
• Record of Digital data logger for
temperature and humidity monitoring of
stability chambers (accelerated conditions)
is submitted
Decision: Approved.
• Registration letter will be issued after submission of Tests for antimicrobial preservative content
and efficacy of preservative as recommended by USP chapter <51> for finished product as well as
In use stability study of reconstitution suspension
380. Name, address of Applicant M/s Titlis Pharma (Private) Limited, Plot No. 528-A, Sundar Industrial
/ Marketing Authorization Estate, Raiwand Road, Lahore
Holder
Name, address of M/s Titlis Pharma (Private) Limited, Plot No. 528-A, Sundar Industrial
Manufacturing site. Estate, Raiwand Road, Lahore
☐ Importer
submission
(slip No#56031211)
The proposed proprietary Dapatit 5mg Tablet
name / brand name
Strength / concentration of Each film coated Tablet contains:
drug of Active Dapagliflozin as propanediol monohydrate …….5mg
(API) per unit
Pharmaceutical form of
Film coated tablet
applied drug
Pharmacotherapeutic
sodium-glucose co-transporter 2 (SGLT2) inhibitors
Group of (API)
Reference to Finished Manufacturer’s specification
The status in reference
FARXIGA (5mg, 10mg) film coated tablets USFDA Approved
For generic drugs (me-too
Dapa 5mg Tablet by M/s Hilton Pharma (Reg#089367)
status)
GMP status of the Finished New section granted on 17th & 18th March, 2022 and letter issued on 10th
product manufacturer May, 2022
Name and address of API M/s Fuxin Long Rui Pharmaceuticals CO., Ltd, Fluoride Industrial Park,
manufacturer. Fumeng county (Yi Ma Tu), Fuxin city, Liaoning Province- 123000,
China
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD template. Summarized
Summary) information related to nomenclature, structure, general properties,
solubilities, physical form, manufacturers, impurities, specifications,
analytical procedures and its verification, batch analysis and
justification of specification, reference standard, container closure
system and stability studies of drug substance and drug product is
submitted.
manufacturing process and controls, tests for impurity & related
substances, specifications, analytical procedures, batch analysis and
Batches: (160108, 160124, 160220)
Product): manufacturing process and controls, specifications, analytical procedure
and its validation studies, batch analysis and justification of
specification, reference standard, container closure system and stability
Pharmaceutical Pharmaceutical Equivalence have been established against the brand
equivalence and Dapa 5mg Tablet of M/s Hilton Pharma by performing quality tests
comparative dissolution (disintegration, weight variation, Assay, Dissolution, of dosage form).
profile CDP has been performed against the same brand that is Dapa 5mg
Tablet of M/s Hilton Pharma in Acid media (pH 1.2), acetate buffer (pH
4.5) & Phosphate Buffer (pH 6.8). The values for f2 are in the acceptable
range.
Analytical method Firm has submitted method validation studies including linearity, range,
validation/verification of accuracy, precision, specificity.
product
Manufacturer of API M/s Fuxin Long Rui Pharmaceuticals CO., Ltd, Fluoride Industrial Park, Fumeng
county(Yi Ma Tu), Fuxin city, Liaoning Province- 123000, China
API Lot No. L-DG-20210418-D01-DG06-01
Description of Pack Alu-Alu blister packed in unit carton (2×7’s)
(Container closure
system)
Batch No. DP-01 DP-02 DP-03
Batch Size 1,000 1,000 tablets 1,000 tablets
tablets
No. of Batches 03
1. Reference of previous The firm has referred to previous inspection for authenticity of stability
approval of applications data of their product on the basis of which Registration Board in its 289th
with stability study data of meeting held on 14-16th May, 2019 decided to approve registration of
the firm (if any) Delanso 30mg capsule and Delanso 60mg capsule.
LC20AT); with time and date locked but it is not 21 CFR compliant.
• Power backup by UPS and 200kv generator was available. Digital data
logger was not installed for continuous monitoring and control of
stability chambers. Storage conditions were being recorded thrice daily
manually.
2. Approval of API/ The firm have submitted written confirmation for active substance
DML/GMP certificate of exported to EU to M/s Fuxin Long Rui Pharmaceuticals CO., Ltd,
API manufacturer issued by Fluoride Industrial Park, Fumeng county (Yi Ma Tu), Fuxin city,
concerned regulatory Liaoning Province- 123000, China for Active substance Dapagliflozin
authority of country of Propanediol Monohydrate issued by Liaoning Drug Administration P.R
origin. China confirming that the manufacturing plant complies with
requirement of Chinese Good Manufacturing practices.
3. Documents for the The firm has submitted copy of commercial invoice attested by AD I&E
procurement of API with DRAP, Lahore dated 12-08-2021
approval from DRAP (in Invoice No. & Batch No. Quantity
case of import). date Imported
HN210630-J L-DG-20210418- 0.150 kg
dated 30-06- D01-DG06-01
2021 L-DG-20210418- 0.005 kg
D01-DG06-02
L-DG-20210418- 0.005 kg
D01-DG06-03
The invoice is issued from M/s Beijing Sino Hason Import & Export
Co., Ltd in the name of M/s Titlis Pharma (Pvt) Ltd and it does not
contain the name of manufacturer.
4. Data of stability batches Firm has submitted stability study data of all three batches supported by
will be supported by attested respective documents like chromatograms, Raw data sheets,
attested respective COA, summary data sheets etc.
documents like
sheets etc.
audit trail reports on
product testing
6. Record of Digital data Not submitted
logger for temperature and
stability chambers (real
Firm has stated that they have R&D
section as date of manufacturing of
batches is September 2021 and grant
of additional section is March 2022
3.2.S.4 • Analytical Method Verification Firm has submitted Analytical Method Verification
studies including specificity, studies including specificity, accuracy and
accuracy and repeatability (method repeatability (method precision) performed by the
precision) performed by the Drug Drug Product manufacturer for drug substance
Product manufacturer for drug
3.2.P.2 • You have not performed CDP and • The firm submitted that innovator product is not
pharmaceutical equivalence against registered in Pakistan therefore, Comparative
the innovator brand justify? dissolution profile of Dapatit 5mg Tablet was
• Justification is required as your performed against the reference product Dapa
formulation contains Ac-Di-Sol 5mg Tablet manufactured by Hilton Pharma (Pvt)
(croscarmellose) while innovator Limited which is available in the market.
product does not contain this • The firm further stated that the data of
excipient? comparative dissolution profile report for Dapatit
5mg tablet is remarkable and the product is highly
soluble and dissolves more than 80% within
15minutes in all three media (0.1 N HCl pH 1.2,
Acetate buffer pH 4.5 and Phosphate buffer pH
6.8) at all sampling points. The results show that
dissolution profile of test and reference products
are almost similar.
• Moreover, f2 values comply with the acceptance
criteria.
• The firm submitted that Formulation of Dapatit
5mg Tablet is as similar as the formulation of
innovator product except AC-Di-Sol
(croscarmellose) in its composition.
• The firm submitted that AC-Di-Sol is an inert
excipient, has compatibility with other excipients
and active pharmaceutical ingredient of Dapatit
5mg tablet. Its safety and compatibility have also
been established as no harsh / adverse effect has
been observed in our stability studies.
• As per literature review and study of Hand Book
for Pharmaceutical Excipients, it is notable that
the said excipient enhances disintegration,
dissolution and performance of the tablet which is
very clearly depicted from the comparative
dissolution profile studies of Dapatit 5mg Tablet.
3.2.P.5 • Justify the dissolution studies at 75 • The firm submitted that Initially we performed
rpm, 0.1N HCl (900ml) and 45 min dissolution by using following parameters: Media:
since the innovator product review 0.1N HCl (900ml), RPM: 75, Apparatus: II
documents specifies 60 rpm, acetate (Paddle), Time 45 min.
buffer pH 4.5 (1000ml) and 15 min • Stability batches were analyzed at 0, 3, & 6
for dissolution studies. months on in house testing but after reviewing the
FDA drug approval /literature review (FDA
reviewing document, we revised our testing
method as follows:
Media: Acetate buffer (pH 4.5) 1000ml

RPM: 60
Apparatus: II (Paddle)
Time 15 min.
We develop the following protocol for stability
studies
1. To manufacture 3 new batches (Batch
numbers: DP-07, DP-08 and DP-09) for
performance of accelerated and long run
stability testing as per innovator’s
specifications / dissolution parameters.
• We have analyzed these batches as per

innovator’s specifications / dissolution
parameters; and “0”, 3rd month testing has been
completed and results are complying with
innovator specification which are submitted
2. To perform one-month stress testing at 60℃

± 2℃ / 75% ± 5% RH on samples of ongoing
stability studies as per innovator’s
• We have drawn samples from our ongoing

stability studies and kept them on stress
conditions for one month (from 12th July -2022 to
12th August-2022); and analyzed that results are
complying with innovator specification. The
Reports and chromatogram are being submitted
3. To perform the ongoing/long run stability

studies of 9th month and other time intervals
as per innovator’s specifications / dissolution
parameters.
• We have performed 9th month stability studies as

per innovator’s specifications / dissolution
parameters and analyzed that results are
complying with innovator specification. Reports
and chromatogram are submitted
• Moreover, we have performed 9th month stability

study as per Titlis specifications and conclude
that results are comparable. Results on both
conditions are found similar and no impact
observed in the results due to change in
dissolution parameters. (Reports and
chromatogram are submitted
3.2.P.8 • Submit documents for the • The firm has submitted copy of form 6
procurement of API No#12099/2021-DRAP dated 12-08-2021 from
• Submit Record of Digital data Fuxin Long Rui Pharmaceutical Co., Ltd., for the
logger for temperature and humidity import of 0.16kg of Dapagliflozin propanediol
monitoring of stability chambers Monohydrate attested by AD (I&E) DRAP
(accelerated conditions) Lahore.
• Compliance record of HPLC • We have performed the stability study of
software 21CFR & audit trail Dapatit 5mg Tablet on our HPLC (QC-HPLC-
reports on product testing is 001) SHIMAZDZU Model No. LC-20 AT,
required. which is not 21CFR Compliant.
• However, it is certified that date and time of
this HPLC (QC-HPLC-001) is locked and
data alteration/editing is strictly restricted.
Moreover, this HPLC (QC-HPLC-001) has
access control and only two authorized QC
analysts have authorization to access and
operate this HPLC (QC-HPLC-001).
• Record of Digital data logger for temperature and
humidity monitoring of stability chambers
(accelerated conditions) is submitted
as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021
381. Name, address of Applicant M/s Titlis Pharma (Private) Limited, Plot No. 528-A, Sundar Industrial
/ Marketing Authorization Estate, Raiwand Road, Lahore
Holder
Name, address of M/s Titlis Pharma (Private) Limited, Plot No. 528-A, Sundar Industrial
Manufacturing site. Estate, Raiwand Road, Lahore
☐ Importer
submission
(slip No#7997424171)
The proposed proprietary Dapatit 10mg Tablet
name / brand name
Strength / concentration of Each film coated Tablet contains:
drug of Active Dapagliflozin as propanediol monohydrate ….10mg
(API) per unit
Film coated tablet
applied drug
Pharmacotherapeutic
sodium-glucose co-transporter 2 (SGLT2) inhibitors
Group of (API)
Reference to Finished Manufacturer’s specification
The status in reference
FARXIGA (5mg, 10mg) film coated tablets USFDA Approved
Dapa 10mg Tablet by M/s Hilton Pharma (Reg#089368)
status)
GMP status of the Finished New section granted on 17th & 18th March, 2022 and letter issued on 10th
product manufacturer May, 2022
Name and address of API M/s Fuxin Long Rui Pharmaceuticals CO., Ltd, Fluoride Industrial Park,
manufacturer. Fumeng county (Yi Ma Tu), Fuxin city, Liaoning Province- 123000,
China
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD template. Summarized
Summary) information related to nomenclature, structure, general properties,
solubilities, physical form, manufacturers, impurities, specifications,
system and stability studies of drug substance and drug product is
submitted.
manufacturing process and controls, tests for impurity & related
substances, specifications, analytical procedures, batch analysis and
Batches: (160108, 160124, 160220)
Product): manufacturing process and controls, specifications, analytical procedure
and its validation studies, batch analysis and justification of
specification, reference standard, container closure system and stability
Pharmaceutical Pharmaceutical Equivalence have been established against the brand
equivalence and Dapa 10mg Tablet of M/s Hilton Pharma by performing quality tests
comparative dissolution (disintegration, weight variation, Assay, Dissolution, of dosage form).
profile CDP has been performed against the same brand that is Dapa 10mg
Tablet of M/s Hilton Pharma in Acid media (pH 1.2), acetate buffer (pH
4.5) & Phosphate Buffer (pH 6.8). The values for f2 are in the acceptable
range.
Analytical method Firm has submitted method validation studies including linearity, range,
validation/verification of accuracy, precision, specificity.
product
Manufacturer of API M/s Fuxin Long Rui Pharmaceuticals CO., Ltd, Fluoride Industrial Park, Fumeng
county(Yi Ma Tu), Fuxin city, Liaoning Province- 123000, China
API Lot No. L-DG-20210418-D01-DG06-01
Description of Pack Alu-Alu blister packed in unit carton (2×7’s)
(Container closure
system)
Batch No. DP-04 DP-05 DP-06
Batch Size 1,000 tablets 1,000 tablets 1,000 tablets
No. of Batches 03
1. Reference of previous The firm has referred to previous inspection for authenticity of stability
approval of applications data of their product on the basis of which Registration Board in its 289th
with stability study data of meeting held on 14-16th May, 2019 decided to approve registration of
the firm (if any) Delanso 30mg capsule and Delanso 60mg capsule.
LC20AT); with time and date locked but it is not 21 CFR compliant.
• Power backup by UPS and 200kv generator was available. Digital data
logger was not installed for continuous monitoring and control of
stability chambers. Storage conditions were being recorded thrice daily
manually.
2. Approval of API/ The firm have submitted written confirmation for active substance
DML/GMP certificate of exported to EU to M/s Fuxin Long Rui Pharmaceuticals CO., Ltd,
API manufacturer issued by Fluoride Industrial Park, Fumeng county (Yi Ma Tu), Fuxin city,
concerned regulatory Liaoning Province- 123000, China for Active substance Dapagliflozin
authority of country of Propanediol Monohydrate issued by Liaoning Drug Administration P.R
origin. China confirming that the manufacturing plant complies with
requirement of Chinese Good Manufacturing practices.
3. Documents for the The firm has submitted copy of commercial invoice attested by AD I&E
procurement of API with DRAP, Lahore dated 12-08-2021
approval from DRAP (in Invoice No. Batch No. Quantity
case of import). & date Imported
HN210630-J L-DG-20210418- 0.150 kg
dated 30-06- D01-DG06-01
2021 L-DG-20210418- 0.005 kg
D01-DG06-02
L-DG-20210418- 0.005 kg
D01-DG06-03
The invoice is issued from M/s Beijing Sino Hason Import & Export
Co., Ltd in the name of M/s Titlis Pharma (Pvt) Ltd and it does not
contain the name of manufacturer.
4. Data of stability batches Firm has submitted stability study data of all three batches supported by
will be supported by attested respective documents like chromatograms, Raw data sheets,
attested respective COA, summary data sheets etc.
documents like
sheets etc.
audit trail reports on
product testing
6. Record of Digital data Not submitted
3.2.S.4 • Analytical Method Verification studies Firm has submitted Analytical Method
including specificity, accuracy and Verification studies including specificity,
repeatability (method precision) accuracy and repeatability (method precision)
manufacturer for drug substance(s) shall performed by the Drug Product manufacturer for
be submitted. drug substance
3.2.P.2 • You have not performed CDP and • The firm submitted that innovator product is not
pharmaceutical equivalence against the registered in Pakistan therefore, Comparative
innovator brand justify? dissolution profile of Dapatit 10mg Tablet was
• Justification is required as your performed against the reference product Dapa
formulation contains Ac-Di-Sol 10mg Tablet manufactured by Hilton Pharma
(croscarmellose) while innovator product (Pvt) Limited which is available in the market.
does not contain this excipient? • The firm further stated that the data of
comparative dissolution profile report for
Dapatit 10mg tablet is remarkable and the
product is highly soluble and dissolves more
than 80% within 15minutes in all three media
(0.1 N HCl pH 1.2, Acetate buffer pH 4.5 and
Phosphate buffer pH 6.8) at all sampling points.
The results show that dissolution profile of test
and reference products are almost similar.
• Moreover, f2 values comply with the
acceptance criteria.
• The firm submitted that Formulation of Dapatit
10mg Tablet is as similar as the formulation of
innovator product except AC-Di-Sol
(croscarmellose) in its composition.
• The firm submitted that AC-Di-Sol is an inert
excipient, has compatibility with other
excipients and active pharmaceutical ingredient
of Dapatit 10mg tablet. Its safety and
compatibility have also been established as no
harsh / adverse effect has been observed in our
stability studies.
• As per literature review and study of Hand
Book for Pharmaceutical Excipients, it is
notable that the said excipient enhances
disintegration, dissolution and performance of
the tablet which is very clearly depicted from
the comparative dissolution profile studies of
Dapatit 10mg Tablet.
3.2.P.5 • Justify the dissolution limits NLT 75% in • The firm have revised dissolution specifications
45 minutes in specifications since as Q….NLT 75% in 15 minutes.
innovator product review documents • The firm submitted that Initially we performed
specifies 15 min for dissolution studies. dissolution by using following parameters:
• Justify the dissolution studies at 75 rpm, Media: 0.1N HCl (900ml), RPM: 75,
0.1N HCl (900ml) and 45 min since the Apparatus: II (Paddle), Time 45 min.
innovator product review documents • Stability batches were analyzed at 0, 3, & 6
specifies 60 rpm, acetate buffer pH 4.5 months on in house testing but after reviewing
(1000ml) and 15 min for dissolution the FDA drug approval /literature review (FDA
studies. reviewing document, we revised our testing
method as follows:
Media: Acetate buffer (pH 4.5) 1000ml

RPM: 60
Apparatus: II (Paddle)
Time 15 min.
We develop the following protocol for stability

studies
1. To manufacture 3 new batches (Batch
numbers: DP-010, DP-11 and DP-12) for
performance of accelerated and long run
stability testing as per innovator’s
• We have analyzed these batches as per

innovator’s specifications / dissolution
parameters; and “0”, 3rd month testing has been
completed and results are complying with
innovator specification which are submitted
2. To perform one-month stress testing at 60℃

± 2℃ / 75% ± 5% RH on samples of
ongoing stability studies as per innovator’s
• We have drawn samples from our ongoing

stability studies and kept them on stress
conditions for one month (from 13th July -2022
to 13th August-2022); and analyzed that results
are complying with innovator specification.
The Reports and chromatogram are being
submitted
3. To perform the ongoing/long run stability

studies of 9th month and other time intervals
as per innovator’s specifications /
dissolution parameters.
• We have performed 9th month stability studies

as per innovator’s specifications / dissolution
parameters and analyzed that results are
complying with innovator specification.
Reports and chromatogram are submitted
• Moreover, we have performed 9th month
stability study as per Titlis specifications and
conclude that results are comparable. Results
on both conditions are found similar and no
impact observed in the results due to change in
dissolution parameters. (Reports and
chromatogram are submitted
3.2.P.8 • Justify the manufacturing of trial batches • Firm has stated that they have R&D section and
for stability study in September 2021 as development of trial batches of Dapatit 10mg
approval of new section is granted on 17th was performed in our development (R&D)
& 18th March, 2022 and new section letter section.
issuance date is 10-05-2022. • The firm has submitted copy of form 6
• Submit documents for the procurement of No#12099/2021-DRAP dated 12-08-2021 from
API Fuxin Long Rui Pharmaceutical Co., Ltd., for
• Submit Record of Digital data logger for the import of 0.16kg of Dapagliflozin
temperature and humidity monitoring of propanediol Monohydrate attested by AD (I&E)
stability chambers (accelerated DRAP Lahore.
conditions) • The firm submitted that We have performed
• Compliance record of HPLC software the stability study of Dapatit 10mg Tablet on
21CFR & audit trail reports on product our HPLC (QC-HPLC-001) SHIMAZDZU
testing is required. Model No. LC-20 AT, which is not 21CFR
Compliant.
• However, it is certified that date and time
of this HPLC (QC-HPLC-001) is locked
and data alteration/editing is strictly
restricted. Moreover, this HPLC (QC-
HPLC-001) has access control and only two
authorized QC analysts have authorization to
access and operate this HPLC (QC-HPLC-
001).
• Record of Digital data logger for temperature
(accelerated conditions) is submitted
as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021
Case No. 3: Registration applications of New DML of human drugs on Form 5F
M/s Carer Pharmaceuticals Industries, Plot # 27, Main Road, Rawat Industrial Estate, Rawat.
The Central Licensing Board in its 278th meeting held on 10th-11th December, 2020 has considered and approved
the grant of Drug Manufacturing License by way of formulation with following five sections to M/s, Carer
Pharmaceuticals Industries Plot # 27, Main Road, Rawat Industrial Estate, Rawat under Drug Manufacturing
License No. 000925 by way of Formulation vide approval letter No. F. 1-32/2016-Lic dated 07th June 2021. The
Drug Manufacturing License No. 000925 by way of formulation is hereby issued w.e.f. 18-03-2021.
S No. Section
1. Capsule Section (General) Section
2. Dry Powder Suspension (General) Section
3. Sachet (General) Section
4. Ampoule (General) Section
5. Tablet (General) Section
382. Name, address of Applicant / M/s, Carer Pharmaceuticals Industries, Plot # 27, Main Road,
Marketing Authorization Rawat Industrial Estate, Rawat
Holder
Name, address of M/s, Carer Pharmaceuticals Industries. Plot # 27, Main Road,
Manufacturing site. Rawat Industrial Estate, Rawat
☐ Importer
submission
The proposed proprietary Capliva 200mg /5ml Dry Powder Suspension
name / brand name
Strength / concentration of Each 5ml of reconstituted suspension contains:
drug of Active Azithromycin as dihydrate………..200mg
(API) per unit
Pharmaceutical form of Dry Powder for oral suspension
applied drug
Pharmacotherapeutic Group Macrolides
of (API)
Reference to Finished USP Specifications
Proposed Pack size 1’s (15ml, 30ml)
The status in reference Zithromax powder for oral suspension 200mg/5ml by M/s
regulatory authorities Pfizer Ltd MHRA Approved
For generic drugs (me-too Zetro oral suspension 200mg by M/s Getz Pharma
status) (Reg#047145)
GMP status of the Finished New license granted on 18/03/2021
product manufacturer
Name and address of API M/s Hebei Guolong Pharmaceutical Co, Ltd., No 9 Xingye
manufacturer. street, Shiiazhuang Economic and Technological Development
Zone, Hebei Province, China.
Tel: 0086-575-82736468
Fax: 0086-575-82735575
Summary) Summarized information related to nomenclature, structure,
impurities, specifications, analytical procedures and its
verification, batch analysis and justification of specification,
studies of drug substance and drug product is submitted.
Module III (Drug Substance) The firm submitted detail of nomenclature, structure, general
properties, solubilities, physical form, manufacturers, tests for
impurities specifications, analytical procedures and its
Batches: (U129-141124-1, U129-141125-1, U129-141126-1)
manufacturing process and controls, impurities, specifications,
product.
Pharmaceutical equivalence Firm has performed Pharmaceutical Equivalence against the
and comparative dissolution Azomax suspension 200mg/5ml by M/s Novartis Pharma.
profile
validation/verification of
product
Manufacturer of API M/s Hebei Guolong Pharmaceutical Co, Ltd., No 9 Xingye street,
Shiiazhuang Economic and Technological Development Zone, Hebei
Province, China
Tel: 0086-575-82736468
Fax: 0086-575-82735575
API Lot No. 210507019
Description of Pack White to off-white granular powder filled in amber color glass bottle, with
(Container closure system) white Aluminium cap, is packed in a printed unit carton.
Real Time: 0, 3, 6, 9, 12, 18, 24, 36 (Months)
No. of Batches 03
1. Reference of previous N/A
approval of applications with
stability study data of the firm
(if any)
2. Approval of API/ DML/GMP Not submitted
certificate of API
manufacturer issued by
approval from DRAP (in case
of import).
4. Data of stability batches will Attached
be supported by attested
respective documents like
sheets etc.
5. Compliance Record of HPLC Not submitted
monitoring of stability
chambers (real time and
accelerated)
1.5.15 – Commitments not submitted Firm has submitted commitments as
1.5.20 per form 5-F
1.6.5 Submit valid GMP certificate of the GMP certificate is not submitted
Drug Substance manufacturer issued by
relevant regulatory authority of country
of origin.
2.3.R.1 Provide copy of Batch Manufacturing Firm has submitted copy of Batch
Record (BMR) for all the batches of Manufacturing Record (BMR) for all
drug product for which stability studies the batches of drug product for which
data is provided in Module 3 section stability studies data is provided in
3.2.P.8.3> Module 3 section 3.2.P.8.3>
3.2.S.4.1. - • Copies of the Drug substance • Copies of the Drug substance
3.2.S.4.2 specifications and analytical specifications and analytical
procedures used for routine testing of procedures used for routine testing
the Drug substance /Active of the Drug substance /Active
Pharmaceutical Ingredient by Drug Pharmaceutical Ingredient by Drug
substance manufacturer is required. substance manufacturer is not
• Submit signed analytical procedures submitted
used for routine testing of the Drug • Firm have submitted analytical
substance /Active Pharmaceutical procedures used for routine testing of
Ingredient by Drug product the Drug substance /Active
manufacturer is required. Pharmaceutical Ingredient by Drug
• Justify the declared potency of drug product manufacturer.
substance on COA as it is given on • The firm submitted that potency of
dried basis while in pharmacopeia it is API has been calculated on anhydrous
given on anhydrous basis? basis, whereas the term “on dried
basis” was inadvertently mentioned
considering it a broader term
3.2.S.4.3 Analytical Method Verification studies No reply submitted
of drug substance(s) for specificity
study by the Drug Product
manufacturer shall be submitted.
3.2.S.4.4 Batch number of submitted batch The firm have again submitted same
analysis by drug product manufacturer COA of drug substance provided by
(201507019) is different from the batch drug substance manufacturer and drug
number submitted by drug substance product manufacturer having different
manufacturer given in batch analysis batch number and no clarification is
(210507019) provided.
3.2.S.5 COA of primary standard including Firm has submitted COA of primary
source and lot number is submitted. reference standard and stated that the
Clarify whether the same reference same is used by drug product
standard is used by the drug substance manufacturer.
manufacturer or drug product
manufacturer?
3.2.P.2.1.1 Compatibility studies of the Drug • The excipients used in the applied
Substance(s) with excipients shall be formulation are complying with
provided as the qualitative composition current pharmacopeial monograph.
of the formulation is not similar to These excipients are
innovator / reference product. pharmaceutically inert substance and
we have used these excipients below
Applied product ZITHROMAX the IIG limit of FDA orange book as
for oral well as we have done extensive
suspension analysis of the product after
USFDA formulation and found satisfactory
Azithromycin as Azithromycin result of the assay.
dihydrate as dihydrate • Also, we have done stability study
Sucrose (Extra Sucrose during development stage and found
Fine) satisfactory result of the product. So,
Mannitol Hydroxypropyl we can conclude that these excipients
cellulose are not incompatible with API.
Xanthan gum Xanthan gum
Trisodium Sodium
phosphate phosphate,
anhydrous tribasic,
anhydrous
Colloidal FD&C Red
anhydrous silica #40; spray
(Aerosil 200) dried artificial
cherry, creme
de vanilla, and
banana flavors
Sodium benzoate
Tutti Frutti
powder (PDF
245)
3.2.P.2.2.1 • In Description of formulation The firm have submitted corrected
development, you have submitted composition table and manufacturing
manufacturing outline. In outline.
manufacturing outline, you have
mentioned Sodium hydroxy methyl
benzoate and sodium propyl hydroxy
benzoate, Saccharine sodium, citric
acid monohydrate, glycerin, maltitol
sodium, strawberry flavor which are
not part of applied formulation,
clarify?
• Furthermore, you have submitted
manufacturing outline for liquid
suspension while the applied product
is dry suspension, clarify?
3.2.P.3.2 In batch formula the amount of The firm have submitted revised batch
azithromycin is mentioned without formula and stated that dihydrate will
considering the hydrated form clarify? be adjusted by actual potency (on as is
basis) given by QC.
3.2.P.5.1 The USP monograph for azithromycin The firm submitted that they followed
suspension has given the test for USP-37 monograph of azithromycin
dissolution while you have not oral suspension which did not include
mentioned the dissolution test in dissolution test. The firm further
specification, clarify? submitted that now they have included
dissolution test in specifications and
had also performed it on recent time
point of long-term stability studies. The
firm have submitted revised
specifications.
3.2.P.5.2 Submit detailed signed analytical Firm have submitted analytical
procedures used for testing the drug procedures used for testing of drug
product shall be provided. product
3.2.P.5.3 Analytical Method Verification studies Firm have submitted Analytical
including specificity, accuracy and Method Verification studies. However,
repeatability (method precision) results of repeatability (method
performed by the Drug Product precision) is not submitted
3.2.P.5.4 You have not performed dissolution Reply submitted as above in section
test as per USP monograph of the 3.2.P.5.1
applied product, clarify?
3.2.P.8 • The results of assay of Batch #01, • The firm submitted that there had
Batch #02, Batch #03 mentioned in been an erroneous drafting error in
COA of accelerated and real time stability sheets, corrected stability
stability study is different from the summary sheets are submitted again.
assay result given in raw data sheet Further it is submitted that
• Two different method used for dissolution test results at initial time
sample preparation mentioned in point, 3rd month time point and 6th
submitted raw data sheet of Batch month time point of real time and
#T01, clarify? accelerated stability study were given
• The results of stability study data of in stability summary sheets which
all the three batches at real time and were neither included in
accelerated conditions given in raw specifications and not performed
data sheet and chromatogram reflects previously.
the same value for all the three • No clarification is submitted
batches, clarify? • No clarification is submitted. The
submitted raw data sheets reflect that
same standard peak area value has
been applied for the calculation of
Assay results at all time points of
stability studies for all three batches.
• Compliance Record of HPLC • No document/details are submitted
software 21CFR & audit trail reports • No document/details are submitted
on product testing is not submitted • No document/details are submitted
• Submit documents for the
procurement of API with approval
• Submit record of Digital data logger
monitoring of stability chambers (real
• Submission of valid GMP certificate / DML of the Drug Substance manufacturer issued by relevant
• Submission of Copies of the Drug substance specifications and analytical procedures used for testing
of the Drug substance by Drug substance manufacturer.
• Submission of results of specificity test in Analytical Method Verification studies of drug substance
performed by the Drug Product manufacturer.
• Clarification since Batch number of drug substance mentioned in batch analysis by drug product
manufacturer (201507019) is different from the batch number mentioned by drug substance
manufacturer given in batch analysis (210507019)
• Submission of results of repeatability (method precision) test in method verification studies for drug
product
• Clarification since results of dissolution test were included at initial time point, 3rd month time point
and 6th month time point of real time and accelerated stability study in stability summary sheets
which were neither included in specifications and not performed previously.
• Clarification for considering same standard peak area value for the calculation of Assay results at
all-time points of stability studies for all three batches.
• Submission of documents for the procurement of API with approval from DRAP (in case of import).
• Submit record of Digital data logger for temperature and humidity monitoring of stability chambers
(real time and accelerated).
383. Name, address of Applicant / M/s, Carer Pharmaceuticals Industries, Plot # 27, Main Road,
Marketing Authorization Rawat Industrial Estate, Rawat
Holder
Name, address of M/s, Carer Pharmaceuticals Industries, Plot # 27, Main Road,
Manufacturing site. Rawat Industrial Estate, Rawat
☐ Importer
Dy. No. and date of
Dy. No. 30255; dated 05/11/2021
submission
The proposed proprietary Emeton Injection 4mg/2ml
name / brand name
Strength / concentration of Each ampoule contains:
drug of Active Ondansetron (as ondansetron HCl Dihydrate)…………..4mg
(API) per unit
Injection
applied drug
Pharmacotherapeutic Group Serotonin (5HT3) Antagonist
of (API)
Reference to Finished USP
The status in reference Zofran 2mg base/ml injection USFDA Approved
regulatory authorities Discontinued **Federal Register determination that
product was not discontinued or withdrawn for safety or
efficacy reasons**
Zofran Injection 4mg/2ml by M/s GSK (Reg#052259)
status)
Name and address of API M/s Anugraha Chemicals, No D-47 to D-50, C-62 and C-63,
manufacturer. KSS DC, Industrial Estate, Doddaballapur, Banglore,
Karnataka, India
Module III (Drug Substance) The firm as submitted detail of nomenclature, structure, general
properties, solubilities, physical form, manufacturers,
description of manufacturing process and controls, tests for
impurities & related substances, specifications, analytical
procedures and its verification, batch analysis and justification
of specification, reference standard and stability studies of drug
substance
Batches: (ON130001, ON130002, ON130003)
analytical procedure and its verification studies, batch analysis
and justification of specification, reference standard, container
closure system and stability studies of drug product.
Pharmaceutical equivalence Firm has performed Pharmaceutical Equivalence studies
and comparative dissolution against the Zofran injection by M/s GSK
profile
Analytical method Method verification studies have submitted.
product
Manufacturer of API M/s Anugraha Chemicals No D-47 to D-50, C-62 and C-63, KSS DC,
Industrial Estate, Doddaballapur, Banglore, Karnataka, India
API Lot No. AOND-18006
Description of Pack Colorless liquid filled in 2ml / 5cc clear glass vial labeled and packed in
(Container closure system) standard unit carton (1 x 1’c) and leaflet.
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. T1/21 T2/21 T3/21
Batch Size 2000 2000 ampoules 2000 ampoules
ampoules
No. of Batches 03
1. Reference of previous Not applicable
stability study data of the firm
(if any)
2. Approval of API/ DML/GMP Not submitted
certificate of API
manufacturer issued by
approval from DRAP (in case
of import).
4. Data of stability batches will Submitted
be supported by attested
respective documents like
sheets etc.
5. Compliance Record of HPLC Not applicable. Our HPLC systems are not 21 CFR compliant
6. Record of Digital data logger The report of temperature and humidity log is attached (only
for temperature and humidity real time)
monitoring of stability
chambers (real time and
accelerated)
1.5.15 – Commitments not submitted Firm has submitted commitments as per
1.5.20 form 5-F
1.6.5 Submit valid GMP certificate of the GMP certificate is not submitted
Drug Substance manufacturer issued
by relevant regulatory authority of
country of origin.
2.3.R.1 Provide copy of Batch Manufacturing Firm has submitted Batch Manufacturing
Record (BMR) for all the batches of Record (BMR) for all the batches of drug
drug product for which stability product for which stability studies data is
studies data is provided in Module 3 provided in Module 3 section 3.2.P.8.3>
section 3.2.P.8.3>
3.2.S.4.1. - Submit signed analytical procedures Firm have submitted analytical procedures
3.2.S.4.2 used for routine testing of the Drug used for routine testing of the Drug
substance /Active Pharmaceutical substance /Active Pharmaceutical
Ingredient by both Drug substance & Ingredient by Drug Product manufacturer.
Drug Product manufacturer. However, analytical procedures used for
routine testing of the Drug substance /
Active Pharmaceutical Ingredient by
Drug substance manufacturer is not
submitted.
3.2.S.4.3 Clarify whether the Analytical No clarification is submitted
Method Verification studies of drug
substance have been performed by
drugs substance manufacturer or drug
3.2.S.6 Description of the container closure No details submitted
system(s) for the shipment and
storage of the API including
materials of construction of each
primary packaging component and
other information on the container
closure system(s) (e.g. suitability
studies) may be submitted.
3.2.S.7 The submitted stability study is No clarification is submitted
performed by M/s CTX Lifesciences
while the manufacturer of drug
substance is Anugraha Chemicals,
clarification is required?
3.2.P.1 You have not performed the tests of No justification is submitted
identification, bacterial endotoxin
test and particulate matter in
pharmaceutical equivalence, justify?
3.2.p.3.3. Submit the flowchart of No reply submitted
manufacturing outline since the
submitted manufacturing outline is
not clearly visible.
3.2.P.5.1 • You have not mentioned the tests of No justification is submitted
identification, bacterial endotoxin
test and particulate matter, justify?
• Revise your specifications in line
with USP specifications along with
submission of applicable fee
3.2.P.5.3 Analytical Method Verification No clarification is submitted
studies of drug product is same as that
of drug substance. Clarification is
required
3.2.P.7 Specify the container closure system No details are submitted
of your product including details
whether ampoule or vial, filled
volume and type of glass, since both
ampoule and vials and different
volumes have been mentioned in
different sections
3.2.P.8.3 • The stability batches have been • No justification is submitted
manufactured on 01-2021 while the • COA of 3rd month stability study data not
stability chromatograms are submitted
acquired in 2019, justify? • No clarification is submitted
• COA of 3rd month stability study • Firm has submitted raw data sheet at 6th
data not submitted? month time point. However, COA at 6th
• The ph values given in stability data month time point is still not submitted
sheet and raw data sheet is different
at all time point?
• COA and raw data sheet at 6th
month time point is not submitted
• Audit trail reports on product No document/record is submitted
testing is not submitted
• Submit documents for the
procurement of API with approval
• Submit record of Digital data
humidity monitoring of stability
chambers (accelerated)
• In submitted reply the BMR shows
that batch size is 1500 ampoule,
while raw data sheet shows 2000
ampoule
• Submission of valid GMP certificate / DML of the Drug Substance manufacturer issued by relevant
• Submission of Copies of the Drug substance specifications and analytical procedures used for routine
testing of the Drug substance /Active Pharmaceutical Ingredient by Drug substance manufacturer
• Clarification is required since the submitted stability study is performed by M/s CTX Lifesciences
while the manufacturer of drug substance is Anugraha Chemicals.
• Justification for not including the tests of identification, bacterial endotoxin test and particulate
matter in product specifications.
• Clarification for submission of same Analytical Method Verification studies for drug product as that
of drug substance.
• Specify the container closure system of your product including details whether ampoule or vial, filled
volume and type of glass, since both ampoule and vials and different volumes have been mentioned
in different sections
• Justification since the stability batches have been manufactured on 01-2021 while the stability
chromatograms are acquired in 2019.
• Clarification since the pH values given in stability data sheet and raw data sheet is different at all-
time point.
• Submission of COA and raw data sheet at 6th month time point.
• Submission of documents for the procurement of API with approval from DRAP (in case of import).
• Submit record of Digital data logger for temperature and humidity monitoring of stability chambers
384. Name, address of Applicant M/s Carer Pharmaceuticals Industries., plot No. 27 Main
/ Marketing Authorization Road, Rawat Industrial Estate, Rawat
Holder
Name, address of M/s Carer Pharmaceuticals Industries., plot No. 27 Main
Manufacturing site. Road, Rawat Industrial Estate, Rawat
☐ Importer
Dy. No. and date of Dy. No. 13411; dated 02/06/2022
submission
The proposed proprietary Carazole 30mg Capsule
name / brand name
Strength / concentration of Each Capsule contains:
drug of Active Lansoprazole as enteric coated pellets
Pharmaceutical ingredient (8.5%)……………..30mg
(API) per unit
Pharmaceutical form of Capsule
applied drug
Pharmacotherapeutic Group PPI
of (API)
Reference to Finished USP
The status in reference PREVACID (15mg, 30mg) delayed-release capsules,
regulatory authorities USFDA approved
For generic drugs (me-too Caralans 30mg capsule by M/s Caraway Pharmaceuticals
status) (Reg#50809)
Name and address of API Vision Pharmaceuticals (Pvt.) Ltd. Plot No. 22-23, Industrial
manufacturer. Triangle, Kahuta Road, Islamabad Pakistan.
Tel : + 92-51-4493587-90
Fax : + 92-51-4493591
controls, specifications, analytical procedures and its
Module III (Drug The firm as submitted detail of nomenclature, structure,
Substance) general properties, solubilities, physical form,
controls, tests for related substances, specifications,
closure system and stability studies of drug substance
Batches: (LPS0129, LPS0134, LPS0141)
specifications, analytical procedure (including dissolution
testing at acidic and buffer medium) and its verification
Pharmaceutical equivalence Pharmaceutical Equivalence have been established against
and comparative dissolution the Caralans 30mg capsule by Caraway Pharmaceuticals by
profile performing quality tests (Identification, Assay, Dissolution).
Caralans 30mg capsule by Caraway Pharmaceuticals in Acid
media (pH 1.0-1.2) & Phosphate Buffer (pH 6.8).
product
Manufacturer of API Vision Pharmaceuticals (Pvt.) Ltd. Plot No. 22-23, Industrial Triangle,
Kahuta Road, Islamabad Pakistan.
Tel : + 92-51-4493587-90
Fax : + 92-51-4493591
API Lot No. LPS0382
Description of Pack Alu-Alu blister packed in unit carton
Batch No. T-001 T-002 T-003
Batch Size 2500 2500 capsules 2500 capsules
capsules
No. of Batches 03
1. Reference of previous N/A
stability study data of the
firm (if any)
2. Approval of API/ The firm have submitted cGMP certificate of M/s Vision
DML/GMP certificate of Pharmaceuticals issued on 25-03-2022 based on inspection
API manufacturer issued by conducted on 11-02-2019 and further extended till 09-05-
concerned regulatory 2022.
authority of country of
origin.
3. Documents for the No document submitted
case of import).
4. Data of stability batches will Firm have submitted data of stability batches supported by
be supported by attested attested respective documents like chromatograms, Raw data
respective documents like sheets, summary data sheets etc.
sheets etc.
audit trail reports on product
testing
for temperature and
and accelerated)
1.6.5 • Submit valid GMP certificate of the • The firm have submitted cGMP
Drug Substance manufacturer certificate of Vision Pharmaceuticals
issued on 25-03-2022 based on inspection
conducted on 11-02-2019 and further
extended till 09-05-2022.
2.3.R.1 • Provide copy of Batch Manufacturing • Firm have submitted Batch
Record (BMR) for all the batches of Manufacturing Record (BMR) for all the
drug product for which stability batches of drug product for which
studies data is provided in Module 3 stability studies data is provided in
section 3.2.P.8.3> Module 3
3.2.S.4. • Copies of the Drug substance • Firm have submitted Copies of
specifications and analytical analytical procedures used for routine
procedures used for routine testing of testing of the Drug substance / Active
the Drug substance / Active Pharmaceutical Ingredient by Drug
Pharmaceutical Ingredient by Drug Product manufacturer. However, Copies
Product manufacturer is required.” of the Drug substance specifications by
• Drug substance manufacturer have Drug Product manufacturer is not
claimed USP specifications while submitted.
monograph for lansoprazole enteric • The firm submitted that API
coated pellets are not available in manufacturer claimed and followed USP
USP., clarification is required specifications because Lansoprazole
• Analytical Method Verification pellets are delayed release and ready to
studies including specificity, accuracy fill in capsule.
and repeatability (method precision) • Firm have submitted Analytical Method
performed by the Drug Product Verification studies including specificity,
manufacturer for drug substance(s) accuracy and repeatability (method
shall be submitted. precision) performed by the Drug Product
manufacturer for drug substance
3.2.S.4.4 Provide results of analysis of relevant • Firm have submitted results of analysis of
batch(es) of Drug Substance performed relevant batch(es) of Drug Substance
by Drug Product manufacturer used performed by Drug Product manufacturer
during product development and used during product development and
stability studies, along with Certificate stability studies, along with Certificate of
of Analysis (CoA) of the same batch Analysis (CoA) of the same batch from
from Drug Substance / /Active Drug Substance / /Active Pharmaceutical
Pharmaceutical Ingredient Ingredient manufacture.
manufacture.
3.2.P.2 • Justify why the pharmaceutical • No justification submitted
equivalence study does not include • Fir submitted that study conducted we
complete testing of the drug product me-too product due to unavailability of
and the comparator product including innovator product
the tests recommended by USP • The firm has submitted CDP considering
monograph (uniformity of dosage multiple time points for both reference
units, loss on drying). (comparator) and test product. CDP has
• Justification is required since been performed against the same brand
pharmaceutical equivalence and CDP that is Caralans 30mg capsule by
studies have not been conducted Caraway Pharmaceuticals in Acid media
against the innovator product. (pH 1.0-1.2), acetate buffer (pH 5.5) &
• A minimum of three time-points Phosphate Buffer (pH 6.8).
should be included for CDP, the time-
points for both reference (comparator)
and test product being the same as per
WHO guidelines while you have
performed at only one time points i.e.
15 min, justification is required
3.2.P.5 • Justification is required since the • The firm has submitted revised
submitted specification does not specifications and included tests for
include tests for uniformity of dosage uniformity of dosage units and loss on
units and loss on drying as drying as recommended by USP.
recommended by USP. • The firm have submitted revised method
• Justification shall be submitted as the of sample and standard solution
concentration and method of sample preparation in assay test having same
and standard solution preparation in concentration of both standard and
assay test is different than that sample solution.
recommended by USP. • The firm submitted that writing of 20µl
• Justification is required since drug injection volume instead of 10µl injection
product manufacturer have proposed volume in chromatographic conditions in
20µl injection volume in assay was a human error/typing mistake
chromatographic conditions in assay • Firm have submitted results of Analytical
test instead of 10µl as recommended method verification studies of drug
by USP. product performed by drug product
• Results of Analytical method manufacturer including specificity,
verification studies of drug product repeatability (method precision) and
performed by drug product accuracy.
manufacturer including specificity,
repeatability (method precision) and
accuracy shall be submitted
3.2.P.8 • Justification is required as 6th month • The firm submitted that 6th month
stability study is performed at 04-05- stability study was conducted as realized
2022 while trial batches are the provided study was 5th month. The
manufactured at 12-2021 before due firm has submitted stability study at 6th
time (01 month before) of all batches month time point
as depicted from raw data sheet and • COA of the stability batches throughout
chromatograms at real time and the stability study is not submitted
accelerated conditions • The firm submitted that content
• COA of the stability batches uniformity was conducted at the time of
throughout the stability study is not batch release but not mentioned in COA
submitted of the product. The firm requested to
• Test of uniformity of dosage unit has consider the COA of the product
not been performed at the time of submitted now. However, the firm have
batch release, justify? not submitted COA of the product
• Submit documents for the • Firm have not submitted documents for
procurement of API the procurement of API
• Submit Record of Digital data logger • Record of Digital data logger for
for temperature and humidity temperature and humidity monitoring of
monitoring of stability chambers stability chambers (accelerated
(accelerated conditions) conditions) is not submitted
• Compliance record of HPLC software • Compliance record of HPLC software
21CFR & audit trail reports on 21CFR & audit trail reports on product
product testing is required. testing is not submitted.
• Submission of Copies of the Drug substance specifications by Drug product manufacturer
• Submission of justification as the pharmaceutical equivalence study does not include complete testing
of the drug product and the comparator product including the tests recommended by USP
monograph i.e., uniformity of dosage units, loss on drying.
• Submission of COA of the stability batches throughout the stability study
• Submission of record of Digital data logger for temperature and humidity monitoring of stability
385. Name, address of Applicant / M/s Carer Pharmaceuticals Industries., plot No. 27 Main
Marketing Authorization Holder Road, Rawat Industrial Estate, Rawat
Name, address of Manufacturing M/s Carer Pharmaceuticals Industries., plot No. 27 Main
site. Road, Rawat Industrial Estate, Rawat
☐ Importer
Intended use of pharmaceutical ☒ Domestic sale
product ☐ Export sale
Dy. No. and date of submission Dy. No. 19659; dated 05/07/2022
The proposed proprietary name / Caraconazole 100mg Capsule
brand name
Strength / concentration of drug Each Capsule contains:
of Active Pharmaceutical Itraconazole as enteric coated pellets…………100mg
ingredient (API) per unit
Pharmaceutical form of applied Capsule
drug
Pharmacotherapeutic Group of PPI
(API)
specifications
The status in reference regulatory Sporanox 100mg capsule USFDA Approved
authorities
For generic drugs (me-too status) Rolac 100mg capsule by M/s Sami Pharmaceuticals,
(Reg#024491)
Name and address of API Vision Pharmaceuticals (Pvt.) Ltd. Plot No. 22-23,
manufacturer. Industrial Triangle, Kahuta Road, Islamabad Pakistan.
Tel : + 92-51-4493587-90
Fax : + 92-51-4493591
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD
Summary) template. Summarized information related to
stability studies of drug substance and drug product is
submitted.
06 months real time stability of two batches ICZ1464,
ICZ1465 is submitted while three months real time
stability study of one batch ICZ1466 is submitted.

Only 03 months accelerated stability study data of batch
ICZ1466 is submitted.
Batches: (ICZ1464, ICZ1465, ICZ1466)

Pharmaceutical equivalence and Pharmaceutical Equivalence have been established
comparative dissolution profile against the brand POLAC 100mg capsule by SAMI
Pharmaceuticals by performing quality tests (Assay).
CDP has been performed against the same POLAC
100mg capsule by SAMI Pharmaceuticals in Acid media
(pH 1.2), acetate buffer (pH 4.5) & Phosphate Buffer
(pH 6.8) and in Acid media (0.1N HCl with 0.25% w/v
SLS).
Analytical method Not submitted.
Manufacturer of API Vision Pharmaceuticals (Pvt.) Ltd. Plot No. 22-23, Industrial Triangle,
Kahuta Road, Islamabad Pakistan.
Tel : + 92-51-4493587-90
Fax : + 92-51-4493591
API Lot No. ICZ1498
Description of Pack Alu-Alu blister packed in unit carton
Batch No. T-001 T-002 T-003
No. of Batches 03
1. Reference of previous approval N/A
of applications with stability
2. Approval of API/ DML/GMP The firm have submitted cGMP certificate of M/s Vision
certificate of API manufacturer Pharmaceuticals issued on 25-03-2022 based on
issued by concerned regulatory inspection conducted on 11-02-2019 and further
authority of country of origin. extended till 09-05-2022.
3. Documents for the procurement No document submitted
of API with approval from DRAP
(in case of import).
4. Data of stability batches will be Firm have submitted data of stability batches supported
supported by attested respective by attested respective documents like chromatograms,
documents like chromatograms, Raw data sheets, summary data sheets etc.
data sheets etc.
5. Compliance Record of HPLC Not submitted
6. Record of Digital data logger for Not submitted
temperature and humidity
1.5.2 • The applied product contains • The firm submitted that itraconazole
immediate release pellets while you pellets are immediate release while
have applied enteric coated pellets, enteric coated pellets was written by
clarify mistake and now rectified. The firm
submitted revise label as:
Each Capsule contains:
Itraconazole 22.0% IR pellets equivalent
to Itraconazole …………100mg
1.5.5 • You have stated that itraconazole • The firm have revised Pharmacological
belongs to PPI. Indicate correct class of the API (drug substance) as
Pharmacological class of the API Antifungal agent
(drug substance) with proper
reference.
1.6.5 • Submit valid GMP certificate of the • The firm have submitted cGMP
Drug Substance manufacturer certificate of Vision Pharmaceuticals
issued on 25-03-2022 based on
inspection conducted on 11-02-2019 and
further extended till 09-05-2022.
2.3.R.1 • Provide copy of Batch Manufacturing • Firm have submitted Batch
Record (BMR) for all the batches of Manufacturing Record (BMR) for all the
drug product for which stability batches of drug product for which
studies data is provided in Module 3 stability studies data is provided in
section 3.2.P.8.3> Module 3
3.2.S.4 • Copies of the Drug substance • Firm have submitted Copies of
specifications and analytical analytical procedures used for routine
procedures used for routine testing of testing of the Drug substance / Active
the Drug substance / Active Pharmaceutical Ingredient by Drug
Pharmaceutical Ingredient by Drug Product manufacturer. However,
Product manufacturer is required.” Copies of the Drug substance
• Drug substance manufacturer have specifications by Drug Product
claimed USP specifications while manufacturer is not submitted.
monograph for Itraconazole IR coated • The firm submitted that API
pellets are not available in USP., manufacturer claimed and followed USP
clarification is required specifications because Itraconazole
• Analytical Method Verification pellets are ready to fill in capsule.
studies including specificity, accuracy • Firm have submitted Analytical Method
and repeatability (method precision) Verification studies including
performed by the Drug Product specificity, accuracy and repeatability
manufacturer for drug substance(s) (method precision) performed by the
shall be submitted. Drug Product manufacturer for drug
• Results of dissolution studies given in substance
batch analysis in only 0.1N HCl • No clarification is submitted
without SLS, while drug substance
manufacturer uses 0.25% w/v SLS in
0.1N HCl., clarification is required
3.2.S.7 • Stability study data of drug substance • No reply submitted
till proposed shelf life shall be
submitted
3.2.P.2 • Justify why the pharmaceutical • No justification submitted
equivalence study does not include • Fir submitted that study conducted we
complete testing of the drug product me-too product due to unavailability of
and the comparator product including innovator product
the tests recommended by USP • The firm has submitted CDP
monograph (uniformity of dosage considering multiple time points for both
units, dissolution, identification). reference (comparator) and test product.
• A minimum of three time-points CDP has been performed against the
should be included for CDP, the time- POLAC 100mg capsule by SAMI
points for both reference (comparator) Pharmaceuticals in Acid media (pH 1.2),
and test product being the same as per acetate buffer (pH 4.5) & Phosphate
WHO guidelines while you have Buffer (pH 6.8)
performed at only one time points i.e. • No justification is submitted
15 min, justification is required • Similarity factor (F2) of the resulting
• As per WHO guideline surfactants comparative dissolution profiles is not
should be avoided in comparative provided
dissolution testing while you have • No clarification is submitted
used surfactant in CDP, clarify?
• Justification is required since
pharmaceutical equivalence and CDP
studies have not been conducted
against the innovator product.
• Similarity factor (F2) of the resulting
comparative dissolution profiles
should be calculated
• The brand name of Comparator
product mentioned in pharmaceutical
equivalence and CDP studies is Polac
100mg capsule while the brand name
of product as per available database is
rolac 100mg capsule, clarification is
required
3.2.P.5 • Detailed analytical procedures used • Firm has submitted analytical
for testing of the drug product shall be procedures used for testing of the drug
provided. product
• Results of Analytical method • Firm have submitted results of
verification studies of drug product Analytical method verification studies
performed by drug product of drug product performed by drug
manufacturer including specificity, product manufacturer including
repeatability (method precision) and specificity, repeatability (method
accuracy shall be submitted precision) and accuracy.
3.2.P.8 • Manufacturing date of pellets as per • The firm submitted that COA of drug
submitted COA of drug substance substance was not of the material
manufacturer is 22-12-2021 and received and was replaced but
release date as per COA is 10-01- unfortunately submitted with the
2022 while manufacturing of applied dossier.
product is 12-2021. Justification is • COA of the stability batches
required throughout the stability study is not
• COA of the stability batches submitted
throughout the stability study is not • No justification is submitted
submitted • Firm has not submitted documents for
• Test of uniformity of dosage unit has the procurement of API
not been performed at the time of • Record of Digital data logger for
batch release, justify? temperature and humidity monitoring
• Submit documents for the of stability chambers (accelerated
procurement of API conditions) is not submitted
• Submit Record of Digital data logger • Compliance record of HPLC software
for temperature and humidity 21CFR & audit trail reports on product
monitoring of stability chambers testing is not submitted.
• Compliance record of HPLC software
21CFR & audit trail reports on
product testing is required.
• Submission of Copies of the Drug substance specifications by Drug product manufacturer
• Submission of clarification since results of dissolution studies for drug substance (pellets) given in
batch analysis in only 0.1N HCl without SLS, while drug substance manufacturer uses 0.25% w/v
SLS in 0.1N HCl.
• Submission of Stability study data of drug substance till proposed shelf life as the submitted stability
data is till 06th months.
• Submission of justification as the pharmaceutical equivalence study does not include complete
testing of the drug product and the comparator product including the tests recommended by USP
monograph.
• Submission of justification for using surfactant in CDP studies which is not recommended as per
WHO guideline.
• Submission of COA of the stability batches throughout the stability study
• Submission of justification for not performing test of uniformity of dosage unit at the time of batch
release.
• Submission of record of Digital data logger for temperature and humidity monitoring of stability
Case No. 04: New cases for registration of Human Drugs on Form 5F (Import)
386. Name, address of Applicant / Importer M/s AMGOMED., Office # 4, First Floor Ghausia
Plaza, Jinnah Avenue Blue area Islamabad Pakistan
Details of Drug Sale License of importer License No: DSL-002-ICT/2013
Address: M/s Amgomed office # 4, First floor
Ghausia Plaza, Main Jinnah Avenue Blue area
Islamabad
Address of Godown: Office number 5, First floor
Rose-I plaza, I-8 Markaz Islamabad.
Validity: 30-01-2022
Status: Drug Sale License by way of Whole Sale
Name and address of marketing authorization PT Fonko International Pharmaceuticals
holder (abroad) Address: Kawasan Industri Jababeka II, JI. Industri
Selatan V, Blok PP No.7, Cikarang Selatan, Bekasi,
Jawa Barat - Indonesia
Name, address of manufacturer(s) Manufacturer & Product License Holder:
Name: PT Fonko International Pharmaceuticals
Address: Kawasan Industri Jababeka II, JI. Industri
Selatan V, Blok PP No.7, Cikarang Selatan, Bekasi,
Jawa Barat - Indonesia
Telephone: +62 21 29566111 Fax: +62 21 29566011
Name of exporting country Indonesia
Detail of certificates attached (CoPP, Freesale Firm has submitted legalized CoPP Certificate No.
certificate, GMP certificate) RG.01.05.32.321.05.21.2804 dated 13-05-2021 issued
by BADAN PENGAWAS OBAT DAN MAKANAN.
(National Agency of drug and Food Control) Indonesia
for FONDRONIC (ZOLEDRONIC ACID)
Concentrate for Solution for Infusion; 1 vial /5 mL;
The COPP confirms free sale status of the product in
exporting country as well as GMP status of the
manufacturing site through periodic inspection every 2
years.
The name of importing country on CoPP is
mentioned as Pakistan.
Details of letter of authorization / sole agency Firm has submitted original letter of Authorization
agreement dated 28th April, 2021 from M/s PT Fonko
International Pharmaceuticals Indonesia. The firm M/s
PT Fonko International Pharmaceuticals Indonesia
appoint and authorizes M/s Glorious Dexa Singapore
PTE. LTD 80 Robin son Road#17-20, Singapore
068898 an exclusive marketer and distributor of Fonko
to appoint M/s AMGOMED., Office # 4, First Floor
Ghausia Plaza, Jinnah Avenue Blue area Islamabad
Pakistan as distributor of product Fondronic
Concentrate for solution for infusion (Zoledronic Acid
4mg/5ml) in Pakistan and to submit application of drug
registration in Drug Regulatory Authority of Pakistan.
M/s PT Fonko International Pharmaceuticals
Indonesia is the manufacturer and product license
holder of the product in Indonesia.
☒ Importer
☐ Export sale
purpose only
Dy. No. and date of submission Dy. No. 26800: dated 28 -09 -2021
Details of fee submitted PKR 150,000/-: 16-09-2021 (Slip#71027968991)
The proposed proprietary name / brand name FONDRONIC 4mg/5ml Concentrate for Solution for
Infusion
Strength / concentration of drug of Active Each 5mL contains:
Pharmaceutical ingredient (API) per unit Zoledronic acid monohydrate equivalent to
zoledronic acid……………….4 mg
Pharmaceutical form of applied drug Concentrate for Solution for Infusion
Pharmacotherapeutic Group of (API) Bisphosphonates
WHO ATC code: M05BA
Reference to Finished product specifications Not provided
Proposed Pack size 1 vial x 5ml
Proposed unit price AS PER SRO
The status in reference regulatory authorities Zoledronic acid Fresenius Kabi 4 mg/5 ml concentrate
for solution for infusion by M/s Fresenius Kabi
Australia Pvt Ltd MHRA Approved
ZOMETA (4mg/5ml) solution for injection USFDA
Approved
For generic drugs (me-too status) Macdronic Injection 4mg/5ml by M/s Macter
International (Reg# 079757)
template. Firm has summarized information related to
solubilities, physical form, manufacturers, description
specifications, analytical procedures and its validation,
stability studies of drug substance.
Name, address of drug substance manufacturer Hetero Labs Limited., S. No. 10, I.D.A.,
Gaddapotharam Village, Jinnaram Mandal,
Sangareddy District-502319, Telangana, India
Module-III Drug Substance: Firm has submitted detailed drug substance data
related to nomenclature, structure, general properties,
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of
(Conditions & duration of Stability studies) API at accelerated as well as real time conditions. The
real time stability data is conducted at 25 ºC ± 2ºC / 60
± 5% RH for 60 months while accelerated stability
study is conducted at 40 ºC ± 2ºC / 75 ± 5% RH for 06
months.
Batch No# (ZL0030410, ZL0040410, ZL0010215)
Module-III Drug Product: Firm has submitted data of drug product including its
development, manufacture, manufacturing process and
process control, process validation protocols, control
of excipients, control of drug product, specifications,
analytical procedures, verification of analytical
procedures, batch analysis, justification of
specifications, reference standard or materials,
Pharmaceutical Equivalence and Comparative Firm has submitted comparative quantitative
Dissolution Profile composition of applied product along with reference
product.
Firm has also submitted results of pharmaceutical
equivalence against the product Zoledronic acid
4mg/5ml injection manufactured by M/s Hetero Labs
Ltd and reference product which is Zometa injection 4
mg/5 mL, manufactured by Novartis Pharma Stein
AG, Switzerland.
Analytical method validation/verification of Firm has submitted analytical method verification
product studies instead of analytical method validation for the
applied product by performing test for specificity,
accuracy, precision and solution stability
Container closure system of the drug product The final container closure system used for Zoledronic
acid concentrate for solution for infusion 4 mg/5 mL is
5 mL round clear cyclic olefin polymer (COP) plastic
vial with 20 mm neck covered by 20 mm grey
chlorobutyl fluorotec rubber stopper and sealed by
aluminium and 20 mm red flip off.
Stability study data of drug product, shelf life and Firm has submitted stability study data of 3 batches.
storage conditions The accelerated stability study data is conducted at
40○C ±2oC / 75% ± 5% RH for 6 months. The real
time stability study data is conducted at 30oC ±2oC /
75% ± 5% RH. The real time stability study data is till
36 months for 3 batches.
Batch No. Mfg. date Initiation
date
K-10462- Dec 2015 Dec 2015
00-F-PSC-1
K-10462- February 2016 April 2016
00-F-PSC-2
D0004 February 2017 February 2017
1.3.4 Submit copy of Valid Drug Sale License The firm have submitted valid copy of drug sale
license. The details are given below.
License No: DSL-002-ICT/2013
Address: M/s Amgomed office No.4, 1st floor,
Ghousia Plaza, Main Jinnah Avenue Blue area
Islamabad
Address of Godown: Office No. 5, First floor
Rose-I plaza, I-8 Markaz Islamabad.
Renewed upto: 30-01-2024
Status: Drug Sale License by way of Whole
Sale
1.5.6 Mention the reference specifications of the Firm has submitted that Finished product
finished product specification is not listed in any compendium,
therefore finished product specification was
developed in house based on general chapter of
European Pharmacopeia and hetero Labs
Limited quality documents. The specification of
finished product from Hetero Labs Limited is
submitted
1.5.15- Commitments must be submitted by Firm has submitted commitments as per the
1.5.20 applicant (marketing authorization Holder) guidance document
instead of manufacturer
1.6.5 Submit valid GMP certificate of drug Firm has submitted Drug License No.
substance manufacturer 25/MD/AP/97/B/R dated 23/11/2021 valid upto
21/11/2024 of M/s Hetero Labs Limited., S. No.
10, I.D.A., Gaddapotharam Village, Jinnaram
Mandal, Sangareddy District-502319,
Telangana, India
3.2.S.4 • Copies of the Drug substance • Specifications and analytical procedure from
specifications and analytical procedures PT Fonko International Pharmaceutical is
used for routine testing of the Drug submitted
substance /Active Pharmaceutical • The drug product manufacturer has submitted
Ingredient by Drug Product manufacturer method verification studies for drug
is required substance.
• Analytical Method Verification studies
including specificity, accuracy and
manufacturer for drug substance(s) shall
be submitted.
3.2.P.5 Results of Analytical method validation of We hereby declare that this product is a
drug product performed by drug product technology transfer from Hetero Labs Limited
manufacturer including linearity, range and and we adopted the same analytical procedure
robustness shall be submitted from them. We performed verification (based
on USP 43<1226> Verification of Compendial
Procedures) to validate the process in our
laboratory.
Hereby we would like to inform you:
• For the assay procedure; intermediate
precision, linearity, range and robustness tests
were not performed as part of method
verification as the same as are available in the
method validation document (tech transfer
document protocol no. AD6/AMV/P/12-046
and report document no. AD6/AMV/R/12-
046.
• For the related compounds procedure;
accuracy, intermediate precision, limit of
detection, linearity, range and robustness tests
were not performed as part of method
verification as the same as are available in the
method validation document (tech transfer
document protocol no. AD6/AMV/P/12-039
and report document no. AD6/AMV/R/12-
039.
Decision: Approved with innovators specifications and as per Policy for inspection of Manufacturer abroad
and verification of local storage facility.
• Firm shall submit the fee of Rs. 7,500/- for correction/pre-approval change/ in product specifications, as
387. Name, address of Applicant / Importer M/s AMB HK ENTERPRISES (PVT) LTD., 2nd
Floor, Plaza 60, Commercial, Block-K, Phase 1
DHA Lahore
Details of Drug Sale License of importer License No: 05-352-0058-066904D
Address: 2nd Floor, Plaza 60, Commercial Block-K,
Phase 1 DHA Lahore
Address of Godown: NA
Validity: 24-02-2023.
Status: License to sell drugs as distributor
Renewal: NA
Name and address of marketing authorization holder Hainan Brilliant Pharmaceutical Co., Ltd., 4
(abroad) Medicine Valley, No. 1 Road, Haikou National
High-tech Development Zone, Haikou City, China.
Name, address of manufacturer(s) Hainan Brilliant Pharmaceutical Co., Ltd., No. 4 Fist
Road of Yaogu, Haikou National High-tech
Industrial Development Zone, Haikou City, Hainan
Province, China.
Name of exporting country China
Detail of certificates attached (CoPP, Freesale CoPP: Firm has submitted original legalized CoPP
certificate, GMP certificate) certificate (No. 20210060) dated 16-04-2021 issued
by Hainan Provincial Medical Products
Administration China for azithromycin for injection
0.5g. The CoPP confirms that the product strength is
not in market of exporting country as well as GMP
status of the manufacturing site through periodic
inspection every year.
mentioned as Pakistan. Furthermore, the CoPP was
valid till 15-04-2023.
Details of letter of authorization / sole agency Firm has submitted notarized copy of agency
agreement agreement from M/s Hainan Brilliant
Pharmaceutical Co., Ltd. The letter species that the
manufacturer appoints M/s AMB HK
ENTERPRISES Pvt Ltd, Lahore to register their
products in Pakistan. The authorization letter is valid
till 22-10-2024. The letter issued for azithromycin
for injection 500mg.
☒ Importer
☐ Export sale
purpose only
Dy. No. and date of submission Dy. No. 26416: 23-09-2021
Details of fee submitted PKR 150,000/-: 29-06-2021
(Slip#306286776760)
The proposed proprietary name / brand name ZITHROBAR INJECTION 500mg
Strength / concentration of drug of Active Active ingredient Name; Azithromycin
Pharmaceutical ingredient (API) per unit Strength; 500mg
Pharmaceutical form of applied drug Powder for injection (Lyophillized)
Pharmacotherapeutic Group of (API) Antibacterials for systemic use, Macrolides
Proposed Pack size 1’s
Proposed unit price Rs 215/-
The status in reference regulatory authorities ZITHROMAX 500mg for injection USFDA
Approved.
For generic drugs (me-too status) Azineu 500mg Injection by M/s Neutro Pharma
(Reg# 097656)
drug product.
Name, address of drug substance manufacturer Zhejiang Goubang Pharmaceutical Co., Ltd., No.6,
Weiwu Road, Hangzhou Gulf Shangyu Economic &
Technological Development Zone, Zhejiang China
(Conditions & duration of Stability studies) of API at accelerated as well as real time conditions.
The real time stability data is conducted at 30 ºC ±
2ºC / 75 ± 5% RH for 24 months while accelerated
stability study is conducted at 40 ºC ± 2ºC / 75 ± 5%
RH for 06 months.
Batch No# (103-180306-11, 103-180307-11, 103-
180308-11)
Module-III Drug Product: Firm has submitted data of drug product including
analytical procedures, batch analysis, justification of
Pharmaceutical Equivalence and Comparative Firm has submitted results of pharmaceutical
Dissolution Profile equivalence against the innovator product
Zithromax 500mg Inj by performing quality test
(pH, Water Content, Bacterial Endotoxin, Sterility,
Visible particle, Assay).
Analytical method validation/verification of product Firm has submitted analytical method validation
studies for the applied product.
Container closure system of the drug product Injection Vial made of Middle Borosilicate Glass
tubing (10ml) with brominated rubber stopper and
caps made of aluminium-polypropylene
combinations
Stability study data of drug product, shelf life and Firm has submitted stability study data of 3 batches.
storage conditions The accelerated stability study data is conducted at
40oC ±2oC / 75% ± 5% RH for 6 months. The real
time stability study data is conducted at 30oC ±2oC /
65% ± 5% RH. The real time stability study data is
submitted for 18 months only.
Batch No. Mfg. date Batch size
1905051 05.05.2019 5000 vials
1905091 09.05.2019 5000 vials
1905131 13.05.2019 5000 vials
1.3.3 The submitted CoPP confirms that the The firm submitted clarification from Director
product strength is not in market of Quality Department, Hainan Brilliant
exporting country, clarify? Pharmaceutical Co., Ltd and stated that the
azithromycin for injection 0.5g has been
marketed in China (Exporting Country). The
person responsible for the application of CoPP
misunderstood he exporting country was
referring to Pakistan thus ticked wrong column
in CoPP.
1.5.2 Strength of Active ingredient shall be stated The firm have submitted the label claim as:
clearly. In case API is in the form of salt / Each vial contains:
hydrate, specify the equivalent strength of Azithromycin as dihydrate…….500mg
the base e.g., AAA sodium 50 mg
(equivalent to AAA) etc.
1.5.15- Commitments must be submitted by The firm has submitted commitments as per
1.5.20 applicant (marketing authorization Holder) guidance document
instead of manufacturer
1.6.5 Valid GMP certificate / DML of the Drug The firm has submitted GMP certificate No.
Substance manufacturer issued by relevant ZJ20190170 in the name of M/s Zhejiang
regulatory authority of country of origin is Goubang Pharmaceutical Co., Ltd., No.6,
required Weiwu Road, Hangzhou Gulf Shangyu
Economic & Technological Development
Zone, Zhejiang China valid upto 29/11/2024
3.2.S.4 • Copies of the analytical procedures used • Copies of the analytical procedures used for
for routine testing of the Drug substance routine testing of the Drug substance /Active
/Active Pharmaceutical Ingredient by Pharmaceutical Ingredient by Drug substance
Drug substance manufacturer and drug manufacturer and drug product manufacturer
product manufacturer is required is submitted.
• Analytical Method Verification studies • Analytical Method Verification studies
including specificity, accuracy and including specificity, linearity range,
repeatability (method precision) precision, accuracy, solution stability and
performed by the Drug Product robustness performed by the Drug Product
manufacturer for drug substance(s) shall manufacturer for drug substance(s) is
be submitted. submitted.
3.2.P.5 • You have applied for USP specifications. The firm submitted that specification applied
However, the limits for assay test given in for azithromycin for injection 0.5g is in-house
specifications is not according to USP specification rather than USP, so there is
monograph, clarify? difference in specification, test items and
Release specifications; (103%-113%) chromatographic conditions compared to USP.
Shelf life specifications; (101%-115%)
Monograph: (90%-110%)
• Test for uniformity of dosage units is not
included in specifications recommended
by USP
• The chromatographic conditions of the
analytical method are different from the
USP monograph (mobile phase, injection
volume, lambda,
3.2.P.8 • Submit stability study data of drug The firm have submitted stability study data of
product till the claimed shelf life three batches. The accelerated stability study
data is conducted at 40oC ±2oC / 75% ± 5% RH
for 6 months. The real time stability study data
is conducted at 30oC ±2oC / 65% ± 5% RH for
24 months
Decision: Deferred for following points:
• clarification for not complying USP specifications of finished drug product as USP specifications are
more stringent to in-house specifications.
• Whether manufacturing has been done via lyophilization or dry powder filling and relevant
manufacturing facility there of.
388. Name, address of Applicant / Importer M/s AMB HK ENTERPRISES (PVT) LTD., 2nd Floor,
Plaza 60, Commercial, Block-K, Phase 1 DHA Lahore
Phase 1 DHA Lahore
Validity: 24-02-2023.
Renewal: NA
Name and address of marketing authorization Reyoung Pharmaceutical Co., Ltd., No.1 Ruiyang Road,
holder (abroad) Yiyuan County, Shandong Province, China
Name, address of manufacturer(s) Reyoung Pharmaceutical Co., Ltd., No.1 Ruiyang Road,
Yiyuan County, Shandong Province, China
Detail of certificates attached (CoPP, Freesale CoPP: Firm has submitted original legalized CoPP
certificate, GMP certificate) certificate (No. 201910005) issued by Yiyuan Market
Supervision Administration of P.R China for vitamin C
Injection 500mg/5ml. The CoPP confirms free sale status
of the product in exporting country as well as GMP status
of the manufacturing site through periodic inspection
every year.
The name of importing country on CoPP is mentioned as
Pakistan. Furthermore, the CoPP is valid till 23-10-2021.
Details of letter of authorization / sole agency Firm has submitted copy of Registration & Distribution
agreement agreement dated 29-08-2019 from M/s Reyoung
Pharmaceutical Co., Ltd. The letter species that the
manufacturer appoints M/s AMB HK ENTERPRISES
Pvt Ltd, Lahore to register and develop pharmaceutical
market of their products in Pakistan. The authorization
letter remains valid for 05 years from the date of product
registration certificate. The letter issued for vitamin C
injection 500mg/5ml in addition to 08 other product.
☒ Importer
☐ Export sale
☐ Buk import and local repackaging for export purpose
only
The proposed proprietary name / brand name VITA-C INJECTION 500mg
Strength / concentration of drug of Active Ascorbic Acid 10.0% w/v.
Pharmaceutical form of applied drug Solution for Injection
Pharmacotherapeutic Group of (API) Ascorbic acid (vitamin C), plain
ATC Code: A11GA
Proposed Pack size 5ml type I glass ampoule; 10
ampoules/tray,10trays/boxes*12boxes/carton
Proposed unit price PKR 21.35/unit
The status in reference regulatory authorities Ascorbic Acid Injection BPC 500mg/5ml MHRA
Approved.
For generic drugs (me-too status) Ascorbic Acid Injection 500mg by M/s Enam Ellahie
Karachi (Reg# '004784)
drug substance and drug product.
Name, address of drug substance manufacturer CSPC Weisheng Pharmaceutical (Shijiazhuang) Co.,
Ltd., No. 236 Huanghe Street High-tech Industrial
Development Zone, Shijiazhuang City, Hebei Province,
China
Module-III Drug Substance: Firm has submitted detailed drug substance data related
solubilities, physical form, manufacturers, description of
specifications, batch analysis and justification of
real time stability data is conducted at 30 ºC ± 2ºC / 65 ±
5% RH for 36 months while accelerated stability study is
conducted at 40 ºC ± 2ºC / 75 ± 5% RH for 06 months.
Batch No# (1150452001, 1150452002, 1150452003)
description, composition, pharmaceutical development,
manufacture, manufacturing process and process control,
process validation protocols, control of excipients,
control of drug product, specifications, analytical
procedures, verification of analytical procedures, batch
analysis, justification of specifications, reference
standard or materials, container closure system and
stability study of drug product.
Pharmaceutical Equivalence and Comparative Firm has submitted results of pharmaceutical equivalence
Dissolution Profile against the reference product acido Ascorbico labesfal
injection 500mg by performing quality test
(identification, Acidity, Oxalic acid, Bacterial Endotoxin,
Sterility, Visible particle, content of ascorbic acid).
Analytical method validation/verification of Firm has submitted analytical method verification studies
product for the applied product.
Container closure system of the drug product USP type-I glass ampoule (5ml)
Stability study data of drug product, shelf life and Firm has submitted stability study data of 3 batches. The
storage conditions accelerated stability study data is conducted at 40oC ±2oC
/ 75% ± 5% RH for 6 months. The real time stability study
data is conducted at 30oC ±2oC / 75% ± 5% RH. The real
time stability study data is submitted for 36 months only.
Batch No. Mfg. date Date of
initiation
173212044 03-2017 03-2017
173212045 03-2017 03-2017
173212046 03-2017 03-2017
1.3.3 Submit valid CoPP certificate for the Firm has submitted original legalized CoPP
applied product certificate (No. 2021120004) issued by Yiyuan
Market Supervision Administration of P.R China
for vitamin C Injection 500mg/5ml. The CoPP
confirms free sale status of the product in
exporting country as well as GMP status of the
manufacturing site through periodic inspection
every year.
mentioned as Pakistan. Furthermore, the CoPP is
1.5.2 Strength of Active ingredient shall be Each 5ml ampoule contains:
stated clearly. In case API is in the form Ascorbic acid …….500mg
of salt / hydrate, specify the equivalent
strength of the base e.g., AAA sodium 50
mg (equivalent to AAA) etc.
1.5.15- Commitments must be submitted by Firm has submitted commitments as per guidance
1.5.20 applicant (marketing authorization document
Holder) instead of manufacturer
1.6.5 • The drug substance manufacturer as per • The firm submitted that drug substance
section 3.2.S.2 is CSPC Weisheng manufacturer is CSPC Weisheng
Pharmaceutical (Shijiazhuang) Co., Pharmaceutical (Shijiazhuang) Co., Ltd., No.
Ltd., No. 236 Huanghe Street High-tech 236 Huanghe Street High-tech Industrial
Industrial Development Zone, Development Zone, Shijiazhuang City, Hebei
Shijiazhuang City, Hebei Province, Province, China and it was a mistake at their
China while you have written Reyoung end by writing wrong name of manufacturer
Pharmaceutical Co., Ltd., No.1 • The firm has submitted copy of GMP certificate
Ruiyang Road, Yiyuan County, No. HE20150023 in the name of M/s CSPC
Shandong Province, China in this Weisheng Pharmaceutical (Shijiazhuang) Co.,
section, clarify? Ltd., No. 236 Huanghe Street High-tech
• Submit GMP certificate of drug Industrial Development Zone, Shijiazhuang,
substance manufacturer China valid upto 14/02/2020
3.2.S.4 • The specifications and analytical • The firm submitted that specifications of drug
procedure of the drug substance substance provided according to Chinese
provided is according to Chinese pharmacopeia is from API manufacturer, the
pharmacopeia while the product is finished product manufacturer test the API
available in BP. Justify that according to BP. Now the finished product
specification of drug substance are
equivalent to BP specifications (the manufacturer have supplemented the standards
number and limits of tests are within for raw material
range of BP.) • Firm have submitted copies of the Drug
• Copies of the Drug substance substance specifications and analytical
specifications and analytical procedures procedures used for routine testing of the Drug
used for routine testing of the Drug substance /Active Pharmaceutical Ingredient by
substance /Active Pharmaceutical Drug Product manufacturer.
Ingredient by Drug Product • The firm submitted that vitamin C produced by
manufacturer is required. CSPC WEISHENG is tested in strict
• Analytical Method Verification studies accordance with Chinese Pharmacopoeia, there
including specificity, accuracy and is not need to verify the analytical method.
shall be submitted.
3.2.S.5 COA of primary / secondary reference The firm stated that the primary reference
standard including source and lot number standard is from EDQM and government sector,
shall be provided hence no COA is submitted.
3.2.P.2.1.1 • Compatibility studies of the Drug • Firm have submitted Compatibility studies of
Substance(s) with excipients shall be the Drug Substance(s) with excipients and
provided as the qualitative composition observe the colour change and change in ph
of the formulation is not similar to during the study
reference product. • Firm have provided details of reference /
• Applied product: Ascorbic acid, comparator product including batch numbers,
Sodium bicarbonate, Sodium expiry date in pharmaceutical equivalence
metabisulfite, cysteine HCl, Disodium • The firm submitted that at that time innovator
edetate, water for injection product has been delisted
• Reference product: Ascorbic Acid,
Sodium Bicarbonate, Sodium
Metabisulphite Hydrochloric acid
Water for injections
• Details of reference / comparator
product including batch numbers,
manufacturing & expiry date in
pharmaceutical equivalence are
required to be provided
• Justify why Pharmaceutical
equivalence of the applied product has
not been performed against the
innovator product?
Decision: Deferred for submission of following documents:
• Pharmaceutical equivalence against innovator drug ptoduct.
• Verification studies of analytical method of drug substance by drug product manufacturer.
389. Name, address of Applicant / Importer M/s AMB HK ENTERPRISES (PVT) LTD., 2nd Floor,
Plaza 60, Commercial, Block-K, Phase 1 DHA Lahore
Phase 1 DHA Lahore
Validity: 24-02-2023.
Renewal: NA
Name and address of marketing authorization JARI Pharmaceutical Co., Ltd., 18 Zhenhua Road,
holder (abroad) Lianyungang City, Jiangsu P.R China, 222006
Name, address of manufacturer(s) JARI Pharmaceutical Co., Ltd., 18 Zhenhua Road,
Lianyungang City, Jiangsu P.R China, 222006
Detail of certificates attached (CoPP, Freesale CoPP: Firm has submitted original, legalized CoPP
certificate, GMP certificate) certificate (No. JS20210117) dated 04-02-2021 issued by
Jiangsu drug Administration China for oxaliplatin for
injection 50mg. The CoPP confirms free sale status of the
product in exporting country as well as GMP status of the
manufacturing site through periodic inspection every
year.
Details of letter of authorization / sole agency Firm has submitted notarized copy of foreign agency
agreement agreement dated February 02, 2021 in which M/s JARI
Pharmaceutical Co., Ltd., referred to as the manufacturer
grants M/s Liaoning Hongyan Pharmaceutical Co., Ltd
exclusive right to export and sell all product (Ten (10) in
number) including oxaliplatin for injection 50mg in
Pakistan.
M/s Liaoning Hongyan Pharmaceutical Co., Ltd referred
to as exporter grants M/s AMB HK ENTERPRISES Pvt
Ltd, Pakistan exclusive rights to sell and distribute the
products from M/s Liaoning Hongyan Pharmaceutical
Co., Ltd in Pakistan which has an understanding with M/s
JARI Pharmaceutical Co., Ltd.,
The agreement shall be effective from date of execution
and shall remain in force for five (05) years.
☒ Importer
☐ Export sale
only
The proposed proprietary name / brand name Runplatin Injection 50mg
Strength / concentration of drug of Active Active ingredient Name: Oxaliplatin
Pharmaceutical ingredient (API) per unit Strength; 50mg
Pharmaceutical form of applied drug Lyophilized powder for Injection
Pharmacotherapeutic Group of (API) Not applicable
Reference to Finished product specifications Chinese Pharmacopeia
Proposed Pack size 20 ml
Proposed unit price PKR 7700/-
The status in reference regulatory authorities GN-OXALIPLATIN oxaliplatin 50 mg powder for
injection vial TGA Approved.
For generic drugs (me-too status) Oxaliplatino Varifarma Lyophilized Powder for Injection
50mg by M/s Medinet Pharmaceuticals (Reg# '095884)
drug substance and drug product.
Name, address of drug substance manufacturer Kunming Guiyan Pharmaceutical Co., Ltd., Room 706,
Integrated Business Building in Jinding Science &
technology zone, 690#, Xuefu Road, Kuming, Yunnan,
China, 650033
specifications, batch analysis and justification of
real time stability data is conducted at 25 ºC ± 2ºC / 60 ±
5% RH for 36 months of following batches.
Batch No# (L20150613, L20161010, L20161106)
Accelerated stability study is conducted at 40 ºC ± 2ºC /
75 ± 5% RH for 06 months of following batches.
Batch No# (L20090107, L20090108, L20090109)
procedures, batch analysis, justification of specifications,
reference standard or materials, container closure system
and stability study of drug product.
Pharmaceutical Equivalence and Comparative Not submitted
Dissolution Profile
Analytical method validation/verification of Not submitted
product
Container closure system of the drug product Medium boron silicon glass tube-type vial (20ml),
pharmaceutical bromobutyl rubber stopper and caps
made of aluminium plastic combination
Stability study data of drug product, shelf life and Firm has submitted stability study data of 3 batches. The
storage conditions accelerated stability study data is conducted at 40oC ±2oC
/ 75% ± 5% RH for 6 months. The real time stability study
data is conducted at 30oC ±2oC / 75% ± 5% RH. The real
time stability study data is submitted for 36 months only.
Batch No. Mfg. date Date of
initiation
17101817 02-2017 03-2017
17102517 02-2017 03-2017
18051217 02-2017 03-2017
1.4.1 Applicant needs to clarify whether the The firm have submitted that applied product is
applied product (drug product) is intended intended both for domestic and export sale
for sale in domestic market or both for
domestic and export market. There is no
column for overseas sale
1.5.2 Strength of Active ingredient shall be Each vial contains:
stated clearly. In case API is in the form of Oxaliplatin …….50mg
salt / hydrate, specify the equivalent
strength of the base e.g., AAA sodium 50
mg (equivalent to AAA) etc.
1.5.5 Indicate Pharmacological class of the API Firm have indicated Pharmacological class of the
(drug substance) with proper reference. API (drug substance).
Also, state the WHO ATC code for each Third generation platinum anticancer drug
distinct therapeutic indication. ATC Code; L01XA03
1.5.15- Commitments must be submitted by Firm have submitted commitment as per
1.5.20 applicant (marketing authorization guidance document
1.6.5 • The drug substance manufacturer as per • The firm submitted that drug substance
section 3.2.S.2 is Kunming Guiyan manufacturer is Kunming Guiyan
Pharmaceutical Co., Ltd., Room 706, Pharmaceutical Co., Ltd., Room 706,
Integrated Business Building in Jinding Integrated Business Building in Jinding
Science & technology zone, 690#, Science & technology zone, 690#, Xuefu Road,
Xuefu Road, Kuming, Yunnan, China, Kuming, Yunnan, China, 650033 and it was a
650033 while you have written JARI mistake at their end by writing wrong name of
Pharmaceutical Co., Ltd., 18 Zhenhua manufacturer
Road, Lianyungang City, Jiangsu P.R • The firm has submitted copy of GMP
China, 222006 China in this section, certificate No. YN20170040 in the name of
clarify? M/s Kunming Guiyan Pharmaceutical Co.,
• Submit GMP certificate of drug Ltd., Inside Kunming Precious Metals
substance manufacturer Research Institute, No. 988, Keji Road, High-
tech Development Zone, Kunming City China
valid upto 24/12/202
3.2.S.4 • Test for content of platinum is not • We refer to EP, content of platinum is not
included in specifications although included in EP specifications
recommended by USP • Firm have submitted copies of the Drug
• Copies of the Drug substance substance specifications and analytical
specifications and analytical procedures procedures used for routine testing of the Drug
used for routine testing of the Drug substance /Active Pharmaceutical Ingredient
substance /Active Pharmaceutical Drug Product manufacturer. Copies of Drug
Ingredient by both drug substance substance specifications and analytical
manufacturer and Drug Product procedures used for routine testing of the
manufacturer is required. Drug substance /Active Pharmaceutical
• Analytical Method Verification studies Ingredient by Drug substance manufacturer
including specificity, accuracy and is not submitted
repeatability (method precision) • Analytical Method Verification studies is not
performed by the Drug Product submitted as per requirement
manufacturer for drug substance(s) shall • The firm submitted batch analysis of drug
be submitted. substance as per EP.
• Test results of Batch analysis are
submitted as per USP specifications.
However, the specifications of applied
product are given according to EP,
clarify?
3.2.S.8 Justify why stability study data of Firm have submitted long term stability study
different batches of drug substance data at 25 ºC ± 2ºC / 60 ± 5% RH for 36 months
conducted at accelerated and real time of same batches for which stability study data at
conditions is submitted. accelerated conditions is submitted.
Batch No# (L20090107, L20090108,
L20090109)
3.2.P.2 • Reference product has used lactose • The firm submitted that through conversion
monohydrate while you have use lactose lactose content is consistent with reference
product
in composition of applied product, • The firm submitted pharmaceutical
clarify? equivalence of applied product with product
• Submit Pharmaceutical equivalence of of Jiangsu Hengrui Pharmaceutical Co., Ltd
the applied product against the innovator
product
3.2.P.5 • Analytical Method Verification studies Firm have submitted Analytical Method
including specificity, accuracy and Verification studies including specificity, and
repeatability (method precision) repeatability (method precision). However,
performed by the Drug Product results of accuracy test is still not submitted
manufacturer for drug product shall be
submitted.
The firm has applied for Chinese pharmacopeia specifications while the monograph for the applied product
is available in USP and the limits of tests of applied product are in line with USP specifications.
• Submission of Pharmaceutical equivalence studies against the innovator product.
• Submission of Copies of Drug substance specifications and analytical procedures used for routine testing of
the Drug substance /Active Pharmaceutical Ingredient by Drug substance manufacturer.
• Submission of Analytical Method Verification studies for drug substance
• Submission of results of accuracy test in method verification studies for drug product
Case No.05; Registration applications of Human Drugs on Form 5 (Local)

390. Name and address of manufacture / M/s Perfect Pharma Pvt Ltd. 5-Km, Manga Road, Raiwind,
Applicant Lahore, Pakistan
Contract Manufactured by: M/s Semos Pharmaceuticals Pvt
Ltd. Plot No. 11, Sector 12-A, North Karachi, Karachi-75850,
Pakistan"
Brand Name + Dosage Form and Tazdim 1000mg dry powder Injection IV/IM
Strength
Ceftazidime Sodium eq to Ceftazidime………1000mg
Dairy No. date of R &I fee Form-5 Dy.No 11378 dated 05-03-2019 Rs.50,000/- dated
04-03-2019
Pharmacological Group Cephalosporine
Type of form Form 5
Finished product specifications USP
Pack size and Demand Price As per SRO
Approval status of product in Ceftazidime 1g powder for solution for injection/infusion
Reference Regulatory Authorities MHRA Approved
Me-too-status Kefamin Injection 1g IM/IV by M/s Maxitech Pharma
(Reg#097036)
GMP Status The firm M/s Semos Pharmaceuticals was inspected on 02-09-
2021 and conclusion of inspection was:
Based on the stated observations, facts and keeping in view the
attitude of the firm towards continuous improvements their
current GMP compliance level is rated as GOOD.
The firm M/s Perfect Pharma was inspected on 22/09/2021 &
08/10/2021 and conclusion of inspection was:
Overall, the firm showed satisfactory improvements as per
cGMP requirements.
Remark of the Evaluator XI • The firm have submitted revised form 5 and corrected the
salt and hydrated form of ceftazidime in label claim and
master formulation along with submission of Rs. 75000/- on
deposit slip#6872949424. The revised label claim is as
under:
Each Vial Contains:
Ceftazidime (Ceftazidime as pentahydrate)…….…1000mg
• Form 5 is submitted by the applicant i.e. M/s Perfect Pharma
Pvt Ltd
• The firm submitted list of 06 approved sections of applicant.
i.e. M/s Perfect Pharma Pvt Ltd
• The firm submitted that they never applied before any
product for registration on contract manufacturing
• The firm submitted unsigned copy of contract manufacturing
agreement between M/s Perfect Pharma Pvt Ltd and /s
Semos Pharmaceuticals Pvt Ltd.
Decision: Approved with following label claim:
Each Vial Contains:
assessment of manufacturing and testing facility of M/s Semos Pharmaceuticals Pvt Ltd. Plot No.
11, Sector 12-A, North Karachi, Karachi-75850, Pakistan"
Ltd. Plot No. 11, Sector 12-A, North Karachi, Karachi-75850,
Pakistan"
Brand Name + Dosage Form and Tazdim Dry Powder Injection 250mg IV/IM
Strength
Ceftazidime Sodium eq to Ceftazidime…….…250mg
04-03-2019
Type of form Form 5
Approval status of product in Ceftazidime 250mg powder for solution for injection MHRA
Reference Regulatory Authorities Approved
Me-too-status Kefamin Injection 250mg IM/IV by M/s Maxitech Pharma
(Reg#097037)
cGMP requirements.
deposit slip#008346330. The revised label claim is as under:
Each Vial Contains:

Pvt Ltd
Each Vial Contains:
Ltd. Plot No. 11, Sector 12-A, North Karachi, Krachi-75850,
Pakistan"
Brand Name + Dosage Form and Tazdim Dry powder Injection 500mg IV/IM
Strength
Ceftazidime Sodium Eq To Ceftazidime……….500mg
04-03-2019
Type of form Form 5
Approval status of product in Ceftazidime 500mg powder for solution for injection MHRA
Reference Regulatory Authorities Approved
Me-too-status Kefamin Injection 500mg IM/IV by M/s Maxitech Pharma
(Reg#097038)
Each Vial Contains:

Pvt Ltd
Each Vial Contains:
Case No. 06: Deferred cases:

a. Deferred cases of Human Drugs on form 5
393. Name and address of manufacture / M/s M.S. Enterprises Ltd., 3.5km Raiwind Kot Radha kishan Road,
Applicant kasur
Brand Name + Dosage Form and Pakcip 200mg/100ml Infusion
Strength
Ciprofloxacin………....2mg
Dairy No. date of R &I fee Form-5 Dy.No 16542 dated 04-05-2018 Rs.20,000/- Dated 03-05-
2018
Duplicate Dossier, R&I Verified
Pharmacological Group Fluoroquinolones
Type of form Form 5
Pack size and Demand Price 100ml; As per SRO
Approval status of product in Ciprofloxacin 2mg/ml solution for infusion
Reference Regulatory Authorities (MHRA approved)
Me-too-status Riget 200Mg/100ml Infusion by Saydon Pharmaceutical Industries
(Pvt) Ltd (Reg#36936)
GMP Status The firm was inspected on 22.01.2020 and conclusion of inspection
was:
Keeping in view the observations and after going through the
documentation and overall operations, the panel was of the opinion that
the firm M/s M.S. Enterprises Ltd., Lahore was GMP compliant on the
day of inspection
Previous Remark of Evaluator XI
• The firm submitted copy of fee challan No. 0776351 dated
03.05.2018 submitted for the applied product.
• The firm have revised the label claim and mentioned the correct
salt form of ciprofloxacin along with submission of Rs. 5000/- on
deposit slip No#2103609 dated 04.05.2021. The revised label
claim is as under:
Each 100ml Vial Contains:
Ciprofloxacin Lactate 254mg eq. to Ciprofloxacin …200mg
• Clarification is required as in manufacturing outline filling in

polypropylene bags is mentioned while in type of container PE
100ml bottle is mentioned
Previous Decision (307-DRB) • Deferred for clarification for type of primary packaging container
of the applied formulation
Evaluation by PEC • The firm submitted that solution is filtered close to filling point of
the machine. After filtration the solution is filled into Low Density
Polyethylene (LDPE) 100ml Plastic Bottles and then these bottles
are packed in PE (polyethylene) bags. However, the reference
formulation is packed in PVC bag contained in a
polypropylene/polyester aluminium/polyester pouch.
Decision: Deferred for deliberation regarding formulation and salt form of ciprofloxacin.
Applicant kasur
Brand Name + Dosage Form and Paklev 500mg/100ml Infusion
Strength
Composition Levofloxacin Hemihydrate…………..512mg
Sodium Chloride……………………..0.9g
Dairy No. date of R &I fee Form-5 Dy.No 16541 dated 04-05-2018 Rs.20,000/- 03-05-2018
Type of form Form 5
Finished product specifications Manufacturer’s specifications
Approval status of product in
Reference Regulatory Authorities
Me-too-status
was:
day of inspection
Previous Remark of Evaluator XI • The firm submitted copy of fee challan No. 0776355 dated
• Undertaking at the end of form 5 is missing
• The firm have revised the label claim along with submission of
Rs. 5000/- on deposit slip No#2103611 dated 04.05.2021. The
revised label claim is as under:
Levofloxacin Hemihydrate 512.42mg eq. to Levofloxacin ….…500mg
• The firm provided evidence of approval of product in RRA.

Levofloxacin 5mg/mL Solution for infusion MHRA approved
• The firm provided evidence of approval of me-too. Liv-Mark
Infusion 500mg/100ml by M/s Medimarker’s Pharmaceuticals
(Reg#100410)
Previous Decision (307-DRB) Deferred for following:
• Submission of undertaking at the end of form 5
• Clarification for type of primary packaging container of the applied
formulation
Evaluation by PEC • The firm submitted undertaking at the end of form 5
• The firm submitted that solution is filtered close to filling point of
are packed in PE (polyethylene) bags.
Decision: Approved with JP specifications and following label claim:
Levofloxacin Hemihydrate 512.42mg eq. to Levofloxacin ….…500mg
• Firm shall submit the fee of Rs. 25,000/- for correction/pre-approval change in composition
(correction/change of salt form of the drug substance), and product specifications, as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Registration Board further decided to verify fee challan as per decision of 285th meeting of Registration
Board.
Applicant kasur
Brand Name + Dosage Form and Pakzole 500mg/100ml Infusion
Strength
Composition Metronidazole……...…5mg/ml
2018
Pharmacological Group Imidazole derivatives
Type of form Form 5
Approval status of product in Metronidazole 500mg/100mL Solution for infusion MHRA approved
Me-too-status Anagyl 5mg/ml IV Infusion by M/s Iqra Pharmaceuticals (Reg#
097712)
was:
day of inspection
Previous Remark of Evaluator XI • The firm submitted copy of fee challan No. 0776353 dated
• Undertaking at the end of form 5 is missing
• The firm have revised the label claim along with submission of
Rs. 5000/- on deposit slip No#2103612 dated 04.05.2021. The
revised label claim is as under:
Metronidazole….…500mg
• Submission of undertaking at the end of form 5
formulation
Evaluation by PEC • The firm submitted undertaking at the end of form 5
• The firm submitted that solution is filtered close to filling point of
Metronidazole….…500mg
• Firm shall submit the fee of Rs. 25,000/- for correction/pre-approval change in composition
(correction/change of salt form of the drug substance), as per notification No.F.7-11/2012-B&A/DRAP
dated 13-07-2021.
Board.
Applicant kasur
Brand Name + Dosage Form and Moxin 400mg/250ml Infusion
Strength
Moxifloxacin HCl 436mg eq. to Moxifloxacin….…400mg
2018
Type of form Form 5
Approval status of product in Moxifloxacin 400mg/250mL Solution for infusion MHRA Approved
Me-too-status M-Floxsel Infusion 400mg/250ml by M/s Pharmasol (Pvt) Ltd (Reg#
100857)
was:
day of inspection
Previous Remark of Evaluator XI
• The firm submitted copy of fee challan No. 0776356 dated
• Master formulation and manufacturing method not submitted
• Clarification is required as in type of container PE 100ml bottle is
mentioned
• Submission of master formulation and manufacturing method of the
applied formulation
formulation
Evaluation by PEC • The firm submitted that solution is filtered close to filling point of
• Master formulation and manufacturing method of the applied
formulation is still not submitted
Decision: Approved with innovator’s specifications
Board.
397. Name and address of manufacture / M/s Hudson Pharma Private Limited. Site-Plot No. D-93, North
Applicant Western Industrial Zone, Port Qasim Authority, Pakistan
Brand Name+Dosage Form+Strength Recuro UD Eye Drops (solution)
Carboxymethylcellulose Sodium…..…5mg
Glycerin………………………………10mg
Polysorbate 80………………………...5mg
Pharmacological Group Lubricating and moisturizing comfort solution
Type of form Form 5
Pack size and Demand Price 0.4ml (30’s ampoules), 0.4ml (60’s ampoules); As per SRO
Me-too-status
GMP Status Firm was inspected on 03-04-2019 and conclusion of inspection
was:
Overall cGMP is found at acceptable level and the management
is committed for continual improvement and has assured further
cGMP compliance.
Previous Remark of Evaluator XI • The firm provided evidence of RRA. Refresh Optive Advanced
Lubricant Eye Drops OTC product by M/s Allergan Inc, (Daily
Med)
• The firm provided evidence of me-too. Recuro Drops 0.5% by
M/s Hudson Pharma (Reg#091123). However, the provided
me-too is not as per applied product (contain only
carboxymethyl cellulose 5mg).
Previous Decision (307-DRB) • Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration number,
brand name and name of firm.
Evaluation by PEC • The firm again provided evidence of same me-too. Recuro
Drops 0.5% by M/s Hudson Pharma (Reg#091123). However,
the provided me-too is not as per applied product (contain only
carboxymethyl cellulose 5mg).
• The firm itself revised the formulation and revised the label
claim along with submission of Rs 30000/- on deposit
SlipNo.991599286662. The revised label claim is as under:
Each ml Contains:
Carboxymethylcellulose Sodium…..…5mg
Evidence of RRA: Celluvisc 0.5 %w/v eye drops solution
(Ireland approved)
Pack size: 30’s (0.4ml LDPE container), 60’s (0.4ml LDPE
container)
• The same molecule is already registered with the firm
• The firm submitted revised master formulation of already
applied product containing all three APIs.
Previous Decision (313-DRB) • Deferred for evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm OR
submission of stability study data as per the guidelines
approved in 293rd meeting of Registration Board.
Evaluation by PEC • The firm submitted that they have already registered RECURO
(Carboxymethylcellulose) Eye Drops 5mg in multi-dose
container of 15ml with the registration No. 091123.
• The firm further stated that they want the same composition in
unit dose container of 0.4mlx30’s, but mistakenly we had
added two of its excipients (glycerin & polysorbate) in
composition of registration application. For the same we have
submitted the fee of standardization of formulation as per
international reference and locally available product and
requested to accept the clarification.
Previous Decision (316-DRB) • Deferred for clarification regarding manufacturing of applied
product in the proposed manufacturing facility “Plastic
ampoules (BFS) section.
Evaluation by PEC • The firm submitted that our product is a unit dose formulation
of 0.4ml that is available in plastic ampoules as per the
innovator product “ Celluvisc 0.5% w/v eye drops solution”.
• The firm further submitted that we have Rommelag 360M
filling machine (BFS) which has the capacity to fill the volume
from 0.1ml to 40ml, and the firm also submitted latest GMP
report for evidence.
• It is to submit that carboxy methyl cellulose sodium 0.5% eye
drops is a stability molecule
Decision:Registration Board deliberated the matter in detail and observed that the applied
formulation is already registered in Pakistan in 15ml fill volume as multi-dose (LDPE) container
and instant application is with same formulation and container closure system and thus stability
study is not required being a generic product applied on Form 5. Therefore, the Board decided to
approve the product with innovator’s Specifications.
398. Name and address of manufacture / M/s Wilson's Pharmaceuticals., 387-388, I-9, Industrial Area,
Applicant Islamabad
Brand Name + Dosage Form+ Wilsonide Plus Dry Powder Inhaler 400/12 mcg capsule
Strength
Composition Each DPI Capsule Contains:
Budesonide….…400mcg
Formoterol fumarate dihydrate…….12mcg
Pharmacological Group Glucocorticosteroid/Selective β2 adrenoceptor

agonist
Type of form Form 5
Pack size and Demand Price 10’s, 20’s, 30’s; As per SRO
Approval status of product in Symbicort Turbohaler 400 micrograms / 12 micrograms /

Reference Regulatory Authorities inhalation, inhalation powder (MHRA approved)
Me-too-status Formiget DPI Capsule 400mcg+12mcg by Getz Pharma
(Reg#098828)
GMP Status The firm was inspected on 24-01-2018 and conclusion of
inspection was:
“Overall the firm was found to be operating at a very good level
of CGMP Compliance at the time of inspection.”
Remark of the Evaluator XI
Remarks Response by the firm
• As per 290th decision of Registration board, The firm submitted approved layout plan for
provide evidence of separate manufacturing manufacturing of DPI and panel constituted
facility/section for manufacturing of DPIs letter for onsite inspection but have no approved
including specialized mixing facility to ensure the section/manufacturing facility at present.
required particle size of the formulation blend. Moreover the firm submitted a list of
equipments that will be used in manufacturing
including eqipments for DPI mixing and DPI
filling.
• As per 290th decision of Registration board, The firm informed that equipments for
provide evidence of equipments for performing performing the test of “Uniformity of Delivered
the test of “Uniformity of Delivered Dose” and Dose” and “Aerodynamic Particle Size
“Aerodynamic Particle Size Distribution” as per Distribution” have been procured and are
Pharmacopoeia. available for testing.
• The reference formulation have mentioned the The firm have revised the label claim
hydrated form (dihydrate) of Formoterol fumarate mentioning the hydrated form of Formoterol
in the label claim while you have not mentioned fumarate in the label claim
the hydrated form. Revise the label claim as per
reference formulation mentioning the hydrated
form along with submission of applicable fee.
• Submission of stability studies data of three The firm have submitted commitment for
batches as per Requirements of Registration performing the stability study as per
Board decision of 293rd meeting. Requirements of Registration Board decision of
293rd meeting.
Previous Decision (296- Deferred for confirmation of required manufacturing facility “Dry Powder
DRB) inhaler” section with manufacturing and testing equiments for applied
formulation.
Evaluation by PEC • The firm have submitted letter No. F. 1-19/92-Lic (Pt-I) dated 15th
September 2021 issued by secretary Central Licensing Board confirming
the presence of Dry Powder Inhaler Capsule (Steroidal) section
• Moreover, the firm submitted a list of equipments that will be used in
manufacturing and testing for applied formulation.
• Stability studies data of three batches as per Requirements of
Registration Board decision of 293rd meeting is not submitted.
Decision: Deferred for Submission of Stability study data as per guidelines approved in 293rd
Pakistan"
Brand Name + Dosage Form and Draxil 125mg/5ml Suspension
Strength
Cefadroxil as Monohydrate………125mg
Dairy No. date of R &I fee Form-5 Dy.No 11368 dated 05-03-2019 Rs.50,000/- dated 04-
03-2019
Type of form Form 5
Finished product specifications Manufacturer’ s Specifications
Me-too-status Ozix Dry Powder Suspension 125mg/5ml by M/s Maxitech
Pharma (Reg#097182)
cGMP requirements.
Previous Remark of the Evaluator XI
• The firm did not provide evidence of approval of applied
formulation in reference regulatory authorities / agencies which
were adopted by the Registration Board in its 275th meeting
Pvt Ltd
• The firm submitted that they never applied before any product
for registration on contract manufacturing
• The firm did not submit list of products applied for contract
manufacturing.
• The firm submitted contract manufacturing agreement between
M/s Perfect Pharma and M/s Semos Pharmaceuticals
• The firm have revised specifications from manufacturer’s
specifications to USP specifications without submission of
applicable fee.
• Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were adopted by the
Registration Board in its 275th meeting.
• Submission of fee of Rs. 7,500 for correction/pre-approval
change in product specifications, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Evaluation by PEC • The firm have submitted fee of Rs. 7,500 vide deposit
slip#50708779569 for correction/pre-approval change in
product specifications, as per notification No.F.7-11/2012-
• Biodroxil 125mg/5ml powder for oral suspension AGES
Austria approved
Decision: Approved with USP specifications
Pakistan"
Brand Name + Dosage Form and Cefra 125mg/5ml Suspension
Strength
Cephradine as Monohydrate………..…125mg
03-2019
Pharmacological Group Cephalosporin
Type of form Form-5
Me-too-status Cefra Dry Suspension 125mg by M/s Max Pharmaceuticals,
(Reg#075406)
cGMP requirements.
Previous Remark of the Evaluator XI • The firm did not provide evidence of approval of applied
formulation in reference regulatory authorities/agencies which
were adopted by the Registration Board in its 275th meeting.
Pvt Ltd
• The firm submitted that they never applied before any product
for registration on contract manufacturing
• The firm did not submit list of products applied for contract
manufacturing.
• The firm submitted contract manufacturing agreement between
M/s Perfect Pharma and M/s Semos Pharmaceuticals
• The firm have revised the specifications from manufacturer’s
specifications to USP specifications along with submission of
Rs. 7500/- on deposit slip No#49340178993.
Previous Decision (316-DRB) • Deferred for evidence of approval of applied formulation in
reference regulatory authorities/agencies which were adopted
by the Registration Board in its 275th meeting.
Evaluation by PEC • The firm provided evidence of applied product in RRA.
Velosef 125mg/5ml for oral suspension USFDA approved.
However, the applied product is discontinued
401. Name and address of manufacture / M/s Paramount Pharmaceuticals., Plot No. 36, Industrial
Contract Manufactured By: M/s Bio Labs Pvt Ltd.
Plot # 145, Industrial Triangle, Kahuta Road, Islamabad
Brand Name + Dosage Form and Colistacin 1 M IU Injection
Strength
Colistimethate Sodium eq. to Colistimethate Lyophilized
Powder…….1MIU
03-2019
Pharmacological Group other antibacterials (polymyxins)
Type of form Form 5
Approval status of product in Colistimethate Sodium 1 Million I.U. Powder for Solution for
Reference Regulatory Authorities Injection MHRA Approved
Me-too-status Colicraft Injection by Biolabs (Pvt) Ltd. (Reg# 082407)
GMP Status The firm M/s Paramount Pharmaceuticals was inspected on 08-
02-2019 and conclusion of inspection was:
During review of approval of above-mentioned
sections/manufacturing facilities, it was assessed that following
two sections needs regularization from Licensing Division:
1- Cream/Ointment
2- Tablet (General)
The firm has applied for the regularization of same in Licensing
Division.
Keeping in view the observations noticed during inspection as
narrated above, the panel is of the opinion that the firm may be
allowed to start manufacturing in the light of GMP guidelines.
The panel further recommended granting the GMP certificate
for export purpose.
Certificate of GMP Issued to M/s Bio Labs Pvt on 25-05-2019.

Previous Remark of the Evaluator XI • The firm have submitted differential fee Rs. 55000/- on
deposit slip No# 873385180685 for contract manufacturing.
• Form 5 is submitted by the applicant i.e. M/s Paramount
Pharmaceuticals duly signed by the applicant
i.e. M/s Paramount Pharmaceuticals
• The firm submitted list of 11 products registered/approved on
contract manufacturing in name of applicant. i.e. M/s
Paramount Pharmaceuticals
• The firm submitted list of 14 products applied for contract
manufacturing by the applicant.
• The firm submitted copy of contract manufacturing agreement
between M/s Paramount Pharmaceuticals and M/s Bio Labs
Pvt Ltd
• The firm have not revised the label claim as per reference
formulation without considering the salt factor. The submitted
label claim is as under:
Each Vial Contains:
Colistimethate Sodium eq. to Colistimethate …….1MIU
Lyophilized Powder
• Confirmation of method of manufacturing of applied
formulation whether by lyophilization or otherwise.
• Further deliberation for revision of label claim as per reference
formulation and pharmacopoeial specifications.
Evaluation by PEC • The firm have submitted revised form 5 and revised label
claim as per reference formulation without submission of
applicable fee. The revised label claim is as under:
Each Vial Contains:
Colistimethate Sodium …….1MIU
(Lyophilized Powder)
• Firm has submitted revised form 5 and revised manufacturing
method and stated that the product is manufactured by
lyophilization.
• Registration Board in its 293rd meeting held on 06-08th January
2020 allowed contract manufacturing from M/s Bio-Labs
(Pvt) Ltd. Plot No.145 Industrial Triangle, Kahuta Road,
Islamabad for
following sections:
Dry Suspension (Cephalosporin)
Capsule (Cephalosporin)
Dry vial injectable (Cephalosporin)
lyophilized vial injectable (General)
Decision: Registration Board deferred for following reasons:
• Submission of batch manufacturing details of most recent commercial batch from M/s Bio
Labs Pvt Ltd., for applied formulation to confirm the fact whether Colistimethate injection
is formulated from pre-lyophilised drug substance or otherwise.
• Firm shall submit fee of Rs.7,500/- for correction/pre-approval change in the method of
manufacture, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Submission of GMP audit report for both M/s Paramount Pharmaceuticals and M/s Bio
Labs Pvt Ltd from QA&LT Division, valid within last three years
Contract Manufactured By: M/s Bio Labs Pvt Ltd.
Brand Name + Dosage Form and Paracin 1g Injection
Strength
Vancomycin HCl eq. to Vancomycin……………1g
(lyophilized powder)
03-2019
Pharmacological Group Glycopeptide antibacterials
Type of form Form 5

Approval status of product in Vancomycin 1g Powder for Solution for Infusion MHRA
Reference Regulatory Authorities approved
Me-too-status Vancozon 1000mg Injection by M/s Horizon Healthcare
(Reg#099988)
During review of approval of above mentioned
1- Cream/Ointment
2- Tablet (General)
Division.
for export purpose.

Pvt Ltd
Previous Decision (316-DRB) • Deferred for confirmation of method of manufacturing of
applied formulation as well as of innovator, whether by
lyophilization or otherwise.
Evaluation by PEC • Firm has submitted revised form 5 and revised manufacturing
lyophilization.
Decision: Approved.
• Submission of GMP audit report for both M/s Paramount Pharmaceuticals and M/s Bio Labs Pvt
Ltd from QA&LT Division, valid within last three years
• Registration Board in its 293rd meeting held on 06-08th January 2020 allowed contract
manufacturing from M/s Bio-Labs (Pvt) Ltd. Plot No.145 Industrial Triangle, Kahuta Road,
Islamabad for
following sections:
Contract Manufactured By: M/s Bio Labs Pvt Ltd.,
Brand Name + Dosage Form and Paracin 500mg Injection
Strength
Vancomycin HCl eq. to Vancomycin ……….…500mg
(lyophilized powder)
03-2019
Pharmacological Group Glycopeptide antibacterials
Type of form Form 5
Approval status of product in Vancomycin 500mg Powder for Solution for Infusion MHRA
Reference Regulatory Authorities approved
Me-too-status Vancozon 500mg Injection by M/s Horizon Healthcare
(Reg#099987)
During review of approval of above mentioned
1- Cream/Ointment
2- Tablet (General)
Division.
for export purpose.

Pvt Ltd
Previous Decision (316-DRB) • Deferred for confirmation of method of manufacturing of
applied formulation as well as of innovator, whether by
lyophilization or otherwise.
Evaluation by PEC • Firm has submitted revised form 5 and revised manufacturing
lyophilization.
Decision: Approved.
• Submission of GMP audit report for both M/s Paramount Pharmaceuticals and M/s Bio Labs Pvt
Ltd from QA&LT Division, valid within last three years
• Registration Board in its 293rd meeting held on 06-08th January 2020 allowed contract
manufacturing from M/s Bio-Labs (Pvt) Ltd. Plot No.145 Industrial Triangle, Kahuta Road,
Islamabad for
following sections:
404. Name and address of manufacture / M/s Aulton Pharmaceuticals., Plot No. 84/1, Block A, Phase V,
Applicant Industrial Estate, Hattar, K.P.K
Brand Name + Dosage Form and Aultopride 50mg Tablet
Strength
Itopride………………….50mg
Dairy No. date of R &I fee Form-5 Dy.No 24088 dated 11-07-2018 Rs.20,000/- Dated 11-
07-2018
Pharmacological Group Propulsive
Type of form Form 5
Finished product specifications JP
Pack size and Demand Price 1x10’s, 1x30’s; As per SRO
Approval status of product in Reference Ganaton 50mg film coated tablet (PMDA) Japan Approved
Regulatory Authorities
Me-too-status Itonext 50mg Tablet by M/s Next Pharmaceutical Products
(Reg#095612)
inspection was:
As per observations made during inspection, the manufacturing,
quality control and environmental facilities, provided the
qualified staff employed, the documentation maintained,
implementation of the SOP’s the GMP compliance status of the
firm M/s Aulton Pharma is found to be satisfactory.
Previous Remark of the Evaluator XI • The firm have claimed for JP specifications and the official
monograph is not available in any pharmacopeia
• The firm have not mentioned the salt form of itopride in the
label claim. Revise the label claim as per reference formulation
mentioning the salt form of itopride along with submission of
applicable fee.
• The firm did not submit 1st page of form 5
• The firm submitted revised master formulation and removed
methylene chloride from formulation
• Revision of the label claim mentioning the salt form of itopride
as per reference formulation along with submission of applicable
fee.
• Submission of 1st page of form 5 as per prescribed format
Evaluation by PEC • The firm have revised the label claim and mentioned the salt form
of itopride as per reference formulation along with submission of
Rs. 7500/- on deposit slip#52202875778. The revised label claim
is as under:
Itopride hydrochloride………………….50mg
• Firm have submitted 1st page of form 5 as per prescribed format
Decision: Approved with innovator’s specifications and following label claim:
Itopride hydrochloride………………….50mg
Firm shall submit the fee of Rs. 22,500/- for correction/pre-approval change in composition
(correction/change of salt form of the drug substance), as per notification No.F.7-11/2012-B&A/DRAP
dated 13-07-2021.
405. Name and address of manufacture / M/s Aulton Pharmaceuticals., Plot No. 84/1, Block A, Phase V,
Applicant Industrial Estate, Hattar, K.P.K
Brand Name + Dosage Form and Diclo injection 75mg
Strength
Composition Each injection contains:
Diclofenac sodium………75mg
Dairy No. date of R &I fee Form-5 Dy.No 24089 dated 11-07-2018 Rs.20,000/- Dated 11-
07-2018
Type of form Form 5
Pack size and Demand Price 3mlx5’s; As per SRO
Approval status of product in Reference Econac 75mg/3ml Solution for Injection MHRA Approved
Me-too-status Difisal 75mg/3ml Injection by M/s Iqra Pharmaceuticals (Reg#
097721)
inspection was:
As per observations made during inspection, the manufacturing,
quality control and environmental facilities, provided the
qualified staff employed, the documentation maintained,
implementation of the SOP’s the GMP compliance status of the
firm M/s Aulton Pharma is found to be satisfactory.
Previous Remark of the Evaluator XI • The firm have claimed for USP specifications and the
official monograph is not available in any pharmacopeia.
• The applied label claim is not as per reference formulation.
Revise the label claim as per reference formulation along
with submission of applicable fee.
• Provide evidence of required manufacturing facility/section
approval letter
• Revision of the label claim as per reference formulation along
with submission of applicable fee.
• Evidence of required manufacturing facility / section from
Licensing Division.
Evaluation by PEC • The firm have revised the label claim and mentioned the per
reference formulation along with submission of Rs. 7500/- on
Each 3ml ampoule contains:
• The firm have submitted cGMP certificate issued on 04-06-2021
based on inspection conducted on 11-12-2020 showing presence
of Liquid Injectable general section.
Decision: Approved with innovator’s specifications and following label claim:
406. Name and address of manufacture / M/s Hi-Med Pharmaceuticals., 208C Sunder Industrial Estate,
Brand Name + Dosage Form and Medonac 75mg Tablet
Strength
Composition Each enteric coated tablet contains:
Diclofenac sodium……………..75mg
2019
Pharmacological Group NSAIDS
Type of form Form-5
Pack size and Demand Price 2x10’s; As per SRO
Approval status of product in Reference VOLTAREN (25mg, 50mg, 75mg) Delayed Release/ enteric-
Regulatory Authorities coated tablets USFDA Approved
Discontinued **Federal Register determination that product was
not discontinued or withdrawn for safety or efficacy reasons**
Me-too-status Torelief 75mg Tablet by M/s Maple Pharmaceuticals (Reg.#
058203)
GMP Status The firm M/s Himed Pharma was inspected on 7.04.2018,
wherein grant of DML was recommended for 4 sections.
Previous Remark of the Evaluator XI • Revise the 1st page of form 5 as per approved format
• Undertaking at the end of form 5 is not signed by the technical
persons.
• All the details of form 5 submitted are of the wimits
pharmaceuticals, clarify?
Previous Decision (296-DRB) Deferred for clarification regarding submission of details of M/s
Wimits pharmaceuticals while applied product is for Hi-Med
Pharmaceuticals
Evaluation by PEC • Firm have submitted revised form 5 as per prescribed format and
undertaking at the end of form 5 signed by technical persons.
• The firm submitted that writing wrong name of company was a
typographical error and submitted revised documents.
Decision: Approved.
b. Deferred case of Priority Registration of Fludrocortisone tablets

The Drug Regulatory Authority of Pakistan in its 91st meeting held on 4th September 2020, exercising its power
under Rule 26 of Drugs (LRA) Rules amended vide SRO 713(I)/2018 dated 8th June, 2018, allowed to submit
registration applications on Form 5 / Form 5-A / Form 5-D instead of Form 5F, for Registration of
Fludrocortisone tablets in light of approvals granted by the reference regulatory authorities and with the
following additional conditions:
i. The applicants can submit their applications till 30-09-2020 and these applications will be considered
out of queue.
ii. Registration Board may consider grant of registration and submission of data of product development
and 6 months accelerated and 6 months real time stability studies data before sale of product along with
other data as may be required.
407. Name and address of manufacture / M/s Pharmix Laboratories Pvt Ltd., 21 Km, Ferozepur Road,
Applicant Lahore
Brand Name+Dosage Form+Strength Flocort 0.1mg Tablet
Fludrocortisone Acetate………………0.1mg
Dairy No. date of R &I fee Form-5D Dy.No 25619 dated 30-09-2020 Rs.50,000/- 30-09-2020
Pharmacological Group Mineralocorticoid
Type of form Form 5D
Approval status of product in Fludrocortisone Acetate 0.1mg Tablets MHRA Approved
Me-too-status
GMP Status The firm was inspected on 13.09.2019 with the following
recommendations:
The panel of inspector recommends the renewal of M/s Pharmix
Laboratories Pvt Ltd. Located at 21 Km, Ferozepur Road, Lahore
bearing DML No. 000397 subject to verification of all approved
sections by the licensing division, DRAP, Islamabad.
Previous Remark of the Evaluator XI • The firm have mentioned only generic name of product and does
not mentioned the dosage form, strength and brand name of drug
on fee challan
• The firm submitted letter No. F. 1-28/93-Lic issued by secretary
central licensing board dated 30-06-2020 confirming the
presence of tablet hormonal section and not tablet steroidal
section
Previous Decision (297-DRB) • Deferred for evidence of approval of required manufacturing
facility for the applied product.
Evaluation by PEC • The firm have submitted a letter stating that they are having
Steroidal Hormonal section (on section approval it is mentioned
Hormonal section as in 2008 there was no classification) and
having steroidal hormone products like methyl testosterone
tablets Registration No#064653 under manufacturing so as we are
having approved Steroidal Hormone section, and requested to
approve the applied product.
Decision: Deferred for evidence of approval of required manufacturing facility / section from Licensing
Division.
c. Deferred cases of Human Drugs on form 5F (Import)

408. Name, address of Applicant / Importer M/s Biocare Pharmaceutica. Address: 807 Shadman-1,
Lahore
Address: 807 Shadman-1, District Lahore.
Address of Godown: First floor B-C, Street No. 3, Near LGS
School, Shah Jamal District Lahore.
Validity: 17-04-2022.
Renewal: N/A. Valid Drug sales License is attached with
CTD dossier Module 1.
Name and address of marketing authorization Hainan Hualon Pharmaceutical Co., Ltd
holder (abroad) Address: - Pharmacy Valley Three Cross Road No.8,
Haikou National Hi-Tech Industrial Development Zone,
Hainan Province, China.
Name, address of manufacturer(s) Hainan Hualon Pharmaceutical Co., Ltd
Address: - Pharmacy Valley Three Cross Road No.8,
Haikou National Hi- Tech Industrial Development Zone,
Hainan Province, China.
Detail of certificates attached (CoPP, Free CoPP: Firm has submitted embassy attested copy of CoPP
sale certificate, GMP certificate) certificate (No.Hainan20200100) dated 25-11-2020 issued
by Hainan Medical Product Administration to M/s Hainan
Hualon Pharmaceutical Co., Ltd No. 8, Three Cross Road,
Medicine Valley, National Hi-Tech Industrial Development
Zone, Haikou, Hainan Province China for Aztreonam for
injection 1g. The CoPP confirms free sale status of the
product in exporting country as well as GMP status of the
manufacturing site through periodic inspection every year.
Firm has submitted embassy attested copy of GMP
certificate No. HI20180041 issued by Hainan Provincial
Medical Product Administration to M/s Hainan Hualon
Pharmaceutical Co., Ltd No. 8, Three Cross Road, Medicine
Valley, National Hi-Tech Industrial Development Zone,
Haikou, Hainan Province valid till 18/11/2023.
Details of letter of authorization / sole agency Firm has submitted copy of distribution and agency
agreement agreement contract signed by both parties Biocare
Pharmaceutica & Hainan Hualon Pharmaceutical Co., Ltd.
Agreement mention manufacturer Hualon Pharmaceutical
appoints M/s Biocare Pharmaceutica to register/market/sell
their product Aztreonam 1 gm in Pakistan and is valid for 5
years from the first day of month when distributor receives
registration certificate.
☒ Importer
☐ Export sale
☐ Buk import and local repackaging for export purpose only
The proposed proprietary name / brand name AZTAM, AZOM, AZENOT
Strength / concentration of drug of Active Each vial contains mixture of Aztreonam and Arginine
Pharmaceutical ingredient (API) per unit equivalent to Aztreonam 1.0g
Pharmaceutical form of applied drug Sterile powder for injection
white or off-white powder or loose cake in 10ml tubular vial,
sealed with rubber stopper and aluminium-plastic
combination cap.
Pharmacotherapeutic Group of (API) Anti-infectives for systemic use-Monobactams
ATC code: J01DF01
Reference to Finished product specifications USP 39 &CP (Chinese Pharmacopeia)

Proposed unit price Rs 800/- single dose vial
The status in reference regulatory authorities Azactam (Aztreonam for injection) 1 gm by M/s Bristol
Myers Squibb Co., (USFDA Approved).
For generic drugs (me-too status) Azactam (Aztreonam) 1 gm Injection of Squibb (Karachi)
(Reg # 009002)
Firm has summarized information related to nomenclature,
and its validation, batch analysis and justification of
and stability studies of drug substance.
Name, address of drug substance Fuan Pharmaceutical Group Chongqing Bosen

manufacturer Pharmaceutical Co., Ltd;
Address: No.1, Huanan Yi Road, Changshou, Chongqing,
China
Module-III Drug Substance: Firm has submitted detailed drug substance data for both
sources related to nomenclature, structure, general
validation, batch analysis and justification of specification,
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of API
(Conditions & duration of Stability studies) at accelerated as well as real time conditions. The
accelerated study is complete for 3 batches at
40±2°C/75±5%RH (Batch No. Az(Ar)150101V，
Az(Ar)150102V，Az(Ar)150103V). The real time stability
data is conducted at 30±2°C/65±5%RH (Batch No.
Az(Ar)150101V，Az(Ar)150102V，Az(Ar)190101). The
stability study data of two batches is performed till 36
months while stability of one batch (No# Az(Ar)190101) is
performed upto 18th months
process validation, control of drug product, specifications,
analytical procedures, validation of analytical procedures,
batch analysis, justification of specifications, reference
standard or materials, container closure system and stability.
Pharmaceutical Equivalence and Comparative Firm has submitted Comparative Specifications of Test
Dissolution Profile performed with Reference Product Azactam (Aztreonam) 1
gm of Bristol Myers Squibb.
Analytical method validation/verification of Firm has submitted analytical method
product validation/verification studies for the applied product.
Container closure system of the drug product Low Borosilicate tubular vial, sealed with Halogenated
butyl rubber stopper, covered by aluminium-plastic
combination cap for antibiotic bottle
Stability study data of drug product, shelf life • Firm has submitted stability study data of 3 batches of
and storage conditions Aztreonam for Injection 1.0g vial. The firm has submitted
accelerated stability study data at 40°C ± 2°C / 75% ± 5%
RH for 6 months and real time stability study data at 30
°C ±2 °C / 65 % ± 5%RH for 24 months.
•
Batch No. Mfg. Date Initiation date
20181201 Dec.12, 2018 Dec.12, 2018
20190101 Jan.4, 2019 Jan.4, 2019
20190102 Jan.4, 2019 Jan.4, 2019
Evaluation by PEC XI:
1.3 Provided form 5F is from the New Form 5F duly signed/stamped by Drug Sale
manufacturer / Marketing authorization License holder Biocare Pharmaceutica is
holder side while it should be from the submitted
applicant holding the Drug sale license.
1.3.4 Provide valid legalized GMP certifcate Title as per Online Link:
from the manufacturer as the name and Hainan Huanglong Pharmaceutical Co., Ltd.
adress of manufacturer in the submitted Address: No. 8, Sanheng Road, Yaogu, National
GMP is different from the one verified High-tech Industrial Development Zone, Haikou,
from China CFDA website Hainan Province
Title as per submitted GMP:
Hainan Hualon Pharmaceutical Co., Ltd
Address: No. 8, Three Cross Road, Medicine
Valley, National Hi-Tech Industrial Development
Zone, Haikou, Hainan Province
The firm submitted that they have two
manufacturing site;
1. Pharmacy Valley Three Cross Road No.8,
Haikou National Hi- Tech Industrial
Development Zone, Hainan Province
2. Guilinyang Economic Development Area,
Haikou Hainan (for tablets).
Aztreonam for injection is in 1st manufacturing
address.
1.5.6 In Form 5F you have mentioned both Manufacturer/In-house quality specifications
USP 39 &CP (Chinese Pharmacopeia) referenced USP39 and Chinese Pharmacopoeia
reference for the product under section parameters/limits
1.5.6. specify a particular specification Referencing USP and Chinese Pharmacopoeia,
for applied product. we established our enterprise quality
specifications. Our enterprise quality
specifications are stringent in which limits or
parameters comply with both USP and Chinese
Pharmacopoeia reference standard. For the
critical items, our enterprise specifications are
equivalent to, or even stricter than USP. For
example, pH, sterile, water, related substances are
equivalent to USP., while bacterial endotoxins
and assay are stricter than USP. Below reference
is given for DRAP reference.
Submit valid and original product Valid notarized product specific Soles agency
specific sole agency agreement/ letter of agreement duly signed/stamped by both Biocare
authorization for applied product Pharmaceutica & manufacturer Hainan Hualon
Pharmaceutical Co., Ltd is submitted.
1.5.15- Commitments must be submitted by Commitments is submitted by applicant
1.5.19 applicant (marketing authorization (marketing authorization Holder)
3.2.S.4.2.2 Chromatographic conditions e.g. mobile We have separately tested the same batch of
phase is not same as mentioned in USP aztreonam under chromatographic conditions of
monograph of aztreonam for injection, Chinese pharmacopoeia and USP.
clarify? The study shows that, under the chromatographic
conditions of Chinese pharmacopoeia, the peak
shape of each compound is better than that of
USP, and the number of impurities detected and
the resolution of each compound are better than
those under the USP test methods. Therefore, our
mobile phase adopts the chromatographic
conditions of Chinese pharmacopoeia.
3.2.S.7.3 Long term stability data of drug The dossier was submitted in the year 2020 and
substance batch No. Az(Ar)190101 is the batch No. Az(Ar)190101 was manufactured in
performed upto 18th months only in the year 2019, so we could only submitted 18th
months data then and did not submit complete 36th
months stability data.
Now we submit 24th months stability data No.
Az(Ar)190101 and complete 36th months stability
data of Az(Ar)150103V.
3.2.S.7.3 Stability study data of one different batch At that time, the batch number of three batches of
of drug substance is performed at real long term stability data which were provided to us
time and accelerated conditions by the API manufacturer were Az(Ar)150101V，
Az(Ar)150102V，Az(Ar)190101). We directly
quoted these three batches of long-term stability
data without careful consideration.
To reply this point, we asked the API
manufacturer to provide us the complete data of
Az(Ar)150103V. The long-term stability data of
same batch is submitted
3.2.P.1 Quantity of arginine is not mentioned in We use mixture of aztreonam and arginine
composition? (premixed by API manufacturer). The quantity of
aztreonam: arginine is 1:0.78, which is same as
the originator (Bristol-Myer Squibb Company
USA).
So, in one vial there are 1.0g aztreonam and 0.78g
arginine
3.2.P.1 Provide information including type of The firm submitted that their product Aztreonam
diluent, its composition, quantity or Sterile powder for injection will be supplied to
volume, specifications (as applicable) Biocare Pharmaceutica in a pack that only contain
and regulatory status in Pakistan (as Aztreonam Vial without any diluent. We are not
applicable) for the diluent which is to be providing any diluent. Our pack only contains
provided along with the applied drug. Aztreonam Vial.
3.2.P.5.2 Chromatographic conditions e.g. mobile We have separately tested the same batch of
phase is not same as mentioned in USP aztreonam under chromatographic conditions of
monograph of aztreonam for injection, Chinese pharmacopoeia and USP.
clarify? The study shows that, under the chromatographic
conditions of Chinese pharmacopoeia, the peak
shape of each compound is better than that of
USP, and the number of impurities detected and
the resolution of each compound are better than
those under the USP test methods. Therefore, our
mobile phase adopts the chromatographic
conditions of Chinese pharmacopoeia.
Note that the chromatographic conditions of the
injection and its API is the same because the
injection is produced by simply filling the API
into the bottle without adding any other
excipients.
Previous Decision Deferred for clarification as the name and address mentioned on submitted GMP is different
(316-DRB): from the name and address verified from online weblink of the “NMPA” of China.
Evaluation by PEC The firm submitted that name and address of the manufacturer in weblink of NMPA of China
to those submitted in GMP is same upon verification. Difference in address in English version
of NMPA weblink might be due to translation error or confusion might be due to shorter
version of address given on GMP certificate. In Chinese version of NMPA website, address
mention in GMP certificate and on NMPA weblink is same. There is no difference in address.
Hence, it is confirmed from our end after verification, name and address mentioned on
submitted GMP is same as the name and address given on weblink of NMPA
Decision: Approved with USP specifications and as per Policy for inspection of Manufacturer abroad and
verification of local storage facility.
• Firm shall submit the fee of Rs. 7,500/- for correction/pre-approval change/ in product specifications, as per
409. Name and address of manufacture / M/s MTI Medical Pvt Ltd.
Applicant 586-587, Sundar Industrial Estate, Lahore, Pakistan
Brand Name + Dosage Form and Pioglet 30mg Tablet
Strength
Pioglitazone as HCl….…30mg
03-2019
Pharmacological Group Thiazolidinediones
Type of form Form 5
Pack size and Demand Price 1x14’s; As per SRO
Approval status of product in Reference ACTOS (15mg, 30mg, 45mg) tablets USFDA approved
Me-too-status Glzone 30mg Tablet by M/s Innvotek Pharmaceuticals,
(Reg#099251)
GMP Status GMP certificate issued on 25.11.2020 based on inspection
conducted on 23.11.2020
Previous Remark of Evaluator XI • The firm have removed coating composition from master
formulation, however the firm did not submit revised
manufacturing outline. Furthermore, firm have not adjusted
the weight of pioglitazone in master formulation without
considering the salt factor
Previous Decision (316-DRB) • Deferred for adjustment of the weight of pioglitazone in master
formulation without considering the salt factor and revision of
manufacturing outline as per innovator product.
• Furthermore, firm shall submit fee of Rs. 7,500 for
correction/pre-approval change in Form-5 (correction/pre-
approval change in master formulation & manufacturing
method), as per notification No.F.7-11/2012-B&A/DRAP dated
13-07-2021.
Evaluation by PEC • The firm have adjusted the weight of pioglitazone in master
formulation after considering the salt factor and submitted
revised manufacturing outline along with submission of Rs.
7500/- on deposit slip #36322906059.
Decision: Approved. Firm shall submit the fee of Rs. 22,500/- for correction/pre-approval change in
composition (correction/change of salt factor and adjustment of weight in master formulation), as per
Agenda of Evaluator PEC-XIII.
Registration applications of locally manufactured New License / New Section on form 5F.
Firm has submitted copy of Acknowledgment of receipt of application for grant of additional section under DML
No. 000465 (Formulations) to M/s Well Care Pharmaceuticals (Pvt.) Ltd., dated 24-11-2021 from Secretary
Central Licensing Board. The letter specifies that CLB in its 283rd meeting held on 28-10-2021 has approved the
grant of following additional section to M/s Well Care Pharmaceuticals (Pvt.) Ltd., A/7, Small Industrial Estate,
Lahore Road, Sargodha:
1. Capsule (General) New.
410. Name, address of Applicant / Marketing M/s Well care Pharmaceuticals (Pvt.) Ltd., A/7,
Authorization Holder Small Industrial Estate, Lahore Road, Sargodha.
Name, address of Manufacturing site. M/s Well care Pharmaceuticals (Pvt.) Ltd., A/7,
Small Industrial Estate, Lahore Road, Sargodha.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 12631: dated 24-03-2022.
Details of fee submitted PKR 30,000/-: dated 21/02/2022.
The proposed proprietary name / brand name Tzole 20mg Capsule.
Pharmaceutical ingredient (API) per unit Omeprazole (as enteric coated pellets) ………..
20mg
Pharmaceutical form of applied drug Oral capsule
Pharmacotherapeutic Group of (API) Proton Pump Inhibitor.
Reference to Finished product specifications USP Specifications.
Proposed Pack size 14’s.
Proposed unit price As per SRO.
The status in reference regulatory authorities Omeprazole 20mg delayed release capsule,
USFDA Approved.
For generic drugs (me-too status) Helezol 20mg Capsule, Focus & Rulz, Reg. No.
027104.
GMP status of the Finished product manufacturer Not submitted.
Evidence of section approval. Capsule (general) - New section approved vide
No.F.1-12/97-Lic (Vol-II) dated 24-11-2021.
Name and address of API manufacturer. Pharmazone Chemicals (Pvt.) Ltd., Plot No. 37,
Sundar Industrial Estate, Lahore.
template. Firm has summarized information
related to nomenclature, structure, manufacturers,
and its validation, batch analysis and justification
substance and drug product.
Module III (Drug Substance) Firm has submitted detailed data for drug
general properties, solubility, physical form,
process and controls, specifications, analytical
drug substance.
Stability studies (Drug substance.) Firm has submitted stability study data of 3
batches of drug substance at both accelerated as
well as real time conditions. The accelerated
stability data is conducted at 40°C ± 2°C / 75% ±
5% RH for 6 months. The real time stability data
is conducted at 30°C ± 2°C / 65 ± 5% RH for 36
months.
Batches: (OEC-8.5-001, OEC-8.5-002 & OEC-
8.5-003)
Module-III (Drug Product): Firm has submitted data of drug product including
development, manufacture, manufacturing
process and process control, process validation
protocols, control of excipients, control of drug
product, specifications, analytical procedures,
validation of analytical procedures, batch analysis,
justification of specifications, reference standard
or materials, container closure system and
stability.
dissolution profile equivalence for quality tests (Description,
identification, Average weight, dissolution &
assay) for their product against Omega 20mg
Capsule.
Firm has submitted CDP against the same brand
i.e. Omega 20mg Capsule manufactured by the
Ferozesons. However, no strength, Batch number,
manufacturing date, Expiry date etc. are
mentioned.
Analytical method validation/verification of Not submitted.
product
Manufacturer of API Pharmazone Chemicals (Pvt.) Ltd., Plot No. 37, Sundar
Industrial Estate, Lahore.
API Lot No. OEC-08-040.
Description of Pack
14 capsules are packed in Alu-Alu plain in packing box.
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH
Batch No. T1/21 T2/21 T3/21
No. of Batches 03
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board.
1. Reference of previous approval of applications with N/A
2. Approval of API/ DML/GMP certificate of API Firm has submitted GMP certificate No.43/2022-
manufacturer issued by concerned regulatory DRAP (AD-00196339815-153) dated 07-04-2022
authority of country of origin. on the basis of inspection conducted on 30-03-
2022.
3. Documents for the procurement of API with Firm has submitted commercial invoice No. 0571
approval from DRAP (in case of import). dated 01-10-2021 of pharma zone chemical (Pvt.)
Limited with buyer’s name of Well care
pharmaceuticals mentioning 1kg quantity of each
8.5% Omeprazole pellets & 22.5% pellets of
Omeprazole.
5. Compliance Record of HPLC software 21CFR & Firm has submitted that their system is not 21 CFR
audit trail reports on product testing compliant.
6. Record of Digital data logger for temperature and Not Submitted
and accelerated)
Remarks by the Evaluator:
Sr. Section Observation Submission by the firm.
No. number
1. 1.3.4 • Valid copy of DML of the Copy of DML is submitted which is not in
manufacturer shall be submitted. readable form.
• GMP certificate/last inspection One page of inspection report is submitted
report of the drug product conducted on 10-09-2021 signed by only one
manufacturer shall be submitted. member out the three panel members wherein
following is recommended;
“Panel recommended resumption of
production and grant of new capsule section.
Detailed report was prepared on prescribed
format and copy was handed over to the firm
for record and reference.”
2. 2.3 Table for literature references of the Firm has submitted that omeprazole pellets
drug substance has mentioned drug specification is manufacturer specifications
substance in different pharmacopoeias. and pharmacopoeial specifications were
Clarification shall be submitted. typographical error.
No revised table for literature references has
been submitted by the firm.
3. 3.2.S.1.3 General properties, solubilities and Submitted.
physical form related data for the drug
substance shall be submitted.
4. 3.2.S.4.1 • Finished product manufacturer has Firm has submitted that omeprazole pellets
submitted Specification as per USP specification is manufacturer specifications
for drug substance while there is no and pharmacopoeial specifications were
monograph for the pellets in the USP. typographical error.
No revised specifications are
provided/submitted by the firm.
5. 3.2.S.4.2 Analytical procedures submitted by the Firm has submitted that drug substance
drug product manufacturer are analytical procedure is manufacturer
completely different from drug specifications because Omeprazole EC pellets
substance manufacturer. Clarification is is not available in any pharmacopoeia.
required. However, new analytical procedure for the
drug substance as per manufacturer
specifications are not provided by the drug
product manufacturer.
6. 3.2.S.4.3 Verification studies of the drug Submitted.
substance performed by the finished
product manufacturer shall be
submitted.
7. .2.S.4.5. Justification of specifications has Firm has submitted that omeprazole pellets
declared USP specification. specification is manufacturer specifications
Clarification is required. and pharmacopoeial specifications were
typographical error.
8. 3.2.S.5 COA of the reference standard used Firm has submitted COA for the working
shall be submitted. standard for omeprazole.
However, the drug substance source as per
submitted dossier is M/s Pharmazone
Chemicals (Pvt.) Ltd., Plot No. 37, Sundar
Industrial Estate, Lahore while the submitted
COA is for M/s Vision Pharmaceuticals,
Islamabad.
9. 3.2.P.2 • Justification shall be submitted Firm has submitted that test is performed
regarding dissolution and assay of according to the monograph but this time is
the applied formulation in the typographical mistake.
pharmaceutical equivalence studies.
As the medium of the dissolution and
time are not in accordance with the
monograph.
• Justification shall be submitted for Firm has submitted new CDP results of the
not performing CDP against the applied formulation with Risek 20mg capsules
innovator product. in three mediums and the f2 values are in
acceptable range.
However, submitted results are for Tzole
40mg capsule instead of 20mg & at acidic
medium pH 1.2, results for only 45 minutes
time points are submitted instead of 2 hours.
Furthermore, pH of the medium is not
mentioned with the submitted results.
Firm has submitted that dissolution studies are

• Justify the condition of dissolution performed according to monograph; we have
used in comparative dissolution 5 sampling intervals in 0.1 N HCl and
studies. phosphate buffer pH 4.5 and phosphate buffer
pH 6.5.
Firm has submitted that it is a typographic
• Justification shall be submitted for error while the dissolution in 0.1 N HCl is
carrying dissolution studies up to 30 performing 120minutes.
minutes time point only in 0.1N HCl Initially submitted results have shown more
in Comparative Dissolution studies. than 10% release in 30 minutes while
actually there should be NMT 10% in initial
2 hours.
No details of the comparator product are
submitted.
• No data for the comparator product
for CDP has been submitted.
10. 3.2.P.3.2 Justification shall be submitted for use Firm has submitted that they have used
of Omeprazole powder in the master Omeprazole 8.5% Ec pellets in the
formulation. formulation. Omeprazole powder was
11. 3.2.P.5.1 • Specification provided for the drug No reply/justification is submitted against
product has not mentioned this point.
dissolution at acidic stage.
• Dissolution test shall be specified
whether test I or any of the other test No reply/justification is submitted against
is followed by the drug product this point.
manufacturer or otherwise.
12. 3.2.P.5.2 Analytical procedures for the drug Firm has submitted that all stability studies
product are completely different from performed according to USP monograph.
the official monograph. Clarification is However, the conditions for dissolution test
required. and conditions for assay test applied by the
drug product manufacturer are completely
different from that of the USP monograph.
Standard solution, test soltion, wavelength
applied & injection volume etc. all are
different from USP.
13. 3.2.P.5.2 Analytical method Submitted.
validation/verification of product shall
be submitted.
14. 3.2.P.5.4 • Specification of dissolution test in Firm has submitted that all limits are
the batch analysis are without time mentioned in analytical procedures but
for buffer stage and without mistakenly not mentioned in batch analysis.
percentage for acid stage.
• Batch analysis has only buffer stage No reply submitted against this point.
dissolution results.
15. 3.2.P.8.1 • Stability summary and conclusion Firm has submitted that manufacturing date of
has manufacturing date of Jan-2022 their batches is October, 2021 but the January
with batch No. of RLE-001, RLE- 2021 is testing interval date.
002 & RLE-003 while the stability
data sheets have mentioned
manufacturing date of 10-2021 with
batch No. of T1/21, T2/21 & T3/21.
16. 3.2.P.8.3 • Stability data sheets have no Firm has submitted that details of dissolution
dissolution at acidic stage. at acidic and buffer stage are described in
Clarification is required. stability summary data sheets.
Stability summary sheets have only buffer
stage dissolution results dissolution stage
results are missing in stability summary data
sheets.
• Justification shall be submitted Firm has submitted that testing of the product
regarding the run time, injection is performed as per USP. The run time is about
volume and wavelength used for the 10 minutes and injection volume are 20µl and
assay of finished product as the flow rate is 1ml/min. column used is 4.6 mm
applied run time, injection volume x 15cm; 5µm packing L1 and detector is
and wavelength are different from 302nm.
that of the official monograph. However, in the submitted chromatograms
the conditions are different from that
mentioned in the official pharmacopoeia.
Official monograph has mentioned
wavelength of 305nm while firm has applied
302nm.
• Stability data sheets have mentioned Firm has submitted that stability raw data
weight of capsule as 295 while the sheets have two different weights one is
raw data has mentioned 235mg. content weight of pellets and second weight is
Clarification is required. gross weight with capsule shell.
• Dates in the submitted
chromatograms have been over No reply submitted against this point.
written by hand. Clarification shall
be submitted.
17. 3.2.P.8.3 Justification shall be submitted Firm has submitted that during stability
regarding the retention time of the studies they have used two different
omeprazole in the provided companies HPLC column in which one of that
chromatograms as two different have minimum 5000 number of theoretical
retention time are mentioned for the plates and other have less than 5000 plates due
same omeprazole. to which retention time have some difference.
Submitted chromatograph have shown two
different retention times for the omeprazole
i.e. 5minutes and 10 minutes.
18. • Compliance Record of HPLC Only one-page Esomeprazole capsule 06
software 21CFR & audit trail reports standard injection is provided.
on product testing. Not complete.
• Complete Record of Digital data Submitted.
logger for temperature and humidity
• Provide specifications of HPLC Only specifications of HPLC are provided
system with its model including while 21 CFR compliant certificate is not
information whether gradient or provided.
isocratic column, 21 CFR
compliance system.
• Raw data sheets for dissolution and Raw data sheets for dissolution and assay tests
assay test of the finished product are not provided by the firm.
shall be submitted with calculation
formula used.
• Justification shall be submitted for Firm has submitted that they have performed
the stability of both drug substance only drug product stability studies accelerated
and finished product that the values and real time in different intervals but we take
at both accelerated and real time are print out at same time after completion of
exactly similar at same time points. stability studies.
Real time and accelerated stability studies of
both the drug substance and drug product of
all three batches have exact similar values.
19. • Justification regarding the drug Firm has submitted that they purchased
substance shall be submitted with Omeprazole 8.5% and 22% each 1kg for three
respect to the total quantity of the trial batches. Total material use in trial batches
drug substance purchased and total for testing.
quantity used in manufacturing and Executed BMR’s have shown that in Tzole 20
testing of all the three trial batches of mg capsules 8.5% of pellets have been used.
Tzole 20mg capsule. Stability data sheets have three different
batches each with 4100 capsules batch size.
In this regard total number of capsules
manufactured are;
5600 x 3 = 12,300
Each 20mg capsule will have 235mg of
Omeprazole EC pellets.
12300 x 235 = 2,890,500 mg of pellets
2.89 kg pellets are required to fill the three
trial batches while firm has purchased only
1kg.
Decision: Registration Board decided to deferr the case for onsite verification and authenticity of the
submitted stability data due to following observtaions:
• Drug substance analytical procedure applied by the drug product manufacturer is different from
that applied by the drug substance manufacturer.
• Submitted COA of working standard is from M/s Vision Pharmaceuticals whereas drug substance
has been procured from M/s Pharmazone Chemicals.
• Submitted analytical record of CDP reflects that for pH 1.2, comparative dissolution studies have
been conducted for 45 minutes only while the limits are NMT 10% release in pH 1.2 for two hours.
• The analytical method for dissolution test and for assay test applied by the drug product
manufacturer are completely different in terms of run time, injection volume, wavelength, standard
solution preparation etc.., from that of the USP monograph as also evident from the submitted
HPLC chromatograms.
• Submitted HPLC chromatograms reflect two different retention time for 20mg and 40 mg
Omeprazole EC pellets. i.e. 5minutes and 10 minutes.
• Quantity of Omeprazole pellets procured, as evident from submitted invoice is not justified for the
manufacturing of trial batches of submitted batch size.
• Both accelerated and real time stability data sheets are having exactly similar values at same time
points.
• Drug product Batch analysis has only buffer stage dissolution results.
• Stability data sheets have mentioned weight of capsule as 295 while the raw data has mentioned
235mg. Clarification is required.
• Dates in the submitted chromatograms have been over written by hand.
• Raw data sheets for dissolution and assay tests are not provided by the firm.
• Stability data sheets have mentioned weight of capsule as 295 while the raw data has mentioned
235mg.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Rezole 40mg Capsule.
Pharmaceutical ingredient (API) per unit Omeprazole (as enteric coated pellets) ………..
40mg
Pharmaceutical form of applied drug Oral capsule
Pharmacotherapeutic Group of (API) Proton Pump Inhibitor.
The status in reference regulatory authorities Omeprazole 40mg delayed release capsule,
USFDA Approved.
For generic drugs (me-too status) Omega 40mg Capsule, Ferozsons Laboratories,
Reg. No. 050818.
drug substance.
months.
Batches: (OEC-22-001, OEC-22-002 & OEC-22-
003)
stability.
identification, Average weight, dissolution &
assay) for their product against Omega 40mg
Capsule.
Firm has submitted CDP against the brand i.e.
Risek 40mg Capsule manufactured by the Getz
pharma. Results of the f2 values are in acceptable
range.
product
API Lot No. OEC-22-015.
Description of Pack
2 blisters of 7’s capsules of Alu-Alu in single unit carton.
Batch No. RLE001 RLE002 RLE001
No. of Batches 03
2022.
Omeprazole.
and accelerated)
No. number
2. 2.3 Table for literature references of the Firm has submitted that omeprazole pellets
No revised table for literature references
has been submitted by the firm.
3. 3.2.S.1.3 General properties, solubilities and Submitted.
physical form related data for the drug
substance shall be submitted.
4. 3.2.S.4.1 • Finished product manufacturer has Firm has submitted that omeprazole pellets
submitted Specification as per USP specification is manufacturer specifications
for drug substance while there is no and pharmacopoeial specifications were
monograph for the omeprazole pellets typographical error.
in the USP. No revised specifications are
provided/submitted by the firm.
5. 3.2.S.4.2 Analytical procedures submitted by the Firm has submitted that drug substance
drug product manufacturer are different analytical procedure is manufacturer
from drug substance manufacturer. specifications because Omeprazole EC pellets
Clarification is required. is not available in any pharmacopoeia.
However, new analytical procedure for the
drug substance as per manufacturer
submitted.
7. .2.S.4.5. Justification of specifications has Firm has submitted that omeprazole pellets
declared USP specification. specification is manufacturer specifications
Clarification is required. and pharmacopoeial specifications were
8. 3.2.S.5 COA of the reference standard used Firm has submitted COA for the working
shall be submitted. standard for omeprazole.
However, the drug substance source as per
submitted dossier is M/s Pharmazone
Chemicals (Pvt.) Ltd., Plot No. 37, Sundar
Industrial Estate, Lahore while the submitted
COA is for M/s Vision Pharmaceuticals,
Islamabad.
9. 3.2.P.2 • Pharmaceutical equivalence studies Firm has submitted that it was typographic
are performed with Risek 40mg by error and pharmaceutical equivalence studies
Getz pharma while the results are are performed with Risek.
given for Omega 40mg by Ferozsons
laboratories. Clarification is
required.
• Justification shall be submitted for No reply submitted.
not performing CDP against the
innovator product.
• Justification shall be submitted Firm has submitted that test is performed
regarding dissolution and assay of according to the monograph but this time is
the applied formulation in the typographical mistake.
pharmaceutical equivalence studies.
As the medium of the dissolution and
time are not in accordance with the
monograph. Firm has submitted that dissolution studies are
performed according to monograph; we have
5 sampling intervals in 0.1 N HCl and
• Justify the condition of dissolution phosphate buffer pH 4.5 and phosphate buffer
used in comparative dissolution pH 6.5.
studies. Firm has submitted that it is a typographic
error while the dissolution in 0.1 N HCl is
performing 120minutes.
carrying dissolution studies up to 30
minutes time point only in 0.1N HCl
in Comparative Dissolution studies.
10. 3.2.P.5.2 • Analytical procedures for the drug No reply/justification submitted.
product are different from the official
monograph. Clarification is required.
• Assay in the official monograph is No reply/justification submitted.
through HPLC while applicant has
mentioned UV spectroscopy in its
analytical procedures. Clarification
shall be submitted.
11. 3.2.P.5.2 Analytical method
be submitted.
12. 3.2.P.5.4 • Specification of dissolution test in No reply/justification submitted.
the batch analysis are without time
for buffer stage and without
• Batch analysis has only buffer stage No reply/justification submitted.
dissolution results.
13. 3.2.P.8.3 • Stability data sheets have no No reply/justification submitted.
dissolution at acidic stage.
• Weight/10 capsule in the stability No reply/justification submitted.
data sheets is 268mg ± 10%.
Clarification shall be submitted in
this regard.
• Raw data sheets for stability has No reply/justification submitted.
mentioned label claim of 20mg.
clarification shall be submitted.
• Justification shall be submitted No reply/justification submitted.
regarding the run time for the assay
of finished product as the applied run
time is different from that of the
official monograph.
• Justification regarding the drug No reply/justification submitted.
substance shall be submitted with
respect to the total quantity of the
drug substance purchased and total
quantity used in manufacturing and
testing of all the three trial batches of
Rezole 40mg capsule.
14. 3.2.P.8.3 Justification shall be submitted No reply/justification submitted.
regarding the retention time of the
omeprazole in the provided
chromatograms as two different
retention time are mentioned for the
same omeprazole.
15. • Compliance Record of HPLC No reply/justification submitted.
software 21CFR & audit trail reports
on product testing.
No reply/justification submitted.
• Complete Record of Digital data
monitoring of stability chambers No reply/justification submitted.
• Provide specifications of HPLC
system with its model including
information whether gradient or
compliance system. No reply/justification submitted.
• Raw data sheets for dissolution and
assay test of the finished product
shall be submitted with calculation No reply/justification submitted.
formula used.
the stability of both drug substance
and finished product that the values
at both accelerated and real time are
exactly similar at same time points.
Decision: Registration Board decided to deferr the case for onsite verification and authenticity of the
• Submitted COA of working standard is from M/s Vision Pharmaceuticals whereas drug substance
has been procured from M/s Pharmazone Chemicals.
• Assay in the official monograph is through HPLC while applicant has mentioned UV spectroscopy
in its analytical procedures.
• The analytical method for dissolution test and for assay test applied by the drug product
manufacturer are completely different in terms of run time, injection volume, wavelength, standard
solution preparation etc.., from that of the USP monograph as also evident from the submitted
HPLC chromatograms.
• Submitted HPLC chromatograms reflect two different retention time for 20mg and 40 mg
Omeprazole capsule.
• Quantity of Omeprazole pellets procured, as evident from submitted invoice is not justified for the
• Drug product Batch analysis has only buffer stage dissolution results.
• Dates in the submitted chromatograms have been over written by hand.
• Raw data sheets for dissolution and assay tests are not provided by the firm.
• Stability data sheets have no dissolution at acidic stage. Clarification is required.
• Raw data sheets for stability has mentioned label claim of 20mg.
• In performance of Assay test the applied run time is different from that of the official monograph.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name ESOWELL 20mg Capsule
Pharmaceutical ingredient (API) per unit Esomeprazole magnesium trihydrate enteric
coated pellets Eq. to Esomeprazole
……………….. 20mg
Pharmaceutical form of applied drug Blue & Transparent colored Delayed Release
Capsules
Pharmacotherapeutic Group of (API) PPI (Proton Pump Inhibitors).
Proposed Pack size 2×7
The status in reference regulatory authorities Nexium 40mg & 40mg delayed release capsule,
USFDA Approved.
For generic drugs (me-too status) Nexum 20mg Capsule, Getz Pharma, Reg. No.
033890.
general properties, solubility, manufacturers,
substance.
months.
Batches: (EEC-22-002, EEC-22-003 & EEC-22-
004)
stability.
identification, Weight variation, Loss on drying,
Uniformity of dosage unit, dissolution & assay)
for their product against Nexum 20mg capsules
manufactured by Getz Pharma.
i.e. Nexum 20mg capsules (B. No. 384C12)
product
API Lot No. EEC-22-222.
Description of Pack 14 capsules are blistered in Alu-Alu foil and with aluminum
(Container closure system) foil.
Batch No. EW1 EW2 EW3
No. of Batches 03
2022.
Esomeprazole.

and accelerated)
No. number
• GMP certificate/last inspection report One page of inspection report is submitted
of the drug product manufacturer shall conducted on 10-09-2021 signed by only one
be submitted. member out the three panel members wherein
2. 1.5.15 – All the commitments submitted are Signed commitments are submitted by the
1.5.19 unsigned. Signed commitments shall be firm.
submitted.
3. 2.3 Table for literature references of the Firm has submitted that esomeprazole pellets
4. 3.2.S.4.1 Finished product manufacturer has Firm has submitted that it was typographical
submitted Specification as per USP for error while the specifications of the
drug substance while there is no Esomeprazole pellets are manufacturer
monograph for the pellets in the USP. specifications.
Clarification is required. However, new specifications for the drug
substance as per manufacturer
5. 3.2.S.4.2 • Analytical procedure for drug Firm has submitted that drug substance
substance provided by the finished analytical procedure is manufacturer
product manufacturer is completely specifications.
different from that of drug substance However, new analytical procedure for the
manufacturer. Clarification shall be drug substance as per manufacturer
submitted. specifications are not provided by the drug
• Drug substance has mentioned assay Firm has submitted that manufacturer have
by HPLC while finished product two testing methods one that on HPLC &
manufacturer has mentioned UV other on UV and we have used HPLC method
spectroscopy. Clarification shall be of testing for the drug substance testing.
submitted.
• Justify the preparation of standard Firm has submitted that manufacturer has
solution and sample solution in used omeprazole working standard against
dissolution test of analytical Esomeprazole test in assay and dissolution but
procedure with respect to the drug we have used esomeprazole working standard
substance manufacturer. for the testing of Esomeprazole EC pellets.
Completly different from manufacturer of
drug substance.
submitted.
7. 3.2.S.4.5. Justification of specifications for the Submitted.
drug substance shall be submitted.
8. 3.2.S.5 COA of the reference standard used Submitted.
shall be submitted.
9. 3.2.P.2 • Standard Operating procedure for No reply submitted.
product design and development is
for syrup and suspension dosage
form.
not performing CDP against the applied formulation with Nexum 20mg
innovator product. capsules in three mediums and the f2 values
are in acceptable range.
However, at acidic medium pH 1.2, results
for only 45 minutes time points are submitted
instead of 2 hours.
Furthermore, submitted CDP results for
Esowell 20mg capsules are having 100%
similar results and values as that of
submitted results for Esocare 40mg.
• Justify the condition of dissolution No justification is submitted against this

used in comparative dissolution point. pH 7.3 and pH 11 are used in the
studies. method.
• Justify the analytical procedure for No justification is submitted against this
CDP as it has mentioned Phosphate point.
buffer of pH7.3, pH 11.
• Justify the results of CDP at acid No justification is submitted against this
stage as more than 10% of the drug is point.
released in 30 minutes.
10. 3.2.P.5.1 • Specification provided for the drug Firm has submitted that details of dissolution
product has not mentioned at acidic and buffer stage are described in
dissolution at acidic stage. stability summary data sheets.
sheets.
• Dissolution test shall be specified No justification is submitted against this
whether test I or any of the other test point.
is followed by the drug product
11. 3.2.P.5.2 • Calculation formula for assay test of No justification is submitted against this
the finished product is different from point.
USP. Clarification is required.
• Standard solution in dissolution test The manufacturer is using Omeprazole
is different from USP. Clarification working standard against Esomeprazole test
is required. in assay and dissolution but we have used
Esomeprazole working standard for the
testing of Esomeprazole EC pellets.
Omeprazole RS for preparation of standard
solution in the assay of Esomeprazole
delayed release capsule.
be submitted.
• Batch analysis has only buffer stage
dissolution results. Firm has submitted that details of dissolution
at acidic and buffer stage are described in
stability summary data sheets.
sheets.
sheets.
• Stability raw data sheets provided for Firm has submitted that stability raw data
EW1 & EW2 have two different sheets of EC1 & EC2 have two different
weight for the sample. Clarification weights one is content weight of pellets and
shall be submitted. second weight is gross weight with capsule
shell.
regarding the run time and injection is performed as per USP. The run time is
volume used for the assay of finished about 10 minutes and injection volume are
product as the applied conditions are 20µl and flow rate is 1ml/min. column used is
different from that of the official 4.6 mm x 15cm; 5µmpacking L1 and detector
monograph. is 302nm.
Conditions are different from official
monograph.
• Provide specifications of HPLC
system with its model including Only specifications of HPLC are provided
information whether gradient or while 21 CFR compliant certificate is not
isocratic column, 21 CFR provided.
compliance system.
• Raw data sheets for dissolution and
assay test of the finished product Raw data sheets for dissolution and assay
shall be submitted with calculation tests are not provided by the firm.
formula used.
the stability of finished product that No reply is submitted against this point.
the values at both accelerated and
real time are exactly similar at same
time points.
16. Justification regarding the drug Firm has submitted that they purchased
substance shall be submitted with Esomeprazole 8.5% and 22% each 1kg for
respect to the total quantity of the drug
three trial batches. Total material use in trial
substance purchased and total quantity batches for testing.
used in manufacturing and testing of allHowever, firm has not provided any
the three trial batches of Esowell 20mg document for purchase of 8.5%
capsule. Esomeprazole EC pellets.
Executed BMR’s have shown that in Esowell
20 mg capsules 22.5% of pellets have been
used. Stability data sheets have three
different batches each with 5600 capsules
batch size.
manufactured are;
5600 x 3 = 16800
Each 20mg capsule will have 88.8 mg of
Esomeprazole EC pellets.
16800 x 88.8 = 1,491,840 mg of pellets
1kg.
17. Justification shall be submitted Firm has submitted that the chromatograph of
regarding the chromatograms provided Esowell 20mg and Esocare 40mg are print on
for Esowell 20mg and Esocare 40 mg same date but the test is performed in different
capsules as chromatograms for both the dates.
products have same time and exact Chromatographs of both the 20mg and 40mg
values in respect of everything. Esomeprazole are complete copies in respect
of time, Areas of the sample and standards,
retentions time etc.
Decision: Registration Board decided to defer the case for onsite verification and authenticity of the
• The results of CDP at acid stage of different samples were more than 10% of the drug is released in
30 minutes.
• Firm has used Esomeprazole reference standard while Official monograph has mentioned
Omeprazole RS for preparation of standard solution in the dissolution test of Esomeprazole delayed
release capsule.
Omeprazole RS for preparation of standard solution in the assay test of Esomeprazole delayed
release capsule.
• Verification of chromatographic conditions used in the dissolution and assay test of the
Esomeprazole delayed release capsule from chromatograms in the HPLC software with reference
to official monograph.
• Quantity of Esomeprazole pellets procured, as evident from submitted invoice is not justified for the
points.
• The chromatograms for both Esomeprazole 20mg and 40mg capsules have same time and exact
values in respect of everything.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Esocare 40mg Capsule
Pharmaceutical ingredient (API) per unit Esomeprazole magnesium trihydrate enteric
coated pellets Eq. to Esomeprazole
……………….. 40mg
Pharmaceutical form of applied drug Delayed Release Capsules.
Pharmacotherapeutic Group of (API) PPI (Proton Pump Inhibitors).
Proposed Pack size 2×7
The status in reference regulatory authorities Nexium 40mg & 40mg delayed release capsule,
USFDA Approved.
For generic drugs (me-too status) Nexum 20mg Capsule, Getz Pharma, Reg. No.
033891.
general properties, solubility, manufacturers,
substance.
months.
Batches: (EEC-22-002, EEC-22-003 & EEC-22-
004)
stability.
identification, Weight variation, Loss on drying,
Uniformity of dosage unit, dissolution & assay)
for their product against Nexum 20mg capsules
i.e. Nexum 40mg capsules (B. No. 382C12)
product
API Lot No. EEC-22-222.
Description of Pack 14 capsules are blistered in Alu-Alu foil and with aluminum
(Container closure system) foil.
Batch No. EC1 EC2 EC3
No. of Batches 03
2022.
Esomeprazole.
and accelerated)
No. number
2. 1.5.15 – All the commitments submitted are Signed commitments are submitted by the
1.5.19 unsigned. Signed commitments shall be firm.
submitted.
3. 2.3 Table for literature references of the Firm has submitted that esomeprazole pellets
4. 3.2.S.4.2 • Analytical procedures for drug Firm has submitted that drug substance
substance provided by the finished analytical procedure is manufacturer
product manufacturer is completely specifications (In-house method).
different from that of drug substance However, new analytical procedure for the
manufacturer. Clarification shall be drug substance as per manufacturer
submitted. specifications are not provided by the drug
• Justify the preparation of standard Firm has submitted that manufacturer has
solution and sample solution in used omeprazole working standard against
dissolution test of analytical Esomeprazole test in assay and dissolution but
procedure with respect to the drug we have used esomeprazole working standard
substance manufacturer. for the testing of Esomeprazole EC pellets.
Completely different from manufacturer of
drug substance.
submitted.
6. 3.2.S.4.5. Justification of specifications for the Submitted.
7. 3.2.P.2 • Standard Operating procedure for No reply submitted.
product design and development is
for syrup and suspension dosage
form.
not performing CDP against the applied formulation with Nexum 20mg
innovator product. capsules in three mediums and the f2 values
are in acceptable range.
However, at acidic medium pH 1.2, results
for only 45 minutes time points are submitted
instead of 2 hours.
Furthermore, submitted CDP results for
Esocare 40mg capsules are having 100%
similar results and values as that of
submitted results for Esowel 20mg.
• Justify the condition of dissolution No justification is submitted against this

used in comparative dissolution point.
studies.
• Justify the analytical procedure for No justification is submitted against this
CDP as it has mentioned Phosphate point.
buffer of pH7.3, pH 11.
• Justify the results of CDP at acid No justification is submitted against this
stage as more than 10% of the drug is point
released in 30 minutes.
8. 3.2.P.5.1 • Specification provided for the drug Firm has submitted that details of dissolution
product has not mentioned at acidic and buffer stage are described in
dissolution at acidic stage. stability summary data sheets.
sheets.
• Dissolution test shall be specified No justification is submitted against this
whether test I or any of the other test point.
is followed by the drug product
9. 3.2.P.5.2 • Calculation formula for assay test of No justification is submitted against this
the finished product is different point.
from USP. Clarification is required.
• Standard solution preparation in The manufacturer is using Omeprazole
dissolution test is different from working standard against Esomeprazole test
USP. Clarification is required. in assay and dissolution but we have used
Esomeprazole working standard for the
testing of Esomeprazole EC pellets.
Omeprazole RS for preparation of standard
solution in the assay of Esomeprazole
delayed release capsule.
be submitted.
• Batch analysis has only buffer stage Firm has submitted that details of dissolution
dissolution results. at acidic and buffer stage are described in
stability summary data sheets.
sheets.
12. 3.2.P.8.1 Stability summary and conclusion has Firm has submitted that manufacturing date of
manufacturing date of Jan-2022 with their batches is October, 2021 but the January,
batch No. of RLE-001, RLE-002 & 2021 is a testing interval date.
RLE-003 while the stability data sheets
have mentioned manufacturing date of
10-2021 with batch No. of T1/21, T2/21
& T3/21. Clarification is required.
sheets.
• Stability raw data sheets provided for Firm has submitted that stability raw data
EC1 & EC2 have two different sheets of EC1 & EC2 have two different
weight for the sample. Clarification weights one is content weight of pellets and
shall be submitted. second weight is gross weight with capsule
shell.
regarding the run time and injection is performed as per USP. The run time is
volume used for the assay of finished about 10 minutes and injection volume are
product as the applied conditions are 20µl and flow rate is 1ml/min. column used is
different from that of the official 4.6 mm x 15cm; 5µm packing L1 and detector
monograph. is 302nm.
Conditions are different from official
monograph.
• Provide specifications of HPLC Only specifications of HPLC are provided
system with its model including while 21 CFR compliant certificate is not
information whether gradient or provided.
compliance system.
• Raw data sheets for dissolution and Raw data sheets for dissolution and assay
assay test of the finished product tests are not provided by the firm.
shall be submitted with calculation
formula used.
15. Justification regarding the drug Firm has submitted that they purchased
substance shall be submitted with Esomeprazole 8.5% and 22% each 1kg for
respect to the total quantity of the drug three trial batches. Total material use in trial
substance purchased and total quantity batches for testing.
used in manufacturing and testing of all However, firm has provided the documents
the three trial batches of Esocare 40mg for 22.5% esomeprazole only for 1kg
capsule. quantity. Executed BMR’s have shown that
in Esocare 40 mg capsules 22.5% of pellets
have been used. Stability data sheets have
three different batches each with 5600
capsules batch size.
manufactured are;
5600 x 3 = 16800
Each 40mg capsule will have 177.7mg of
Esomeprazole EC pellets.
16800 x 177.7 = 2,985,360 mg of pellets
1kg.
16. Justification shall be submitted Firm has submitted that the chromatograph of
regarding the chromatograms provided Esowell 20mg and Esocare 40mg are print on
for Esowell 20mg and Esocare 40 mg same date but the test is performed in different
capsules as chromatograms for both the dates.
products have same time and exact Chromatographs of both the 20mg and 40mg
values in respect of everything. Esomeprazole are complete copies in respect
of time, Areas of the sample and standards,
retentions time etc.
Decision: Registration Board decided to defer the case for onsite verification and authenticity of the
• The results of CDP at acid stage of different samples were more than 10% of the drug is released in
30 minutes.
Omeprazole RS for preparation of standard solution in the dissolution test of Esomeprazole delayed
release capsule.
Omeprazole RS for preparation of standard solution in the assay test of Esomeprazole delayed
release capsule.
• Verification of chromatographic conditions used in the dissolution and assay test of the
Esomeprazole delayed release capsule from chromatograms in the HPLC software with reference
to official monograph.
• Quantity of Esomeprazole pellets procured, as evident from submitted invoice is not justified for the
points.
The chromatograms for both Esomeprazole 20mg and 40mg capsules have same time and exact values in
respect of everything.
On the recommendations of panel of experts, the CLB in its 273rd meeting held on 15th January, 2020 has
considered and approved the grant of Drug Manufacturing License by way of formulation with following four
sections:
i. Tablet Section (General)
ii. Capsule Section (General)
iii. Sachet Section (General)
iv. Dry powder injection section (pre-lyophilized) vial
414. Name, address of Applicant / Marketing Variant Pharmaceuticals (Pvt.) Ltd., Plot # 5 M-2,
Authorization Holder Pharmazone, 26Km Lahore-Sharaqpur road,
Sheikhupura, Sheikhupura.
Name, address of Manufacturing site. Variant Pharmaceuticals (Pvt.) Ltd., Plot # 5 M-2,
Pharmazone, 26Km Lahore-Sharaqpur road,
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Levosulpiride 25mg Tablet
Strength / concentration of drug of Active Each tablet contains Levosulpiride …….. 25mg
Pharmaceutical form of applied drug Tablet.
Pharmacotherapeutic Group of (API) Antipsychotic.
Reference to Finished product specifications Innovator’s specifications
The status in reference regulatory authorities Levosulpiride 25mg tablet, AIFA ITALY Approved.
For generic drugs (me-too status) Syconor Tablet 25mg, Opal Laboratories, Reg. No.
096116.
GMP status of the Finished product New license granted on 13/02/2020.
manufacturer General Tablet, General Capsule, General Sachet and
General dry powder injectable (pre-lyophilized) Vial.
Evidence of section approval. Tablet general section is approved vide letter No. F.1-
1/2016/Lic. Dataed 24-02-2020.
Name and address of API manufacturer. Alcon Biosciences Private Limited,
A-1/2104, phase III, GIDC, Vapi, Gujarat –396 195
India.
nomenclature, structure, manufacturers, description
drug product.
Module III (Drug Substance) Official monograph of Levosulpiride is not present in
USP/BP. The firm as submitted detail of
tests for impurity & related substances, specifications,
Stability studies (Drug substance.) Firm has submitted stability study data of 3 batches
time conditions.
The accelerated stability data is conducted at 40°C ±
2°C / 75% ± 5% RH for 6 months.
The real time stability data is conducted at 30°C ± 2°C
/ 65 ± 5% RH for 48 months.
Batches:(ALC/LSP/180304, ALC/LSP/180305,
ALC/LSP/180306).
Module-III (Drug Product): Firm has submitted data of drug product including its
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence is established against the
dissolution profile brand that is LEVOPRAID 25 mg Tablets by M/s
Pacific Pharma (Pvt.) Ltd., B. No. AQ2309Q by
performing quality tests (description, Assay,
Dissolution).
is LEVOPRAID 25 mg Tablets by M/s Pacific
Pharma (Pvt.) Ltd., in Acid media (pH 1.2), Acetate
buffer (pH 4.5) & Phosphate Buffer (pH 6.8).
Manufacturer of API Alcon Biosciences Private Limited, A-1/2104, phase III, GIDC, Vapi,
Gujarat –396 195 India.
API Lot No. 31L01Z2122-001.
Description of Pack White colored round, biconvex, plain on the both sides core tablet,
(Container closure system) blistered in Alu-Alu.
Batch No. T-001 T-002 T-001
Batch Size 2000 Tablets. 2000 Tablets. 2000 Tablets.
No. of Batches 03
1. Reference of previous approval of applications N/A
2. Approval of API/ DML/GMP certificate of API Firm has submitted Copy of GMP certificate No. S-
manufacturer issued by concerned regulatory GMP/20102297 in the name of Alcon Biosciences
authority of country of origin. Private Limited, A-1/2104, phase III, GIDC, Vapi,
Gujarat –396 195 India issued by the Food & Drug
Control Administration Gandhinagar, Gujarat State,
India valid till 21-10-2022.
3. Documents for the procurement of API with Firm has submitted Invoice No. ALC/20210215
approval from DRAP (in case of import). wherein quantity of 1.1kg of Levosulpiride for
test/analysis is imported by the firm.
The invoice is signed and stamped by the Assistant
Director I&E, DRAP, Lahore dated 28-07-2021.
chromatograms,
5. Compliance Record of HPLC software 21CFR N/A
Sr. Section Observation Response by the firm
No.
1. 3.2.S.4.1 Specifications of the drug substance Firm has submitted specification for drug
by the finished product manufacturer product instead of Drug substance.
shall be submitted.
2. 3.2.S.4.2 Analytical procedures for the dug Submitted.
substance by the finished product However, the assay method in the analytical
manufacturer shall be submitted. procedure submitted by the drug product
manufacturer is by UV method and HPLC
method while the drug substance has
mentioned potentiometric method for the
assay of the drug substance.
substance performed by the drug
submitted.
4. 3.2.S.4.4 Analytical record for the drug Firm has submitted analytical record for the
substance shall be submitted. drug substance.
Submitted analytical has shown hand written
date of 16-08-2021 while the firm has also
submitted new COA with release date of 16-
08-2021.
However, in the initially submitted dossier,
COA with release date of 24-05-2021 was
submitted.
Furthermore, submitted chromatograms of the
drug substance in the analytical record
submitted by the firm has also shown
processing date of 22-05-2021.
5. 3.2.S.4.5 Justification of specifications for the Justifications of specification submitted by
drug substance shall be submitted. the firm has assay value of 98.5% - 101%
while the drug substance manufacturer has
assay limits of 99% - 101%.
6. 3.2.P.2.2 • Justification shall be submitted for Firm has submitted that according to WHO
not carrying the CDP against the technical report series, No. 902,2002, if the
innovator’s brand. innovator product is not available in the local
market you can use the market leader product.
They further submitted that in their case
Levopraid 25mg tablets manufactured by
Pacific pharmaceuticals under the license
from Ravizza pharmaceutici S.p.A. Milan,
Italy is considered appropriate for
pharmaceutical equivalence studies as this
product is currently widely used within our
local market and repute of company and the
product is also satisfactory.
• Calculation of F2 for CDP shall be Firm has submitted complete calculations of
submitted. F2 value for all the three mediums used in
CDP.
7. 3.2.P.8 Documents for the procurement of Firm has submitted commercial invoice No.
API with approval from DRAP AB/I/00001/21-22 dated 02-04-2021
mentioning the batch number of the mentioning 05kg of Levosulpiride, batch No.
drug substance shall be submitted. LSP/N/21/001, manufacturing date Feb, 2021
attested by Assistant Director I&E, DRAP,
Lahore dated 12-04-2021.
However, the API lot used in the formulation
development studies has batch number of
31L01Z2122-001.
Decision: Registration Board decided to defer the case for verification or submission of the following
points:
• COA of the drug substance initially submitted was having release date of 24-05-2021 while the
substance clearance (invoice) is signed and stamped by the Assistant Director I&E, DRAP, Lahore
dated 28-07-2021.
• Furthermore, submitted chromatograms of the drug substance in the analytical record submitted
by the firm has also shown processing date of 22-05-2021. Justification shall be submitted.
• API lot used in the formulation development studies has batch number of 31L01Z2122-001, while
firm has submitted commercial invoice No. AB/I/00001/21-22 dated 02-04-2021 mentioning 05kg
of Levosulpiride, batch No. LSP/N/21/001, manufacturing date Feb, 2021.
415. Name, address of Applicant / Marketing Variant Pharmaceuticals (Pvt.) Ltd., Plot # 5 M-2,
Authorization Holder Pharmazone, 26Km Lahore-Sharaqpur road,
Name, address of Manufacturing site. Variant Pharmaceuticals (Pvt.) Ltd., Plot # 5 M-2,
Pharmazone, 26Km Lahore-Sharaqpur road,
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Levosulpiride 50mg Tablet
Strength / concentration of drug of Active Each tablet contains Levosulpiride …….. 50mg
Pharmaceutical form of applied drug Tablet.
Pharmacotherapeutic Group of (API) Antipsychotic.
The status in reference regulatory authorities Levosulpiride 50mg tablet, AIFA ITALY Approved.
For generic drugs (me-too status) Levopraid 50mg tablets, Opal Laboratories, Reg. No.
019755.
GMP status of the Finished product New license granted on 13/02/2020.
manufacturer General Tablet, General Capsule, General Sachet and
General dry powder injectable (pre-lyophilized) Vial.
Evidence of section approval. Tablet general section is approved vide letter No. F.1-
1/2016/Lic. Dataed 24-02-2020.
Name and address of API manufacturer. Alcon Biosciences Private Limited,
A-1/2104, phase III, GIDC, Vapi, Gujarat –396 195
India.
nomenclature, structure, manufacturers, description
drug product.
Module III (Drug Substance) Official monograph of Levosulpiride is not present in
USP/BP. The firm as submitted detail of
tests for impurity & related substances, specifications,
Stability studies (Drug substance.) Firm has submitted stability study data of 3 batches
time conditions.
The accelerated stability data is conducted at 40°C ±
2°C / 75% ± 5% RH for 6 months.
The real time stability data is conducted at 30°C ± 2°C
/ 65 ± 5% RH for 48 months.
Batches:(ALC/LSP/180304, ALC/LSP/180305,
ALC/LSP/180306).
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence is established against the
dissolution profile brand that is LEVOPRAID 25 mg Tablets by M/s
Pacific Pharma (Pvt.) Ltd., B. No. AP0909Q by
performing quality tests (description, Assay,
Dissolution).
is LEVOPRAID 50 mg Tablets by M/s Pacific
Pharma (Pvt.) Ltd., in Acid media (pH 1.2), Acetate
buffer (pH 4.5) & Phosphate Buffer (pH 6.8).
Manufacturer of API Alcon Biosciences Private Limited, A-1/2104, phase III, GIDC, Vapi,
Gujarat –396 195 India.
API Lot No. 31L01Z2122-001.
Description of Pack White colored round, biconvex, plain on the both sides core tablet,
(Container closure system) blistered in Alu-Alu.
Batch No. T-001 T-002 T-003
Batch Size 2000 Tablets. 2000 Tablets. 2000 Tablets.
No. of Batches 03
1. Reference of previous approval of applications N/A
2. Approval of API/ DML/GMP certificate of API Firm has submitted Copy of GMP certificate No. S-
manufacturer issued by concerned regulatory GMP/20102297 in the name of Alcon Biosciences
authority of country of origin. Private Limited, A-1/2104, phase III, GIDC, Vapi,
Gujarat –396 195 India issued by the Food & Drug
Control Administration Gandhinagar, Gujarat State,
3. Documents for the procurement of API with Firm has submitted Invoice No. ALC/20210215
approval from DRAP (in case of import). wherein quantity of 1.1kg of Levosulpiride for
test/analysis is imported by the firm.
The invoice is signed and stamped by the Assistant
Director I&E, DRAP, Lahore dated 28-07-2021.
chromatograms,
5. Compliance Record of HPLC software 21CFR N/A
No.
1. 3.2.S.4.1 Specifications of the drug substance Firm has submitted specification for drug
by the finished product manufacturer substance.
shall be submitted. However, the assay limits provided by the
drug product manufacturer are 98.5% -
101% while that of the drug substance
manufacturer are 99% - 101%.
2. 3.2.S.4.2 Analytical procedures for the dug Not Submitted.
substance by the finished product
substance performed by the drug
submitted.
4. 3.2.S.4.4 Analytical record for the drug Firm has submitted analytical record for the
substance shall be submitted. drug substance.
Submitted analytical has shown hand written
date of 16-08-2021 while the firm has also
submitted new COA with release date of 16-
08-2021.
5. 3.2.S.4.5 Justification of specifications for the Not Submitted.
6. 3.2.P.2.2 • Justification shall be submitted for Firm has submitted that according to WHO
not carrying the CDP against the technical report series, No. 902,2002, if the
innovator’s brand. innovator product is not available in the local
market you can use the market leader product.
They further submitted that in their case
Levopraid 50mg tablets manufactured by
Pacific pharmaceuticals under the license
from Ravizza pharmaceutici S.p.A. Milan,
Italy is considered appropriate for
pharmaceutical equivalence studies as this
product is currently widely used within our
local market and repute of company and the
product is also satisfactory.
Firm has submitted complete calculations of
• Calculation of F2 for CDP shall be F2 value for all the three mediums used in
submitted. CDP.
7. 3.2.P.8 Documents for the procurement of Firm has submitted commercial invoice No.
API with approval from DRAP AB/I/00001/21-22 dated 02-04-2021
mentioning the batch number of the mentioning 05kg of Levosulpiride, batch No.
drug substance shall be submitted. LSP/N/21/001, manufacturing date Feb, 2021
attested by Assistant Director I&E, DRAP,
Lahore dated 12-04-2021.
However, the API lot used in the formulation
development studies has batch number of
31L01Z2122-001.
Decision: Registration Board decided to defer the case for verification or submission of the following
points:
• COA of the drug substance initially submitted was having release date of 24-05-2021 while the
substance clearance (invoice) is signed and stamped by the Assistant Director I&E, DRAP, Lahore
dated 28-07-2021.
• Furthermore, submitted chromatograms of the drug substance in the analytical record submitted
by the firm has also shown processing date of 22-05-2021. Justification shall be submitted.
• API lot used in the formulation development studies has batch number of 31L01Z2122-001, while
firm has submitted commercial invoice No. AB/I/00001/21-22 dated 02-04-2021 mentioning 05kg
of Levosulpiride, batch No. LSP/N/21/001, manufacturing date Feb, 2021.
Registration applications of locally manufactured (Human) drugs on Form 5F.

416. Name, address of Applicant / Marketing M/s Tabros Pharma (Pvt.) Ltd., L-20/B, Sector-22, F.B.
Authorization Holder Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Tabros Pharma (Pvt.) Ltd., L-20/B, Sector-22, F.B.
Industrial Area, Karachi.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 23870 dated 31-08-2021.
Details of fee submitted PKR 30,000/- dated 16-08-2021.
Elzanor 5mg/850mg Tablet.
name
Strength / concentration of drug of Each film coated tablet contains:
Active Pharmaceutical ingredient (API) Empagliflozin ……….………………5mg
per unit Metformin HCl ……………………….850mg
Pharmaceutical form of applied drug Immediate release film coated tablets.
Pharmacotherapeutic Group of (API) Combinations of oral blood glucose lowering drugs.
A10BD20.
Tabros Specifications.
specifications
Proposed unit price As per DPC.
The status in reference regulatory Synjardy 5 mg/850 mg film-coated tablets, MHRA
authorities approved.
For generic drugs (me-too status) Diampa-M 5mg/850mg Tablet, Getz Pharma, Reg. No.
103093.
GMP status of the Finished product GMP certificate issued based upon inspection conducted
manufacturer on 28-02-2020
Evidence of section approval. Tablet section vide letter No. F.2-5/87-Lic. (Vol-III) 30-
06-2020.
Name and address of API manufacturer. Empagliflozin:
Fuxin Long Rui Pharmaceutical Co. Ltd., Fluoride
Industrial Park, Fumeng Country (Yi Ma Tu), Fuxin
City, Liaoning Province, China.
GMP certificate issued by Liaoning Fuxin Management
Committee for Fluoride Industrial Development Zone
Metformin HCl:
Aarti drugs Limited (Unit-II), Plot No. 211 & 213, Road
No. 2 G.I.D.C., Sarigam City Dist. Valsad, Gujrat State,
India.
GMP certificate No. 20031933 issued by Food & Drugs
Control Administration Gandhinagar, Gujrat State India
Module-II (Quality Overall Summary) Firm has submitted QOS as per template provided in 293
DRB meeting. Firm has submitted summarized
information related to general information,
physical description, manufacturer, Characterization,
Firm has summarized information of drug product
including its description, composition, pharmaceutical
process control, control of critical steps and
intermediate, process validation protocols, control of
excipients, control of drug product, specifications,
analytical procedures, validation of analytical
specifications, reference standard or materials, container
closure system and stability. Firm has also submitted
data for facilities, equipments and regional information.
Module III (Drug Substance) Firm has submitted detailed drug substance data related
to general information, nomenclature, structure, general
properties, solubilities, physical description,
manufacturer, Characterization, impurities,
Specifications, analytical procedures and its validation,
Stability studies (Drug Substance) Stability study conditions:
Empagliflozin:
Real time: 30°C ± 2°C / 65%RH ± 5% RH for 24 months.
Accelerated: 40°C ± 2°C / 75% RH ± 5 %RH for 6
months.
Batches: (20160606, 20161017, 20161219)
Metformin HCl:
Real time: 30°C ± 2°C / 75% RH ± 5% RH for 24
months.
months.
Batches: (MEF/1510145, MEF/1510146,
MEF/1510147)
Module-III (Drug Product): Firm has summarized information of drug product
closure system and stability.
Pharmaceutical equivalence and Pharmaceutical Equivalence is established against the
comparative dissolution profile Innovator product Synjardy 5mg/850mg tablet, Batch
No. 902007, Mfg. date Feb-19, Exp. Date Jan-22
manufactured by Boehringer Ingelheim Limited by
performing quality tests (Appearance, Identification,
disintegration time, water content, Assay &
Dissolution).
Synjardy 5mg/850mg tablet in Acid media (pH 1.2),
acetate buffer pH 4.5 & Phosphate Buffer pH 6.8. The
F2 values are in the acceptable range.
Analytical method validation Analytical method validation for drug substance
/verification of product (Empagliflozin & Metformin HCl) performed by drug
product manufacturer also submitted including
following parameters:
Linearity & Range, Accuracy, Precision, Specificity.
Method validation studies for finished product have
submitted including following parameters: Linearity &
range, Accuracy, Precision, Specificity, Detection limit,
Quantitation limit, Robustness, Stability indicating.
Manufacturer of API Empagliflozin:
Fuxin Long Rui Pharmaceutical Co. Ltd., Fluoride Industrial Park, Fumeng
Country (Yi Ma Tu), Fuxin City, Liaoning Province, China.
Metformin HCl:
Aarti drugs Limited (Unit-II), Plot No. 211 & 213, Road No. 2 G.I.D.C.,
Sarigam City Dist. Valsad, Gujrat State, India.
API Lot No. Metformin HCl (MEF10020695).
Empagliflozin (E-20190921-D02-E06-01)
Description of Pack
Alu-Alu foil packed in unit carton (1×14’s)
Time Period Real time: 09months
Real Time: 0, 3, 6, 9 (Months)
Batch No. TR001-5/ELZN TR002-5/ELZN TR003-5/ELZN
Batch Size 1100 tablets 1100 tablets 1100 tablets
No. of Batches 03
1. Reference of previous approval of Firm has referred last onsite panel inspection for instant
applications with stability study data of dosage form conducted during last two years BAXIB
the firm (if any) (Apixaban) 2.5mg & 5mg Tablets on 5th January, 2021
by following panel:
1. Prof. Dr. Rafeeq Alam Khan, Dean, Faculty of
Pharmacy, Zia Uddin University, Karachi. (Member
Registration Board).
2. Dr. Saif-Ur-Rehman Khattak, Director / FGA, CDL,
DRAP, Karachi.
2. Approval of API/ DML/GMP certificate Empagliflozin:
of API manufacturer issued by concerned The firm has submitted copy of GMP certificate for M/s
regulatory authority of country of origin. Fuxin Long Rui Pharmaceutical Co., Ltd, China issued
by Liaoning Fuxin Management Committee for Fluoride
Industrial Development Zone
The certificate is valid till 23-08-2023.
Metformin HCl:
The firm has submitted copy of GMP certificate No.
20031933 for M/s Aarti Drugs limited, India 20031933
issued by Food & Drugs Control Administration
Gandhinagar, Gujrat State India
3. Documents for the procurement of API Empagliflozin:
with approval from DRAP (in case of Firm has provided attested commercial invoice No.
import). HN200424-L dated 21-05-2020 wherein they imported
0.4Kg Empagliflozin from M/s Fuxin Long Rui
Pharmaceutical Co. Ltd., Fluoride Industrial Park,
Fumeng Country (Yi Ma Tu), Fuxin City, Liaoning
Province, China. ADC signed Form 6, & invoice is
available. Form 3 and form 7 also available.
Metformin HCl:
Firm has provided attested commercial invoice No.
EXP/3151/19-20 dated March 07, 2020 wherein they
imported 1000Kg API Metformin HCl from M/s. Aarti
drugs limited India. Form 3 and form 7 also available.
4. Data of stability batches will be
supported by attested respective
documents like chromatograms, Submitted
Raw data sheets, COA, summary data
sheets etc.
5. Compliance Record of HPLC software
21CFR & audit trail reports on product Submitted
testing
6. Record of Digital data logger for
temperature and humidity monitoring of Submitted
stability chambers (real time and
accelerated)
No. No.
1. 1.6.5 Valid GMP certificate of drug substance The firm has submitted copy of GMP
manufacturer for Empagliflozin issued certificate for M/s Fuxin Long Rui
by the concerned regulatory authority Pharmaceutical Co., Ltd, China issued by
shall be submitted. Liaoning Fuxin Management Committee
for Fluoride Industrial Development Zone
2. 3.2.S.2.2 Manufacturing process has not Firm has submitted revised manufacturing
mentioned metformin HCl incorporation process wherein they have incorporated the
into the final product. Clarification is step of metformin HCl in the final product.
required. However, no fee is submitted by the firm for
changes in the manufacturing outline.
3. 3.2.S.4.2 Assay test of metformin HCl of the drug Firm submitted that previously USP-42
substance manufacturer is by described the potentiometric titration
potentiometry while the finished product method for metformin HCl and the same
manufacturer has applied HPLC method. method was used for analysis. Afterword’s
Clarification is required. potentiometric method was switched to
HPLC method, whereas HPLC method
derived from the method present in JP
(Metformin HCl Tablets) with slight
modification. HPLC method is more
reliable authenticated then potentiometry
method. The HPLC assay method for drug
substance validated as per ICH guidelines.
4. 3.2.S.4.4 Batch analysis of the drug substance Assay of drug substance Metformin HCl is
(Metformin HCL) has mentioned in switched to potentiometric method to
house specifications for the assay test. HPLC method. Hence in-house
Clarification is required. specification is mentioned.
• Registration letter will be issued after submission of fee of Rs. 7,500/- for correction/pre-
approval change in the method of manufacture/specifications, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
417. Name, address of Applicant / Marketing M/s Tabros Pharma (Pvt.) Ltd., L-20/B, Sector-22, F.B.
Authorization Holder Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Tabros Pharma (Pvt.) Ltd., L-20/B, Sector-22, F.B.
Industrial Area, Karachi.
☐ Importer
☐ Export sale
Details of fee submitted PKR 30,000/- dated 16-08-2021.
Elzanor 12.5mg/850mg Tablet.
name
Active Pharmaceutical ingredient (API) Empagliflozin ……….……………… 12.5mg
per unit Metformin HCl ……………………….850mg
Pharmaceutical form of applied drug Immediate release film coated tablets.
A10BD20.
Tabros Specifications.
specifications
Proposed unit price As per DPC.
The status in reference regulatory Synjardy 12.5 mg/850 mg film-coated tablets, MHRA
For generic drugs (me-too status) Xenglu -Met 12.5/850mg Tablets, Hilton Pharma, Reg.
No. 093103.
Evidence of section approval. Tablet section vide letter No. F.2-5/87-Lic. (Vol-III) 30-
06-2020.
Name and address of API manufacturer. Empagliflozin:
Fuxin Long Rui Pharmaceutical Co. Ltd., Fluoride
Industrial Park, Fumeng Country (Yi Ma Tu), Fuxin
City, Liaoning Province, China.
GMP certificate issued by Liaoning Fuxin Management
Committee for Fluoride Industrial Development Zone
Metformin HCl:
Aarti drugs Limited (Unit-II), Plot No. 211 & 213, Road
No. 2 G.I.D.C., Sarigam City Dist. Valsad, Gujrat State,
India.
GMP certificate No. 20031933 issued by Food & Drugs
Control Administration Gandhinagar, Gujrat State India
Module-II (Quality Overall Summary) Firm has submitted QOS as per template provided in 293
DRB meeting. Firm has submitted summarized
information related to general information,
physical description, manufacturer, Characterization,
Firm has summarized information of drug product
closure system and stability. Firm has also submitted
data for facilities, equipments and regional information.
Module III (Drug Substance) Firm has submitted detailed drug substance data related
to general information, nomenclature, structure, general
properties, solubilities, physical description,
manufacturer, Characterization, impurities,
Specifications, analytical procedures and its validation,
Stability studies (Drug Substance) Stability study conditions:
Empagliflozin:
Real time: 30°C ± 2°C / 65%RH ± 5% RH for 24 months.
months.
Batches: (20160606, 20161017, 20161219)
Metformin HCl:
Real time: 30°C ± 2°C / 75% RH ± 5% RH for 24
months.
months.
Batches: (MEF/1510145, MEF/1510146,
MEF/1510147)
Module-III (Drug Product): Firm has summarized information of drug product
comparative dissolution profile Innovator product Synjardy 12.5mg/850mg tablet,
Batch No. 003442, Mfg. date Feb-19, Exp. Date Jan-22
manufactured by Boehringer Ingelheim Limited by
performing quality tests (Appearance, Identification,
disintegration time, water content, Assay &
Dissolution).
Synjardy 5mg/850mg tablet in Acid media (pH 1.2),
acetate buffer pH 4.5 & Phosphate Buffer pH 6.8. The
F2 values are in the acceptable range.
Analytical method validation Analytical method validation for drug substance
/verification of product (Empagliflozin & Metformin HCl) performed by drug
product manufacturer also submitted including
following parameters:
Linearity & Range, Accuracy, Precision, Specificity.
Method validation studies for finished product have
submitted including following parameters: Linearity &
range, Accuracy, Precision, Specificity, Detection limit,
Quantitation limit, Robustness, Stability indicating.
Manufacturer of API Empagliflozin:
Fuxin Long Rui Pharmaceutical Co. Ltd., Fluoride Industrial Park, Fumeng
Country (Yi Ma Tu), Fuxin City, Liaoning Province, China.
Metformin HCl:
Aarti drugs Limited (Unit-II), Plot No. 211 & 213, Road No. 2 G.I.D.C.,
Sarigam City Dist. Valsad, Gujrat State, India.
API Lot No. Metformin HCl (MEF10020695).
Empagliflozin (E-20190921-D02-E06-01)
Description of Pack
Alu-Alu foil packed in unit carton (1×14’s)
Time Period Real time: 09months
Real Time: 0, 3, 6, 9 (Months)
Batch No. TR001-6/ELZN TR002-6/ELZN TR003-6/ELZN
No. of Batches 03
the firm (if any) (Apixaban) 2.5mg & 5mg Tablets on 5th January, 2021
by following panel:
2. Dr. Saif-Ur-Rehman Khattak, Director / FGA, CDL,
DRAP, Karachi.
2. Approval of API/ DML/GMP certificate Empagliflozin:
of API manufacturer issued by concerned The firm has submitted copy of GMP certificate for M/s
regulatory authority of country of origin. Fuxin Long Rui Pharmaceutical Co., Ltd, China issued
by Liaoning Fuxin Management Committee for Fluoride
Industrial Development Zone
Metformin HCl:
The firm has submitted copy of GMP certificate No.
20031933 for M/s Aarti Drugs limited, India 20031933
issued by Food & Drugs Control Administration
Gandhinagar, Gujrat State India
3. Documents for the procurement of API Empagliflozin:
with approval from DRAP (in case of Firm has provided attested commercial invoice No.
import). HN200424-L dated 21-05-2020 wherein they imported
0.4Kg Empagliflozin from M/s Fuxin Long Rui
Pharmaceutical Co. Ltd., Fluoride Industrial Park,
Fumeng Country (Yi Ma Tu), Fuxin City, Liaoning
Province, China. ADC signed Form 6, & invoice is
available. Form 3 and form 7 also available.
Metformin HCl:
Firm has provided attested commercial invoice No.
EXP/3151/19-20 dated March 07, 2020 wherein they
imported 1000Kg API Metformin HCl from M/s. Aarti
drugs limited India. Form 3 and form 7 also available.
sheets etc.
testing
temperature and humidity monitoring of Submitted
accelerated)
No. No.
1. 1.6.5 Valid GMP certificate of drug substance The firm has submitted copy of GMP
manufacturer for Empagliflozin issued certificate for M/s Fuxin Long Rui
by the concerned regulatory authority Pharmaceutical Co., Ltd, China issued by
shall be submitted. Liaoning Fuxin Management Committee
for Fluoride Industrial Development Zone
2. 3.2.S.2.2 Manufacturing process has not Firm has submitted revised manufacturing
mentioned metformin HCl incorporation process wherein they have incorporated
into the final product. Clarification is the step of metformin HCl in the final
required. product.
However, no fee is submitted by the firm
for changes in the manufacturing outline.
3. 3.2.S.4.2 Assay test of metformin HCl of the drug Firm submitted that previously USP-42
substance manufacturer is by described the potentiometric titration
potentiometry while the finished product method for metformin HCl and the same
manufacturer has applied HPLC method. method was used for analysis.
Clarification is required. Afterword’s potentiometric method was
switched to HPLC method, whereas
HPLC method derived from the method
present in JP (Metformin HCl Tablets)
with slight modification. HPLC method is
more reliable authenticated then
potentiometry method. The HPLC assay
method for drug substance validated as
per ICH guidelines.
4. 3.2.S.4.4 Batch analysis of the drug substance Assay of drug substance Metformin HCl
(Metformin HCL) has mentioned in is switched to potentiometric method to
house specifications for the assay test. HPLC method. Hence in-house
Clarification is required. specification is mentioned.
5. 3.2.P.2.3 Manufacturing process development, Firm submitted that it is typographic error
specifications are for 5mg/850mg and also provided correct document.
tablets. Clarification is required.
11/2012-B&A/DRAP dated 13-07-2021.
418. Name, address of Applicant / Marketing M/s Martin Dow Limited, Plot No. 37, Sector 19,
Authorization Holder Korangi Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Martin Dow Limited, Plot No. 37, Sector 19,
Korangi Industrial Area, Karachi.
☐ Importer
☐ Export sale
Details of fee submitted PKR 30,000/-: dated 09-07-2021.
Duvel Plus XR Tablet 50mg + 500mg.
name
Strength / concentration of drug of Each tablet contains:
Active Pharmaceutical ingredient (API) Sitagliptin Phosphate Monohydrate Eq. to Sitagliptin
per unit ………………………………. 50mg
Metformin HCl (as extended release) ……….. 500mg
Pharmaceutical form of applied drug Film-coated Extended-release tablet
Martin Dow specifications.
specifications
Proposed Pack size 7’s, 10’s, 14’s, 20’s & 28’s.
The status in reference regulatory JANUMET® XR 50/500 (sitagliptin and metformin
authorities hydrochloride extended release) tablets, USFDA
approved.
For generic drugs (me-too status) Inosita Plus XR Tab 50/500 Tablet, PharmEvo (Pvt)
Ltd., Reg. No. 090993.
GMP status of the Finished product GMP certificate issued 11-06-2020 on the basis of
manufacturer inspection conducted on 07-05-2019.
Evidence of section approval. Tablet (general) section approved vide letter No. F. 2-
6/86-Lic (Vol-V) dated 30-07-2018.
Name and address of API manufacturer. Sitagliptin phosphate monohydrate:
Lianyungang Jari Pharmaceutical Co., Ltd.
No. 18, Zhenhua Road, Lianyungang, China.
Validity 11-04-2024.
Metformin HCl:
IPCA Laboratories Limited.
H-4, MIDC, WALUJ Aurangabad, Aurangabad
431136, Maharashtra State, India.
Module-II (Quality Overall Summary) Firm has submitted QOS details as per WHO QOS PD
template.
and controls, tests for impurities & related substances,
stability studies of in APIMFs of both drug substances.
Stability studies (Drug substance.) Stability study conditions:
Sitagliptin Phosphate Monohydrate.
Real time: 30°C ± 2°C / 65% ± 5%RH for 36 months.
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 months.
Batches: (20160301, 20160302, 20160303)
Metformin HCl.
Batches: (9002ML2RMI, 9003ML2RMI, 9004
ML2RMI)
Module-III (Drug Product): The firm has submitted detail of manufacturer,
medium) and its validation studies, batch analysis and
product.
comparative dissolution profile Innovator product that is Janumet XR tablet
50mg+500mg, batch No. S038857 by MSD
international GmbH by performing quality tests
(Identification, Weight variation, Assay, Dissolution,
Impurities).
Janumet XR tablet 50mg+500mg by MSD international
GmbH in Acid media (pH 1.2), Acetate buffer (pH 4.5)
& Phosphate Buffer (pH 6.8). The values for f2 are in
the acceptable range.
Analytical method Method Validation studies have submitted including
validation/verification of product linearity, range, accuracy, precision, specificity.
Manufacturer of API Sitagliptin phosphate monohydrate:
Lianyungang Jari Pharmaceuticals Co., Ltd.
No. 18, Zhenhua Road, Lianyungang City, Jiangsu province, China
Metformin HCl:
H-4, MIDC, WALUJ Aurangabad, Aurangabad 431136, Maharashtra
State, India.
API Lot No. Sitagliptin phosphate monohydrate;
2005000020 (20200401), 2008000002 (20200602),
Metformin HCl:
1908000095 (19370ML2ARMI), 2011000079 (20212ML2ARMI).
Description of Pack
Alu-Alu blister packed in unit carton (2x7’s)
Batch No. NPD-T-1392-L NPD-T-1409-P NPD-T-1410-P
No. of Batches 03
The firm has requested for Exemption from On-site Investigation of their submitted stability data and
provided the following documents in conjunction with the checklist approved by the Registration Board.
1. Reference of previous approval of Firm has referred to onsite inspection report of their
applications with stability study data of product Empator 10mg Tablets which was conducted on
the firm (if any)
6th August 2019 and was presented in 291st meeting of
Registration Board held on 02nd – 4th September 2019.
confirmed.
• The firm has 21 CFR compliant HPLC software.
• The firm has audit trail reports available.
The firm possesses stability chambers with digital data
loggers.
2. Approval of API/ DML/GMP certificate Sitagliptin: Copy of GMP certificate for Lianyungang
of API manufacturer issued by Jari Pharmaceuticals Co., Ltd issued by Lianyungang
concerned regulatory authority of Drug Administration & Valid up to 11-April-2024 is
country of origin. submitted.
Metformin HCl: Copy of GMP Certificate for IPCA
Laboratories Limited (Certificate: New-WHO-
GMP/CERT/AD/67318/2018/11/24741) dated 31-08-
2018 valid till 27-08-2021 issued by Food and Drug
Administration, M.S. Bandra-kurla Complex, Bandra
(E), Mumbai-400051 Maharashtra, India is submitted.
3. Documents for the procurement of API Sitagliptin phosphate monohydrate
with approval from DRAP (in case of Firm has submitted commercial invoice No.
import). 20YX2025B dated 16-07-2020 for Sitagliptin Phosphate
Monohydrate B. No. 20200602 attested by the Assistant
Director, DRAP, Karachi.
Firm has also provided commercial invoice No.
20YX2015B dated 20-04-2020 for Sitagliptin Phosphate
Metformin HCl:
Firm has provided commercial invoice No.
MEG1920/1631259 dated 03-07-2019 for metformin
HCl B. No. 19370ML2ARMI attested by the Assistant
4. Data of stability batches will be Submitted

documents like chromatograms, Raw
data sheets, COA, summary data sheets
etc.
testing
6. Record of Digital data logger for Submitted
accelerated)
Sr. Section Observation. Response by the firm.
No. number
1. 1.3.4 Valid copy of DML of the applicant shall
Firm has submitted valid copy of DML
be submitted. w.e.f. 09-02-2021.
Valid GMP certificate/inspection reportFirm has also submitted GMP inspection
conducted within last three years shall be
report 20-10-2021 wherein it is concluded
submitted. that the firm is considered to be operating
at good level of compliance with cGMP
guidelines.
2. 1.6.5 Valid GMP certificate of the API Firm has submitted Copy of GMP
manufacturer of metformin HCl, issued Certificate for IPCA Laboratories Limited
by the relevant regulatory authority shall (Certificate No.: New-WHO-
be submitted. GMP/CERT/AD/104179/2021/11/37725)
dated 28-10-2021 valid till 27-10-2024
issued by Food and Drug Administration,
M.S. Bandra-kurla Complex, Bandra (E),
Mumbai-400051 Maharashtra, India.
3. 2.3 • Table for literature references for the • Firm has provided revised table for
drug substance i.e. Metformin HCl literature references for the drug
does not declare the status in Japanese substance i.e. Metformin HCl wherein
pharmacopoeia. they declare the status in Japanese
pharmacopoeia.
• The submitted BMR does not reflect The dissolution testing was performed at
performance of dissolution for final stage and results were well within
Metformin HCl before proceeding for specified limits. Since the trial were
seal & active coating step. satisfactory at core stage, a decision was
Justification shall be submitted for made on risk basis to perform the
proceeding further without dissolution testing at final stage after
establishing the Dissolution profile of multiple coating to better evaluate the
Metformin HCl. impact on all stability batches.
Satisfactory initial and stability results are
also evident on Metformin HCl
dissolution performance.
4. 3.2.S.4.2 • Analytical procedure submitted by the • Firm has submitted that Manufacturer
drug substance manufacturer for the has adopted the test method Assay by
Assay test of Metformin HCl is Titration based on USP old version that
different from that adopted by the drug was official at the time of
product manufacturer. Clarification is manufacturing (Lot No. 20212
required. ML2ARMI/Mfg. Date: Feb.2020)
and also the assay limits were set
accordingly.
The API lot was tested at Martin Dow in
December 2020 and method adopted
Assay by HPLC along with revised limits
according to updated versions of USP
monograph (Official as of November
2020).
• USP monograph of Metformin HCl • Firm has submitted that it is a typo
mentions use of 25-cm column in the error. The actual column used is 250
Assay test, while the applicant has instead of 25.
declared use of 250cm column for the
same. Justification is required.
5. 3.2.S.4.4 Assay limits for Metformin HCl Firm has submitted that Manufacturer has
provided by the drug product adopted the test method Assay by
manufacturer is different from that Titration based on USP old version that
declared by the drug substance was official at the time of manufacturing
manufacturer. (Lot No. 20212 ML2ARMI/Mfg. Date:
Feb.2020) and also the assay limits were
set accordingly.
December 2020 and method adopted
Assay by HPLC along with revised limits
according to updated versions of USP
monograph (Official as of November
2020).
6. 3.2.P.8.3 • ADC attested invoices from DRAP for • Firm has provided commercial invoice
metformin HCl B. No. dated 09-12-2020 mentioning
20212ML2ARMI used in stability Metformin HCl B. No.
studies and product development shall 20212ML2ARMI attested by Assistant
be submitted. Director I&E, DRAP, Karachi.
• Date of manufacturing of B # NPD-T- • Batch was manufactured on 12/03/2021
1392-L is 12-03-2021 while the and was processed after each stage
analysis date is 02-04-2021. satisfactory testing result to finished
Justification for this delay shall be product with final coat. The finished
submitted. product was received by 17/03/2021 in
the lab for final testing and after
satisfactory test results of 02 other
batches which was received in 31-03-
2021, stability initiated along with the
other two batches on 02/04/2021.
• Submitted CDP results are for capsules • Firm has submitted that it was typo
formulation instead of tablets. Clarify. error.
7. • Justification of 50% extra amount of • The 50% excess quantity mentioned in
Sitagliptin in master formulation the BPR is for the clarity of the reviewer
(which is required to be based on and the document itself.
study/scientific rationale) for which Excess quantity was added in coating
firm has stated that it was taken to material i.e., Propyl gallate,
compensate the loss during coating. Polyethylene Glycol 6000,
Hydroxyprop.Methylcell.2910/6CP,
Kaolin along with it is the API
Sitagliptin Phosphate Monohydrate
to compensate for the process loss faced
while Coating operation is being carried
out, as it is an API coated tablet.
As it’s a universal truth, losses are
observed/experienced during coating
and thus extra quantities are added as a
recompense. These extra quantities do
not become part of the final film coated
product, as is evident in the Assay
results of Sitagliptin which are well
within limits as per label claim.
• Firm has submitted that the actual water
quantity mentioned in the PBR is a
• Actual quantity of water used for the typographical error while the
preparation of Active coating solution calculation is correct as of 50% excess
does not equate to the 50% extra than quantity to match with rest of the
that mentioned for each tablet. formulation.
• The uniformity of content for
sitagliptin was performed at final stage
• The submitted product development as per procedure and results were found
record does not reflect performance well within specified limits. The assay
of Uniformity of dosage units’ test by (Sitagliptin) was performed on API
way of Assay for Sitagliptin before coat stage before proceeding the next
proceeding for final film coating step. final stage of film coating while it was
Justification shall be submitted for decided to perform the uniformity of
proceeding further without dosage units (Sitagliptin) on finished
establishing the content of Sitagliptin. stage on risk basis and later results
were found satisfactory.
11/2012-B&A/DRAP dated 13-07-2021.
• Regsitartion Board directed the firm to include performance of dissolution profile for
commercial batches at in-process stage of Metformin HCl extended release core prior to
proceeding for Active coating of other drug substance.
419. Name, address of Applicant / Marketing M/s Martin Dow Limited, Plot No. 37, Sector 19,
Authorization Holder Korangi Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Martin Dow Limited, Plot No. 37, Sector 19,
Korangi Industrial Area, Karachi.
☐ Importer
☐ Export sale
Duvel Plus XR Tablet 100mg + 1000mg.
name
Active Pharmaceutical ingredient (API) Sitagliptin Phosphate Monohydrate Eq. to Sitagliptin
per unit ………………………………. 100mg
Metformin HCl (as extended release) ……….. 1000mg
Pharmaceutical form of applied drug Film-coated Extended-release tablet
Martin Dow specifications.
specifications
Proposed Pack size 7’s, 10’s, 14’s, 20’s & 28’s.
approved.
Ltd., Reg. No. 090993.
6/86-Lic (Vol-V) dated 30-07-2018.
Lianyungang Jari Pharmaceutical Co., Ltd.
No. 18, Zhenhua Road, Lianyungang, China.
Metformin HCl:
H-4, MIDC, WALUJ Aurangabad, Aurangabad
431136, Maharashtra State, India.
template.
stability studies of in APIMFs of both drug substances.
Batches: (20160301, 20160302, 20160303)
Metformin HCl.
Batches: (9002ML2RMI, 9003ML2RMI, 9004
ML2RMI)
product.
comparative dissolution profile Innovator product that is Janumet XR tablet
100mg+1000mg, batch No. S011090 by MSD
international GmbH by performing quality tests
(Identification, Weight variation, Assay, Dissolution,
Impurities).
Janumet XR tablet 100mg+1000mg by Martin Dow
Limited in Acid media (pH 1.2), Acetate buffer (pH 4.5)
& Phosphate Buffer (pH 6.8). The values for f2 are
˃50% in all three dissolution medias.
Lianyungang Jari Pharmaceuticals Co., Ltd.
No. 18, Zhenhua Road, Lianyungang City, Jiangsu province, China
Metformin HCl:
H-4, MIDC, WALUJ Aurangabad, Aurangabad 431136, Maharashtra
State, India.
2008000002 (20200602),
Metformin HCl:
1908000095 (19370ML2ARMI).
Description of Pack
Batch No. NPD-T-1366-L NPD-T-1378-P NPD-T-1379-P
No. of Batches 03
applications with stability study data of product Empator 10mg Tablets which was conducted on
the firm (if any) 6th August 2019 and was presented in 291st meeting of
Registration Board held on 02nd – 4th September 2019.
confirmed.
• The firm has 21 CFR compliant HPLC software.
loggers.
2. Approval of API/ DML/GMP certificate Sitagliptin: Copy of GMP certificate for Lianyungang
of API manufacturer issued by Jari Pharmaceuticals Co., Ltd issued by Lianyungang
concerned regulatory authority of Drug Administration & Valid up to 11-April-2024 is
country of origin. submitted.
Metformin HCl: Copy of GMP Certificate for IPCA
Laboratories Limited (Certificate: New-WHO-
GMP/CERT/AD/67318/2018/11/24741) dated 31-08-
Metformin HCl:
Firm has provided commercial invoice No.
MEG1920/1631259 dated 03-07-2019 for metformin
HCl B. No. 19370ML2ARMI attested by the Assistant
etc.
testing
accelerated)
No. number
1. 1.3.4 • Valid copy of DML of the applicant • Firm has submitted valid copy of DML
shall be submitted. w.e.f. 09-02-2021.
• Valid GMP certificate/inspection • Firm has also submitted GMP inspection
report conducted within last three report 20-10-2021 wherein it is concluded
years shall be submitted. that the firm is considered to be operating
at good level of compliance with cGMP
guidelines.
2. 1.6.5 Valid GMP certificate of the API Firm has submitted Copy of GMP Certificate
manufacturer of metformin HCl, issued for IPCA Laboratories Limited (Certificate
by the relevant regulatory authority shall No.: New-WHO-
be submitted. GMP/CERT/AD/104179/2021/11/37725)
dated 28-10-2021 valid till 27-10-2024
issued by Food and Drug Administration,
M.S. Bandra-kurla Complex, Bandra (E),
Mumbai-400051 Maharashtra, India.
3. 2.3 • Table for literature references for the • Firm has provided revised table for
drug substance i.e. Metformin HCl literature references for the drug
does not declare the status in Japanese substance i.e. Metformin HCl wherein
pharmacopoeia. they declare the status in Japanese
• The submitted BMR does not reflect pharmacopoeia.
performance of dissolution for The dissolution testing was performed at
Metformin HCl before proceeding for final stage and results were well within
seal & active coating step. specified limits. Since the trial were
Justification shall be submitted for satisfactory at core stage, a decision was
proceeding further without made on risk basis to perform the dissolution
establishing the Dissolution profile of testing at final stage after multiple coating to
Metformin HCl. better evaluate the impact on all stability
batches. Satisfactory initial and stability
results are also evident on Metformin HCl
dissolution performance.
4. 3.2.S.4.2 • Analytical procedure submitted by the • Firm has submitted that Manufacturer has
drug substance manufacturer for the adopted the test method Assay by
Assay test of Metformin HCl is Titration based on USP old version that
different from that adopted by the drug was official at the time of manufacturing
product manufacturer. Clarification is (Lot No. 20212 ML2ARMI/Mfg. Date:
required. Feb.2020) and also the assay limits were
set accordingly.
December 2020 and method adopted Assay
by HPLC along with revised limits according
to updated versions of USP monograph
(Official as of November 2020).
• USP monograph of Metformin HCl • Firm has submitted that it is a typo error.
mentions use of 25-cm column in the The actual column used is 250 instead of
Assay test, while the applicant has 25.
declared use of 250cm column for the
same. Justification is required.
5. 3.2.S.4.4 Assay limits for Metformin HCl Firm has submitted that Manufacturer has
provided by the drug product adopted the test method Assay by Titration
manufacturer is different from that based on USP old version that was official at
declared by the drug substance the time of manufacturing (Lot No. 20212
manufacturer. ML2ARMI/Mfg. Date: Feb.2020) and also
the assay limits were set accordingly.
December 2020 and method adopted Assay
by HPLC along with revised limits according
to updated versions of USP monograph
(Official as of November 2020).
6. 3.2.P.8.3 • Date of manufacturing of B # NPD-T- • Batch was manufactured on 22/02/2021
1366-L is 22-02-2021 while the and was processed after each stage
analysis date is 16-03-2021. satisfactory testing result to finished
Justification for this delay shall be product with final coat. The finished
submitted. product was received by 25/02/2021 in the
lab for final testing and after satisfactory
test results of 02 other batches which
manufactured in march, 2021, stability
initiated along with the other two batches
on 16/03/2021.
• Submitted CDP results are for capsules • Firm has submitted that it was typo error.
formulation instead of instead of
tablets. Clarify.
7. • Justification of 50% extra amount of • The 50% excess quantity mentioned in the
Sitagliptin in master formulation BPR is for the clarity of the reviewer and
(which is required to be based on the document itself.
study/scientific rationale) for which Excess quantity was added in coating
firm has stated that it was taken to material i.e., Propyl gallate, Polyethylene
compensate the loss during coating. Glycol 6000,
Hydroxyprop.Methylcell.2910/6CP,
Kaolin along with it is the API Sitagliptin
Phosphate Monohydrate to compensate
for the process loss faced while Coating
operation is being carried out, as it is an
API coated tablet.
As it’s a universal truth, losses are
observed/experienced during coating and
thus extra quantities are added as a
recompense. These extra quantities do not
become part of the final film coated
product, as is evident in the Assay results
of Sitagliptin which are well within limits
as per label claim.
• Actual quantity of water used for the • Firm has submitted that the actual water
preparation of Active coating solution quantity mentioned in the PBR is a
does not equate to the 50% extra than typographical error while the calculation is
that mentioned for each tablet. correct as of 50% excess quantity to match
with rest of the formulation.
• The submitted product development • The uniformity of content for sitagliptin
record does not reflect performance of was performed at final stage as per
Uniformity of dosage units test by procedure and results were found well
way of Assay for Sitagliptin before within specified limits. The assay
proceeding for final film coating step. (Sitagliptin) was performed on API coat
Justification shall be submitted for stage before proceeding the next final stage
proceeding further without of film coating while it was decided to
establishing the content of Sitagliptin. perform the uniformity of dosage units
(Sitagliptin) on finished stage on risk basis
and later results were found satisfactory.
throughout proposed shelf life and on accelerated studies for six months as per the commitment
11/2012-B&A/DRAP dated 13-07-2021.
• Regsitartion board directed the firm to include performance of dissolution profile for
420. Name, address of Applicant / Marketing Werrick Pharmaceuticals, Plot No. 216-217, Sector
Authorization Holder I-10/3, Industrial Area, Islamabad.
Name, address of Manufacturing site. Werrick Pharmaceuticals, Plot No. 216-217, Sector
I-10/3, Industrial Area, Islamabad.
☐ Importer
☐ Export sale
☒ Domestic and Export sales.
Dy. No. and date of submission Form-5F Dy. No. 23827 dated 31-08-2021.
The proposed proprietary name / brand name Wardy plus Tablets 5mg/500mg.
Strength / concentration of drug of Active Each film coated tablet contains;
Pharmaceutical ingredient (API) per unit Empagliflozin …………………….…. 5mg
Metformin Hydrochloride …………. 500mg
Pharmaceutical form of applied drug Film coated tablet.
(A10BD20)
Reference to Finished product specifications Innovator’s specifications.
The status in reference regulatory authorities Synjardy 50 mg/ 500 mg film coated tablets,
USFDA approved.
For generic drugs (me-too status) Diampa M tablets 5/500mg, Getz Pharma, Reg. No.
105287.
GMP status of the Finished product GMP certificate issued on basi of inspection
manufacturer concducted on 12-8-2022
Evidence of section approval. Tablet (general) section approved vide No. F. 1-
41/92-Lic (Vol II) dated 19-01-2019.
Name and address of API manufacturer. Metformin hydrochloride.
Abhilasha Pharma Pvt. Limited 1408, 1409, GID,
EST. Anklishwar, 393002, Gujrat state India.
GMP Certificate No: 19081546 valid up to
25/08/2022 issued by Food & Drugs Control
Administration of Gujarat State, India.
Empagliflozin:
Kaifeng Pharmaceutical (Group) Company
Limited. China
Address: No.1, Yunan Street, Kaifeng, Henan
Province, China.
Module III (Drug Substance) Metformin HCl:
The firm submitted detail of nomenclature,
process and controls, tests for related substances
(impurity A & unspecified), specifications,
analyses and justification of specification, reference
Empagliflozin:
The firm submitted detail of nomenclature,
analyses and justification of specification, reference
Metformin HCl.
Real time: 30°C ± 2°C / 65% ± 5% RH for 60 months
Accelerated: 40°C ± 2°C / 75% ± 5% RH for 6
months
Batches: (MET099/13, MET100/13 & MET101/13)
Empagliflozin:
Accelerated: 40°C ± 2°C / 75% ± 5% RH for 6
months
Batches: (180205, 180227 & 180325)
Module-III (Drug Product): The firm has submitted detail of description,
composition, pharmaceutical development,
analytical procedure and its validation studies, batch
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence has been established
dissolution profile against the Brand Leader Synjardy Tablets 5/500mg
Batch No. 707713A by Boehringer Ingelheim by
performing quality tests (Identification,
Disintegration time, Tablet hardness, Assay, and
Dissolution).
that is Synjardy Tablets 5/500mg by Boehringer
Ingelheim in Phosphate Buffer (pH 6.8), Acetate
Buffer (pH 4.5) & Acid media (0.1N HCl). The
Pharmaceutical Equivalence profiles are similar.
Analytical method validation/verification of Method validation studies have been submitted
product including: system suitability, accuracy, and
precision.
Manufacturer of API Metformin hydrochloride.
Abhilasha Pharma Pvt. Limited 1408, 1409, GID, EST. Anklishwar,
393002, Gujrat state India.
GMP Certificate No: 19081546 valid up to 25/08/2022 issued by Food
& Drugs Control Administration of Gujarat State, India.
Empagliflozin:
Kaifeng Pharmaceutical (Group) Company Limited. China
Address: No.1, Yunan Street, Kaifeng, Henan Province, China.
API Lot No. MET065/19 (Metformin HCl)
HF180721 (Empagliflozin)
Description of Pack
Alu-Alu Blister Strip packed in card box of unit carton of 14’s Tablets.
Frequency Accelerated: 0,1,2,3,4, 6 (Months)
Real Time: 0, 3, 6, 9, 12,18 (Months)
Batch No. TRIAL# 01 TRIAL# 02 TRIAL# 03
No. of Batches 03
applications with stability study data of the product Xetine 10mg tablets which was conducted
firm (if any) on 03-03-2020 and was presented in 294th meeting
of Registration Board held on 09th April, 2020.
Registration Board decided to approve registration
of Xetine Tablets 10mg and Xetine Tablets 20mg
with innovator’s specification
8. Approval of API/ DML/GMP certificate of Metformin hydrochloride.
API manufacturer issued by concerned Abhilasha Pharma Pvt. Limited 1408, 1409, GID,
regulatory authority of country of origin. EST. Anklishwar, 393002, Gujrat state India.
GMP Certificate No: 19081546 valid up to
25/08/2022 issued by Food & Drugs Control
Administration of Gujarat State, India.
Empagliflozin:
Kaifeng Pharmaceutical (Group) Company Limited.
China.
Address: No.1, Yunan Street, Kaifeng, Henan
Province, China.
9. Documents for the procurement of API with Firm has submitted copy of commercial invoice of:
approval from DRAP (in case of import). Empagliflozin: Firm has submitted copy of
clearance certificate for Empagliflozin B. No.
HF180721 attested by Assistant Director I&E,
DRAP, Islamabad. Firm has also submitted copy of
commercial Invoice No: CIN20180726G02 dated
Jul. 26, 2018, with 1kg quantity of Empagliflozin B.
No. HF180721 attested by Assistant Director I&E,
DRAP, Islamabad.
Metformin HCl: Not submitted.

No. No.
1. 1.2 Table content from module 1 to module Firm has submitted table of contents
5. from Module 1 to 5.
2. 1.3 • Valid copy of DML of the applicant Firm has submitte dcopy of GMP
shall be submitted. certificate eissued on basis of inspection
conducted on 12-8-2022.
• Latest GMP certificate/inspection
report conducted within last three
years of the finished product
manufacturer shall be provided.
3. 1.6.5 • Section 1.6.5 has mentioned different Firm has corrected section 1.6.5
drug substance manufacturers while wherein they have mentioned Kaifeng
module has mentioned some other Pharmaceutical (Group) Company
manufacturers for the drug substances. Limited, No.1, Yunan Street, Kaifeng,
Clarification is required. Henan Province, China and Abhilasha
Pharma Pvt. Limited 1408, 1409, GID,
EST. Anklishwar, 393002, Gujrat state
India as the name & address of the drug
substance manufacturers.
• GMP certificate for Empagliflozin Firm has submitted copy of GMP
drug substance manufacturer shall be certificate no. HA20190069 valid upto
submitted. 28-9-2024 issued in the name of M/s
Kaifeng Pharmaceutical group Co., Ltd,
China by NMPA of China.
4. 2.3 Table for literature references for the drug Firm has submitted revised table for
substance i.e. Metformin HCl does not literature references for the drug
declare the status other than BP. substance i.e. Metformin HCl wherein
Clarification shall be submitted. they have added USP, Ph. Eur and
Japanese pharmacopoeias in in the
literature.
5. 3.2.P.2.2.1 Pharmaceutical equivalence has Firm has submitted that their proposed
mentioned pack size of 3 x 10’s. packaging at the time of launch would
clarification is required. be an Alu-Alu having pack sizes of 2 x
7’s, 2 x 10’s & 3 x 10’s. that’s why the
pack size was mentioned as 3 x 10’s in
the pharmaceutical equivalence data.
6. 3.2.P.8.3. ADC attested invoices of the drug Firm has submitted Export Invoice No.
substance Metformin HCl used during Exp 013/2019-20 dated 05-06-2019
product development and stability studies mentioning Metformin HCl, B. No.
shall be submitted. MET065/19 with quantity of 300kg
attested by Assistant Director I & E,
DRAP, Islamabad dated 01-07-19.
Decision: Approved.
approval change, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
421. Name, address of Applicant / Marketing Wilson’s Pharmaceuticals, Plot No. 387-388, Sector I-
Authorization Holder 9, Industrial Area, Islamabad.
Name, address of Manufacturing site. Wilson’s Pharmaceuticals, Plot No. 387-388, Sector I-
9, Industrial Area, Islamabad.
☐ Importer
☐ Export sale
☒ Domestic and Export sales.
Dy. No. and date of submission Form-5F Dy. No. 26709 dated 27-09-2021.
Coldenol Sinus Severe Caplets (day).
name
Strength / concentration of drug of Active Each film coated Caplet contains;
Pharmaceutical ingredient (API) per unit Paracetamol ……………………… 325mg
Phenylephrine HCl ………………… 5mg
Guaifenesin ……………………… 200mg
Pharmaceutical form of applied drug Oral tablet.
Pharmacotherapeutic Group of (API) Paracetamol, combinations excl. Psycholeptics.
(N02BE51)
Manufacturer specifications.
specifications
Proposed Pack size 10’s, 20’s & 30’s.
The status in reference regulatory Tylenol Sinus Severe (day), USFDA is provided by the
authorities firm.
However, the same could not be found in USFDA data.
Daily med has the same product as OTC product with
the following disclaimer:
Most OTC drugs are not reviewed and approved by
FDA, however they may be marketed if they comply with
applicable regulations and policies. FDA has not
evaluated whether this product complies.
For generic drugs (me-too status) Could not be confirmed.
GMP status of the Finished product Inspection report of 24-01-2018.
manufacturer Not valid.
Evidence of section approval. Tablet (general) section approved vide No. F. 1-19/92-
Lic (P1) dated 27-07-2015.
Name and address of API manufacturer. Paracetamol:
Saakh Pharma (Pvt.) Ltd., C-7/1, North Western
Industrial Zone. Port Qasim, Karachi.
Guaifenesin:
Zhejiang Haizhou Pharmaceutical Co., Ltd., linhai
Industrial Zone, Linhai Zhejiang China.
Phenylephrine Hydrochloride.
M/s Shenzhen Oriental Pharmaceutical Co., Ltd., No.
43, Dakeng Road, Tongle village, Longgang District,
Shenzhen China.
manufacturing process and controls, analytical
procedures and its validation, batch analyses and
Module III (Drug Substance) Official monograph of Paracetamol (USP/BP),
Guaifenesin (USP) and Phenylephrine HCl (USP/BP) is
present respectively. The firm has submitted detail of
manufacturing process and controls, tests impurities
B,C,D, Individual Impurity I & any unspecified for
Paracetamol, Impurities A,B,C and D for Guaifenesin
and Impurities A,C,D,E and unspecified impurity for
Phenylephrine HCl, specifications, analytical
procedures and its validation, batch analyses and
substance.
Stability studies (Drug substance.) Firm has submitted stability study data of 3 batches of
the following drug substances as per Zone IV-a for both
accelerated as well as real time conditions:
Paracetamol:
(Batch No. 18GN60001, 18GN60002, and 18GN60003)
Guaifenesin:
(Batch No. 08GF04156, 08GF04157, and 08GF04158)
Phenylephrine hydrochloride.
(Batch No. PEH-160404, PEH-160405, and PEH-
160406)
Module-III (Drug Product): The firm has submitted detail of description,
composition, pharmaceutical development,
procedure and its validation studies, batch analysis and
product.
Pharmaceutical equivalence and Pharmaceutical Equivalence has been established
comparative dissolution profile against Tylenol Sinus Severe Caplets DAY by
performing quality tests (Assay, Dissolution,
Disintegration Time test).
CDP has been performed against the same product that
is Tylenol Sinus Severe Caplets DAY, Lot No. 485556
made in Italy, distributed by M/s Johnson & Johnson
Consumer Inc., Mc Neil Consumer Healthcare Division
USA in 0.1 N HCl, Acetate buffer pH 4.5 & Phosphate
Buffer pH 6.8. The values for f2 are in the acceptable
range.
Analytical method validation/verification Method validation studies have been submitted
of product including: system suitability, accuracy, and precision.
Manufacturer of API Paracetamol:
Saakh Pharma (Pvt.) Ltd., C-7/1, North Western Industrial Zone. Port
Qasim, Karachi.
Guaifenesin:
Zhejiang Haizhou Pharmaceutical Co., Ltd., Linhai Industrial Zone,
Linhai Zhejiang China.
M/s Shenzhen Oriental Pharmaceutical Co., Ltd., No. 43, Dakeng
Road, Tongle village, Longgang District, Shenzhen China.
API Lot No. Paracetamol (Batch No.19GN60209, Batch No.19GN60213)
Guaifenesin (Batch No.18GF03204)
Phenylephrine HCl (Batch No.PEH-180101Y1)
Description of Pack
Alu-Alu blister packed in card box unit carton of 10’s, 20’s & 30’s.
Batch No. Trial 01 Trial 02 Trial 03
Batch Size 1500 caplets 1500 caplets 1500 caplets
No. of Batches 03
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided
the following documents in conjunction with the checklist approved by the Registration Board.
1. Reference of previous approval of Firm has submitted Reference of previous approval of
applications with stability study data of applications with stability study data.
the firm (if any)
2. Approval of API/ DML/GMP certificate Firm has submitted GMP certificates of:
of API manufacturer issued by concerned Paracetamol:
regulatory authority of country of origin. Copy of GMP certificate No. 83/2020-DRAP(K) of M/s
Saakh Pharma (Pvt.) Ltd., C-7/1, North Western
Industrial Zone. Port Qasim, Karachi issued by DRAP
Karachi valid till 18/06/2022.
Guaifenesin:
Copy of GMP certificate No. ZJ20180122 of Zhejiang
Haizhou Pharmaceutical Co., Ltd., Linhai Industrial
Zone, Linhai city Zhejiang China issued by China food
& Drug Administration valid until 09-25-2023.
Not provided.
3. Documents for the procurement of API • Paracetamol

with approval from DRAP (in case of Copy of commercial invoice No. PRT/2019/0191
import). dated 18/03/2019 is submitted.
Copy of commercial invoice No. PRT/2019/0197
dated 25/03/2019 is submitted.
• Guaifenesin
Copy of clearance certificate attested by AD (I&E)
DRAP, Islamabad dated 16/07/2018 along with
commercial invoice No.130128 dated 22/06/2018
with quantity of 0.75Kg is submitted.
• Phenylephrine HCl
Copy of clearance certificate attested by AD (I&E)
DRAP, Islamabad dated 10/05/2018 along with
commercial invoice No. SZ-1803039 dated
12/04/2018 with quantity of 308.25 Gram is
submitted.
4. Data of stability batches will be supported Submitted
by attested respective documents like
testing
accelerated)
No. No.
1. 1.3 Valid copy of DML and latest GMP Firm has not provided any renewal of DML.
certificate/inspection report Firm has submitted GMP inspection report
conducted within last three years of dated 24-01-2018.
the finished product manufacturer Provided GMP inspection report is not
shall be provided. within last three years.
2. 1.5.9 Evidence of approval of applied Tylenol Sinus Severe (day), USFDA is
formulation in reference regulatory provided by the firm.
authorities as decided by the However, the same could not be found in
registration board shall be submitted USFDA data.
as the provided reference could not be Daily med has the same product as OTC
confirmed. product with the following disclaimer:
Most OTC drugs are not reviewed and
approved by FDA, however they may be
marketed if they comply with applicable
regulations and policies. FDA has not
evaluated whether this product complies.
3. 1.6.5 • Address of the API manufacturer • Firm has submitted that due to
for guaifenesin provided in section typographical error, the address of the
1.6.5 is different from that of drug substance manufacturer mentioned
mentioned in GMP certificate. in section 1.6.5 was written wrong.
• Valid GMP certificate of the drug Firm has submitted a document
substance manufacturer “Announcement of the state drug
(phenylephrine HCL) issued by administration on matters concerning the
implementation of the Drug Administration
the concerned / relevant regulatory Law of the People’s Republic of China”
authority shall be submitted. wherein under the heading of drug GMP &
GSP management requirements following is
stated.
‘starting from December 1, 2019 the
pharmaceutical GMP and GSP
certifications will be cancelled, GMP and
GSP certificates will no longer be accepted
and pharmaceutical GMP and GSP
certificates will no longer be issued. Where
current regulation require on-site
inspection, on-site inspection shall be
continued after December 1, 2019 and the
company shall be notified of the on-site
inspection results. ’
4. 3.2.S.4.2 Guaifenesin: Submitted.
• Analytical method used for drug
substance (guaifenesin) by the drug
substance manufacturer shall be
submitted.
• Analytical method provided by the Firm has submitted that due typographic
drug product manufacturer for drug error 40g/ml was written instead of
substance (guaifenesin) has 40mcg/ml. However, finished product
mentioned 40g/ml while the manufacturer has followed USP method for
pharmacopoeia has mentioned drug substance.
40mcg/ml in Identification test.
Phenylephrine HCL:
• Analytical method used for drug Submitted.
substance (phenylephrine HCL) by
drug substance manufacturer shall
be submitted.
5. 3.2.S.4.3 Verification studies of all the three
drug substances performed by the Submitted.
drug product manufacturer shall be
submitted.
6. 3.2.S.4.4 Batch analysis of paracetamol from Firm has submitted COA’s wherein it is
Wilson pharma has not mentioned mentioned that the samples complies with
whether USP specifications or BP. both USP and BP.
7. 3.2.S.7.3 Both real time and accelerated Firm has submitted real time and accelerated
stability study data for phenylephrine stability study data for Phenylephrine HCl.
HCl from drug substance
8. 3.2.P.2. Qualitative composition of the • Firm has submitted that they used PVP
applied formulation is different from K30 instead of HPC as binder in their
reference product. Clarification is formulation as both the materials are
required. safely used in pharmaceutical industry for
granulation purpose can be used
interchangeably because of their excellent
binding profiles, as mentioned in the hand
book of pharmaceutical excipients.
• Triacetin is used as plasticizer in the
formulation and is used in the film coating
to add plasticity to the film. Our film
coating yields excellent film without use
of plasticizer, so we didn’t add triacetin in
the formulation.
• Carnauba wax is used to polish the caplet
which is not necessarily required in our
formulation.
• Sucralose is not added in the formulation
as it is used as sweetener and our
formulation is neither chewable nor
dispersible.
9. 3.2.P.2.2.1 Average weight of 10 tablets in Firm submitted that due to typographic error
pharmaceutical equivalence is average weight of 10 tablets was mentioned
776.7gm. clarification is required. 776.7 gm rather than 7.767gm.
10. 3.2.P.3.2 Batch formula has mentioned Firm has submitted new batch formula
innovator’s specification for wherein USP specification is mentioned
paracetamol. clarification is required. against paracetamol.
11. Clearance certificate for Guaifenesin Firm has submitted that drug substance B.
provided by the firm has mentioned No. 18GF03204, quantity 750Gm was used
750Gm (0.75 Kg) quantity. While the in the manufacturing of trial 01, 02 trial
firm has manufactured three trial batches. While B. No. 18GF03204 750gm &
batches of 1500 tablets each. With B. No. 18GF09667, 03 Kg respectively were
this respect only 900gm is required used in the manufacturing of trial 03. We
for the manufacturing of the said had submitted the clearance certificate of
three trial batches. Clarification is one batch 18GF03204 at the time of
required. registration application submission,
whereas the clearance certificate of the
second batch was unintentionally
overlooked.
They also submitted the clearance certificate
of the second batch (B. No. 18GF09667).
However, there is no record of the second
batch in the submitted application nor any
verification studies of the said batch.
Stability data sheets in the initial dossier
has also mentioned batch No. 18GF03204
for all the three trial batches.
12. 2.3.R Dispensing of active materials Firm has submitted that potency was not
without potency adjustment for adjusted for trial manufacturing batches
Guaifenesin and Phenylephrine HCl. (pilot scale) due to small batch size (1500
Justification is required. caplets) the adjustment amount was very
low and does not affect the quality, efficacy
and safety of the drug product. It is pertinent
to mention here, that the finished drug
product release limit is 90% - 110%.
They also undertake that they will adjust the
potency of drug substance at commercial
batch for said drug product.
13. Firm has submitted fee of 7500/- vide slip
No. 67888642 dated 23-05-2022.
Decision: Deferred for further deliberation regarding regulatory stataus of applied formulation in
reference regulatory authorities adopted by Regsitration Board in its 275th meeting.
422. Name, address of Applicant / Marketing M/s Shaigan Pharmaceuticals Pvt. Ltd., 14 Km Adyala
Authorization Holder Road Post office Dahgal, Rawalpindi.
Name, address of Manufacturing site. M/s Shaigan Pharmaceuticals Pvt. Ltd., 14 Km Adyala
Road Post office Dahgal, Rawalpindi.
☐ Importer
☐ Export sale
Admit XR 50mg/500mg Tablet.
name
Active Pharmaceutical ingredient (API) Sitagliptin as Phosphate Monohydrate ……. 50mg
per unit Metformin HCl (as extended release) ……….. 500mg
Innovator’s specifications.
specifications
approved.
Ltd., Reg. No. 090993.
18/92-Lic (Vol-II) dated 30-10-2019.
Changzhou Pharmaceutical Factory,
No. 518, East Laodong Road, Changzhou city China.
Metformin HCl:
Smruthi Organics Limited,
A-27, MIDC Chincholi, Tal-Mohol Solapur,
Maharashtra State of India.
template.
stability studies of of both drug substances.
Batches: (20160301, 20160302, 20160303)
Metformin HCl.
Batches: (DMFH-026/10, DMFH-027/10, DMFH-
028/10)
product.
comparative dissolution profile Innovator product that is Janumet XR 50/500mg tablet
50mg+500mg, Lot No. S022563 by Merck Sharp &
Dohme USA by performing quality tests (Identification,
Average weight of tablets, Impurities, Assay,
Dissolution, total aerobic microbial count).
Janumet XR 50/500mg tablet 50mg+500mg, Lot No.
S022563 by Merck Sharp & Dohme USA in Acid media
(pH 1.2), Acetate buffer (pH 4.5) & Phosphate Buffer
(pH 6.8). The values for f2 are in the acceptable range.
Metformin HCl:
A-27, MIDC Chincholi, Tal-Mohol Solapur, Maharashtra State of
India.
B#20200805
Metformin HCl:
BMET-009/20
Description of Pack Alu-Alu blister of 2 x 7’s light blue color oblong biconvex, plain, film
(Container closure system) coated tablets.
Batch No. T-001 T-002 T-003
No. of Batches 03
1. Reference of previous approval of Firm has referred to their last inspection report for
applications with stability study data of Emdagan 10mg & 20mg Tablets conducted on 06-01-
the firm (if any) 2021, approved in 289th meeting of Registration Board.
Following are details of few points;
• The HPLC software is 21CFR Compliant.
• Audit trail reports were available and physically
checked by the inspection team.
• Firm has adequate monitoring and controls for
stability chambers.
• Software is installed for continuous monitoring of
chambers.
2. Approval of API/ DML/GMP certificate Sitagliptin Phosphate monohydrate:
of API manufacturer issued by Copy of GMP certificate No. Js20180928 Changzhou
concerned regulatory authority of Pharmaceutical Factory, No. 518, East Laodong Road,
country of origin. Changzhou city China issued by the Jiangsu Drug
Administration china is provided.
Validity 12-11-2023
Metformin HCl:
Copy of GMP Certificate for Smruthi Organics Limited,
Maharashtra State of India (Certificate: New-WHO-
GMP/CERT/PD/86368/2019/11/30111) dated 14-11-
Monohydrate B. No. 20200805 with quantity of 28kg x
12 drums (300kg) attested by the Assistant Director,
DRAP, Islamabad.
Metformin HCl:
Firm has provided invoice No. E-185 dated 27-02-2020
for metformin HCl B. No. BMET-009/20 with quantity
of 2000 kg attested by the Assistant Director, DRAP,
Karachi.
etc.
testing
accelerated)
No. number
1. 2.3 • The submitted BMR does not reflect Firm has submitted that Metformin HCl
performance of dissolution for dissolution was performed on lab scale
Metformin HCl before proceeding trial (B. No. LS-001) and also submitted
for active coating step. Justification data of lab scale trial wherein they have
shall be submitted for proceeding performed dissolution for Metformin HCl
before proceeding for active coating step.
st th nd
further without establishing the
Dissolution profile of Metformin
HCl. Firm has submitted new table for literature
• Table for literature references for the references wherein they have added the
drug substance i.e. Metformin HCl status of Metformin HCl in Japanese
does not declare the status in pharmacopoeia. Volume/most recent
Japanese pharmacopoeia. Also, editions are also mentioned in the new
volume/most recent editions are not table for literature references.
mentioned in the table for literature No fee has been submitted.
references.
2. 2.3.R.1 • Justify the dispensed quantity of As 64.25mg sitagliptin phosphate
Sitagliptin against the actual potency monohydrate is equal to 50mg of
declared in the COA of API. sitagliptin as free base. sitagliptin
phosphate monohydrate is used in 20%
excess amount to compensate process loss
and is applied via film coating process. i.e.
64.25mg + 20% (77.1mg/tablet) is
dispensed to achieve 100% assay of
sitagliptin phosphate monohydrate.
3. 3.2.S.4.1 • Submitted COA for Metformin HCl Firm has submitted new COA for
of the finished product manufacturer Metformin HCL with BP specifications.
does not reflects any specification
and Batch number. Clarification is
required.
• Loss on drying test for metformin Firm has submitted that it was
HCl by the finished product typographical error and submitted new
manufacturer has mentioned limits COA for Metformin HCL with
of NMT 0.5% at 80C while BP has temperature conditions in accordance with
mentioned maximum of 0.5% at the pharmacopoeial monograph. i.e. NMT
105C. Temperature conditions are 0.5% at 105C.
not in accordance with the
pharmacopoeial monograph.
• For specifications of drug substance Firm has submitted that it was
Metformin HCl innovator’s typographical error and the drug
specifications are mentioned while substance manufacturer followed BP
monograph is available in USP. specifications.
• Specifications of Metformin HCl has Firm has submitted that specifications of
assay limits of 98.5% - 101.0% while Metformin HCl are as per BP monograph
USP has mentioned 98% - 102%. where assay limits of 98.5% - 101.0%.
Clarify
4. 3.2.S.4.4 • Provide results of analysis of Firm has submitted COA for Sitagliptin
relevant batch(es) of Sitagliptin phosphate monohydrate along with
phosphate monohydrate performed Certificate of Analysis (CoA) of the same
by Drug Product manufacturer used batch from Drug Substance manufacture.
during product development and
stability studies, along with
Certificate of Analysis (CoA) of the
same batch from Drug Substance
manufacture.
• Provide results of analysis of
relevant batch(es) of Metformin HCl Firm has submitted COA for Metformin
performed by Drug Product HCl along with Certificate of Analysis
manufacturer used during product (CoA) of the same batch from Drug
development and stability studies, Substance manufacture.
Substance manufacture.
5. 3.2.P.1 Justification of 20% extra amount of Firm has submitted that in lab scale trial to
Sitagliptin in master formulation (which optimize the application of sitagliptin
is required to be based on phosphate monohydrate to obtain 100% of
study/scientific rationale) for which firm drug, 20% excess quantity was added to
has stated that it was taken to compensate the loss during active coating
compensate the loss during coating. of sitagliptin.
For this purpose, 30% excess drug
solution is prepared i.e. (64.25mg + 30%
excessive drug = 83.525mg/tablet. This
solution was applied in different stages.
Summary is given below;
• At first stage with 100% sitagliptin
solution the assay results were 83.49%.
• At second stage with 110% sitagliptin
6. 3.2.P.2.3 Innovator product has polymeric coating Firm has submitted that ingredients of
over the active coating while there is no their formulation are qualitatively same
such polymeric coating of the applied with reference product. Active drug
formulation, clarification is required. sitagliptin is coated with soluble polymer
carried by film coating with Opadry.
7. 3.2.P.8 • Only 03-month stability data is Firm has submitted 06 month stability
submitted. Stability study data both data for all the trial batches for both real
real time and accelerated for six time and accelerated conditions.
months shall be submitted.
• Protocol has mentioned API lot Firm has submitted that it was due to
number for Empagliflozin instead on typographic error. They also submitted
sitagliptin. Clarify. new/corrected protocol.
• Reference of previous approval of Submitted.
of the firm shall be submitted.
8. 3.2.P.8.3 Raw data sheets for assay test & Firm has submitted raw data sheets.
dissolution test of the finished product
shall be submitted.
Decision: Approved.
423. Name, address of Applicant / Marketing M/s Shaigan Pharmaceuticals Pvt. Ltd., 14 Km Adyala
Authorization Holder Road Post office Dahgal, Rawalpindi.
Name, address of Manufacturing site. M/s Shaigan Pharmaceuticals Pvt. Ltd., 14 Km Adyala
Road Post office Dahgal, Rawalpindi.
☐ Importer
☐ Export sale
Admit XR 100mg/1000mg Tablet.
name
Active Pharmaceutical ingredient (API) Sitagliptin as Phosphate Monohydrate ……. 100mg
per unit Metformin HCl (as extended release) ………..1000mg
Innovator’s specifications.
specifications
approved.
Ltd., Reg. No. 090992.
18/92-Lic (Vol-II) dated 30-10-2019.
Metformin HCl:
Maharashtra State of India.
template.
stability studies of of both drug substances.
Batches: (20160301, 20160302, 20160303)
Metformin HCl.
Batches: (DMFH-026/10, DMFH-027/10, DMFH-
028/10)
product.
comparative dissolution profile Innovator product that is Janumet XR 100/1000mg
tablet, Lot No. S028886 by Merck Sharp & Dohme
USA by performing quality tests (Identification,
Average weight of tablets, Impurities, Assay,
Dissolution, total aerobic microbial count).
Janumet XR 100/1000mg tablet, Lot No. S028886 by
Merck Sharp & Dohme USA in Acid media (pH 1.2),
Acetate buffer (pH 4.5) & Phosphate Buffer (pH 6.8).
The values for f2 are in the acceptable range.
Metformin HCl:
A-27, MIDC Chincholi, Tal-Mohol Solapur, Maharashtra State of
India.
B#20200805
Metformin HCl:
BMET-009/20
Description of Pack Alu-Alu blister of 2 x 7’s light blue color oblong biconvex, plain, film
(Container closure system) coated tablets.
Frequency Accelerated: 0, 3 (Months)
Real Time: 0, 3 (Months)
Batch No. T-001 T-002 T-003
No. of Batches 03
1. Reference of previous approval of Firm has referred to their last inspection report for
applications with stability study data of Emdagan 10mg & 20mg Tablets conducted on 06-01-
the firm (if any) 2021, approved in 289th meeting of Registration Board.
Following are details of few points;
checked by the inspection team.
• Firm has adequate monitoring and controls for
stability chambers.
• Software is installed for continuous monitoring of
chambers.
2. Approval of API/ DML/GMP certificate Sitagliptin Phosphate monohydrate:
of API manufacturer issued by Copy of GMP certificate No. Js20180928 Changzhou
concerned regulatory authority of Pharmaceutical Factory, No. 518, East Laodong Road,
country of origin. Changzhou city China issued by the Jiangsu Drug
Administration china is provided.
Validity 12-11-2023
Metformin HCl:
Copy of GMP Certificate for Smruthi Organics Limited,
Maharashtra State of India (Certificate: New-WHO-
GMP/CERT/PD/86368/2019/11/30111) dated 14-11-
Monohydrate B. No. 20200805 with quantity of 28kg x
12 drums (300kg) attested by the Assistant Director,
DRAP, Islamabad.
Metformin HCl:
Firm has provided invoice No. E-185 dated 27-02-2020
for metformin HCl B. No. BMET-009/20 with quantity
of 2000 kg attested by the Assistant Director, DRAP,
Karachi.
etc.
testing
accelerated)
No. number
1. 2.3 • The submitted BMR does not reflect Firm has submitted that Metformin HCl
performance of dissolution for dissolution was performed on lab scale
Metformin HCl before proceeding trial (B. No. LS-001) and also submitted
for active coating step. Justification data of lab scale trial wherein they have
shall be submitted for proceeding performed dissolution for Metformin HCl
further without establishing the before proceeding for active coating step.
Dissolution profile of Metformin
HCl. Firm has submitted new table for literature
• Table for literature references for the references wherein they have added the
drug substance i.e. Metformin HCl status of Metformin HCl in Japanese
does not declare the status in pharmacopoeia. Volume/most recent
Japanese pharmacopoeia. Also, editions are also mentioned in the new
volume/most recent editions are not table for literature references.
mentioned in the table for literature No fee has been submitted.
references.
2. 2.3.R.1 • Justify the dispensed quantity of As 128.5mg sitagliptin phosphate
Sitagliptin against the actual potency monohydrate is equal to 100mg of
declared in the COA of API. sitagliptin as free base. sitagliptin
phosphate monohydrate is used in 20%
excess amount to compensate process loss
and is applied via film coating process. i.e.
128.5mg + 20% (154.2mg/tablet) is
dispensed to achieve 100% assay of
sitagliptin phosphate monohydrate.
3. 3.2.S.4.1 • Submitted COA for Metformin HCl Firm has submitted new COA for
of the finished product manufacturer Metformin HCL with BP specifications.
does not reflects any specification
and Batch number. Clarification is
required.
• Loss on drying test for metformin Firm has submitted that it was
HCl by the finished product typographical error and submitted new
manufacturer has mentioned limits COA for Metformin HCL with
of NMT 0.5% at 80C while BP has temperature conditions in accordance with
mentioned maximum of 0.5% at the pharmacopoeial monograph. i.e. NMT
105C. Temperature conditions are 0.5% at 105C.
not in accordance with the
pharmacopoeial monograph.
• For specifications of drug substance Firm has submitted that it was
Metformin HCl innovator’s typographical error and the drug
specifications are mentioned while substance manufacturer followed BP
monograph is available in USP. specifications.
• Specifications of Metformin HCl has Firm has submitted that specifications of
assay limits of 98.5% - 101.0% while Metformin HCl are as per BP monograph
USP has mentioned 98% - 102%. where assay limits of 98.5% - 101.0%.
Clarify
4. 3.2.S.4.4 • Provide results of analysis of Firm has submitted COA for Sitagliptin
relevant batch(es) of Sitagliptin phosphate monohydrate along with
phosphate monohydrate performed Certificate of Analysis (CoA) of the same
by Drug Product manufacturer used batch from Drug Substance manufacture.
during product development and
stability studies, along with
Certificate of Analysis (CoA) of the
same batch from Drug Substance
manufacture.
• Provide results of analysis of Firm has submitted COA for Metformin
relevant batch(es) of Metformin HCl HCl along with Certificate of Analysis
performed by Drug Product (CoA) of the same batch from Drug
manufacturer used during product Substance manufacture.
Substance manufacture.
5. 3.2.P.1 Justification of 20% extra amount of Firm has submitted that in lab scale trial to
Sitagliptin in master formulation (which optimize the application of sitagliptin
is required to be based on phosphate monohydrate to obtain 100% of
study/scientific rationale) for which firm drug, 20% excess quantity was added to
has stated that it was taken to compensate the loss during active coating
compensate the loss during coating. of sitagliptin.
For this purpose, 30% excess drug
solution is prepared i.e. (128.5mg + 30%
excessive drug = 167.05mg/tablet. This
solution was applied in different stages.
Summary is given below;
• At second stage with 110% sitagliptin
At first stage with 120% sitagliptin
6. 3.2.P.2.3 Innovator product has polymeric coating Firm has submitted that ingredients of
over the active coating while there is no their formulation are qualitatively same
such polymeric coating of the applied with reference product. Active drug
formulation, clarification is required sitagliptin is coated with soluble polymer
carried by film coating with Opadry.
7. 3.2.P.8 • Only 03 months stability data is Firm has submitted 06 months stability
submitted. Stability study data both data for all the trial batches for both real
real time and accelerated for six time and accelerated conditions.
months shall be submitted.
• Reference of previous approval of
applications with stability study data Submitted.
of the firm shall be submitted.
8. 3.2.P.8.3 Raw data sheets for assay test & Firm has submitted raw data sheets.
dissolution test of the finished product
shall be submitted.
Decision: Approved.
throughout proposed shelf life and on accelerated studies for six months as per the commitment
424. Name, address of Applicant / Marketing M/s Global Pharmaceuticals (Pvt.) Ltd., Plot #
Authorization Holder 204-205, Industrial Triangle, Kahuta Road,
Islamabad.
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt.) Ltd., Plot #
204-205, Industrial Triangle, Kahuta Road,
Islamabad.
☐ Importer
☐ Export sale
Glucosta 100mg Tablets.
name
Strength / concentration of drug of Active Each Film coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Rebamipide ………………………….…100mg.
Pharmaceutical form of applied drug White color, round shaped Film coated tablets.
Pharmacotherapeutic Group of (API) Drugs for Peptic Ulcer and Gastro-Oesophageal
Reflux Disease (GORD)
JP Specifications.
specifications
The status in reference regulatory Rebamipide Tablets 100mg "Otsuka, PMDA Japan
For generic drugs (me-too status) Mucosta 100mg tablets, Otsuka Pharmaceutical,
Reg. No. 078129.
GMP status of the Finished product GMP certificate issued on the basis of inspection
manufacturer conducted on 24-10-2018.
Not valid.
Evidence of section approval. Tablet section (general) vide letter No. F. 1-1/96-Lic.
(Vol-II) dated 13-06-2017.
Name and address of API manufacturer. M/s Fuan Pharmaceutical Group Chongqing Bosen
Pharmaceutical Co., Ltd., No. 1, Huanan Yi Road
Changshou, Chongqing, China.
Certificate No. CQ20190051
Issued by Chongqing Drug Administration.
Valid till 11-04-2024.
Module III (Drug Substance) Ticagrelor is based Inhouse Specification. The firm
as submitted detail of nomenclature, structure,
and controls, tests for impurities, specifications,
Batches: (Rp090801V, Rp090802V & Rp090803V)
product.
comparative dissolution profile against the Mucosta 100mg tablets of M/s Otsuka
Pharmaceutical Co., Ltd., Japan., (Batch No:
MC189182, Mfg. 09-2018 & Exp. 09-2021) by
performing quality tests (Physical attributes,
Identification, Assay & Dissolution).
is Mucosta 100mg tablets of M/s Otsuka
Pharmaceutical Co., Ltd., Japan., (Batch No:
MC189182, Mfg. 09-2018 & Exp. 09-2021) in in
three different mediums i.e. pH 1.2 in 0.1 N HCl, pH
4.5 Acetate buffer & pH 6.8 Phosphate buffer
Manufacturer of API M/s Fuan Pharmaceutical Group Chongqing Bosen Pharmaceutical
Co., Ltd., No. 1, Huanan Yi Road Changshou, Chongqing, China.
Certificate No. CQ20190051
Issued by Chongqing Drug Administration.
Valid till 11-04-2024.
API Lot No. Rp200501
Description of Pack
Alu-alu blister pack of 20’s.
Frequency Accelerated: 0, 3 (Months)
Real Time: 0, 3 (Months)
Batch No. ST21B039 ST21B040 ST21B041
Batch Size 3000 tabs 3000 tabs 3000 tabs
No. of Batches 03
applications with stability study data of the product Promig plus tablets 375mg/20mg which was
firm (if any) conducted on 1st, 13th & 14th March 2019 and was
presented in 289th meeting of Registration Board held
on 14-16th May, 2019.
confirmed.
• The firm has 21 CFR compliant HPLC
software
The firm possesses stability chambers with digital
data loggers.
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. CQ20190051 of drug
API manufacturer issued by concerned substance manufacturer issued by Chongqing Drug
regulatory authority of country of origin. Administration, China valid till 11/04/2024.
3. Documents for the procurement of API with Firm has submitted commercial invoice No.
approval from DRAP (in case of import). KSDS202008232 dated 11-09-2020 attested by the
Assistant Director I&E, DRAP, Islamabad dated 01-
10-2020. Details are also mentioned on the invoice
with quantity of 05Kg with B. No. Rp200501.
testing
accelerated)
Sr. Section Observations Response of the firm.

No. Number
1. 1.3.4 GMP certificate/inspection report Firm has submitted GMP certificate No.
conducted within last three years shall be F. 3-16/2018-Addl. Dir. (QA&LT)-1
submitted. dated 04-01-2022 on the basis of
inspection conducted on 03-01-2022.
2. 1.6.5 This section has mentioned Firm has submitted that it was due to
Dapagliflozin instead of Rebamipide. typographic error and they now submitted
Also, section 2.3.S is for Dapagliflozin. corrected document with Rebamipide
Clarification is required. heading.
3. 3.2.S.4.2 • In analytical procedures for drug Firm has provided revised SAP wherein
substance limits for loss on drying they have added the limits for the
test, limits for chloride test, limits for mentioned tests.
residue on ignition test, upper limits
in assay test are not provided by
finished product manufacturer.
• Assay test of the drug substance Firm has submitted that they have
provided by both the drug substance performed the assay test both on JP and
manufacturer and finished product manufacturer’s specs. In JP specs assay is
manufacturer is different from that of performed by titration while manufacturer
the official monograph. Clarification used HPLC method for assay. We cross
is required. verified the titration result against HPLC
method. But we missed to submit the
titration result. They also provided the
results of titrimetric assay.
• In method verification protocol Firm submitted that due to typographical
provided by the finished product mistake weight of sample is missed in
manufacturer, the formula used for formula but in result they have consider
assay calculation has no weight of the weight of sample. Also provided
sample. Clarification is required. revised protocol.
4. 3.2.S.4.5 Inhouse specifications are mentioned for Firm has submitted that the specifications
drug substance while the official are as JP specs. They also provided
monograph of the drug substance is justification of specifications.
available in JP. Clarify.
5. 3.2.S.7.3 • Long term stability data of the drug Firm has submitted revised stability of the
substance has 65% ± 10% RH drug substance with 30°C ± 2°C / 65% ±
condition. Clarification is required. 5%RH for real time and 40°C ± 2°C / 75%
• Also, one batch long term condition is ± 5%RH for accelerated condition.
60% ± 10% RH. Clarification is
required. New data sheets of the stability studies
• Accelerated stability data sheets for have the assay limit of 99% - 101%.
drug substance is mentioned 98%- Only the stability conditions and assay
102% limits for the assay test while limits have been changed while the data
the monograph has mentioned 99% - remains the same as previous.
101%. Clarification is required.
6. 3.2.P.2 Comparative study protocol has Firm has submitted that this change in
mentioned assay limits of 90%-110% for limit came across due to typographical
finished drug product while the mistake in comparative study protocol.
monograph has mentioned 95%-105%. They also provided revised document.
7. 3.2.P.2.3 Critical quality attributes are for Firm has submitted that CQA’s mentioned
soglumet tablets. are correct for glucosta tablets. However,
due to typographic error heading was for
Soglumet tablets.
8. 3.2.P.5.1 This section has mentioned innovator’s Firm has submitted that specifications of
specifications. Clarification is required. FPP are as per JP specs.
9. 3.2 P.5.2 • Sample preparation method for Submitted.
dissolution test shall be submitted.
• Identify the Q value in dissolution The term Q is used to describe the
limits. cumulative percent of drug dissolved with
respect to label claim at the selected time
point of the dissolution test. A Q value of
80% is generally recommended, except
when a justification with adequate data are
provided to support a lower Q value (e.g.,
clinical or bioavailability/bioequivalence
data). Q values above 80% are not
generally used.
In case of this product JP just provide the
limit i-e NLT 75.0% after 60 minutes.
• Clarification regarding dilution factor Firm has submitted that it is second
used in sample preparation in dilution of the sample to make the final
dissolution test is required. concentration of sample solution as
22mcg/ml.
10. 3.2.P.8.2 Stability study protocol has mentioned Firm has submitted that this change in
assay limits of 90%-110% and limit came across due to typographical
dissolution limits of NLT 80% in mistake in stability study protocol. They
30minutes which are in contradiction to submitted revised document for the same.
the official monograph. Clarification is
required.
11. 3.2.P.8.3 • Stability study data sheet has Initial testing is start on 10-03-2022 and
mentioned 30-03-2021 as date of testing end on 11-03-2022.
initiation of stability study data while Gap between Initial testing and initiation
the data has shown initial testing on stability occur due to non-availability of
10-03-2021. Clarify. machine for blistering, so gap occur in
Initial testing data and initiation stability
• Only three-month stability data is data.
submitted. Stability study data of six Firm has submitted 06 months stability
months shall be submitted. data for all the three batches.
Decision: Approved.
425. Name, address of Applicant / Marketing M/s Novamed Pharmaceuticals (Pvt.) Ltd., 28km
Authorization Holder Ferozepur Road Lahore.
Name, address of Manufacturing site. M/s Novamed Pharmaceuticals (Pvt.) Ltd., 28km
Ferozepur Road Lahore.
☐ Importer
☐ Export sale
Dapaflo 5mg Tablet
name
Strength / concentration of drug of Active Each Film Coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Dapagliflozin Propanediol Monohydrate Eq. to
Dapagliflozin ………………………… 5mg
Pharmaceutical form of applied drug Film coated tablet
Pharmacotherapeutic Group of (API) Sodium-glucose co-transporter 2 (SGLT2) inhibitors.
In-House
specifications
Proposed Pack size 10’s, 14’s, 20’s 28’s

The status in reference regulatory FARXIGA® 5mg (dapagliflozin) film coated tablets,
authorities USFDA approved.
For generic drugs (me-too status) Xiga 5mg tablets, CCL Pharmaceuticals, Reg. No.
090504
GMP status of the Finished product License granted on 08/04/2006 and renewed on
manufacturer 08/04/2021 General tablet section approved and GMP
certificate on 31/08/2021.
Evidence of section approval. Tablet section as per GMP certificate.
Name and address of API manufacturer. Name: Jiangsu Yongan Pharmaceutical Co., Limited.
Address: 18, Provincial Highway, 237 Huaian,
Economic Development Zone, Jiangsu, China.
submitted.
and controls, tests for impurity D, G & related
substances (impurity A & unspecified), specifications,
analytical procedures and its verification, batch analysis
substance.
Batches: (130401, 130402, 130501)
product.
comparative dissolution profile against the brand leader that is Farxiga Tablet 5mg
manufactured by AstraZeneca pharmaceutical (B#
RF812, Mfg. date 11-2019, Exp. Date 10-2022) by
performing quality tests (Identification, weight
variation, Disintegration time & Assay.).
Comparative Dissolution Profile has also been
performed against the same brand that is Farxiga Tablet
5mg manufactured by AstraZeneca pharmaceutical (B#
RF812, Mfg. date 11-2019, Exp. Date 10-2022) in 3
medias i.e; 0.1N HCl, Acetate Buffer pH4.5 &
Phosphate Buffer pH 6.8.The values for f2 are in the
acceptable range.
Analytical method validation/verification Method verification studies have submitted including
of product linearity, range, accuracy, precision, specificity.
Manufacturer of API Name: Jiangsu Yongan Pharmaceutical Co., Limited.
Address: 18, Provincial Highway, 237 Huaian, Economic
Development Zone, Jiangsu, China.
API Lot No. 7100-202006001
Description of Pack Blue color round shaped, biconvex film coated tablets, having both
(Container closure system) sides plain packed in Alu-Alu Blister pack.
Batch No. RD/PR20-010/T2/S1 RD/PR20-010/T2/S2 RD/PR20-010/T2/S3
No. of Batches 03
1. Reference of previous approval of The firm has submitted copy of Last inspection Report
applications with stability study data of conducted on 24/01/2018 (Daclatasvir).
the firm (if any) The board granted the approval in 278th meeting held on
29-31 Jan 2018 of Dasvir Tablet 60mg and 90mg.
2. Approval of API/ DML/GMP certificate Firm has submitted copy of GMP certificate No.
of API manufacturer issued by concerned JS2020921 issued by Jiangsu drug administration valid
regulatory authority of country of origin. till 20/09/2025.
3. Documents for the procurement of API Firm has submitted commercial invoice No.
with approval from DRAP (in case of ZY20061201G/W Dated 16/06/2020 for Dapagliflozin
import). propanediol monohydrate attested by Assistant Director
(I&E) DRAP, Lahore bearing batch number 7100-
202006001.
testing
accelerated)
No. No.
1. 1.3 • Valid copy of DML of drug product Copy of valid DML w.e.f. 08-04-2021
manufacturer shall be submitted. is submitted.
• Latest GMP certificate/inspection Copy of DML renewal inspection report
report conducted within last three years is submitted by the firm wherein the
of the finished product manufacturer panel recommends the renewal of DML
shall be submitted. to M/s Novamed Pharmaceuticals.
2. 1.5.4 Different pack sizes are mentioned in All the marketed pack sizes are applied
different parts of the application. 1.5.4 to meet the market requirement on
(14’s, 28’s) Covering letter has mentioned more economical values.
4 different pack sizes. Clarification is
required.
3. 2.3.R.2 Justify the dispensed quantity drug Firm has submitted that quantity of
substance i.e. Dapagliflozin against the dapagliflozin is calculated with respect
label claim. to label claim & salt for a batch of 2000
tablets.
Label claim = 5mg
Factor = 1.23
6.15mg/ tablet
6.15 x 2000 = 0.013kg
Executed BMR’s have shown
6.5mg/tablet quantity while they are
claiming 6.15mg/tablets.
4. 3.2.S.4.2. • Proposed chromatographic conditions Firm has submitted that we brought
i.e. mobile phase and diluent are some changes in the method for our
different between the analytical method feasibility but to ensure repeatability
proposed by the drug substance results we have validated the changed
manufacturer and drug product method as per international guidelines
manufacturer for the assay test of using USP/ICH.
dapagliflozin. Clarification is required.
5. 3.2.S.4.3 • Accuracy parameter of the verification Firm has submitted that there was typo
studies of drug substance provided by error in the report which has been
the drug product manufacturer is for amended.
some other molecule than applied
molecule. Clarification is required.
6. 3.2.S.4.4 Provide results of analysis of relevant Firm has provided COA for the drug
batch(es) of Dapagliflozin propanediol substance.
monohydrate performed by Drug Product COA of the drug substance provided by
manufacturer used during product the drug product manufacturer has
development and stability studies, along different manufacturing date, Expiry
with Certificate of Analysis (CoA) of the date from that of the drug substance
same batch from Drug Substance manufacturer.
manufacture. Furthermore, the manufacturing date
of the drug substance is June 2021
while the drug product manufacturer
has conducted analysis on 17-08-2020.
7. 3.2.P.1 • Colloidal silicon dioxide is mentioned Firm has submitted that colloidal silicon
as active ingredient in the composition. dioxide is erroneously mentioned as
Clarification is required. active. It is used as glidant in
manufacturing of dapagliflozin.
• Qualitative composition of the applied Firm has submitted that SLS is
formulation is different from innovator excipient and the chemical combability
product. Reference product does not studies are carried out for all excipients
contain SLS while the applied used in the formulation, where no
formulation has SLS as inactive. interference is observed. Also, the
Clarification is required. satisfactory stability studies show that
all excipients are chemically
compatible.
8. 3.2.P.2.2.1 • Raw data sheets of content uniformity Firm has submitted new sheets for
test in pharmaceutical equivalence has content uniformity wherein
pyridoxine HCl. Clarification is dapagliflozin is mentioned.
required.
• Dissolution test has not been Firm has submitted that CDP was
performed in the pharmaceutical performed against the innovator product
equivalence. Clarification is required. and pharmaceutical equivalence was
established through CDP and rest of the
parameters are covered under
pharmaceutical equivalence.
• Manufacturing date and expiry date of Firm has submitted revised sheets for
the same batch of innovator product are manufacturing and expiry dates of the
different. Clarification is required. innovator product.
9. 3.2.P.3.5 This section has mentioned specifications Firm has submitted revised process
for pyridoxine & doxylamine. validation protocol for dapagliflozin.
10. 3.2.P.5.1 • Justify dissolution limits i.e., NLT 80% Firm has submitted that as per FDA’s
(Q) in 45 minutes in 0.1N HCL, dissolution guidelines 2018their
medium volume (500ml) & Speed dissolution conditions are well
(50rpm) since innovator product complied with the conditions mentioned
(Farxiga) specifies NLT (Q) in 15 min in the guidance document for paddle
in acetate buffer 4.5 pH with medium apparatus. They further submitted that
volume of 1000ml & speed of 60 rpm. their current dissolution limit is 30
Clarification is required. minutes instead of 45 minutes.
They further submitted that after
reviewing the dissolution release trend
in CDP report it is evident that more
than 80% drug is released in 15 minutes
so we are revising our current
acceptance specification limit to NLT
80% in 15 minutes instead of 30
minutes.
Drug product specifications has
mentioned 45 minutes for dissolutions
of the drug product.
Furthermore, not only the time limit
but also the dissolution medium,
medium volume and paddle speed all
are different from the innovator
product.
• Accuracy parameter of the validation Firm has submitted revised analytical
report/studies for drug product method validation report wherein they
provided by the drug product have mentioned dapagliflozin.
manufacturer is for some other
molecule than applied molecule.
11. 3.2 P.8 Reference of previous approval of The firm has submitted copy of
applications with stability study data of inspection Report conducted on
the firm shall be submitted. 22/01/2018 for Dasvir 60mg and Dasvir
90mg (Daclatasvir).
12. 3.2.P.8.1 Submit stability data sheets as per Firm has submitted new stability sheets
approved format by the Registration for the stability data wherein they have
Board with inclusion of API lot number. included API lot No. in the new sheets.
However, the API lot No. mentioned in
the new data sheets and API lot No. in
COA, import document are different
from each other.
Decision: Registration Board decided to defer the case for the following points:
• Justify the dispensed quantity drug substance i.e. Dapagliflozin against the label claim as
Label claim is 5mg and after factor calculation (1.23) each tablet will have 6.15mg of
Dapagliflozin while the Executed BMR’s have shown 6.5mg/tablet quantity for
Dapagliflozin.
• Justify dissolution limits i.e., NLT 80% (Q) in 45 minutes in 0.1N HCL, medium volume
(500ml) & Speed (50rpm) since innovator product (Farxiga) specifies NLT (Q) in 15 min in
acetate buffer 4.5 pH with medium volume of 1000ml & speed of 60 rpm.
• Justification shall be submitted regarding the API lot No. mentioned in the new stability data
sheets and API lot No. in COA, import document are different from each other.
• Justification regarding the COA of the drug substance provided by the drug product
manufacturer shall be submitted as it has different manufacturing date, Expiry date from
that of the drug substance manufacturer. Furthermore, the manufacturing date of the drug
substance is June 2021 while the drug product manufacturer has conducted analysis on 17-
08-2020.
426. Name, address of Applicant / Marketing M/s Novamed Pharmaceuticals (Pvt.) Ltd., 28km
Authorization Holder Ferozepur Road Lahore.
Name, address of Manufacturing site. M/s Novamed Pharmaceuticals (Pvt.) Ltd., 28km
Ferozepur Road Lahore.
☐ Importer
☐ Export sale
Dapaflo 10mg Tablet
name
Strength / concentration of drug of Active Each Film Coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Dapagliflozin Propanediol Monohydrate Eq. to
Dapagliflozin ………………………… 10mg
Pharmacotherapeutic Group of (API) Sodium-glucose co-transporter 2 (SGLT2) inhibitors.
In-House
specifications
Proposed Pack size 14’s, 28’s.
The status in reference regulatory FARXIGA® 10mg (dapagliflozin) film coated tablets,
For generic drugs (me-too status) Xiga 10mg tablets, CCL Pharmaceuticals, Reg. No.
090505.
GMP status of the Finished product License granted on 08/04/2006 and renewed on
manufacturer 08/04/2021 General tablet section approved and GMP
certificate on 31/08/2021.
Evidence of section approval. Tablet section as per GMP certificate.
Name and address of API manufacturer. Name: Jiangsu Yongan Pharmaceutical Co., Limited.
Address: 18, Provincial Highway, 237 Huaian,
Economic Development Zone, Jiangsu, China.
submitted.
substance.
Batches: (130401, 130402, 130501)
product.
comparative dissolution profile against the brand leader that is Farxiga Tablet 10mg
manufactured by AstraZeneca pharmaceutical (B#
RB164, by performing quality tests (Identification,
weight variation, Disintegration time, content
uniformity & Assay).
Comparative Dissolution Profile has also been
performed against the same brand that is Farxiga Tablet
10mg manufactured by AstraZeneca pharmaceutical
(B# RB194, Mfg. date 06-2019, Exp. Date 05-2021) in
3 medias i.e; 0.1N HCl, Acetate Buffer pH4.5 &
Phosphate Buffer pH 6.8.The values for f2 are in the
acceptable range.
Analytical method validation/verification Method verification studies have submitted including
of product linearity, range, accuracy, precision, specificity.
Manufacturer of API Name: Jiangsu Yongan Pharmaceutical Co., Limited.
Address: 18, Provincial Highway, 237 Huaian, Economic
Development Zone, Jiangsu, China.
API Lot No. 7100-202006001
Description of Pack Peach color round shaped, biconvex film coated tablets, having
(Container closure system) breaking line on one side and other side is plain.
Batch No. RD/PR20-011/T2/S1 RD/PR20-011/T2/S2 RD/PR20-011/T2/S3
No. of Batches 03
1. Reference of previous approval of The firm has submitted copy of Last inspection Report
applications with stability study data of conducted on 24/01/2018 (Daclatasvir), 06/03/2017
the firm (if any) (Sofosbuvir)
2. Approval of API/ DML/GMP certificate Firm has submitted copy of GMP certificate No.
of API manufacturer issued by concerned JS2020921 issued by Jiangsu drug administration valid
regulatory authority of country of origin. till 20/09/2025.
3. Documents for the procurement of API Firm has submitted commercial invoice No.
with approval from DRAP (in case of ZY20061201G/W Dated 16/06/2020 for Dapagliflozin
import). propanediol monohydrate attested by Assistant Director
(I&E) DRAP, Lahore bearing batch number 7100-
202006001.
testing
accelerated)
No. No.
1. 1.3 • Valid copy of DML of drug product Copy of valid DML w.e.f. 08-04-2021
manufacturer shall be submitted. is submitted.
• Latest GMP certificate/inspection Copy of DML renewal inspection report
report conducted within last three is submitted by the firm wherein the
years of the finished product panel recommends the renewal of DML
manufacturer shall be submitted. to M/s Novamed Pharmaceuticals.
2. 1.5.4 Different pack sizes are mentioned in Firm has submitted that all the marketed
different parts of the application. 1.5.4 pack sizes are applied to meet the market
(14’s, 28’s) Covering letter has requirement on more economical values.
mentioned 4 different pack sizes.
3. 2.3.R.2 Justify the dispensed quantity drug Firm has submitted that quantity of
substance i.e. Dapagliflozin against the dapagliflozin is calculated with respect
label claim. to label claim & salt for a batch of 2000
tablets.
Label claim = 10mg
Factor = 1.23
12.3mg/ tablet
12.3 x 2000 = 0.024kg
Executed BMR’s have shown 13.05
mg/tablet quantity while they are
claiming 12.3mg/tablets.
4. 3.2.S.4.2. Proposed chromatographic conditions Firm has submitted that we brought some
i.e. mobile phase and diluent along with changes in the method for our feasibility
concentration of sample and standard but to ensure repeatability results we
solution are different between the have validated the changed method as
analytical method proposed by the drug per international guidelines using
substance manufacturer and drug product USP/ICH.
manufacturer for the assay test of
dapagliflozin. Clarification is required.
5. 3.2.S.4.4 Provide results of analysis of relevant Firm has provided COA for the drug
batch(es) of Dapagliflozin propanediol substance.
monohydrate performed by Drug COA of the drug substance provided by
Product manufacturer used during the drug product manufacturer has
product development and stability different manufacturing date, Expiry
studies, along with Certificate of
Analysis (CoA) of the same batch from date from that of the drug substance
Drug Substance manufacture. manufacturer.
Furthermore, the manufacturing date
of the drug substance is June 2021
while the drug product manufacturer
has conducted analysis on 17-08-2020.
6. 3.2.P.1 • Colloidal silicon dioxide is mentioned Firm has submitted that colloidal silicon
as active ingredient in the dioxide is erroneously mentioned as
composition. Clarification is active. It is used as glidant in
required. manufacturing of dapagliflozin.
• Qualitative composition of the Firm has submitted that SLS is excipient
applied formulation is different from and the chemical combability studies are
innovator product. Reference product carried out for all excipients used in the
does not contain SLS while the formulation, where no interference is
applied formulation has SLS as observed. Also, the satisfactory stability
inactive. Clarification is required. studies show that all excipients are
chemically compatible.
7. 3.2.P.2.2.1 • Raw data sheets of content uniformity Firm has submitted new sheets for
test in pharmaceutical equivalence content uniformity wherein
has pyridoxine HCl. Clarification is dapagliflozin is mentioned.
required.
• Dissolution test has not been Firm has submitted that CDP was
performed in the pharmaceutical performed against the innovator product
equivalence. Clarification is required. and pharmaceutical equivalence was
established through CDP and rest of the
parameters are covered under
pharmaceutical equivalence.
8. 3.2.P.5.1 • Justify dissolution limits i.e., NLT Firm has submitted that as per FDA’s
80% (Q) in 30 minutes in 0.1N HCL, dissolution guidelines 2018their
medium volume (500ml) & Speed dissolution conditions are well complied
(50rpm) since innovator product with the conditions mentioned in the
(Farxiga) specifies NLT (Q) in 15 min guidance document for paddle apparatus.
in acetate buffer 4.5 pH with medium They further submitted that their current
volume of 1000ml & speed of 60 rpm. dissolution limit is 30 minutes instead of
Clarification is required. 45 minutes.
They further submitted that after
reviewing the dissolution release trend in
CDP report it is evident that more than
80% drug is released in 15 minutes so we
are revising our current acceptance
specification limit to NLT 80% in 15
minutes instead of 30 minutes.
Drug product specifications has
mentioned 45 minutes for dissolutions
of the drug product.
Furthermore, not only the time limit but
also the dissolution medium, medium
volume and paddle speed all are
different from the innovator product.
9. 3.2 P.8 • Reference of previous approval of The firm has submitted copy of
applications with stability study data inspection Report conducted on
of the firm shall be submitted. 22/01/2018 for Dasvir 60mg and Dasvir
90mg (Daclatasvir).
• COA of drug substance i.e. Submitted.
Dapagliflozin propanediol
monohydrate, B# 7100-202006001
shall be submitted.
10. 3.2.P.8.1 Submit stability data sheets as per Firm has submitted new stability sheets
approved format by the Registration for the stability data wherein they have
Board with inclusion of API lot number. included API lot No. in the new sheets.
However, the API lot No. mentioned in
the new data sheets and API lot No. in
COA, import document are different
from each other.
Decision: Registration Board decided to defer the case for the following points:
• Justify the dispensed quantity drug substance i.e. Dapagliflozin against the label claim as
Label claim is 10mg and after factor calculation (1.23) each tablet will have 12.3mg of
Dapagliflozin while the Executed BMR’s have shown 13.05 mg/tablet quantity for
Dapagliflozin.
• Justify dissolution limits i.e., NLT 80% (Q) in 45 minutes in 0.1N HCL, medium volume
(500ml) & Speed (50rpm) since innovator product (Farxiga) specifies NLT (Q) in 15 min in
acetate buffer 4.5 pH with medium volume of 1000ml & speed of 60 rpm.
• Justification shall be submitted regarding the API lot No. mentioned in the new stability data
sheets and API lot No. in COA, import document are different from each other.
• Justification regarding the COA of the drug substance provided by the drug product
manufacturer shall be submitted as it has different manufacturing date, Expiry date from
that of the drug substance manufacturer. Furthermore, the manufacturing date of the drug
substance is June 2021 while the drug product manufacturer has conducted analysis on 17-
08-2020.
Registration applications of Imported products on Form 5 F.
427. Name, address of Applicant / Importer M/s AGP Limited, B-23-C, S.I.T.E., Karachi.
Details of Drug Sale License of importer License No: 1126.
Address: B-23-C, S.I.T.E., Karachi-75700, Pakistan
Address of Godown: AGP Limited, B-23-C, S.I.T.E.,
Karachi.
Validity: 21-09-2021.
Status: License to sell, stock & exhibit for sale,
distribute and sell drugs by way of wholesale by of
manufacturer, importer or indenter.
Name and address of marketing Mylan Laboratories Limited, Plot No. H-12 & H-13,
authorization holder (abroad) MIDC, Waluj, Aurangabad 431136, Maharashtra state,
India.
Name, address of manufacturer(s) M/s Mylan Laboratories Limited, Plot no. H-12 & H-13,
MIDC, Waluj, Aurangabad -431136, Maharashtra state,
India
Name of exporting country India.
Freesale certificate, GMP certificate) Firm has submitted copy of CoPP certificate (No.
COPP/CERT/AD/90474/2020/11/31606/159456) dated
11-Apr-2020 issued by Food and Drug Administration
Maharashtra State Mumbai, India for DOVPRELA-
200mg (Pretomanid Tablets 200mg). The CoPP
confirms free sale status of the product in exporting
country as well as GMP status of the manufacturing site
through periodic inspection every year.
The name of importing country on CoPP is mentioned
as Pakistan. Furthermore, the CoPP was valid till 17-
Dec-2021.
GMP:
Copy of GMP certificate No. NEW-WHO-
GMP/CERT/AD/72573/2018/11/26257 in the name of
M/s Mylan Laboratories Limited, Plot no. H-12 & H-13,
MIDC, Waluj, Aurangabad -431136, Maharashtra state,
India issued by Food and Drug Administration, M.S.
Bandra-Kurla complex Bandra (E), Mumbai
Maharashtra India valid till 17-12-2021 is submitted by
the applicant.
Firm has also submitted notarized copy of GMP
Certificate No. 18368 in the name of M/s Mylan
Laboratories Limited, Plot No. H-12 & H-13, MIDC,
Waluj Industrial Estate, Aurangabad, India issued by
HPRA Ireland on the basis of inspection conducted on
17-11-2017 valid for three years.
WHO Prequalification:
The product is WHO prequalified (Reference
Number: TB386 (a).
Details of letter of authorization / sole Letter of Authorization:
agency agreement Firm has submitted original, legalized & product
specific letter of Authorization from Mylan
Laboratories Limited, having its corporate office at
House No. 8-2-293/82/J-III, Plot No. 564/A/22, Road
No. 92, Jubilee Hills, Hyderabad, India. The letter
specifies that the manufacturer appoints M/s AGP
Limited, B-23-C, S.I.T.E., Karachi to register their
products in Pakistan. The authorization letter is valid till
16-Apr-2023.
☒ Importer
☐ Export sale
For imported products, specify one the ☒ Finished Pharmaceutical product import
these ☐ Buk import and local repackaging
only
Dy. No. and date of submission Dy. No. 26352: 22-09-2021.
Details of fee submitted PKR 50,000/-: 09-07-2020.
The proposed proprietary name / brand Dovprela 200mg Tablet
name
Active Pharmaceutical ingredient (API) Pretomanid ……………………….200mg
per unit
Pharmacotherapeutic Group of (API) Nitroimidazooxazine Antimycobacterial drug (As per
dossier).
J04 Antimycobacterials. (As per ATC code)
Limited Population: Pretomanid Tablet is an
Antimycobacterials indicated, as part of a combination
regimen with bedaquiline and linezolid for the treatment
of adults with pulmonary extensively drug resistant
(XDR), treatment-intolerant or nonresponsive
multidrug-resistant (MDR) tuberculosis (TB). Approval
of this indication is based on limited clinical safety and
efficacy data. This drug is indicated for use in a limited
and specific population of patients.
Reference to Finished product In house
specifications
Proposed Pack size HDPE Bottle (26 Tablets)
Proposed unit price No information provided.
The status in reference regulatory Pretomanid Tablet 200mg, USFDA Approved.
authorities
For generic drugs (me-too status) N/A.
Name, address of drug substance Mylan Laboratories Limited (Unit-9), Plot No. 5, Road
manufacturer No.12, J.N. Pharma City, Tadi Village Parawada
Mandal, Visakhapatnam, Andhra Pradesh, India.
Module-III Drug Substance: Firm has submitted detailed drug substance data for both
sources related to nomenclature, structure, general
(Conditions & duration of Stability API at accelerated for 06 months as well as real time
studies) conditions for 24 months. The real time stability data is
conducted at 25oC ± 2oC, RH 60% ± 5% and accelerated
stability data is conducted at 40oC ± 2oC, RH 75% ± 5%.
(Batch No. 27083789, 27083790 & 27083791)
manufacture, manufacturing process and process
control, process validation protocols, control of
Pharmaceutical Equivalence and Firm has submitted complete data of formulation
Comparative Dissolution Profile development process. Dovprela 200mg Tablet
(Pretomanid) is Innovator Product, therefore, firm has
submitted detailed Module 4 and Module 5.
Analytical method validation/verification Firm has submitted analytical method validation studies
of product for the applied product.
Container closure system of the drug HDPE bottle pack
product
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches.
life and storage conditions The accelerated stability study data is conducted at 40oC
±2oC / 75% ± 5% RH for 6 months (Batch No. 2014678,
2014679 & 2014680).
The real time stability study data is conducted at 30oC
±2oC / 75% ± 5% RH for 24 months (Batch No.
2014678, 2014679 & 2014680).
Evaluation by PEC:
S. Section Observation Remarks by the evaluator
No.
1. 1.1 Fee of 75,000/- shall be submitted. Firm has submitted differential fee of 25000/-
vide slip No. 8216477734 dated 15-07-2022.
2. 1.3.2 Valid copy of GMP of the finished Notarized and legalized GMP certificate No.
product manufacturer. NEW-WHO-
GMP/CERT/AD/106169/2022/11/38759 in
the name of M/s Mylan Laboratories Limited,
Plot no. H-12 & H-13, MIDC, Waluj,
Aurangabad -431136, Maharashtra state,
India issued by Food and Drug
Administration, M.S. Bandra-Kurla complex
Bandra (E), Mumbai Maharashtra India valid
till 11-01-2025 is submitted by the applicant.
3. 1.3.4 Valid copy of DSL of the applicant Firm has submitted new copy of DSL valid till
shall be submitted. 21-09-2023.
4. 3.2.S.7. Real time stability data of drug Firm has submitted new stability studies of
3 substance is conducted at 25oC ± 2oC, the drug substance for the same batches at
RH 60% ± 5% justification is required. 30oC ± 2oC, RH 75% ± 5%.
5. Valid & legalized copy of CoPP shall Firm has submitted valid legalized &
be submitted. notarized CoPP No.
COPP/CERT/AD/110377/2022/11/39211/19
0611 for Dovprela 200mg tablets. The
submitted copy of CoPP valid till 11-01-2025.
6. Packing provided by the applicant has Firm has submitted that Dovprela is a WHO
manufacturing address other than the prequalified product and is manufactured in
specified in GMP and other document. two plants by principal manufacturer and the
data/specification are common for both
plants. The product is imported from Maylan
Aurangabad plant which is WHO approved
plant for this product.
The document provided for the
packing/container closure system is made by
Maylan Nashik plant but these are also
applicable for maylan Aurangabad plant.
These documents are also stamped by QA of
Maylan Aurangabad plant.
Decision: Registration Board approved the product subject to compliance of current Import Policy for
Finished Drugs with innovator’s specifications. Registration letter will be issued after
submission of fee of Rs. 7,500/- for correction/pre-approval change in the method of
manufacture/specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-
2021.
428. Name, address of Applicant / Importer M/s Hakimsons Private Limited., A-58/B, S.I.T.E,
Karachi-75700, Pakistan.
Details of Drug Sale License of License No: 001 No. DHOKW (Drugs)/-0431
importer Address: A-58/B, S.I.T.E, Karachi
Status: Drug sale license by the way of wholesale by
of a manufacturer, importer or indenter.
Name and address of M/s Eugia Pharma Specialties Limited,
marketing Survey No. 550, 551 & 552, Kolthur Village, Shamirpet
authorization holder (abroad) Mandal, Medchal-Malkajgiri, District Telangana,
500101, India.
Name, address of manufacturer(s) M/s Eugia Pharma Specialties Limited,
Survey No. 550, 551 & 552, Kolthur Village, Shamirpet
Mandal, Medchal-Malkajgiri, District Telangana,
500101, India.
Name of exporting country India.
Freesale certificate, GMP certificate) Firm has submitted Original Legalized CoPP
(Certificate#2850/STORES/2020-40) issued by Drugs
Control Administration, Government of Telangana,
India for PACSITA 500 (Capecitabine Tablets USP
500mg). CoPP confirms facilities and operations
conforming to GMP as recommended by the World
Health Organization. The certificate is valid till 10-06-
2021.
CoPP certificate has also mentioned name of applicant
for certificate, if different from license holder that is M/s
Aurobindo Pharma Limited, plot No.2, Maitri Vihar,
Ameerpet, Hyderabad, Telangana, India.
However, the CoPP certificate has mentioned that this

product is not actually on the market of the exporting
country.
GMP certificate:
The firm has submitted legalized copy of GMP
certificate dated 11-06-2018 for M/s Eugia Pharma
Specialties Limited, Survey No. 550, 551 & 552,
Kolthur Village, Shamirpet Mandal, Medchal-
Malkajgiri, District Telangana, 500101, India issued by
Drugs control Administration, Government of
Telangana, India. Certificate has mentioned that
manufacturer conforms to the requirement for Good
manufacturing Practices in the manufacturing and
quality control for 17 products for export in the
international market.
Details of letter of authorization / sole Firm has submitted a copy of letter of authorization from
agency agreement M/s Aurobindo Pharma Limited, plot No.2, Maitri
Vihar, Ameerpet, Hyderabad having its manufacturing
plant at M/s Eugia Parma Specialties Limited, Survey
No. 550, 551 & 552, Kolthur Village, Shamirpet
Mandal, Medchal-Malkajgiri District, Telangana, India.
According to the letter, the firm has appointed “M/s
Hakimsons Pvt. Ltd,” with principal place of business at
A-58/B, S.I.T.E, Manghopir Road, Karachi as its
Exclusive Distributor for the territory of Islamic
Republic of Pakistan. The letter was issued on 10-12-
2020 and it is valid for a period of five years.
The applicant has submitted notarized copy of letter
clarifying the relationship between Eugia pharma
specialties Limited, and Aurobindo Pharma Ltd.,
Eugia pharma specialties Limited is wholly owned
subsidiary company of Aurobindo Pharma Limited with
registered office address “Plot No.2, Maitrivihar,
Ameerpet, Hyderabad, Telangana State, India.
Eugia pharma specialities Limited, with manufacturing
site address “survey no. 550, 551 & 552, Kolthur village,
Shamirpet Mandal, Medchal -Malkagiri District,
Telangana, India, manufactures oncology & Hormonal
products and is one of the manufacturing facilities
associated with Aurobindo Pharma Limited.
☒ Importer
☐ Export sale
For imported products, specify one the ☒Finished Pharmaceutical product import
only
Dy. No. and date of submission Dy. No. 24702: dated: 07/09/2021.
Details of fee submitted PKR 100,000/-: 04/02/2021.
Proposed proprietary name / brand name PACSITA 500 mg tablets.
Strength/concentration of drug of Each film-coated tablet contains:
Active Pharmaceutical ingredient Capecitabine ……………...…….. 500 mg
(API) per unit
Pharmaceutical form of applied drug Film coated tablets.
Pharmacotherapeutic Group of (API) Antineoplastic agents.
(ATC code: L01BC06)
Reference to Finished product USP Specifications
specifications
Proposed Pack size 1 x 10’s
Proposed unit price As per PRC
The status in reference regulatory XELODA (capecitabine) film coated tablets 500mg,
For generic drugs (me-too status) Relicitabine Tablets 500mg by M/s Helix Pharma, Reg.
No. 088875.
The firm has summarized information of drug product
process control, process validation protocols, control of
Name, address of drug substance M/s Divi’s Laboratories Limited, Unit-2, Chippada (V),
manufacturer Annavaram Post Bheemunipatnam (M) Visakhapatnam
District Andhra Pradesh, India.
Stability Studies of Drug Substance Firm has submitted stability study data of 03 batches for
(Conditions & duration of Stability drug substance at accelerated conditions i.e. 40 ± 2° C /
studies) 75 ± 5% RH for 06 months as well as real time stability
data at 30 ± 2° C/65 ± 5%RH for 60 months.
Batch No. (2-WS3O001, 2-WS-3O002 & 2-WS-3O003)
Pharmaceutical Equivalence and Firm has submitted pharmaceutical equivalence with
Comparative Dissolution Profile reference product i.e. Xeloda 500mg by Hoffman La
Rosch Inc. USA, B. No. X3148XI by performing the
following quality test;
Description, Average weight of the tablets,
Disintegration time, Water by KF, impurities and Assay.
Firm has also submitted CDP results against the same
reference product i.e. Xeloda 500mg by Hoffman La
Rosch Inc. USA, B. No. X3993XI in three different
mediums i.e. pH 1.2 in 0.1 N HCl, pH 4.5 Acetate buffer
& pH 6.8 Phosphate buffer (USP-II (Paddle), 500ml &
75 RPM) and similarity factor is comparable.
Analytical method Firm has submitted Assay Method Validation Protocols
validation/verification of product along with Reports of Capecitabine Tablets 500mg
Finished product as well as for Active substance.
USP analytical test methods were developed to
determine the identification (By HPLC), Assay (By
HPLC), Related substance (By HPLC), R-Enantiomer
content (by HPLC), and color absorbance (By UV) in
drug product and methods have been validated as per the
ICH.
Container closure system of the drug PVC/PVDC – Aluminum foil blister pack
product
Stability study data of drug product, Firm has submitted stability study data of 03 batches
shelf life and storage conditions The accelerated stability study data is conducted at 40oC
±2oC / 75% ± 5% RH for 06 months. The real time
stability study data is conducted at 30oC ±2oC /75% ±
5% RH. The real time stability study data of 03 batches
is for 24months.
Batch No. (CB5016001-B, CB5016002-B &
CB5016003-B)
Batch size: 60,000 Tablets each.
Mfg. Date: 09 - 2016
Stability initiation date: 14-10-2016
Evaluation by PEC:
Section Observation Response submitted by the firm.
1.1 Differential fee of Firm has submitted a differential fee of 50000/- vide slip
50,000/- shall be No. 65206501965 dated 27-07-2022.
submitted.
• Notarized copy of Firm has submitted colored copy of the agreement and
the agreement further submitted that original notarized agreement is
shall be submitted in the dossier of Brotoma injection 3.5mg.
submitted.
Firm has referred to the decision of registration Board in

• CoPP confirming its 256th meeting stating as under:
the status of the “"if an imported drug is not on free sale in its respective
product in country of origin / manufacture, such product will be
exporting country registered in Pakistan if the product manufactured in the
that the product is applied facility is approved by any of the regulatory
actually not on authorities from USFDA, EMA, PMDA Japan, Australia
the market for TGA, Health Canada, Switzerland or any of regulatory
sale. Clarification authority of former erstwhile Westren Europe (United
is required. Kingdom, Germany, France, Switzerland, Netherlands,
Austria, Belgium, Denmark, Finland, Sweden, Italy,
Ireland, Luxemburg, Norway, Scotland and Spain) or
three stringent regulatory bodies of former erstwhile
Eastren Europe. However, references countries regarding
availability of drug / molecule / formulation shall remain
the same as specified in 249th meeting of Registration
Board.”
In this context firm has referred to the following product

approved by US FDA:
“Capecitabine 500mg tablet (Application no. A210604)
of M/s Eugia pharma Specialties Ltd.,” verified form
following web links of official websites of US FDA:
https://www.accessdata.fda.gov/scripts/cder/ob/search_p
roduct.cfm
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?set
id=56441153-a1e5-4fdc-96d6-f21baa6b5fbe
The manufacturing site of above cited product has also

been verified as M/s EUGIA Pharma Specialities
Limited, Sy.No.550, 551 & 552, Kolthur Village,
Shameerpet Mandal, Medchal-Malkajgiri District,
Medchal, Telangana 500101, India (IND), from the
following web link of US FDA:
• Valid GMP https://www.accessdata.fda.gov/scripts/cder/drls/getdrls.
certificate of the cfm
finished product
manufacturer Firm has submitted copy of GMP certificate dated 26-11-
shall be 2021 for M/s Eugia Pharma Specialties Limited, Survey
submitted. No. 550, 551 & 552, Kolthur Village, Shamirpet Mandal,
Medchal-Malkajgiri, District Telangana, 500101, India
issued by Drugs Control Administration, Government of
Telangana, India. Certificate has mentioned that
manufacturer conforms to the requirement for Good
Manufacturing Practices in the manufacturing and
quality control for 17 products for export in the
international market.
1.5.22 Good Firm has submitted new document of Hakimsons (Pvt.)
pharmacovigilance Limited.
procedure is for Helix
pharma
3.2.S.4.3 Drug substance Firm has submitted verification studies of the drug
verification studies substance performed by the drug product manufacturer.
performed by finished
shall be submitted.
3.2.P.2.2 In CDP results at 4.5 Firm has submitted that from the dissolution profile it can
pH Acetate buffer, the be seen that the test product dissolution profile is having
value of F2 is less high %RSD at initial time points i.e. more than 10% even
than 50 at 50 RPM. up to 20-minute time point and thereby statistical
Clarification shall be calculation of f2 value is not feasible or applicable. Since
submitted. the observed dissolution % RSD is high for the
dissolution when tested at agitation speed of 50 RPM for
paddle (USP apparatus II), it was decided to generate the
dissolution profile at the agitation speed of 75 RPM to
reduce the %RSD. Hence the dissolution profile of
Capecitabine tablets USP 500mg was generated at 75
RPM in pH 4.5 acetate buffer and %RSD is found
satisfactory and low level for test product dissolution
profile and the calculated statistical f2 value is adequate
(more than 50).
Hence it can be concluded that the generic product
dissolution profile in pH 4.5 acetate buffer is comparable
to the reference drug product.
Decision: Registration Board approved the product subject to compliance of current Import Policy
for Finished Drugs.
429. Name, address of Applicant / Importer M/s Al Habib Pharmaceuticals, Plot No. 81-B Block B,
S.M.C.H.S, Karachi.
Details of Drug Sale License of importer License No: 1245.
Address: 81-B Block B, S.M.C.H.S, Karachi.
Address of Godown:
1. Plot No. 10 sector25 KIA, Karachi.
2. HT – 8, Landhi Industrial Area, Karachi.
Validity: 18-05-2022.
Status: License to sell, stock & exhibit for sale,
distribute and sell drugs by way of wholesale by of
manufacturer, importer or indenter.
Name and address of marketing authorization Laboratories IMA S.A.I.C. Palpa 2862,
holder (abroad) Ciudad Autonoma de Buenos Aires, Argentina.
(Laboratories IMA S.A.I.C. Palpa 2862,
City of Buenos Aires Argentina Republic.)
Name, address of manufacturer(s) Laboratories IMA S.A.I.C. Palpa 2862,
Ciudad Autonoma de Buenos Aires, Argentina.
(Laboratories IMA S.A.I.C. Palpa 2862,
City of Buenos Aires Argentina Republic.)
Name of exporting country Argentina.
Freesale certificate, GMP certificate) Firm has submitted copy of CoPP dated 13-10-2020
issued by National Institute of Drugs Avenida Caseros
2161 City of Buenos Aires Argentina Republic for
PREMETREXED IMA (Pemetrexed 500 lyophilized
powder for injection.) The CoPP confirms free sale
status of the product in exporting country as well as
GMP status of the manufacturing site through periodic
inspection every two year.
The name of importing country on CoPP is mentioned
as Pakistan. Furthermore, the CoPP was valid for one
year.
GMP:
Firm has submitted copy of GMP certificate in the name
of Laboratories IMA S.A.I.C. Palpa 2862,
City of Buenos Aires, Argentina Republic issued by the
National Administration of Drugs, Food and medical
Devices (ANMAT) through the National Institute of
Drugs (INAME) issued on 13-04-2020 which states that
the manufacturing facility at Palpa is subject to regular
inspection to verify compliance with the Good
Manufacturing practices according to the regulation in
force in the Argentina Republic.
Valid for 12 months.
However, status of the finished product manufacturer
has not been revealed whether compliant Good
Manufacturing practices according to the regulation in
force or otherwise.
agency agreement Firm has submitted copy of letter of Authorization
dated 22-10-2018 from M/s Laboratories IMA S.A.I.C.
Palpa 2862, City of Buenos Aires, Argentina Republic
for 11 products which also contain pemetrexed 500mg
injection. The authorization letter is valid for five years.
☒ Importer
☐ Export sale
For imported products, specify one the these ☐ Finished Pharmaceutical product import
only
Dy. No. and date of submission Dy. No. 24062: 01-09-2021.
Details of fee submitted PKR 150,000/-: 26-08-2021.
The proposed proprietary name / brand name Pemex 500mg injection.
Strength / concentration of drug of Active Each vial contains;
Pharmaceutical ingredient (API) per unit Pemetrexed as disodium hemi pentahydrate
……………………. 500mg
Pharmaceutical form of applied drug Lyophilized powder for injection.
Pharmacotherapeutic Group of (API) Antineoplastic Agents
ATC code: L01BA04
Reference to Finished product specifications Pharma Europa Volume 23.
Proposed unit price As per Policy.
The status in reference regulatory authorities ALIMTA (pemetrexed for injection) 500mg, USFDA
Approved.
For generic drugs (me-too status) Almita 500mg injection, Eli Lilly Pakistan, Reg. No.
043068.
Name, address of drug substance Shandong Boyuan Pharmaceutical Co. Ltd.,
manufacturer Qinjiang Street, Jibai Economic Development Zone,
Jinan City, Shandong Province, China.
(Conditions & duration of Stability studies) API at accelerated for 06 months as well as real time
conditions for 24 months. The real time stability data is
conducted at 5 oC ± 3oC, and accelerated stability data
is conducted at 25oC ± 2oC, RH 60% ± 5%.
(Batch No. 1001KL61C, 1002KL61C & 1003KL61C)
Pharmaceutical Equivalence and Pharmaceutical equivalence has been established
Comparative Dissolution Profile against reference product i.e. Almita by ELI LILLY by
performing the following tests;
Appearance, pH, Reconstituted solution, water content
(Karl Fischer), bacterial endotoxin, related substances,
particulate matter and Assay.
Analytical method validation/verification of Firm has submitted analytical method validation studies
product for the applied product.
Container closure system of the drug product Type I colourless glass vial with Bromo butyl
elastomeric stopper and aluminium seal.
Stability study data of drug product, shelf life Firm has submitted stability study data of 3 batches.
and storage conditions The accelerated stability study data is conducted at 40oC
27002 & 27003).
The real time stability study data is conducted at 30oC
27002 & 27003).
Evaluation by PEC:
S. Section Observation Remarks by the evaluator

No.
1. 1.3.4 Valid copy of Drug Sale License of the Attested copy of Drug Sale License No.
applicant shall be submitted. 0230 18-05-2022 in the name of Al Habib
Pharmaceuticals 81-B Block B, S.M.C.H.S,
Karachi is submitted by the firm.
2. • Valid and notarized GMP certificate Firm has submitted copy of GMP certificate
of the finished product manufacturer issued on 03-04-2022 valid for one year.
shall be submitted. Firm has also provided copy of CoPP dated
• Valid and notarized copy of CoPP 13-10-2021 for the product i.e. Pemetrexed
shall be submitted. (disodium hemi pentahydrate) 500mg valid
for one year.
Firm further submitted that the CoPP that we
submitted with the dossier was having
validity till October, 2021 and as it gets
expired during its period in R&I that’s why
as per rule it will be considered as valid as
we received R&I attested letter on 1st
September, 2021.
Neither GMP certificate nor CoPP is
notarized and countersigned by the
embassy of Pakistan.
3. 1.3.8 Site master file and credentials of the Submitted.
4. 3.2.S Drug substance document has Firm has submitted new DMF for
mentioned Heptahydrate while the Pemetrexed disodium hemi penta hydrate.
label claim has mentioned Hemi penta
hydrate. Clarification is required.
5. 3.2.S.4.1 • Water content mentioned in the Firm has submitted new DMF for
specifications of the drug substance is Pemetrexed disodium hemi penta hydrate
8.2% - 10.2% while the monograph wherein the specification of the drug
has mentioned 19.55 to 22.1%. substance mentioned are E.P/USP.
• Assay content is 97.5% to 102% in Firm has submitted that although the limits
monograph while specifications has are different from official monograph but
mentioned 98-102. Clarification is the values are within the limit of the official
required. monograph.
6. 3.2.S.4.2 Also, the acetate buffer condition in the New DMF has the same conditions as
assay test are different from the mentioned in USP.
monograph.
7. 3.2.S.4.3 Analytical Method Verification studies Analytical Method Verification studies
including specificity, accuracy and performed by the IMA laboratories are
repeatability (method precision) submitted.
manufacturer for both compendial as
well as non-compendial by the finished
submitted.
8. 3.2.S.4.4 • Batch analysis of the drug substance Firm has submitted COA for the drug
is for Qilu pharmaceutical Co., Ltd. substance from Shandong Boyuan
Justification is required. Pharmaceutical Co., Ltd.
• COA of primary / secondary Firm has also submitted COA of the primary
reference standard including source / secondary reference standard.
and lot number shall be provided.
9. 3.2.P.5.1 • In section 1.5 firm has claimed Ph. Firm has submitted that it was typographic
Eur. specifications for the finished error and the finished dosage form is having
drug product. Provided evidence of USP specifications.
official monograph of the European
pharmacopoeia for the applied
formulation.
• Justification shall be submitted for Firm has submitted that the dossier was
finished product specifications as prepared in 2018 and at that time the official
general considerations of USP monograph was pending and become part of
references for injections and ICH official USP in 2020 that’s why the
guidelines are followed while the specifications were developed via general
official monograph is available in chapter. They further submitted that the
USP. same specifications are part of the official
monograph of pemetrexed. That’s why the
same is followed.
10. 3.2.P.8 Assay limits in the real time stability of Firm has submitted that it may be typo or
B. No. 27003 at third month time point misprinting error.
is out of specifications. Clarification is They also submitted rectified/new stability
required. data sheets.
Finished Drugs with innovator’s specifications.
• Registration letter will be issued after submission of valid, notarized & legalized CoPP certificate
and valid, notarized & legalized GMP certificate for the finished product manufacturer.
• Firm will also submit fee of Rs. 7,500/- for correction/pre-approval change in the method of
manufacture/specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
430. Name, address of Applicant / Importer M/s Medi Mark Pharmaceuticals, Liaqat Chowk, Sahiwal,
Pakistan.
Details of Drug Sale License of importer DSL NO. 02-367-0154-049333D
Address: M/s Medi Mark Pharmaceuticals, Karbala Road
House No. 588 Sahiwal.
Go-down address: Nil.
Valid up to 20-12-2021.
Status: License to sell drugs as distributor.
Name and address of marketing M/s Shanghai Starry Pharmaceutical Co., Ltd., No. 500,
authorization holder (abroad) Maoye Road, Jinshan Industrial Zone, Shanghai, China.
Name, address of manufacturer(s) M/s Shanghai Starry Pharmaceutical Co., Ltd., No. 500,
Maoye Road, Jinshan Industrial Zone, Shanghai, China.
Name of exporting country China.
Detail of certificates attached (CoPP, Free Detail of certificates attached (CoPP, GMP certificate)
sale certificate, GMP certificate) CoPP:
Firm has submitted original legalized CoPP
(certificate No. Shanghai20210001) dated 08-01-2021
issued by Shanghai Medical Products Administration,
728 Yisan Road, Shanghai China. The document
confirms that the applied product strength is actually
on the market in exporting country. The document
also confirms that the facilities and operations also
confirm to the requirement of Chinese’s GMP.
Valid up to 07-01-2023.
GMP:
Firm has submitted a document from Shanghai
Medical Products Administration, addressed to M/s
Shanghai Starry Pharmaceutical Co., Ltd., wherein it
is informed that we organized an on-site inspection for
the Large Volume parenteral (LVP) of your company
located in No. 500, Maoye Road, Jinshan Industrial
Zone, Shanghai, China from 10-12-2019 to 12-12-
2019 and the inspection result meet the requirement of
cGMP (25-02-2020).

agency agreement Firm has submitted original, notarized & legalized sole
agency agreement dated 22-03-2021 wherein M/s
Shanghai Starry Pharmaceutical Co., Ltd., No. Maoye
Road, Jinshan Industrial Zone, Shanghai, China has
authorized M/s Medi Mark Pharmaceuticals, Liaqat
Chowk, Sahiwal, Pakistan as their sole agent in order to
register, sell and distribute Iohexol injection 350mg
(Iodine/ml) 100ml in the territory of Pakistan.
Validity of the agreement is for five years unless
terminated by three months advance notice by either party.
☒ Importer
☐ Export sale
only
The proposed proprietary name / brand Hexol Injection 100ml.
name
Strength / concentration of drug of Active Each 100ml contain;
Pharmaceutical ingredient (API) per unit 75.5gm of Iohexol equivalent to 35gm of Iodine (350mg
Iodine/ml)
Pharmaceutical form of applied drug Injection.
Pharmacotherapeutic Group of (API) X-RAY CONTRAST MEDIA, IODINATED
ATC code: V08A.
Reference to Finished product Ch. P specifications.
specifications
Proposed Pack size 100ml glass infusion bottle, 10 bottles/box.
The status in reference regulatory OMNIPAQUE 350 mg iodine/mL (755 mg of
authorities Iohexol/mL), USFDA approved.
For generic drugs (me-too status) Kopaq 350mg/ml IV solution for injection, Punjab Medical
Services, Reg. No. 097360.
Firm has summarized information related to nomenclature,
manufacturers, and controls, impurities, specifications,
substance.
development, manufacturer, manufacturing process and
stability.
Name, address of drug substance M/s Zhejiang Starry Pharmaceutical Co. Ltd., No. 1 Starry
manufacturer Road of Xianju Modern Industrial Centralization Zone
Xianju, Zhejiang, China.
Module-III Drug Substance: Firm has submitted detailed drug substance data related to
manufacturing process and controls, specifications,
analytical procedures, batch analysis and justification of
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of drug
(Conditions & duration of Stability studies) substance at accelerated condition for 06 months as well as
real time conditions for 24 months. The real time stability
data is conducted at 25oC ± 2oC, RH 60% ± 5% and
accelerated stability data is conducted at 40oC ± 2oC, RH
75% ± 5%.
(Batch No. C006-0802003, C006-0802004 & C006-
0802005)
process validation protocols`, control of drug product,
Pharmaceutical Equivalence and Firm has submitted pharmaceutical equivalence data of
Comparative Dissolution Profile their products against Omnipaque of GE Healthcare, B.
No. 12909988 by performing the following tests;
Appearance, Identification, pH, related compounds,
insoluble particulate matter, Bacterial endotoxin, sterility,
and Assay.
Analytical method validation/verification Submitted.
of product
Container closure system of the drug Neutral borosilicate glass bottle and chlorinated butyl
product rubber stopper.
Stability study data of drug product, shelf • 24 months real time stability data at 30°C ± 2°C / 65%
life and storage conditions ± 5% RH of 03 batches (A1810251, A1810271 &
A1810291).
• 06 month accelerated stability data 40°C ± 2°C / 75%
± 5% RH of 03 batches (A1810251, A1810271 &
A1810291).
Evaluation by PEC:
No.
1. 1.3.3 Applicant is marked as manufacturer. Applicant has submitted new module I
Clarification is required. wherein they have provided corrected
information.
2. 1.4 Section 1.4 is completely missing. All Firm has submitted complete details of the
the information in section 1.4 shall be section 1.4.
submitted.
3. 1.5.1 – Complete details from 1.5.1 to 1.5.8 Firm has submitted complete details of the
1.5.8 shall be submitted. section 1.5.1 to 1.5.8.
4. CoPP has mentioned two different Firm has submitted that the strength of
strengths of the active ingredients. iohexol injection 350mg I/mL in China
Clarification is required. 100ml contain named 100mL:35g (I), as the strength is
35g Iohexol and 100ml contains calculated by iodine (I). And in the
75.5gm iohexol. Clarification is composition, 100mL of iohexol injection
required. 350mg
I/mL contains 75.5g of iohexol (the API).
Please note that 75.5g of iohexol
(C19H26I3N3O9) is equivalent to 35g of
iodine (I). So, this is not a problem.
5. 3.2.S.4.2 Detailed analytical procedures for the Firm has submitted detailed analytical
drug substance by the finished product procedures for the testing of the drug
manufacturer shall be submitted. substance by the finished product
manufacturer i.e. M/s Shanghai Starry
Pharmaceutical Co., Ltd., No. 500, Maoye
Road, Jinshan Industrial Zone, Shanghai,
China.
6. 3.2.S.4.3 Analytical Method Verification studies Firm has submitted Analytical Method
including specificity, accuracy and Verification studies performed by the
repeatability (method precision) finished product manufacturer.
manufacturer for both compendial as
well as non-compendial by the finished
submitted.
7. 3.2.S.4.4 Provide summarized results of analysis Submitted.

of relevant batch(es) of Drug Substance
performed by Drug Product
manufacturer.
8. 3.2.S.7.3 Real time stability of drug substance as Firm has submitted that real time stability
per Zone IV-a shall be submitted. data of drug substance as per Zone IV-a is not
available as Our API company, Zhejiang
Starry, only conducted stability
25℃/60%RH for the global market. It is
accepted by any other countries. Hope
Pakistan can accept as well.
9. 3.2.P.5.1 Justification of specification has Firm has submitted that for the specifications
mentioned that final specifications of of Iohexol injection350mg Iodine/ml, the
iohexol injection complies with pharmacopoeial reference of analytical
relevant guidelines of ICH and China. procedure is mainly Chinese Pharmacopoeia
However, the official monograph of the (Ch. P. 2020), and we have compared the
applied formulation is available in USP. acceptance criteria in Ch. P with USP and JP,
Clarification is required. to generate some relatively strict acceptance
criteria for our products. They also provided
a comparison table between their shelf life
specifications and USP specifications.
10. Comparison of specification of the
finished product and USP Test Ch. Phar. USP
pharmacopoeia pH: 6.8 – 7.6 6.8 – 7.7
Bacterial ˂ 0.13 NMT 0.2
Endotoxin EU/100ml USP
(I) unit/50mg
(I)
Free iodide NMT NMT
35µg/ml 200µg/ml
Related Same as NMT 0.6%
compounds USP NMT 0.1%
Assay 96.0%- 95.0% -
105% 105%
Test item Method Our release Our shelf-life USP40

specification specification Monograph
Appearance By visual Clear, colourless Clear, colourless Clear,
to pale yellow to pale yellow colourless to
liquid liquid pale yellow
liquid
Refractive Refractive index 1.4349～1.4448 1.4349～1.4448 -
index
Identification HPLC The retention The retention The retention
times of the times of the times of the
major peaks of major peaks of major peaks of
the sample the sample the sample
solution solution solution
correspond to correspond to correspond to
those of the those of the those of the
system suitability system system
solution, as suitability suitability
obtained in the solution, as solution, as
test for Related obtained in the obtained in the
compounds 1 test for Related test for organic
compounds 1 impurities
UV-VIS It exhibits a It exhibits a -
maximum maximum
between 243nm between 243nm
and 247nm. and 247nm.
TLC The color and The color and -
position of the position of the
main spot of the main spot of the
test solution test solution
should be the should be the
same as that of same as that of
the reference the reference
solution solution
Physicochemical test Violet vapors are Violet vapors -
evolved. are evolved.
pH Determination of pH 7.2～7.6 6.8～7.6 6.8～7.7
Color of UV- 400nm NMT 0.220 NMT 0.240 -
solution VIS 420nm NMT 0.060 NMT 0.070 -
450nm NMT 0.030 NMT 0.035 -
Free iodide Potentiometric titration NMT 30μg/ml NMT 60μg/ml NMT 0.02%
Free aromatic UV-VIS NMT 0.05% NMT 0.05% -
amine
Tromethamine Potentiometric titration 0.85～ 0.85～ -
1.57mg/ml 1.57mg/ml
Edetate Chemical titration 0.08～ 0.08～ -
calcium 0.12mg/ml 0.12mg/ml
disodium
Related HPLC O-alkylated NMT 0.6% NMT 0.6% NMT 0.6%
compounds 1 compounds
(corresponds Any other NMT 0.1% NMT 0.1% NMT 0.1%
to the test for individual impurity
Organic Total impurities NMT 0.3% NMT 0.3% NMT 0.3%
Impurities of (excluding O-
USP ) alkylated compounds)
Related TLC Rf value greater than ND ND -
compounds 2 the principal spot
obtained with
reference solution (b)
Impurity A NMT 0.2% NMT 0.2% -
Any other NMT 0.1% NMT 0.1% -
individual impurity
total impurities NMT 0.4% NMT 0.4% -
obtained with
individual impurity
obtained with
Impurity B NMT 0.2% NMT 0.2% -
individual impurity
Heavy metal Determination of NMT 20ppm NMT 20ppm -
heavy metal
Bacterial Gelation method < 0.13 < 0.13 < 0.20
endotoxin EU/100mgI EU/100mgI EU/50mgI
Osmolality Determination of Osmolality 605～ 605～ -
739mOsmol/kg 739mOsmol/kg
Particulate Light ≥10μm NMT 25/ml NMT 25/ml NMT
matter blockage 6000/bottle
method ≥25μm NMT 3/ml NMT 3/ml NMT
600/bottle
Sterile Membrane filter Complies. Complies. Complies.
Assay Potentiometric titration 96.0%～105.0% 96.0%～105.0% 95.0%～05.0%
Decision: Registration Board approved the product with USP specifications subject to compliance of
current Import Policy for Finished Drugs.
• Registration letter will be issued after submission of fee of Rs. 7,500/- for correction/pre-approval
changes in specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
• Firm will also submit corrected, legalized and notarized CoPP certificate for the applied product.
Registration applications of locally manufactured (Human) deferred drugs on Form 5F.

431. Name, address of Applicant / M/s Davis Pharmaceutical Laboratories, Plot No. 121
Marketing Authorization Holder industrial Triangle area, Kahuta Road, Islamabad.
Name, address of Manufacturing site. M/s Bio-Labs (Pvt.) Ltd., Plot No. 145 Industrial
Triangle, Kahuta Road, Islamabad.
☐ Importer
st
505
Intended use of pharmaceutical ☐ Domestic sale
Dy. No. and date of submission Dy. No. 11388; dated 14-04-2021.
The proposed proprietary name / Kerolac 30mg IV/IM Injection.
brand name
Strength / concentration of drug of Each ampoule contains:
Active Pharmaceutical ingredient Ketorolac Tromethamine ……………….. 30mg
(API) per unit
Pharmaceutical form of applied drug Clear colorless liquid filled in glass ampoule
Reference to Finished product Innovator’s
specifications
Proposed Pack size 1ml x 5’s
The status in reference regulatory US FDA approved.
authorities
For generic drugs (me-too status) Tekac 30mg/ml Injection, Sami Pharmaceuticals, Reg.
No. 092855.
GMP status of the Applicant. GMP certificate issued on 08-10-2020 on the basis of
inspection conduct 01-10-2019.
GMP status of the Finished product GMP certificate issued on 21-05-2019 on the basis of
manufacturer inspection conduct 23-4-2019, valid up to 22-04-2022.
Evidence of section approval of the Liquid ampoule (from GMP certificate.)
Finished product manufacturer. Ampoule general vide letter No. F. 1-12/89-Lic (Vol-
II) dated 23-07-2012.
Name and address of API M/s. Saurav Chemicals Limited
manufacturer. 370 Industrial Area, Phase II Panchkula, Haryana,
134109 – India.
Manufacturing site address:
M/s. Saurav Chemicals Limited,
Bhagwanpura, Derabassi – Barwala Road, Mohali
District Punjab India
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD
Summary) template.
physical form, manufacturers, Characterization,
stability studies of drug substance. The firm has
summarized information of drug product including its
analytical procedures, validation/verification of
Module III (Drug Substance) Firm has submitted detailed data for both drug substance
data related to nomenclature, structure, general
Stability studies (Drug substance) Firm has submitted stability study data of 3 batches of
drug substance at both accelerated as well as real time
conditions. The accelerated stability data is conducted at
40 O ± 2 O C /75% ± 5% RH for 6 months. The real time
stability data is conducted at 30OC ± 2 O C / 65% ± 5%
RH for 60 months. (Batch No. KTM06130016,
KTM06130017 & KTM06130018)
impurities, specifications, analytical procedure,
Pharmaceutical equivalence and Firm has performed pharmaceutical equivalence against
comparative dissolution profile the product Toradol Ampoule 30mg, B. No. C2436,
Mfg. date 01, 2020 by Barrett Hodgson by performing
quality tests (Description, Identification, pH, Assay,
Sterility, Bacterial endotoxin.)
Analytical method Method validation studies have submitted including
Manufacturer of API M/s. Saurav Chemicals Limited
370 Industrial Area, Phase II Panchkula, Haryana, 134109 – India.
Manufacturing site address:
M/s. Saurav Chemicals Limited,
Bhagwanpura, Derabassi – Barwala Road, Mohali District Punjab
India
API Lot No. KM-0100918, KTM-180015 & KTM180015.
Description of Pack
Glass ampoule
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. A-439 A-596 A-611
Batch Size 46,200 16,000 Ampoules 33,000 Ampoules
Ampoules
No. of Batches 03
1. Reference of previous approval of NA
firm (if any)
2. Approval of API/ DML/GMP certificate of GMP certificate of M/s. Saurav Chemicals Limited,
API manufacturer issued by concerned Bhagwanpura, Derabassi – Barwala Road, Mohali
regulatory authority of country of origin. District Punjab India Valid till 25-06-2023.
3. Documents for the procurement of API Firm has submitted attested copy of invoice (invoice#
with approval from DRAP (in case of SCL2018/18-19 dated 29-01-2019.
import).
4. Data of stability batches will be supported Firm has submitted record of testing of all batches
by attested respective documents like along with chromatograms, raw data sheets, COA and
5. Compliance Record of HPLC software N/A
testing
6. Record of Digital data logger for Firm has submitted record of data logger for
temperature and humidity monitoring of temperature and humidity monitoring of real time and
stability chambers (real time and accelerated stability chambers.
accelerated)
Sr. Section Observations Firm’s Response
No. Number
1 1.4.3 Total number of approved registered Applicant has 07 approved sections
products on contract basis could not be and applicant has also submitted that
confirmed. Complete details of products they no product is registered on
registered on contract basis shall be contract manufacturing.
submitted.
2 1.5.6 Official monograph is available in USP. Firm has provided new Form 5F
Firm has claimed innovator’s specifications wherein they have revised their
in “1.5.6” section of form 5F. specifications from innovator’s
specifications to USP specifications
without submission of applicable fee.
3 1.6.5 Valid GMP certificate of API manufacturer Valid GMP certificate of API
issued by regulatory body of country shall manufacturer is provided.
be submitted. Valid till 25-06-2023.
4 3.2. S.4 • Results of analysis of relevant batch(es) Batch No. A-439 has been
of drug substance performed by drug manufactured by API lot No. KM-
product manufacturer used during 0100918 while COA has only been
product development and stability submitted for API Lot No. KTM-
studies along with COA of the same 180015
batch from drug substance/Active
manufacturer.
• Detailed analytical procedure for the
drug substance by the drug product Submitted.
manufacturer shall be provided.
• Analytical method verification studies
including specificity, accuracy and Firm has submitted analytical method
repeatability (method precision) for drug verification studies but
substance performed by the drug product chromatograms for finished product
manufacturer shall be submitted. has been submitted.
5 3.2. ADC attested invoices of the drug ADC attested invoice for API Lot No.
P.8.3 substance used during product KM-0100918 used in Batch No. A-439
development and stability studies shall be has not been provided by the firm.
submitted.
6 3.2. Justification of not performing terminal Firm has submitted that we cannot
P.2.3 sterilization of the drug product. perform terminal sterilization of
ketorolac injection because it is heat
sensitive product.
Melting point of the API mentioned in
DMF is 165-170 oC.
7 3.2. Detailed analytical procedure for the drug Submitted.
P.5.2 product by the drug product manufacturer
shall be provided.
8 3.2. In process validation protocol 30.45mg of Firm has submitted that it is potency
P.5.3 ketorolac tromethamine is used. adjustment.
Justification is required whether overage or The potency as per COA of drug
potency adjustment. substance on as is basis is 98.5%. On
the basis of as is potency the quantity
of powder to be dispensed is calculated
as 30.45mg {(100/98.5) x 30 = 30.45}
9 3.2. Submit raw data sheets for stability studies, Submitted.
P.8.3 reflecting the details of Standard weight,
Sample dilution preparation, Potency of
Reference standard and Calculation
formula applied for the Assay test.
Decision of 313th meeting of the Registration Board: Deferred for following;
• Submission of documents/commercial invoice for the procurement of API Lot No. KM-0100918
with approval from DRAP.
• Submission of scientific justification for not performing terminal sterilization of the drug product.
• Submission of 7500/- fee for revision of finished product specifications as per notification No. F. 7-
11/2021-B&A/DRAP dated 13-07-2021.
Submission by the firm;
Sr. Reason for deferment. Submission/Justification by the firm.
No.
1. Submission of documents/commercial Firm has submitted clearance certificate attested by
invoice for the procurement of API Lot No. AD - I&E, DRAP, Islamabad dated 27-04-2018 for
KM-0100918 with approval from DRAP. the ketorolac tromethamine B# KM-0100918.
2. Submission of scientific justification for Firm has submitted that we were not performing
not performing terminal sterilization of the terminal sterilization earlier but now we started
drug product. terminal sterilization. They have also attached
review document.
3. Submission of 7500/- fee for revision of Firm has submitted fee of 7500/- vide slip No.
finished product specifications as per 31868295920 dated 06-01-2022 for revision of
notification No. F. 7-11/2021-B&A/DRAP specifications.
dated 13-07-2021.
Decision of 316th meeting of the Registration Board: Deferred for scientific rationale of performing
terminal sterilization, with reference to the innovator product.
Firm has submitted a document with title of “ketorolac tromethamine injection- Google patents” wherein
they have provided details of a product of a Chinese pharmaceutical i.e. Tianjin Chase Sun Pharmaceutical
Co. Ltd. The document discloses a prescription of ketorolac tromethamine injection and preparation
method. The invention can not only effectively solve the problem that the existing ketorolac tromethamine
injection containing ethanol causes irritation while being injected and improve the safety of the drugs and
compliance of the drugs but also completely avoid the white points caused by the traditional technology
after sterilization treatment, and thus the ketorolac tromethamine injection is good in stability, high in
safety, reliable in quality and significant in efficacy.
The document has also shown that the said injection is terminally sterilized.
Remarks of the Evaluator XIII
In actives mentioned in the formulation of the above said document has no Ethyl alcohol, while the applied
formulation has followed the innovator product which contain ethyl alcohol as solvent which makes the
difference between the two formulations.
Furthermore, the document provided by the firm is not from RRA.
Decision: Registration Board deferred the case for further deliberation regarding the sterilization
method of the applied formulation whether by way of terminal sterilization or otherwise.
DRAP Authority in its 129th meeting held on 17-02-2022 decided as follows:
The Authority appreciated the efforts of PE&R Division for effective and phase wise implementation of
CTD and after detailed deliberations approved the out of queue consideration of registration applications
of New Chemical Entities on CTD format (Form 5F).
Accordingly, the following application is evaluated and placed before the Registration Board for consideration.
432. Name, address of Applicant / Importer Biocare Pharmaceutica, 807-Shadman 1, Lahore-Pakistan.
Details of Drug Sale License of DSL NO. 05-352-0063-032069D.
importer Address: M/s Biocare Pharmaceutica, 807-Shadman 1,
District Lahore.
Go-down address: 8-C, Street No.3, Near LGS School, Shah
Jamal, District Lahore.
Valid up to 17-04-2022.
Name and address of marketing Wanbang Biopharmaceuticals.
authorization holder (abroad) Manufacturing site Address: South of Dongshan,
Comprehensive area, Jinshanqiao Development Zone,
Xuzhou, Jiangsu China.
Name, address of manufacturer(s) Manufactured By: - Wanbang Biopharmaceuticals
Manufacturing site Address: South of Dongshan,
Comprehensive area, Jinshanqiao Development Zone,
Xuzhou, Jiangsu China.
Name of exporting country China.
Detail of certificates attached (CoPP, Detail of certificates attached (CoPP, GMP certificate)
Free sale certificate, GMP certificate) • Original legalized CoPP (certificate No. JS20210074)
issued by Jiangsu Drug Administration, China on 20-01-
2021. The document also confirms that the applied
product strength is actually on the market in exporting
country. Valid up to 19-01-2022.
• Original legalized GMP certificate No. JS20180837 valid
till 21/06/2023 issued by China Food and Drug
Administration is submitted.
Details of letter of authorization / sole Copy of product specific sole agency agreement is submitted.
agency agreement
☒ Importer
☐ Export sale
☐ Buk import and local repackaging for export purpose only
The proposed proprietary name / brand PARIX, Bio-P, Dynastat 40mg Powder for injection (IV/IM).
name
Strength / concentration of drug of Each vial contains:
Active Pharmaceutical ingredient (API) 42.3 mg of parecoxib sodium equivalent to parecoxib
per unit ……………… 40mg.
Pharmaceutical form of applied drug (Parecoxib Sodium) 40 Mg (IM/IV) freez-dried Powder for
Solution for Injection.
Pharmacotherapeutic Group of (API) Anti-inflammatory and Antirheumatic products, Non-steroids
(Coxibs).
ATC code: M01AH04.
For the short-term treatment of postoperative pain in adults.
Reference to Finished product In House specifications.
specifications
Proposed Pack size 10 vials/carton, 50 cartons/box.
Proposed unit price PKR 500/vial.
The status in reference regulatory DYNASTAT Injection contains 40 mg parecoxib (as 42.36
authorities mg parecoxib sodium), TGA approved.
For generic drugs (me-too status) Could not be confirmed.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template. Firm
has summarized information related to nomenclature,
manufacturers, and controls, impurities, specifications,
development, manufacturer, manufacturing process and
excipients, control of drug product, specifications, analytical
procedures, validation of analytical procedures, batch
analysis, justification of specifications, reference standard or
materials, container closure system and stability.
Name, address of drug substance M/s Zhejiang Haisen Pharmaceutical Co. Ltd., Xiangtan
manufacturer Village, Liushi Street, Dongyang, City Zhejiang Province,
China.
Module-III Drug Substance: Firm has submitted detailed drug substance data related to
physical form, manufacturers, description of manufacturing
process and controls, impurities, specifications, analytical
procedures and its verification studies, batch analysis and
Stability Studies of Drug Substance • 36 months real time stability data at 30°± 2°C / 65% RH ±
(Conditions & duration of Stability 5% RH of 03 batches (5316110201, 5316110202,
studies) 5316120201).
• 06 month accelerated stability data 40°C ± 2°C / 75% RH
± 5% RH of 03 batches (5316110201, 5316110202,
5316120201).
process validation protocols, control of excipients, control of
drug product, specifications, analytical procedures, validation
of analytical procedures, batch analysis, justification of
Pharmaceutical Equivalence and Pharmaceutical equivalence has been established against
Comparative Dissolution Profile reference product i.e. Dynastat 40mg powder for solution for
injection, Batch No. R42343 with Exp. Date of 04/2019
manufactured by the Pfizer Limited by performing the
following tests;
Appearance, Identification, pH, Clarity of solution, related
compounds, water content, weight variation, particulate
matter, sterility, bacterial endotoxin, visible particulates and
Assay.
Analytical method Submitted.
Container closure system of the drug 5ml type I clear glass tubular injection vial with brominated
product butyl rubber stopper sealed with a blue flip-off cap on the
aluminum seal.
Stability study data of drug product, • 12 months real time stability data at 30°C ± 2°C / 65% ±
shelf life and storage conditions 5% RH of 03 batches (42001403, 42001404, 42001407).
• 06 month accelerated stability data 40°C ± 2°C / 75% ±
5% RH of 03 batches (42001403, 42001404, 42001407).
Finished product manufacturer has also submitted a
commitment letter wherein they commit/confirm that
complete full 24 month till shelf life Zone IVA stability study
under 30°C ± 2°C / 65% ± 5% RH condition for their product
Parecoxib 40mg powder for injection. They further submitted
that they will update 15, 18 & 24-month time point stability
data under Zone IVA conditions accordingly as soon as it is
completed & tested.
Evaluation by PEC:
Sr. No. Observations Reply by the firm.
1 Notarized agreement shall be submitted. Firm has again submitted copy of agreement.
2 Valid copy of DSL as the DSL is valid up Firm has provided provisional receipt of “Application
to 17-04-2022. for change in drug sale license 352-98572912-2022”
with reference No. 352-98572912-2022 of M/s Biocare
Pharmaceutica, 807 Shadman-1, District Lahore.
3 Valid CoPP shall be submitted. 19-01- Firm has submitted copy of CoPP (certificate No.
2022. JS20220091) issued by Jiangsu Drug Administration,
China on 04-03-2022. The document also confirms that
the applied product strength is actually on the market
in exporting country. Valid up to 03-03-2023.
Not notarized and countersigned by the embassy of
Pakistan.
4 Complete shelf life stability data of the Firm has submitted 24-month real time stability data at
applied formulation shall be submitted. 30°C ± 2°C / 65% ± 5% RH of three batches
(42001403, 42001404, 42001407) for the applied
formulation and results are within the limits.
th
Decision of 317 meeting of Registration Board:
Registration Board after thorough deliberation decided to deferred the case for further incorporations of complete
details including approval status of the of the new chemical entity in reference regulatory authorities, indications,
warnings etc.
• Firm has submitted valid, notarized and embassy of Pakistan countersigned CoPP valid till 03-03-2023.
• Firm has further submitted that the applied formulation is approved in the following reference
regulatory authorities;
a. Dynastat 40 mg powder for solution for injection of M/s Pfizer Limited Ramsgate Road Sandwich Kent
CT13 9NJ United Kingdom, MHRA approved.
Indication; For the short-term treatment of postoperative pain in adults.
Special warnings and precautions for use;
Dynastat has been studied in dental, orthopaedic, gynaecologic (principally hysterectomy) and coronary
artery bypass graft surgery. There is limited experience in other types of surgery, for example
gastrointestinal or urological surgery.
Modes of administration other than IV or IM (e.g. intra-articular, intrathecal) have not been studied and
should not be used.
Because of the possibility for increased adverse reactions at higher doses of parecoxib, other COX-2
inhibitors and NSAIDs, patients treated with parecoxib should be reviewed following dose increase and,
in the absence of an increase in efficacy, other therapeutic options should be considered (see section 4.2).
There is limited clinical experience with Dynastat treatment beyond three days.
If, during treatment, patients deteriorate in any of the organ system functions described below,
appropriate measures should be taken and discontinuation of parecoxib therapy should be considered.
Cardiovascular; COX-2 inhibitors have been associated with increased risk of cardiovascular and
thrombotic adverse events when taken long term. The exact magnitude of the risk associated with a single
dose has not been determined, nor has the exact duration of therapy associated with increased risk.
Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia,
diabetes mellitus, smoking) should only be treated with parecoxib after careful consideration (see section
5.1). Appropriate measures should be taken and discontinuation of parecoxib therapy should be
considered if there is clinical evidence of deterioration in the condition of specific clinical symptoms in
these patients. Dynastat has not been studied in cardiovascular revascularization procedures other than
coronary artery bypass graft (CABG) procedures. Studies in types of surgery other than CABG
procedures included patients with American Society of Anaesthesiology (ASA) Physical Status Class I-
III only.
Acetylsalicyclic acid and other NSAIDs; COX-2 inhibitors are not a substitute for acetylsalicylic acid
for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effects.
Therefore, antiplatelet therapies should not be discontinued (see section 5.1). Caution should be exercised
when coadministering Dynastat with warfarin and other oral anticoagulants (see section 4.5). The
concomitant use of parecoxib with other non- acetylsalicylic acid NSAIDs should be avoided. Dynastat
may mask fever and other signs of inflammation (see section 5.1). In isolated cases, an aggravation of
soft tissue infections has been described in connection with the use of NSAIDs and in nonclinical studies
with Dynastat (see section 5.3). Caution should be exercised with respect to monitoring the incision for
signs of infection in surgical patients receiving Dynastat.
Gastrointestinal; Upper gastrointestinal (GI) complications (perforations, ulcers or bleedings [PUBs]),
some of them resulting in fatal outcome, have occurred in patients treated with parecoxib. Caution is
advised in the treatment of patients most at risk of developing a gastrointestinal complication with
NSAIDs; the elderly, or patients with a prior history of gastrointestinal disease, such as ulceration and
GI bleeding, or patients using acetylsalicylic acid concomitantly. The NSAIDs class is also associated
with increased GI complications when coadministered with glucocorticoids, selective serotonin reuptake
inhibitors, other antiplatelet drugs, other NSAIDs or patients ingesting alcohol. There is further increase
in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal
complications), when parecoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Skin reactions; Serious skin reactions, including erythema multiforme, exfoliative dermatitis and
Stevens-Johnson syndrome (some of them fatal) have been reported through post-marketing surveillance
in patients receiving parecoxib. Additionally, fatal reports of toxic epidermal necrolysis have been
reported through postmarketing surveillance in patients receiving valdecoxib (the active metabolite of
parecoxib) and cannot be ruled out for parecoxib (see section 4.8). DRESS syndrome may occur with
parecoxib exposure based on other serious skin reactions reported with celecoxib and valdecoxib
exposure. Patients appear to be at highest risk for these reactions early in the course of therapy; the onset
of the reaction occurring in the majority of cases within the first month of treatment. Appropriate
measures should be taken by physicians to monitor for any serious skin reactions with therapy, e.g.
additional patient consultations. Patients should be advised to immediately report any emergent skin
condition to their physician. Parecoxib should be discontinued at the first appearance of skin rash,
mucosal lesions, or any other sign of hypersensitivity. Serious skin reactions are known to occur with
NSAIDs including COX-2 selective inhibitors as well as other medicinal products. However, the reported
rate of serious skin events appears to be greater for valdecoxib (the active metabolite of parecoxib) as
compared to other COX-2 selective inhibitors. Patients with a history of sulfonamide allergy may be at
greater risk of skin reactions (see section 4.3). Patients without a history of sulfonamide allergy may also
be at risk for serious skin reactions.
Hypersensitivity; Hypersensitivity reactions (anaphylaxis and angioedema) have been reported in post-
marketing experience with valdecoxib and parecoxib (see section 4.8). Some of these reactions have
occurred in patients with a history of allergictype reactions to sulfonamides (see section 4.3). Parecoxib
should be discontinued at the first sign of hypersensitivity. Cases of severe hypotension shortly following
parecoxib administration have been reported in postmarketing experience with parecoxib. Some of these
cases have occurred without other signs of anaphylaxis. The physician should be prepared to treat severe
hypotension.
Fluid retention, oedema, renal; As with other medicinal products known to inhibit prostaglandin
synthesis, fluid retention and oedema have been observed in some patients taking parecoxib. Therefore,
parecoxib should be used with caution in patients with compromised cardiac function, preexisting
oedema, or other conditions predisposing to, or worsened by, fluid retention including those taking
diuretic treatment or otherwise at risk of hypovolemia. If there is clinical evidence of deterioration in the
condition of these patients, appropriate measures including discontinuation of parecoxib should be taken.
Acute renal failure has been reported through post-marketing surveillance in patients receiving parecoxib
(see section 4.8). Since prostaglandin synthesis inhibition may result in deterioration of renal function
and fluid retention, caution should be observed when administering Dynastat in patients with impaired
renal function (see section 4.2) or hypertension, or in patients with compromised cardiac or hepatic
function or other conditions predisposing to fluid retention. Caution should be used when initiating
treatment with Dynastat in patients with dehydration. In this case, it is advisable to rehydrate patients
first and then start therapy with Dynastat.
Hypertension; As with all NSAIDs, parecoxib can lead to the onset of new hypertension or worsening
of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular
events. Parecoxib should be used with caution in patients with hypertension. Blood pressure should be
monitored closely during the initiation of therapy with parecoxib and throughout the course of therapy.
If blood pressure rises significantly, alternative treatment should be considered.
Hepatic impairment; Dynastat should be used with caution in patients with moderate hepatic
impairment (Child-Pugh score 7-9).
Use with oral anticoagulants; The concomitant use of NSAIDs with oral anticoagulants increases the
risk of bleeding. Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g.
apixaban, dabigatran, and rivaroxaban).
Sodium content; This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say
essentially ‘sodium-free’.
Contraindications;
Hypersensitivity to the active substance or to any of the excipients.
History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as
Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms syndrome (DRESS
syndrome), toxic epidermal necrolysis, erythema multiforme or patients with known hypersensitivity to
sulfonamides.
Active peptic ulceration or gastrointestinal (GI) bleeding.
Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema,
urticaria or other allergic-type reactions after taking acetylsalicylic acid or nonsteroidal anti-
inflammatory drugs (NSAIDs) including COX-2 inhibitors.
The third trimester of pregnancy and breast-feeding.
Severe hepatic impairment (serum albumin ˂ 25g/l or child-pugh score is ≥ 10).
Inflammatory bowel disease.
Congestive heart failure (NYHA II-IV).
Treatment of post-operative pain following coronary artery bypass graft (CABG) surgery.
Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
b. Dynastat 40 mg powder for solution for injection of M/s Pfizer Europe MA EEIG Boulevard de la
Plaine 17 1050 Bruxelles Belgium, EMA approved.
c. DYNASTAT parecoxib (as sodium) 40mg powder for injection vial, Pfizer Australia Pty Ltd., TGA
Australia approved.
Finished Drugs with innovator’s specifications. Registration letter will be issued after submission of fee of
Rs. 7,500/- for correction/pre-approval change in the method of manufacture/specifications, as per
Registration applications of Veterinary drugs on Form 5.
433. Name and address of manufacturer/ M/s Nawan Laboratories (Pvt.) Ltd., plots No. 136,
Applicant sector 15, Korangi Industrial Area Karachi (Dry
powder sachet section (General) veterinary).
Brand Name + Dosage Form + Easy Digest powder.
Strength
Composition Each 1000gm contains:
Propionic Acid Calcium ………..250gm
Propionic Acid Sodium …………400gm
Acetanilide ………………………150gm
Magnesium Oxide ……………….125gm
Iron II Sulphate …………………..0.400mg
Zinc Sulphate …………………….0.100mg
Magnesium Sulphate ……………...0.200mg
Copper Sulphate …………………..0.450mg
Cobalt Sulphate ……………………0.400mg
Sodium Molybdate …………………0.100mg
Sodium Chloride ……………………20gm
Diary No. Date of R & I & fee Dy. No 11444 dated 05-03-2019; Rs.20,000/- dated 04-
03-2019.
Pharmacological Group Appetizing and digestive tonic powder.
Type of Form Form-5
Finished product Specification Manufacturer specifications.
Pack size & Demanded Price 100gm sachet & decontrolled.
Approval status of product in Reference N/A.
Me-too status Alvegest powder, Star Laboratories, Reg. No. 008029.
GMP status Firm has submitted routine GMP inspection report
dated 25-01-2022 wherein it is concluded that keeping
in view the attitude of the management towards
continuous improvements and current observations
their overall GMP compliance is rated as good.
Remarks of the Evaluator • Firm was asked to revise their label claim as per
their demanded pack size. They revised their label
claim as follows;
Each 100-gm powder contains;
Propionic Acid Calcium ………..25gm
Propionic Acid Sodium …………40gm
Acetanilide ………………………15gm
Magnesium Oxide ………………12.5gm
Iron II Sulphate ………………0.040mg
Zinc Sulphate …………………0.010mg
Magnesium Sulphate …………0.020mg
Copper Sulphate ……………...0.045mg
Cobalt Sulphate ………………0.040mg
Sodium Molybdate ……………0.010mg
Sodium Chloride …………………2gm
• Firm has submitted me too details as Alvegest
powder manufactured by Star Laboratories, Reg.
No. 008029.
• However, the composition of the applied
formulation is different from the already
approved formulation.
Decision: Deferred for submission evidence of already approved formulation by the
Registration Board with brand name, Registration number & manufacturer name. As the
composition of the applied formulation is different from submitted me too in concentration
of Iron II Sulphate, Zinc, Magnesium Sulphate, Copper Sulphate, Cobalt Sulphate and
Sodium Molybdate.
Registration applications of deferred Veterinary drugs on Form 5.
434. Name and address of manufacturer/ M/s Attabak Pharmaceutical Industries, 5-C Industrial
Applicant Area, I- 10/3 Islamabad
Brand Name + Dosage Form + Strength TRICLOSOLE Bolus
Composition Each Bolus contains
Triclabendazole ………………………900mg
Levamisole ……………………………90mg
Diary No. Date of R & I & fee Dy. No. 13832, Dated: 24/05/2021, Rs. 30,000/-
Pharmacological Group Anthelmintic
Type of Form Form-5
Finished product Specification As Per Innovator’s Specification
Pack size & Demanded Price 4 x5’S, 10 x5’S & 20 x5’S
Me-too status Tribazole Plus Bolus 900mg/90mg (R# 074039)
Selemore pharmaceuticals Pvt Ltd
GMP status Panel inspection conducted on 08-02-2021 for
renewal of DML & grant of Additional Sections.
Panel recommended grant of Additional Sections.
Previous decision (M-312) Deferred for correction of the salt form of Levamisole
in label claim along with submission of applicable fee.
Evaluation by PEC Firm has submitted that:
Our applied composition is already as per me-too
applied.’
However, As per Product Information Database of
Veterinary Medicines Directorate, MHRA
Levamisole is approved as Levamisole hydrochloride
for oral dosage form.
Previous decision (M-316) Deferred for correction of the salt form of Levamisole
in label claim along with submission of applicable fee.
Submission by the firm. Firm has submitted their revised formulation as per
decision of 316 meeting of the Registration Board
with submission of fee of 7500/- vide slip No.
71086384236 dated 22-06-2022.
Each Bolus contains
Triclabendazole ………………………900mg
Levamisole Hydrochloride……………90mg
XIII
Remarks of the Evaluator However, firm has not revised the label claim as per
Product Information Database of Veterinary
Medicines Directorate, MHRA where Levamisole is
approved as Levamisole hydrochloride while the firm
has applied Levamisole hydrochloride.
Furthermore, for change of salt form full fee shall be
submitted.
• Registration Board further decided that registration letter will be issued upon
submission of revised label claim as per innovator product declaring the salt form
of Levamisole as Levamisole HCl, submission of full fee for correction/pre-approval
change in salt form of drug substance, as per notification No.F.7-11/2012-
Registration applications of deferred Human drugs on Form 5.
435. Name and address of manufacturer/ M/s Fedro Pharmaceuticals Lab Pvt. Ltd, 149-Industrial
Applicant Estate, Hayatabad, Peshawar.
Brand Name + Dosage Form + Keyfed tablet 1mg
Strength
Composition Each film- coated tablet contains:
Ketotifen as Fumarate…………………………1mg
Diary No. Date of R & I & fee Dy.No.27229; 08-08-2018; Rs.20,000 (08-08-2018)
Pharmacological Group Anti- histamine
Type of Form Form- 5
Finished product Specification Manufacturers
Pack size & Demanded Price 20’s, 30’s & as per SRO
Approval status of product in MHRA Approved as uncoated
Me-too status Asthanil 1mg Tab of M/s Siza Lahore
(Reg. # 011751)
GMP status Last GMP inspection was conducted on 30-01-2019 and
the report concludes:
The firm rectified majority of observations noted in the
previous inspection and the management is committed to
further improve their cGMP compliance. The firm may
be
considered operating in satisfactory level of cGMP
compliance.
Remarks of the Evaluator • Initially, film- coated tablet was applied while it is
approved in Italy (AIFA) as uncoated.
• Firm has revised its master formulation according to
the reference and has submitted Rs. 5000/- for change
of formulation.
• The applied formulation is non- pharmacopoeial.
• General tablet section is available in the firm as
mentioned in the submitted GMP certificate.
• Applied salt is not complete because Ketotifen as
“Hydrogen” fumarate is approved in MHRA. Firm
did not correct the salt in reply.
Decision of 293rd meeting of Deferred for revision of formulation as per reference
Registration Board. product along with submission of requisite fee.
Submission by the firm. Firm has submitted that in response to letter No. F.1-
1/2017/PEC-DRAP (AD PEC XIII), they have already
submitted 5000/- fee while their product is still pending.
Remarks of the Evaluator XIII
• Firm has neither submitted revised label claim as per
reference product nor any fee for revision of label
claim against the decision of 293rd meeting of
Registration Board.
• Latest GMP certificate/inspection report conducted
within last three years shall be submitted.
Decision: Approved with innovator’s specifications as per following label claim:
“Each tablet contains:
Ketotifen as Fumarate ……………… 1mg”
• Registration letter will be issued after submission of differential fee of Rs. 2,500
for correction/pre-approval change in dosage from film coated to uncoated tablet,
436. Name and address of manufacturer/ M/s Scilife Pharma Pvt Ltd., Plot # FD-57/58-A2,
Applicant Korangi Creek Industrial Park, Karachi. (Contract
giver)
M/s Vision Pharmaceuticals, Plot # 22,23, Industrial
Triangle, Kahuta Road, Islamabad. (contract acceptor)
(Large volume & small volume parenteral.)
Brand Name + Dosage Form + Strength Orpic 200mg/100ml IV Infusion.
Ciprofloxacin Lactate eq. to Ciprofloxacin …200mg
Diary No. Date of R & I & fee Dy. No 16170 dated 07-03-2019; Rs.50,000/- dated
07-03-2019.
Pharmacological Group Quinolone Antibacterial.
Type of Form Form-5.
Finished product Specification BP Specifications.
Pack size & Demanded Price 1 x 100ml & as per SRO.
Approval status of product in Reference Ciprofloxacin 2 mg/ml (As lactate) solution for
Regulatory Authorities infusion, MHRA approved.
Me-too status Otsuflox IV Infusion 100ml, Otsuka Pakistan, Reg.
No. 086880.
GMP status Vision Pharma:
GMP certificate issued on 31-07-2019 on the basis of
Scilife pharma:
Remarks of the Evaluator • Packaging material of the applied formulation is
LDPE and is different from the reference product
which is PVC bag contained in a
polypropylene/polyester aluminum/polyester
pouch.
• Master formula has ciprofloxacin lactate and
lactic acid while BP monograph states that
ciprofloxacin infusion is a sterile solution
prepared by the interaction of ciprofloxacin and
lactic acid.
• M/s Scilife Pharma has 06 approved sections vide
letter No. F. 2-4/2011-Lic (Vol-I) dated 18-06-
2021.
• M/s Scilife Pharma has also submitted that they
have 09 approved products on contract basis.
Decision of 312th meeting of Deferred for following:
Registration Board. • Packaging material of the applied formulation is
polypropylene/polyester aluminium/polyester
pouch.
• Master formula has ciprofloxacin lactate and
lactic acid while BP monograph states that
ciprofloxacin infusion is a sterile solution
prepared by the interaction of ciprofloxacin and
lactic acid. Master formulation needs revision
along with submission of application of
applicable fee.
Submission by the firm. • Firm has submitted that according to innovator
manufactured by Hospira UK Ltd., ciprofloxacin
solution for infusion supplied in transparent
infusion bags (PVC or Polyolefin). We are
mentioning LDPE, which belongs to polyolefin.
Furthermore, we also performed the stability of
product in LDPE which shows that the product is
compatible with LDPE container.
• Firm has also submitted that we have
manufactured our product according the
innovator product while lactic acid 50% is
mentioned in list of excipients. Lactic acid is
added as an acidifying agent to improve the
solubility of API. Thus, there will be no revision
in formulation.
Remarks of the Evaluator XIII • BP monograph states that ciprofloxacin infusion
is a sterile solution prepared by the interaction of
ciprofloxacin and lactic acid.
Decision: Deferred for following points:
• Revision of formulation as per BP monograph along with submission of full fee.
• Details regarding formulation and salt form of ciprofloxacin along with current
status of the commercial product manufactured by M/s vision pharmaceuticals.
437. Name and address of manufacturer/ M/s Scilife Pharma Pvt Ltd., Plot # FD-57/58-A2,
Applicant Korangi Creek Industrial Park, Karachi. (Contract
giver)
M/s Vision Pharmaceuticals, Plot # 22,23, Industrial
Triangle, Kahuta Road, Islamabad. (contract acceptor)
(Large volume & small volume parenteral.)
Brand Name + Dosage Form + Strength Scimox 400mg/250ml IV Infusion.
Moxifloxacin HCL eq. to Moxifloxacin ……400mg
Diary No. Date of R & I & fee Dy. No 16169 dated 07-03-2019; Rs.50,000/- dated
07-03-2019.
Pharmacological Group Quinolone Antibacterial.
Finished product Specification Manufacturer’s specifications.
Pack size & Demanded Price 1 x 250ml & as per SRO.
Approval status of product in Reference Avelox 400 mg/250 ml solution for infusion, MHRA
Regulatory Authorities approved.
Me-too status Zeker 400mg/250ml Infusion, ISIS Pharmaceutical,
Reg. No. 092704.
GMP status Vision Pharma:
Scilife pharma:
Remarks of the Evaluator • Packaging material of the applied formulation is
polypropylene/polyester aluminum/polyester
pouch.
• M/s Scilife Pharma has 06 approved sections vide
letter No. F. 2-4/2011-Lic (Vol-I) dated 18-06-
2021.
• M/s Scilife Pharma has also submitted that they
have 09 approved products on contract basis.
Registration Board. • Packaging material of the applied formulation is
polypropylene/polyester aluminium/polyester
pouch.
Submission by the firm. • Firm has submitted that according to innovator
Avelox 400mg/250ml solution for infusion,
Moxifloxacin solution for infusion supplied in
polyolefin bags. We are mentioning LDPE,
which belongs to class polyolefin. Furthermore,
we also performed the stability of product in
LDPE which shows that the product is
compatible with LDPE container.
XIII
submission of fee of Rs. 7,500/- for correction/pre-approval change in specifications, as per
438. Name and address of manufacturer/ M/s Semos Pharmaceuticals (Pvt.) Ltd., Plot No. 11,
Applicant Sector 12-A, North Karachi, Krachi-75850,
Brand Name + Dosage Form + Strength Mefalgic 50mg/5ml Suspension
Mefenamic Acid …………………50mg
Diary No. Date of R & I & fee Dy. No 5328 dated 07-02-2019 Rs.20,000/-06-02-
2019
Pharmacological Group Anti-inflammatory and Antirheumatic Products, Non-
Steroids
Type of Form Form-5
Finished product Specification Manufacturer's Specification
Pack size & Demanded Price 60ml, 450ml: As per SSRO
Me-too status Constel 50mg/5ml suspension
GMP status Dated:04-07-2018
Conclusion: Based on above observations their current
GMP compliance level is rated as GOOD.
Remarks of the Evaluator PEC • Mention type of primary packaging material
• Approval status of product in reference regulatory
authorities?
th
Decision of 296 meeting of Deferred for the following:
Registration Board. : • Evidence of approval of applied formulation in
reference regulatory authorities/agencies which
were declared/approved by the Registration
Board in its 275th meeting.
• Mention type of primary packaging material for
applied formulation.
Submission by the firm. Firm has submitted PIL of mefenamic acid 50mg/5ml
suspension approved by Netherland. However, the
same could not be confirmed.
Firm has also submitted the art work of applied
formulation instead of primary packaging material.
Remarks of Evaluator PEC-XIII. • Evidence of approval of applied formulation in
Registration Board. : • Evidence of approval of applied formulation in
Submission by the firm. Firm has submitted an evidence for the applied
formulation approved in MHRA.
Mefenamic Acid 50 mg/5 ml Suspension, Marketing
Authorization holder is Chemidex Pharma Limited
and marketing Authorization number is PL
17736/0146.
Remarks of Evaluator PEC . XIII
• Type of primary packaging material for applied
formulation could not be confirmed.
• Latest GMP status of the firm could not be
confirmed.
• Registration letter will be issued after submission of fee of Rs. 7,500/- for
correction/pre-approval change in specifications, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
• Firm will also submit details of primary packaging material and current GMP
status of the manufacturing site.
439. Name and address of manufacturer/ M/s Hi-Med Pharmaceuticals, (Pvt.) Ltd., 208-C
Applicant Sunder Industrial Estate (P.I.E), Raiwind Road,
Lahore (Tablet general).
Brand Name + Dosage Form + Strength Medigex 100mg Tablet.
Sertraline HCl………………………..100mg
Diary No. Date of R & I & fee Dy. No 9939 dated 04-03-2019; Rs.20,000/- 28-02-
2019
Finished product Specification USP Specifications
Pack size & Demanded Price 20’s & as per SRO.
Approval status of product in ZOLOFT (sertraline hydrochloride), USFDA
Reference Regulatory Authorities approved.
Me-too status Lintre Tab 100mg, Indus Pharma, Reg. No. 048481
GMP status GMP status of the firm could not be confirmed.
Remarks of the Evaluator PEC-XIII. Firm submitted panel inspection report for grant of
new drug manufacturing license conducted on 27-04-
2018 wherein the panel recommended the grant of
DML by the way of formulation to M/s Hi-Med
Pharmaceuticals.
Decision of 307th meeting of Deferred for updated status of GMP of the firm from
Registration Board. : QA & LT Division.
Submission by the firm. Firm has submitted copy of GMP certificate No.
102/2022-DRAP(AD-37320885037) dated 27-06-
2022 issued on the basis of inspection conducted on
10-06-2022.
Remarks of Evaluator PEC XIII.
Decision: Approved.
Brand Name + Dosage Form + Strength Citamed Plus 50mg/1000mg Tablet
Sitagliptin phosphate monohydrate Eq. to
Sitagliptin……………….…50mg
Metformin HCL…………..1000mg
2019
Pharmacological Group Anti-Diabetic
Finished product Specification Manufacturer’s Specification.
Approval status of product in Janumet 50/1000mg tablets (USFDA approved)
Me-too status Duvel plus 50/1000mg tablets, Martin Dow, reg. no.
075895.
Pharmaceuticals.
102/2022-DRAP(AD-37320885037) dated 27-06-
10-06-2022.
submission of fee of Rs. 7,500/- for correction/pre-approval change in
specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength Medopa 250mg Tablet
Methyldopa eq to anhydrous methyldopa…250mg
2019
Pharmacological Group Anti-hypertensive.
Finished product Specification BP Specification.
Approval status of product in Methyldopa 250mg Tablets, Nexcape
Reference Regulatory Authorities Pharmaceuticals Ltd., MHRA approved.
Me-too status Aldomet tablets, MSD, Karachi, Reg. No. 000311.
Pharmaceuticals.
102/2022-DRAP(AD-37320885037) dated 27-06-
10-06-2022.
Decision: Approved.
Applicant Sunder Industrial Estate (P.I.E), Raiwind Road, Lahore
(Tablet general).
Brand Name + Dosage Form + Strength Pentomed 40mg Tablets.
Composition Each enteric coated tablet contains:
Pantoprazole as sodium sesquihydrate …..40mg
2019
Pharmacological Group Proton Pump Inhibitor (PPI’s)
Finished product Specification USP Specification.
Pack size & Demanded Price 10’s, 14’s & as per SRO.
Approval status of product in USFDA approved.
Me-too status Pantberg 40mg Enteric Coated Tablets, Ice Berg
Pharmaceuticals, Reg. No. 079782.
Pharmaceuticals.
102/2022-DRAP(AD-37320885037) dated 27-06-
10-06-2022.
Decision: Approved.
Agenda of Evaluator PEC-XIV
Case no. 01 Registration applications for local manufacturing of (Human) drugs

a. Deferred cases
443. Name and address of manufacturer / M/s. Medisearch Pharmacal Private Limited 51-Km
Applicant Raiwind Manga Road, Lahore Contract
manufacturing from M/s. Friend Pharma (Pvt.) Ltd.
31-Km Ferozpur Road, Lahore
Brand Name +Dosage Form + Strength Levocin 500mg Infusion
Levofloxacin……..500mg
Diary No. Date of R& I & fee (Duplicate Dossier) Dy. No. dated 27-07-2009
Rs.8,000/- (Photocopy) Differential fee
(Photocopy) of Rs.42,000/- submitted on Dy. No.
dated 29-04-2013
Pharmacological Group Antibiotic
Type of Form Form 5
Finished product Specifications BP specs
Pack size & Demanded Price As per S.R. O
Approval status of product in Reference Levofloxacin Ibigen 5 mg/ml solution for infusion
Regulatory Authorities (100ml vial) by M/s Ibigen, MHRA Approved.
Me-too status (with strength and dosage form) Levosafe 500mg/100ml Infusion by M/s safe
Pharma, Reg. no. 048882
GMP status M/s Medisearch Pharmacal: The firm is granted
GMP certificate based on inspection conducted on
22-02-2021.
M/s Friends Pharma: The firm is granted GMP
certificate based on inspection conducted on 27-
03-2019.
Following sections of M/s Friends pharma are
mentioned on said certificate: Capsule, tablet,
cream/ointment, oral dry powder suspension,
Liquid Injection, Dry powder injection and dry
powder for injection (Lyophilized)
Remarks of the Evaluator • Firm provide the details of products already on
contract manufacturing. (3 products are on
contract manufacturing)
• Section approval letter of LVP
• Firm applied for levofloxacin…500mg/100ml
while the reference product is levofloxacin as
hemihydrate. 5 mg/ml solution for infusion
(100ml vial). So, correction/revision of
formulation is required accordingly.
• Firm applied for BP specification while the
official monograph of applied formulation is not
present in BP.
• Firm applied for revision of formulation as per
reference i.e.,
Each vial of 100ml contains: Levofloxacin as
hemihydrate….500mg without submission of the
requisite fee.
• Further requested to change the specification from
BP to Manufacturer’s specification.
• Bacitrol Infusion (Moxifloxacin) 400mg/250ml
(Reg.no.081273) and Nadosaline IV infusion
(Normal Saline)100ml (Reg.no. 088794) are the
two registered products of Friends Pharma which
indicate firm has both LVP and SVP section.
Previous Decision(s) Deferred for revision of formulation considering the
salt factor of active ingredient as per reference
product i.e. Levofloxacin as
hemihydrate…500mg/100ml along with requisite
fee, revised master formulation and manufacturing
method.
Remarks of the Evaluator The firm has revised the formulation alongwith
master formulation and manufacturing outline as
below:
Each 100ml contains:
Levofloxacin as hemihydrate………..500mg
Each 100ml contains:
Levofloxacin as hemihydrate………..500mg
• Registration Board further decided that registration letter will be issued after submission of
75,000/- fee for revision of formulation as per innovator’s product as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
444. Name and address of manufacturer / M/s Medisearch Pharmacal (Pvt.) Ltd.,
Applicant 5-Km, Raiwind Manga Road, Lahore
Brand Name +Dosage Form + Strength Medival Tablet 250mg
Composition Each Tablet contains:
Divalproex Sodium………250mg
Diary No. Date of R& I & fee 20-04-2011 vide diary No. 4616 Rs.8000 dated.31-
07-2013 Rs.12,000/-
Pharmacological Group (Anticonvulsant)
Type of Form Form-5
Finished product Specifications BP specifications
Approval status of product in Reference Approved in USFDA as delayed release tablet with
Regulatory Authorities the following
box warning:
WARNING: LIFE THREATENING ADVERSE
REACTIONS See
full prescribing information for complete boxed
warning.
• Hepatotoxicity, including fatalities, usually during
the first 6 months of treatment. Children under the
age of two years and patients with mitochondrial
disorders are at higher risk.Monitor patients
closely, and perform serum liver testing prior to
therapy and at frequent intervals thereafter.
• Fetal Risk, particularly neural tube defects, other
major malformations, and decreased IQ
• Pancreatitis, including fatal hemorrhagic cases
Me-too status (with strength and dosage form) Epival 250mg by M/s Abbott.
GMP status The firm is granted GMP certificate based on
Previous remarks of the Evaluator.
Previous Decision(s) Deferred for revision of formulation as per the
reference i.e. Each delayed-release tablet contains:
divalproex sodium equivalent to valproic acid 500
mg along with submission of requisite fee, Form-5,
master formulation and Manufacturing method
(308).
Evaluation by PEC • Firm has submitted copy of differential fee challan
details are given above.
• Firm claimed BP Specification
• Remaining documents as per the decision of
previous meeting (M-256) has provided by the
firm
• Firm has revised the formulation from film coated
to enteric coated tablet and accordingly change
form-5, master formulation & manufacturing
process without the requisite fee.
Each delayed-release tablet contains:

Divalproex sodium equivalent to valproic
acid………….500 mg
Each delayed-release tablet contains:
Divalproex sodium equivalent to valproic acid………….500 mg
30,000/- fee for revision of formulation as per innovator’s product as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
445. Name and address of manufacturer / M/s Medisearch Pharmacal (Pvt.) Ltd.,
Applicant 5-Km, Raiwind Manga Road, Lahore
Brand Name +Dosage Form + Strength Medicef Capsule 400mg
Composition Each capsule contains:
Cefixime as trihydrate…................400mg
Diary No. Date of R& I & fee Form-5 Dy. No. 1312 dated. 20-12-2013 Rs.
20000/-
Pharmacological Group Cephalosporin
Type of Form Form-5
Finished product Specifications Manufacturer,s Spec,s
Pack size & Demanded Price AS Per SRO/10’s
Approval status of product in Reference USFDA Suprax (Lupin Ltd.)
Me-too status (with strength and dosage form) Cefiget (Getz Pharma Pakistan (Pvt.) Ltd.)
GMP status The firm is granted GMP certificate based on
Previous remarks of the Evaluator. The firm has provided Capsule (General &
cephalosporin) section as mentioned in GMP
certificate
Previous decision(s) (M-307) Registration Board deferred the case for further
deliberation regarding finished product
specifications of applied formulation/strength as
product is not available in JP (M-307).
Evaluation by PEC The firm has submitted revised finished product
specifications as manufacturer’s specifications in
accordance with DRAP letter no. F. 14-1/2022-PEC
dated 14-03-2022.
Decision: Approved with manufacturer’s specifications in accordance with DRAP letter no. F.
14-1/2022-PEC dated 14-03-2022.
7,500/- fee for revision of specifications as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021.
446. Name and address of manufacturer / M/s Bajwa Pharmaceuticals Pvt. Ltd. 36-Km,
Applicant Lahore-Gujranwala Road Khori District
Sheikhupura
Brand Name +Dosage Form + Strength Calcium chloride Injection
Calcium chloride 2H2O…..……..2000mg
Diary No. Date of R& I & fee Dy. No 28768 Dated 28-08-2018, Rs. 20,000/- 28-
08-2018
Pharmacological Group Electrolyte
Type of Form Form-5
Finished product Specifications USP specifications
Pack size & Demanded Price 10ml x 10 Ampoules, 10ml x 5 Ampoules & As
per SRO
Me-too status (with strength and dosage form) Calcium Chloride Injection of M/s LC&PW, Lahore
GMP status DML by way of formulation dated 02-12-2014 &
GMP compliance inspection dated 21-02-2018
Previous decision(s) Deferred for evidence of approval of applied
formulation in reference regulatory authorities /
agencies which were adopted by the Registration
Board in its 275th meeting (M-292).
Evaluation by PEC The firm has submitted reference
Baxter Healthcare corporation 15mg/100ml
Calcium chloride : 1g /10ml ampoules Galenica MA
(Italy)
Decision: Deferred for evidence of approval of applied formulation in 10ml fill volume in
reference regulatory authorities / agencies which were adopted by the Registration Board in its
275th meeting.
447. Name and address of manufacturer / M/s The Searle Company Limited, 32Km Multan Road,
Brand Name +Dosage Form + Strength Spingab capsule 225mg
Pregabalin………………………225mg
Diary No. Date of R& I & fee Dy.No 2023, 03-04-2017, Rs.20,000/- 03-04-2017
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 2 x 7’s; As per SRO
Approval status of product in Reference USFDA approved.
Me-too status Not available in the applied strengths
(50,75,100,150,200 & 300 available)
GMP status GMP certificate issued on 13-08-2020 on the basis of
Previous remarks of the Evaluator. Confirmed as 2ml, 10 ml and 20ml vial in MHRA, UK.
Previous Decision The product approved in 316th meeting of RB (M-316).
Evaluation by PEC Me-too reference of Nurica 225mg Capsule of M/s
Macter international (Reg # 086889) has been verified.
The firm has submitted that the said product has been
approved with wrong manufacturing site. The correct
manufacturing site is
“M/s The Searle Company Limited, 32Km Multan Road,
Lahore, Pakistan”.
It is requested to grant us registration as per the correct
manufacturing site.
7,500/- fee for revision of specifications as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021.
448. Name and address of manufacturer / M/s The Searle Company Limited, F-319 SITE, Karachi,
Applicant Pakistan
Brand Name +Dosage Form + Strength HEMONSTIL 500mg/10ml INJECTION
Composition Each 10ml injection contains:
Iron as Ferric carboxymaltose………………500mg
Diary No. Date of R& I & fee Diary No: 1793, 12-01-2018, Rs: 20,000/-, 11-01-2018
Pharmacological Group Haematinic
Type of Form Form-5
Pack size & Demanded Price 1'sx10ml/As per SRO
Approval status of product in Reference Ferinject 50 mg iron/mL solution for injection/infusion.
Regulatory Authorities By M/s Vifor France (MHRA approved)
Me-too status Ferinject 500mg/10ml by M/s RG. Pharmaceuticals
(Reg#072548)
GMP status The firm has submitted copy of GMP certificate issued
on the basis of inspection conducted on 11-07-2019.
Previous Decision Registration Board deferred the case for comments
regarding patent status of applied formulation from legal
division (M-292).
Evaluation by PEC The firm has submitted that recently multiple companies
have been granted with product approval, details
appended below:
Sr. Applicant name Product name Approval
No.
1. Welmark pharma Irofer 500mg 316 DRB
/10ml
2. CCL Pharma Wirose inj. 308 DRB
50/ml
3. Rotex Pharma Ferriject 307 DRB
500mg/10ml
inj
4. Welwrd pharma Faltose 307 DRB
50mg/ml Inj.
The firm has revised the label claim as below:

Each ampoule of 10ml contains:
Iron as ferric carboxymaltose………….500mg
Fee of PKR 30,000/- (slip number 159269612045) dated
03-08-2022 has been submitted.
The firm has provided liquid injectable (ampoule)
section.
07-05-2021.
449. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Applicant Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Combifer Infusion 500mg/10ml
Composition Each 10ml vial contains:
Iron carboxymaltose complex eq to Elemental
Iron………………500mg
Diary No. Date of R& I & fee Diary No: 24080, 13-12-2017, Rs: 20,000/-
Type of Form Form-5
Finished product Specifications Innovator’s specifications
Pack size & Demanded Price 1'sx10ml/As per SRO
Approval status of product in Reference Ferinject 50 mg iron/mL solution for injection/infusion.
Regulatory Authorities By M/s Vifor France (MHRA approved)
Me-too status Ferinject 500mg/10ml by M/s RG. Pharmaceuticals
(Reg#072548)
based on inspection conducted on 25-07-2019.
Previous Decision Registration Board deferred the case for comments
regarding patent status of applied formulation from legal
division (M-292).
Evaluation by PEC The firm has submitted that Drug Registration Board has
approved this formulation for various firms.
Decision: Approved.
450. Name and address of manufacturer / M/s ISIS Pharmaceuticals and chemicals 25/1-3 sector
Applicant 12-C, North Karachi industrial area, Karachi
Brand Name +Dosage Form + Strength Ispidon 175mg/25mg Tablet
Composition Each sustained release tablet contains:
Propyphenazone…………...175 mg
Caffeine…………………….25 mg
Diary No. Date of R& I & fee Dy.No 1720, 30-08-2016, Rs.20,000/-
Pharmacological Group Other Analgesics and antipyretics
Type of Form Form-5
Approval status of product in Reference Optalidon Dragees of Perrigo spain (Spanish agency for
Regulatory Authorities medicines and health products)
Me-too status Optalidon of Novartis Pharma
GMP status Last GMP Inspection dated 12-6-17 with conclusive
remarks of good cGMP compliance.
Previous remarks of the Evaluator. Evidence of approval of applied formulation in reference
regulatory authorities/agencies can’t be verified.
Previous Decision Deferred for revision of formulation as per reference
product alongwith submission of applicable fee (M-307).
Evaluation by PEC Approval status of applied formulation has been verified
in Spanish agency for medicines and health products.
The firm has revised the formulation as per reference
formulation as below:
Each sugar coated tablet contains:
Fee challan of Rs. 30,000/- (slip number: 53424604786)
dated 13-06-2022 has been submitted for revision of
formulation.
Decision: Approved with Innovator’s specifications and with following label claim.
Each sugar coated tablet contains:
07-05-2021.
451. Name and address of manufacturer / M/s Hoover Pharmaceuticals (Pvt) Ltd., Plot # 16, Zain
Applicant park, Industrial Area, Saggian Bypass Road, Lahore
Brand Name +Dosage Form + Strength Hydrok oral liquid syrup
Diphenhydramine Hydrochloride…….13.5mg
Ammonium Chloride………………….131.5mg
Diary No. Date of R& I & fee Dy. No.4615; 1-06-2017; Rs.20,000/- (1-06-2017)
Pharmacological Group Antihistamine/expectorant
Type of Form Form-5
Approval status of product in Reference Benadryl original oral liquid by Johnson & Johnson
Regulatory Authorities Pacific Pty Ltd (TGA approved)
Me-too status B dryl cough syrup by Efroze
GMP status Last inspection report 20-1-2017 Panel recommended
the grant of additional section.
Previous remarks of the Evaluator. International availability in RRA could not be
confirmed.
Previous Decision Deferred for submission of evidence of approval in
reference regulatory authorities (M-274)
Evaluation by PEC The firm has submitted that we may be allowed to correct
the composition as Diphenhydramine hydrochloride
12.5mg/5ml instead of Diphenhydramine hydrochloride
13.5mg/5ml.
Me-too: Sydinate Syrup of M/s Sayyed Pharma (Reg #
064310)
The submitted me-too reference contains
Dimenhydrinate instead of Diphenhydramine. Further,
the product is not in line with international reference.
Decision: Deferred for following submissions:
• Evidence of approval of applied formulation in reference regulatory authorities / agencies
which were adopted by the Registration Board in its 275th meeting.
status) alongwith registration number, brand name and name of firm.
Case no. 02 Registration applications for local manufacturing of (Veterinary) drugs
a. Deferred cases
452. Name and address of manufacturer / M/s Izfaar Pharmaceutical Industries, 542-A, Sundar
Applicant Industrial Estate, Lahore
Brand Name +Dosage Form + Strength MYCOFAR-30 Injection
Tilmicosin as Phosphate…………………300mg
Diary No. Date of R& I & fee 14257, 17-04-2018, 20,000/-, 16-04-2018
Pharmacological Group Macrolide antibiotic
Type of Form Form-5
Finished product Specification USP specifications
Pack size & Demanded Price 50ml; Decontrolled
Me-too status HICOS-300 INJECTION of M/s Hilton (Reg#043503)
Previous remarks of the Evaluator. The firm has provided Veterinary Liquid Injection
(General) section.
Salt form of applied formulation is not mentioned.
Revision of Form-5 with requisite fee is required to be
submitted.
Previous decision(s) Registration Board referred the case to QA & LT to
update GMP status of the firm on priority (M-248).
Evaluation by PEC The firm has submitted copy of GMP certificate issued
Decision: Approved.
Brand Name +Dosage Form + Strength ADENO-FAR Injection
Selenium ……………….0.50 mg
Vitamin E Acetate………..70.0mg
Vitamin B1………………..20.0mg
Vitamin B12……………...0.010mg
Adenosine-5 Phosphate……………5.00mg
Pharmacological Group Vitamins
Type of Form Form-5
Finished product Specification In-house specifications
Pack size & Demanded Price 50ml, 100ml; Decontrolled
Me-too status SELPHOS Injection of M/s Selmore Pharma (Reg #
029647)
Previous remarks of the Evaluator. The submitted me-too reference is of different strength.
The submitted me-too reference is of different strength
as under:
EACH 100ML CONTAINS: -
SELENIUM (AS SODIUM SELENITE) B.P. VET.
0.050GM.
VITAMIN-E B.P./USP 7.00M.
VITAMIN B-12 B.P/USP 0.010GM.
VITAMIN B-1 B.P/USP 2.00M.
ADENOSINE 5-MONOPHOSPHATE B.P/USP
0.500GM..
(generic / me-too status) alongwith registration number, brand name and name of firm.
Brand Name +Dosage Form + Strength FLORO-FAR INJECTION
Florfenicol………………400mg
Pharmacological Group Broad spectrum antibiotic
Type of Form Form-5
Finished product Specification In-house specification
Pack size & Demanded Price 50 ml; Decontrolled
Me-too status Not submitted
Previous remarks of the Evaluator. The me-too reference of applied formulation could not
be verified from available database.
The firm has revised the composition as below:
Each ml contains:
Florfenicol……………300mg
Me-too: Neflox Injection of M/s Selmore Pharma (Reg
# 049648)
Decision: Approved with innovator’s specifications and with following label claim:
Each ml contains:
Florfenicol……………300mg
30,000/- fee for revision of formulation as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021.
Brand Name +Dosage Form + Strength NITRO-FAR INJECTION
Nitroxynil………………340mg
Pharmacological Group Broad Spectrum Antibiotic
Type of Form Form-5
Finished product Specification In-house
Pack size & Demanded Price 50ml; Decontrolled
Me-too status TROXY-34% INJECTION of M/s Selmore Pharma
(Reg#034597)
Previous remarks of the Evaluator. Latest GMP inspection report which should have been
conducted within period of 3 years is required to be
submitted.
Previous decision(s) Registration Board referred the case to QA & LT to update
GMP status of the firm on priority (M-248).
07-05-2021.
456. Name and address of manufacturer / M/s Mallard Pharmaceutical (Pvt) Ltd, 23 Km, Lahore
Applicant Road, Multan.
Brand Name +Dosage Form + Strength Renotone Plus oral Powder
Composition Each 1000gm contains:
Hexamine………………....…480gm
Sodium Acid Phosphate…….160gm
Ascorbic acid……………...30gm
Trihydroxyethyl Rutin….….3gm
Diary No. Date of R& I & fee 18-01-2011 vide diary No. 381 Rs.8,000 & 30-07-2013
vide diary No. 937 Rs.12000
Pharmacological Group Anti-Infective
Type of Form Form-5
Finished product Specification In-house specifications
Pack size & Demanded Price Decontrolled/ 100gm, 250gm, 500gm, 1000gm &2.5 Kg.
Me-too status Exitone Oral Powder of M/s A & K Pharma (Reg#033289)
GMP status The firm is granted GMP certificate based on inspection
Previous decision(s) Deferred for following (M-265)
Complete product specifications
Last GMP inspection report conducted within one year
Clarification regarding availability of potentiometer as
claimed by applicant for analysis of API.
Evaluation by PEC The firm has claimed manufacturer’s specifications.
The firm is granted GMP certificate based on inspection
Decision: Referred to Expert Working Group on Veterinary Drugs for review of applied
formulation for the intended role as “Anti-infective”.
457. Name and address of manufacturer / M/s Mallard Pharmaceutical (Pvt) Ltd, 23 Km, Lahore
Applicant Road, Multan.
Brand Name +Dosage Form + Strength Delta Mall Solution 2.5%
Deltamethrin…………….. 2.5% w/v
Diary No. Date of R& I & fee 04-06-2012, Rs.8000/-, 30-07-2013, Rs. 12000 /-
Pharmacological Group Disinfectant
Type of Form Form-5
Finished product Specification Not mentioned
Pack size & Demanded Price Decontrolled/ 100ml, 250ml, 500ml, 1000ml & 2.5 L
Me-too status I-Dmeth Solution of International Pharma Labs
(Reg#052388)
GMP status The firm is granted GMP certificate based on inspection
Previous decision(s) Deferred for reference of finished product specification
(M-265).
Evaluation by PEC The firm has claimed BP specifications for finished
product.
07-05-2021.
Case No.02: Registration applications of drugs for which stability study data is submitted
a. Verification of stability study data
458. Name and address of manufacturer / M/s Hudson Pharma (pvt.) Ltd., D-93, North Western
Applicant industrial Zone, Port Qasim, Karachi
Brand Name +Dosage Form +
LULISON CREAM 1%
Strength
Composition Each gm contains:
Luliconazole……..…10mg
Diary No. Date of R& I & fee Dy No. 3791, 30-01-2018, Rs. 50,000/-,17-01-2018
Pharmacological Group Antifungal agent
Finished product Specification Manufacturer’s specifications
Pack size & Demanded Price 10gm; As per SRO
Approval status of product in LUZU Cream of Medicis (USFDA approved)
Me-too status Not available
GMP status Routine GMP inspection conducted on 11-12-2017 concluded
that the overall cGMP compliance of the firm with respect to
building, facilities and procedures demonstrated at the time of
inspection found at acceptable level.
Drug LULISON CREAM 1%
Name of Manufacturer M/s Hudson Pharma (pvt.) Ltd., D-93, North Western industrial Zone, Port
Qasim, Karachi
Manufacturer of API M/s Viwit Pharmaceutical Co., Ltd. 88 Weizhi Road, Tengzhou Biopharma
Park, Shandong, China
API Lot No. 333001-201705001
Description of Pack Plastic tubes
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 06 (months)
Real Time: 06 (months)
Frequency Accelerated: 0,1,3,6 (Months)
Real Time: 0,1,3,6 (Months)
Batch No. LCS04 LCS05 LCS06
Batch Size 200 tubes 200 tubes 200 tubes
No. of Batches 03
Date of Submission 29340 (03-09-2018)
Sr. Documents To Be Provided Status
No.
1. COA of API. Copy of COA from M/s Viwit Pharmaceutical Co., Ltd.,
Shandong, China is submitted.
2. Approval of API by regulatory authority of Copy of GMP certificate for M/s Viwit Pharmaceutical
country of origin or GMP certificate of API Co., Ltd., Shandong, China issued by Tengzhou Food
manufacturer issued by regulatory authority and Drug Administration of People’s Republic of
of country of origin. China. It is valid until 24-09-2017.
3. Protocols followed for conduction of Yes
stability study and details of tests.
4. Data of 03 batches will be supported by Yes
chromatograms, laboratory reports, data
sheets etc.
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice
attested by ADC, DRAP, Karachi dated 19-06-2017.
6. All provided documents will be attested Yes
(name, sign and stamp) for ensuring
authenticity of data / documents.
7. Commitment to continue real time stability Yes
study till assigned shelf life of the product.
8. Commitment to follow Drug Specification Yes
Rules, 1978.
REMARKS OF EVALUATOR
● The firm has submitted 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Batches.
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided
the following documents in conjunction with the checklist approved by the Registration Board in its 278 th
Meeting:
Date of submission: 03-09-2018 vide diary no. 29340
1. Reference of last onsite panel Registration Board decided to approve the registration of
inspection for instant dosage form “Acneson Gel 5% (Dapsone)” by M/s Hudson Pharma (Pvt.)
conducted during last two years. Ltd., D-93, North Western Industrial Zone, Port Qasim-
Karachi. Manufacturer will place first three production batches
of both products on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
Date of Inspection: 10-05-2018.
• The HPLC software is 21 CFR compliant
• Audit trail reports on testing of finished product are
available.
2. Documents for the procurement of The firm has submitted copy of commercial invoice attested by
API with approval from DRAP (in ADC, DRAP, Karachi dated 19-06-2017.
case of import).
3. Documents for the procurement of The firm has not submitted copy of invoice of working
reference standard & impurity standard.
standards.
4. Approval of API/ DML/GMP Copy of GMP certificate for M/s Viwit Pharmaceutical Co.,
certificate of API manufacturer issued Ltd., Shandong, China issued by Tengzhou Food and Drug
by regulatory authority of country of Administration of People’s Republic of China. It is valid until
origin. 24-09-2017.
5. Mechanism for Vendor pre- The firm has submitted SOP for Evaluation of Vendors.
qualification
6. Certificate of analysis of the API, • Copy of COA of API submitted.
reference standards and impurity • Copy of COA of working standard has been submitted
standards • Copy of COA of impurity standard has not been submitted.
7. Documents for the procurement of The firm has not submitted photocopy of Commercial
excipients used in product invoices/COAs of the excipients used in the formulation of
development? applied product.
8. List of qualified staff involved in The firm has not submitted List of qualified staff involved in
product development with relevant R&D department.
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of “Protocols/SOPs for the
development & stability testing of trial Pharmaceutical Development of Product.”
batches.
10. Complete batch manufacturing record The firm has submitted photocopy of Batch Manufacturing
of three stability batches. Records of following 03 Batches:
Batch No. Batch Size Mfg. Date
LCS01 200 Tubes -----
LCS02 200 Tubes -----
LCS03 200 Tubes -----
LCS04 200 Tubes 11-09-2017
LCS05 200 Tubes 13-09-2017
LCS06 200 Tubes 28-10-2017
11. Record of remaining quantities of
stability batches. Trial Batch size Consumed Remaining Quantity,
No. in stability Lab trials, QC
batches sample and retention
LCS01 200 Tubes 20g 10g,
LCS02 200 Tubes 20g 10g,
LCS03 200 Tubes 20g 10g
LCS04 200 Tubes 20g
LCS05 200 Tubes 20g
LCS06 200 Tubes 20g
QA / QC DATA
12. Record of Digital data logger for Firm has submitted photocopies of digital data logger record of
temperature and humidity monitoring Accelerated stability chamber and real time chamber from 01-
of stability chambers (real time and 08-2017 to 28-02-2018.
accelerated)
13. Method used for analysis of API along The firm has submitted photocopy of Raw Material
with COA. Specifications, Raw Material Testing Procedures along with
COA for Luliconazole.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product Testing
complete record of testing of stability Procedure for Luliconazole Cream 1% along with Stability
batches (i.e. chromatograms, lab Study Reports.
reports, raw data sheets etc.)
15. Reports of stability studies of API The firm has submitted reports of real time stability studies
from manufacturer. (25oC ± 2oC/65 ± 5% RH) for 6 months and accelerated
stability studies (40oC ± 2oC/75 ± 5% RH) for 36 months of
Luliconazole.
16. Analysis reports for excipients used. The firm has submitted photocopy of Analytical reports of
excipients used.
17. Drug-excipients compatibility studies. Not submitted
18. Record of comparative dissolution The firm has performed comparative dissolution studies with
data. Lulimac Cream manufactured by M/s. Optimus Pharma Pvt.
Limited, Solan India with Batch No.OA7012B. The firm‘s
product results are comparable to that of the comparator
product.
19. Compliance Record of HPLC software Audit trail on testing reports of Luliconazole Cream 1% from
21CFR & audit trail reports on product 13-09-2017 to 19-07-2018 has been submitted.
testing.
The firm has initiated stability studies on 13-09-2017 whereas firm was granted section approval letter for
Cream/Ointment/Gel section from licensing on 21-02-2018.
Finished product specifications do not mention dissolution test for applied formulation. Similarly, comparative
Dissolution Profile does not dissolution conditions under which dissolution was performed.
Decision: Registration Board after thorough discussion decided to reject the stability data on the basis
of following reasons (M-287):
“Manufacturing of batches of applied formulation i.e. Cream before the approval of relevant section
i.e. Cream/Ointment/ Gel section by Licensing Division, DRAP.
Evaluation by PEC: The firm has submitted that we have re-manufactured 03 stability batches and kept them
on accelerated and ambient stability which is enclosed herewith.
Drug LULISON CREAM 1%
Name of Manufacturer M/s Hudson Pharma (pvt.) Ltd., D-93, North Western industrial Zone, Port
Qasim, Karachi
Manufacturer of API M/s Viwit Pharmaceutical Co., Ltd. 88 Weizhi Road, Tengzhou Biopharma
Park, Shandong, China
API Lot No. 333001-201705001
Description of Pack Plastic tubes
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 06 (months) Real Time: 06 (months)
Frequency Accelerated: 0,1,3,6 (Months) Real Time: 0,1,3,6 (Months)
Batch No. LCS07 LCS08 LCS09
No. of Batches 03
Date of Submission 21937 (25-10-2019)
Sr.# Documents To Be Provided Status
1. Certificate of analysis of drug substance Copy of COA from M/s Viwit Pharmaceutical Co., Ltd.,
Shandong, China is submitted.
2. Approval of API by regulatory authority of Copy of GMP certificate for M/s Viwit Pharmaceutical
country of origin or GMP certificate of API Co., Ltd., Shandong, China issued by Tengzhou Food
manufacturer issued by regulatory authority and Drug Administration of People’s Republic of
of country of origin. China. It is valid until 24-09-2017.
3. Protocols followed for conduction of Yes
stability study and details of tests.
4. Data of 03 batches will be supported by Yes
chromatograms, laboratory reports, data
sheets etc.
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice
attested by ADC, DRAP, Karachi dated 19-06-2017.
6. All provided documents will be attested Yes
(name, sign and stamp) for ensuring
authenticity of data / documents.
7. Commitment to continue real time stability Yes
study till assigned shelf life of the product.
8. Commitment to follow Drug Specification Yes
Rules, 1978.
REMARKS OF EVALUATOR
● The firm has submitted 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Batches.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of LULISON
CREAM 1% (Luliconazole), Pack Size 1x10g by M/S. Hudson Pharma (Pvt) Ltd., D-93, North Western
Industrial Zone, Post Qasim, Karachi.
Reference No: F.1-2/2020-PEC dated 29th March, 2021.

Investigation Date and Time: 05th January, 2022 (Morning).
Investigation Site: Factory premises of M/S. Hudson Pharma (Pvt) Ltd., Port Qasim
Industrial Zone, Karachi.
Background:
Chairman Registration Board considered the applications of M/S. Hudson Pharma (Pvt) Ltd., Port Qasim,
Karachi for registration of LULISON CREAM 1% (Luliconazole) 10mg and constituted a two member panel
to investigate the authenticity / genuineness of data (import of raw material and stability data). Panel was
advised to conduct inspection of the firm and to submit report for further consideration.
Composition of Panel:
1. Dr. Saif-ur-Rehman Khattak, Director/ FGA, CDL, Karachi.
2. Mr. Awais Ahmad, Assistant Director, CDL, DRAP, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data),
manufacturing of stability batches and stability studies on these batches.
Tools for Investigation:
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence
physical inspection of the facilities for manufacturing and quality control, material used and retained,
personnel involved, ongoing studies, printed data and integrity and security of data in respective databases
were also audited. The details of investigation may be summarized as under:
Sr.# Question Observation
1. Do you have documents Luliconazole imported from Optrix laboratories Pvt Ltd,
confirming the import of India with proper approval from DRAP Karachi with
Luliconazole API including following details.
approval from DRAP?
Batch No. Date of Invoice Quantity Imported
Import No.
OT-
27/10/201
LCZ/04/17/00 035 150 g
7
2
As per PEC observation the firm to adjust the pH again
manufactured 3 new batches of Lulison cream for which they
procured API Luliconazole from same source, Optrix
laboratories Pvt Ltd, India, with following details:
Batch No. Date of Import Invoice Quantity
No. Imported
1/OT- SS-
29/07/21 110 g
LCZ/S2/013/21 02482
2. What was the rationale behind The rationale for selection of API manufacturer is the vendor
selecting the particular qualification criteria as per SOP # QA/GN/OP/023 that
manufacturer of API? contains GMP Certificate, DMF, SMF, API, Impurity
standards etc.
3. Do you have documents confirming The firm has imported Luliconazole working standard and
the import of Luliconazole impurity standards from Optrix laboratories India.
reference standard and impurity
standards?
4. Do you have a certificate of The firm has COA for the API, working standards and
Analysis of the API, reference impurity standards.
standards and impurity standards?
5. Do you have any approval of API or The firm has a copy of GMP certificate of Optrix Laboratories
GMP certificate of API Pvt Ltd India issued by regulatory authority of India valid upto
manufacturer issued by regulatory 02/06/2025.
authority of country of origin?
6. Do you use API manufacturer The firm has used an in-house method for testing of
methods of testing? Luliconazole based on API manufacturer method of testing.
7. Do you have stability studies The firm has real time & accelerated stability study reports of
reports on API? Luliconazole conducted by the API manufacturer.
8. If yes, whether the stability testing The stability testing has been performed as per SIM method.
has been performed as per SIM
method and degradation products
have been quantified?
9. Do you have a method for The firm has a method for quantifying the impurities in the API
quantifying the impurities in the based on manufacturer specification.
API?
10. Do you have some remaining The firm has some remaining quantity of API, impurities and
quantities of the API, its reference reference standard procured for the new batches.
standard and impurities standards?
11. Have you used pharmaceutical The firm has used the following pharma grade excipients.
grade excipients? Benzyl alcohol from Sigma Aldrich, USA.
Butylated Hydroxy toluene from Hangzhou Zhongbao Import
& Export Corp Ltd, China.
Cetostearyl alcohol from Emery, Malaysia.
Isopropyl myristate from KLK Oleo, Malaysia.
Caprylic Capric Triglyceride from KLK Oleo, Malaysia.
Methylparaben from UENO Fine Chemicals, Japan.
Polysorbate 60 (tween 60) from Croda, India.
Propylene glycol from Merck, Germany.
Sorbitan monostearate (Span 60) from Croda, India.
12. Do you have documents confirming All the excipients have been locally purchased, with proper
the import of the used excipients? invoice and COAs.
13. Do you have test reports and other The firm has test reports & other records on the excipients
records on the excipients used? used.
14. Do you have written and authorized The firm has written & authorized protocols for the
protocols for the development of development of Lulison 1% cream.
Lulison cream 1%?
15. Have you performed Drug- Since the firm has used the same excipient as used by innovator
excipients compatibility studies? (Luzu 1% Cream), therefore compatibility studies are not
needed.
16. Have you performed comparative The firm has not performed comparative studies, with
studies? innovator product.
17. Do you have a product development The firm has a product development section.
(R&D) section?
18. Do you have necessary equipment The firm has necessary equipment is PD section for
available in the product manufacturing while for QC routine QC equipment are used.
development section for
development of Lulison cream 1%?
19. Are the equipment in the product All the equipment are qualified.
development section qualified?
20. Do you have a proper maintenance / There is a proper maintenance & calibration / re-qualification
calibration / re-qualification program for the equipment used in the PD section.
program for the equipment used in
the PD section?
21. Do you have qualified staff in the The firm has 2 Pharmacists assisted by the staff of
product development section with manufacturing & QC, in product development.
proper knowledge and training in
product development?
22. Have you manufactured three The firm has manufactured three stability batches for the
stability batches for the stability stability study of Lulison cream(pH:3-4.5), with details as
studies of Lulison cream 1% as below:
required?
Batch No. Mfg. Date Batch Size
LCS07 09-04-2019 200 tubes each of 10g
The firm has further manufactured three stability batches for
the stability study of Lulison cream (pH:5-7) as per PEC
recommendations with details as below:
Batch No. Mfg. Date Batch Size
SB-LUL-CR-01 07-09-2021 250 tubes each of 10g
23. Do you have any criteria for fixing The firm has manufactured stability batches based on number
the batch size of stability batches? of tests & frequency of testing.
24. Do you have a complete record of The firm has a complete record of production of stability
production of stability batches? batches.
25. Do you have protocols for stability The firm has developed protocol for stability testing of
testing of stability batches? stability batches (Doc#QC/GN/OP/015).
26. Do you have developed and The firm has developed & validated methods for testing of
validated the method for testing of stability batches of Lulison 1% cream.
stability batches?
27. Do you have method transfer N/A

studies in case when the method of
testing being used by your firm is
given by any other lab?
28. Do you have documents confirming The firm has proper documents confirming the qualification of
the qualification of equipments / equipment/instruments being used in the test & analysis of
instruments being used in the test Luliconazole & the finished product (Lulison 1% Cream).
and analysis of Luliconazole and
the finished drug?
29. Does your method of analysis The firm has performed analytical method validation on their
stability indicating? product forced degradation studies from basis for the method
to be stability indicating.
30. Does your HPLC software is The firm has HPLC software is 21CFR compliant.
21CFR compliant?
31. Can you show Audit Trail reports Audit trail reports on testing of API and finished product is
on Luliconazole testing? available.
32. Do you have some remaining Impurities studies are available.

quantities of degradation products
and stability batches?
33. Do you have stability batches kept The three new batches manufactured in July 2021 have been
on stability testing? kept for stability testing. Currently three months studies are
complete with satisfactory results.
34. Do you have valid calibration status The firm has valid calibration status for the equipment used in
for the equipments used in Lulison the production & analysis of lulison cream 1%.
cream 1% production & analysis?
35. Do proper and continuous Adequate monitoring & controls are available for stability
monitoring and control are available chambers. Chambers are controlled & monitored through data
for the stability chamber? loggers.
36. Do related manufacturing area, Related manufacturing area, equipment, personnel & utilities
equipments, personnel and utilities are GMP compliant.
be rated as GMP compliant?
37. Queries of PEC: Firm has shown studies on two different formulations
Results of pH of applied manufactured at pH specs as 3.0 to 4.5 and 5.0 to 7.0.
formulation in the light of innovatorrespectively. Six months studies conducted at real time and
product (LUZU 1% w/w cream) accelerated conditions on three batches of the first formulation
having pH accepting criteria have been already submitted to Islamabad. Three batches of
ranging from 5.0 to 7.0. the second formulation having pH specs 5.0 to 7.0 have been
kept on real time and accelerated condition. Currently three
months studies are complete which are being evaluated by the
panel. The studies with both the formulation demonstrate that
the product is stable within a pH range of 3.0 to 7.0.
The firm has also submitted their safety testing on both
formulations for acute dermal irritant test. The results of the
test show that no sign of irritation / inflammation were found
during the observation period of (optimized test conditions).
(Copy of Reports Attached).
Performance of test of viscosity and Firm has also performed viscosity testing on the manufactured
homogeneity for evaluation of batches from PCSIR. The results are within the range i.e.
topical formulation. 20,000 to 40,000 (common ranges for cream formulation).
(Copy of Report Attached).
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the
firm for registration of Lulison 1% Cream Pack Size 1x10g are verifiable to satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and suited for
the manufacturing of Lulison 1% Cream Pack Size 1x10g.
Recommendations:
The panel recommends registration of Lulison 1% Cream (Luliconazole).
Decision: Deferred for submission of following:
Sr. # Decision of 316th meeting Response by the firm

1. Stability data, upto 6th month time point, of The firm has submitted 06 m onths stability study
the trial batches which were presented data including raw data sheets, chromatograms,
before inspection panel with pH audit trail and digital data logger.
specifications of 5.0 to 7.0.
Batch No. SB- SB- SB-LUL-
LUL- LUL- CR-03
CR-01 CR-02
Batch Size 250tubes 250 250 tubes
tubes
Manufacturin 07-2021 07-2021 07-2021
g Date
Date of 07-09- 29-09- 29-09-
Initiation 2021 2021 2021
No. of 03
Batches
2. Pharmaceutical equivalence with innovator The firm has submitted pharmaceutical equivalence
/ reference drug product shall also be with reference product Luzu Cream (Batch #
submitted. LOT8131016) of M/s Valent pharmaceuticals by
performing Identification, pH and Assay.
3. Firm shall also submit fee of Rs. 30,000 for The firm has submitted fee of Rs. 30,000 vide slip
revision in stability data, as per notification number 2581583454 for revision in stability data, as
No.F.7-11/2021-B&A/DRAP dated 13-07- per notification.
2021.
proposed shelf life and on accelerated studies for six months.
07-05-2021.
Case No. 3 Registration applications for local manufacturing of human drugs submitted on CTD
format
Deferred cases (New License):
On the recommendations of panel of experts, the CLB in its 276th meeting held on 03rd September, 2020 has
considered and approved the grant of Drug Manufacturing License in the name of M/s Alpenglow
pharmaceuticals (Pvt) Ltd, Plot No. A7, Risalpur Export processing Zone, Risalpur.
i. Capsule (Cephalosporin)
ii. Dry Powder injection section (Cephalosporin) (1 molecule / 6 products)
iii. Dry powder suspension section (Cephalosporin)
iv. Tablet (Psychotropic)
459. Name, address of Applicant / Marketing M/s Alpenglow Pharmaceuticals Plot # A/7,
Authorization Holder Export Processing Zone Risalpur, District
Nowshera (KP) Pakistan.
Name, address of Manufacturing site. M/s Alpenglow Pharmaceuticals Plot # A/7,
Export Processing Zone Risalpur, District
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 5231 Dated 24-02-2022
Details of fee submitted PKR 30,000/-: Dated 20-10-2021
The proposed proprietary name / brand name CIAXON 250mg IV Injection
Strength / concentration of drug of Active Each vial contains:
Pharmaceutical ingredient (API) per unit Ceftriaxone as Sodium……………..250mg
Pharmaceutical form of applied drug Dry Powder Injection
Pharmacotherapeutic Group of (API) Anti-bacterials for systemic use, Third-
generation cephalosporins.
The status in reference regulatory authorities Rocephin 250mg IV Injection
USFDA Approved.
For generic drugs (me-too status) AVENTRIAX 250mg IV Injection
GMP status of the Finished product manufacturer New license granted on 22-09-2020.
Name and address of API manufacturer. M/s Sinopharm Weiqida Pharmaceutical Co.,
Ltd. Address: First Medical Zone, Economic &
Technological Development Zone, Datong,
Shanxi, China.
submitted.
Module III (Drug Substance) Official monograph of ceftriaxone sodium is
present in USP. The firm has submitted details
of nomenclature, structure, general properties,
substance
months
months
Batches: (011302001, 011302002, 011302003).
Pharmaceutical equivalence and comparative Pharmaceutical equivalence has been
dissolution profile established against comparator product Aventrix
250mg Injection by Sanofi Aventis Pharma by
specificty.
Manufacturer of API M/s Sinopharm Weiqida Pharmaceutical Co., Ltd., First Medical
Zone, Economic & Technological Development Zone, Datong,
Shanxi, China.
API Lot No. Q0121039028
Description of Pack Transparent PVC tray Sealed with printed A.foil filled with Dry
(Container closure system) Sterile Powder ceftriaxone in clear glass vial One Ampoule of water
for injection and aluminum Foil with embossed board unit carton UV
coated. (1’s)
Batch No. 001 002 003
Batch Size 2000 Vials 2000 Vials 2000 Vials
No. of Batches 03
DOCUMENTS/DATA ALONG WITH STABILITY STUDY DATA
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate
manufacturer issued by concerned regulatory No. SX20180229 issued by CFDA valid till 05-
authority of country of origin. 06-2023.
3. Documents for the procurement of API with The firm has submitted copy of letter
approval from DRAP (in case of import). No.0090/2021/DRAP-CPS/1330 CD(I&E) dated
16/04/2021 wherein the permission to import
different APIs like ceftriaxone sodium for the
granted.
AHPAO505150 dated 04-05-2021.
attested respective documents like Submitted
chromatograms, Raw data sheets, COA, summary
data sheets etc.
5. Compliance Record of HPLC software 21CFR & The firm has submitted that our current HPLC
audit trail reports on product testing system is not 21 CFR compliant, we will try to
upgrade our system as soon as possible.
Sr.# Observations communicated Response by the firm
1. Copies of the Drug substance specifications Copies of drug substance specifications and
and analytical procedures used for routine analytical procedures were provided by drug
testing of the Drug substance /Active substance manufacturer.
Pharmaceutical Ingredient by both Drug However, copies of drug substance specifications
substance & Drug Product manufacturer is and analytical procedures were not provided by
required. drug product manufacturer.
2. Analytical method verification studies The submitted analytical method verification
including specificity, accuracy and studies were performed by drug substance
repeatability (method precision) performed by manufacturer. Method verification studies were not
the Drug Product manufacturer for both performed by drug product manufacturer.
compendial as well as non-compendial drug
3. The tests for crystallinity and particulate matter Not submitted.
are not performed by drug product
manufacturer.
The assay limit specified by drug substance Assay limit as specified by drug substance
manufacturer (>84.0%) is different from that manufacturer > 84% is according to CP 2010 as
specified by drug product manufacturer (NLT provided by Sinopharm.
79%). Justification is required. While QC department of Alpenglow has followed
USP 43 which specifies assay limit = NLT 79%.
4. Provide COA of reference standard which is Instead of providing CoA from drug substance
actually used in the analysis of drug substance. manufacturer, the firm has provided CoA of
working standard of FPP manufacturer.
5. Submit master formulation including The firm has provided theoretical fill weight of
theoretical fill weight per vial. ceftriaxone sodium per vial.
6. Compatibility studies for the dry powder for Not submitted.
injections and dry powder for suspension shall
be performed as per the instructions provided
in individual label of the drug product.
7. Justify your process validation protocols Not submitted.
without any process for optimization of
sterilization process and sealing of vials etc.
8. Specifications of the drug product does not Not submitted.
include tests as recommended by USP
including test for constituted solution,
crystallinity and complete assay test.
9. Provide detailed testing method for the applied The firm has provided testing method of
drug product instead of submitting copy of ceftriaxone sodium raw material. The
USP monograph. chromatographic conditions are different from
USP.
Parameters Submitted USP monograph
monograph
Column 4mm × 4.6-mm × 25-cm; 5-
15cm μm packing
packing L1
Flow rate 2.0 ml/min 1.5 ml/min
Detector 270nm UV 254 nm
Mobile Tetraheptyl Tetradecyl
phase ammonium ammonium
bromide in bromide and
400ml of tetraheptyl
acetonitrile ammonium
bromide in a
mixture of 440 mL
of water, 55 mL of
Buffer, 5.0 mL of
Solution C, and 500
mL of acetonitrile.
10. Provide standard and sample preparation Not submitted.
method used in analytical method verification
studies.
11. Specify the details of the accuracy and Not submitted
specificity test including the details of
concentration of 80%, 100% and 120%
solutions. Test method for Empazin 25mg
Tablet is provided in analytical method
verification studies.
12. Justification of method of specificity test in The firm has submitted analytical method
analytical method verification studies shall be verification studies of drug product including
submitted. Clarification is required. specificity, accuracy and precision.
Analytical method verification reports of each
parameter like specificity, accuracy and
repeatability (method precision) performed by
the Drug Product manufacturer shall be
submitted. Not submitted.
The peak area of standard solution
concentration in analytical method verification
studies is approximately 6472293 while the
peak area of the standard solution of same
concentration in stability studies is 436282
approximately. Clarify the difference in peak
areas.
13. Provide COA of reference standard actually The firm has submitted COA of working standard
used in the analysis of drug product. from drug product manufacturer.
14. • In-use studies for drug products which Not submitted
are to be reconstituted before use, along with
proposed in-use storage statement and in-use
shelf-life shall be provided.
• The tests for water contents,
constituted solution etc are not performed Not provided
during stability studies since these tests are
required to make assessment of the stability
profile.
• Submit compliance Record of HPLC The firm has submitted that our current HPLC
software 21CFR & audit trail reports on system is not 21 CFR compliant, we will try to
product testing. Reference of previous upgrade our system as soon as possible.
approval of applications with stability study
data of the firm (if any).
15. • Pharmaceutical equivalence of the The firm has submitted pharmaceutical
developed formulation and the innovator / equivalence data against Rocephin 250mg IV
reference / comparator product including the injection (batch # 4121z015) by performing quality
results of all the quality tests shall be tests.
submitted.
Sr. Decision of 316th meeting of RB Response by the firm

No.
1. Analytical method verification report of drug The firm has submitted analytical method
substance performed by drug product verification studies for testing of ceftriaxone
manufacturer as per requirement of section sodium as per USP recommendations.
3.2.S.4.3 of Form-5F.
2. Performance of tests of crystallinity and The tests were performed as per USP
particulate matter by drug product manufacturer. monograph. The crystallinity test was
performed however, particulate matter test was
performed for product.
3. Justify the difference in assay limit specified by The drug substance manufacturer follows USP
drug substance manufacturer (>84.0%) and drug as well as Chinese pharmacopoeia monograph
product manufacturer (NLT 79%). for ceftriaxone sodium, so claims the assay limit
> 84%.
While being the drug product manufacturer we
have followed the USP monograph for
ceftriaxone and USP specifies the limit of NLT
79.5%.
4. Justify the chromatographic conditions in the The chromatographic conditions specified in
submitted analytical procedures which are analytical procedure are as per older version of
different from USP monograph. USP 29. We have updated the specifications
according to the latest version of USP. The
product was tested in accordance with updated
conditions and the results were found
satisfactory and within limits.
5. Submit master formulation including details of The firm has submitted master formulation with
potency adjustment as per assay results on calculations of fill weight as per assay result on
certificate of analysis. certificate of analysis.
6. Justification of submission of pharmaceutical The firm has submitted pharmaceutical
equivalence data with Rocephin 250mg IV equivalence study with comparator product
Injection since the formulation in the same Oxidil 250mg injection (Batch # 002H) of Sami
strength is not available. Pharma by performing tests of Identification,
pH, Clarify of solution and assay.
7. Performance of compatibility studies for the dry Sterile water for injection is the recommended
powder for injections as per the instructions diluent for intravenous injection of ceftriaxone
provided in individual label of the drug product. sodium prior to administration. The results of
compatibility and reconstitution studies are
provided.
8. Provide standard and sample preparation method The firm has provided methods for standard and
used in analytical method verification studies. sample preparation used in method verification
9. Specify the details of the accuracy and The firm has specified the concentrations of
specificity test including the details of 80% (0.24mg/ml), 100% (0.30mg/ml) and
concentration of 80%, 100% and 120% 120% (0.36mg/ml) used in accuracy studies.
solutions. Moreover, details of blank solution, placebo and
sample solution were provided specificity
study.
10. Analytical method verification reports of drug The firm has submitted method verification
product performed by drug product studies of drug product as per the USP
manufacturer. recommendation.
11. Clarify the difference in peak area for standard The reason for area difference was that in
solution concentration in analytical method verification studies the injection volume was
verification studies which is approximately different. The change in injection volume was a
6472293 while the peak area of the standard deviation to USP method, so the method was re-
solution of same concentration in stability verified using standard USP method without
studies is 436282 approximately. any deviation. The area obtained was
approximately same as that in stability studies.
12. Provide COA of reference standard actually used COA of USP primary reference standard with
in the analysis of drug product. lot no: H0J296 has been provided.
13. Provide in-use studies for drug products which The product is recommended to be used
are to be reconstituted before use, along with instantly after reconstitution, however if stored
proposed in-use storage statement and in-use in refrigerator the product can be used in 24 h.
shelf-life. So 24 h in-use stability study was performed.
14. Performance of tests for water contents, The firm has submitted that the constituted
constituted solution etc during stability studies solution was checked at every point of stability
since these tests are required to make assessment study since the assay is performed after
of the stability profile. reconstituting the injection. After reconstitution
and before assay, the injection was checked for
particulate matter or other foreign matter. The
revised stability summary sheets were provided.
15. Evidence of procurement of API with approval The firm has submitted copy of invoice
from DRAP. specifying import of Ceftriaxone sodium 50Kg
(Batch # Q012102085) attested by Assistant
Director (I & E), Peshawar dated 16-04-2021.
Decision: Approved.
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No.5233 Dated 24-02-2022
The proposed proprietary name / brand name CIAXON 250mg IM Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone as Sodium……………250mg
Pharmaceutical form of applied drug Intramuscular Injection
Reference to Finished product specifications USP specifications
The status in reference regulatory authorities Rocephin 250mg IM Injection USFDA
Approved.
For generic drugs (me-too status) AVENTRIAX 250mg IM inj
manufacturer Tablet (General & General Antibiotic) section
approved.
Ltd. Address: First Medical Zone, Economic &
Shanxi, China.
submitted.
Module III (Drug Substance) Official monograph of Ceftrioxone Sodium is
substance
months
months
Batches: (011302001, 011302002, 011302003)
Pharmaceutical equivalence and comparative Pharmaceutical equivalence has been established
dissolution profile against the brand leader that is Aventrix 250mg
Injection by Sanofi Aventis Pharma by
specificity.
Manufacturer of API M/s Sinopharm Weiqida Pharmaceutical Co., Ltd., First Medical Zone,
Economic & Technological Development Zone, Datong, Shanxi, China.
API Lot No. Q0121039028
Description of Pack Transparent PVC tray Sealed with printed Alu foil filled with Dry Sterile
(Container closure system) Powder ceftriaxone in clear glass vial One Ampoule of water for injection
and aluminum Foil with embossed board unit carton UV coated. (1’s)
Batch No. 004 005 006
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. SX20180229
3. Documents for the procurement of API with Copy of letter No.0090/2021/DRAP-CPS/1330
approval from DRAP (in case of import). CD(I&E) dated 16/04/2021 is submitted
wherein the permission to import different
APIs ceftriaxone as sodium for the purpose of
AHPAO505150 dated 04/05/2021
5. Compliance Record of HPLC software 21CFR The firm has submitted that our current HPLC
& audit trail reports on product testing system is not 21 CFR compliant, we will try to
Sr. Observations communicated Response by the firm
No.
1. Copies of the Drug substance specifications and Copies of drug substance specifications and
analytical procedures used for routine testing of analytical procedures were provided by drug
the Drug substance /Active Pharmaceutical substance manufacturer.
Ingredient by both Drug substance & Drug
Product manufacturer is required.
2. Analytical method verification studies including The submitted analytical method verification
specificity, accuracy and repeatability (method studies were performed by drug substance
precision) performed by the Drug Product manufacturer. Method verification studies were
manufacturer for both compendial as well as not performed by drug product manufacturer.
non-compendial drug substance(s) shall be
submitted.
are not performed by drug product
manufacturer.
specified by drug product manufacturer (NLT provided by Sinopharm.
79%). Justification is required. While QC department of Alpenglow has
followed USP 43 which specifies assay limit =
NLT 79%.
5. Submit master formulation including theoretical The firm has provided theoretical fill weight of
fill weight per vial. ceftriaxone sodium per vial.
6. Compatibility studies for the dry powder for Not submitted
be performed as per the instructions provided in
individual label of the drug product.
7. Justify your process validation protocols Not submitted
8. Specifications of the drug product does not Not submitted
include tests as recommended by USP including
test for constituted solution, crystallinity and
complete assay test.
drug product instead of submitting copy of USP ceftriaxone sodium raw material. The
monograph.
chromatographic conditions are different from
USP.
monograph
Column 4mm × 15cm 4.6-mm × 25-
packing L1 cm; 5-μm
packing
bromide in a
mixture of 440
mL ofwater, 55
mL of Buffer,
5.0 mL of
Solution C, and
500 mL of
acetonitrile.
studies.
11. Specify the details of the accuracy and
concertation of 80%, 100% and 120% solutions.
Test method for Empazin 25mg Tablet is
provided in analytical method verification
studies.
submitted.
The peak area of standard solution Not submitted.
concentration in analytical method verification
areas.
13. Provide COA of reference standard actually The firm has submitted COA of working
used in the analysis of drug product. standard from drug product manufacturer.
• Provide raw data sheets to justify the Not submitted
calculation of results for assay testing at each
time point during the stability testing of each
batch.
• The tests for water contents, constituted Not provided
solution etc are not performed during stability
studies since these tests are required to make
assessment of the stability profile. The firm has submitted that our current HPLC
• Submit compliance Record of HPLC system is not 21 CFR compliant, we will try to
software 21CFR & audit trail reports on product upgrade our system as soon as possible.
testing.
Reference of previous approval of applications
with stability study data of the firm (if any).
developed formulation and the innovator / equivalence data against Rocephin 250mg IM
reference / comparator product including the injection (batch # 4121z015) by performing
results of all the quality tests shall be submitted. quality tests.

No.
3.2.S.4.3 of Form-5F.
> 84%.
79.5%.
6. Justification of submission of pharmaceutical The firm has submitted pharmaceutical
equivalence data with Rocephin 250mg IV equivalence study with comparator product
Injection since the formulation in the same Oxidil 250mg injection (Batch # 002H) of Sami
strength is not available. Pharma by performing tests of Identification,
pH, Clarify of solution and assay.
7. Performance of compatibility studies for the dry Sterile lignocaine for injection is the
powder for injections as per the instructions recommended diluent for intravenous injection
provided in individual label of the drug product. of ceftriaxone sodium prior to administration.
The results of compatibility and reconstitution
studies are provided.
study.
and before assay the injection was checked for
Decision: Approved.
proposed shelf life and on accelerated studies for six months as per the commitment submitted
Nowshera (KP) Pakistan
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No.5234 Dated 24-02-2022
The proposed proprietary name / brand name CIAXON 500mg IM Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone as Sodium…………..500 mg
Pharmaceutical form of applied drug Dry Powder for Injection
The status in reference regulatory authorities Rocephin 500mg IM Injection
USFDA Approved.
For generic drugs (me-too status) AVENTRIAX 500mg IM injection
Ltd. Address: First Medical Zone, Economic
& Technological Development Zone, Datong,
Shanxi, China.
Module-II (Quality Overall Summary) The firm has submitted QOS as per WHO
and stability studies of drug substance and drug
substance.
months
months
Batches: (011302001, 011302002, 011302003)
Module-III (Drug Product): The firm has submitted details of
analytical procedure (including dissolution
testing at acidic and buffer medium) and its
verification studies, batch analysis and
justification of specification, reference
dissolution profile established against the comparator product
Aventrix 500mg IM Injection by Sanofi
Aventis Pharma by performing quality tests
of dosage form).
specificity.
Manufacturer of API M/S Sinopharm Weiqida Pharmaceutical Co. Ltd., First Medical Zone,
API Lot No. Q0121039028
Description of Pack Transparent PVC tray Sealed with printed A.foil filled with Dry Sterile
Batch No. 010 011 012
No. of Batches 03
stability study data of the firm (if any).
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP
manufacturer issued by concerned regulatory certificate No. SX20180229 issued by CFDA
approval from DRAP (in case of import). No.0090/2021/ DRAP-CPS/1330 CD (I&E)
dated 16-04-2021 wherein the permission to
import different APIs including ceftriaxone
sodium for the purpose of test/analysis and
stability studies is granted.
AHPAO505150 dated 04-05-2021.
attested respective documents like chromatograms, Submitted
5. Compliance record of HPLC software 21CFR & The firm has submitted that our current HPLC
audit trail reports on product testing. system is not 21 CFR compliant, we will try to
time and accelerated).
No.
1. Copies of the Drug substance specifications Copies of drug substance specifications and analytical
and analytical procedures used for routine procedures were provided by drug substance
testing of the Drug substance /Active manufacturer.
Pharmaceutical Ingredient by both Drug
substance & Drug Product manufacturer is
required.
2. Analytical method verification studies The submitted analytical method verification studies
including specificity, accuracy and were performed by drug substance manufacturer.
repeatability (method precision) performed Method verification studies were not performed by
by the Drug Product manufacturer for both drug product manufacturer.
3. The tests for crystallinity and particulate Not submitted.
matter are not performed by drug product
manufacturer.
specified by drug product manufacturer provided by Sinopharm.
(NLT 79%). Justification is required. While QC department of Alpenglow has followed USP
43 which specifies assay limit = NLT 79%.
actually used in the analysis of drug manufacturer, the firm has provided CoA of working
substance. standard of FPP manufacturer.
injections and dry powder for suspension
shall be performed as per the instructions
provided in individual label of the drug
product.
9. Provide detailed testing method for the The firm has provided testing method of ceftriaxone
applied drug product instead of submittingsodium raw material. The chromatographic conditions
copy of USP monograph. are different from USP.
monograph
Column 4mm × 15cm 4.6-mm × 25-cm; 5-
packing L1 μm packing
Mobile Tetraheptyl Tetradecyl ammonium
phase ammonium bromide and
bromide in tetraheptyl ammonium
400ml of bromide in a mixture
acetonitrile of 440 mL ofwater, 55
mL of Buffer, 5.0 mL
of Solution C, and 500
mL of acetonitrile.
method used in analytical method
11. Specify the details of the accuracy and
concertation of 80%, 100% and 120%
solutions. Test method for Empazin 25mg
Tablet is provided in analytical method
12. Justification of method of specificity test in The firm has submitted analytical method verification
analytical method verification studies shall studies of drug product including specificity, accuracy
be submitted. Clarification is required. and precision.
Analytical method verification reports of
each parameter like specificity, accuracy
and repeatability (method precision)
manufacturer shall be submitted. The peak
area of standard solution concentration in Not submitted.
analytical method verification studies is
approximately 6472293 while the peak area
of the standard solution of same
approximately. Clarify the difference in
peak areas.
13. Provide COA of reference standard actually The firm has submitted COA of working standard from
used in the analysis of drug product. drug product manufacturer.
14. • In-use studies for drug products Not submitted
which are to be reconstituted before use,
along with proposed in-use storage
statement and in-use shelf-life shall be
provided. The tests for water contents,
profile. Submit compliance Record of HPLC
software 21CFR & audit trail reports on The firm has submitted that our current HPLC system
product testing. Reference of previous is not 21 CFR compliant, we will try to upgrade our
approval of applications with stability study system as soon as possible.
data of the firm (if any).
15. • Pharmaceutical equivalence of the The firm has submitted pharmaceutical equivalence
developed formulation and the innovator / data against Rocephin 500mg IM injection (batch #
reference / comparator product including the 4121z015) by performing quality tests.
results of all the quality tests shall be
submitted.
Deferred for submission of following:

No.
3.2.S.4.3 of Form-5F.
> 84%.
79.5%.
powder for injections as per the instructions recommended diluent for intravenous injection
provided in individual label of the drug product. of ceftriaxone sodium prior to administration.
The results of compatibility and reconstitution
study.
Decision: Approved.
• Manufacturer will submit results of pharmaceutical equivalence against the innovator’s product
before issuance of Registration Letter.
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name CIAXON 500mg IV Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone as sodium………….500 mg
The status in reference regulatory authorities Rocephin 500mg IV Injection of M/s Roche
(MHRA Approved).
For generic drugs (me-too status) AVENTRIAX 500mg IV Injection of M/s
Sanofi Aventis
Shanxi, China.
submitted.
substance.
months
months
Batches: (011302001, 011302002, 011302003)
dissolution profile established with comparator product Aventrix
500mg Injection by Sanofi Aventis Pharma by
performing quality tests (Identification, assay,
dissolution, uniformity of dosage form).
specificty.
Manufacturer of API M/S Sinopharm Weiqida Pharmaceutical Co. Ltd., First Medical Zone,
API Lot No. Q0121039028
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated: 0, 2, 4, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. 007 008 009
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP
manufacturer issued by concerned regulatory certificate No. SX20180229 issued by CFDA
authority of country of origin. valid till 05-06-2023.
approval from DRAP (in case of import). No.0090/2021/ DRAP-CPS/1330 CD(I&E)
dated 16-04-2021 wherein the permission to
import different APIs ceftriaxone sodium for
the purpose of test/analysis and stability studies
is granted.
AHPAO505150 dated 04-05-2021.
attested respective documents like chromatograms, Submitted
audit trail reports on product testing. system is not 21 CFR compliant, we will try to
humidity monitoring of stability chambers (real Submitted
manufacturer for both compendial as well as not performed by drug product manufacturer.
submitted.
are not performed by drug product Assay limit as specified by drug substance
manufacturer. manufacturer > 84% is according to CP 2010 as
The assay limit specified by drug substance provided by Sinopharm.
manufacturer (>84.0%) is different from that While QC department of Alpenglow has
specified by drug product manufacturer (NLT followed USP 43 which specifies assay limit =
79%). Justification is required. NLT 79%.
include tests as recommended by USP including
test for constituted solution, crystallinity and
complete assay test.
drug product instead of submitting copy of USP ceftriaxone sodium raw material. The
monograph. chromatographic conditions are different from
USP.
monograph
Column 4mm × 15cm 4.6-mm × 25-
packing L1 cm; 5-μm
packing
bromide in a
mixture of 440
mL ofwater, 55
mL of Buffer,
5.0 mL of
Solution C, and
500 mL of
acetonitrile.
studies.
11. Specify the details of the accuracy and Not submitted.
concertation of 80%, 100% and 120% solutions.
studies.
submitted. The peak area of standard solution
concentration in analytical method verification Not submitted.
areas.
13. Provide COA of reference standard actually The firm has submitted COA of working
used in the analysis of drug product. standard from drug product manufacturer.
• The tests for water contents, constituted
solution etc are not performed during stability Not provided
assessment of the stability profile.
software 21CFR & audit trail reports on product system is not 21 CFR compliant, we will try to
testing. upgrade our system as soon as possible.
Reference of previous approval of applications
developed formulation and the innovator / equivalence data against Rocephin 500mg IV
No.
3.2.S.4.3 of Form-5F.
> 84%.
79.5%.
provided.
sample solution were provided in specificity
study.
Decision: Approved.
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name CIAXON 1 gm IM Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone as sodium ……………. 1 gm
generation cephalosporins
The status in reference regulatory authorities Rocephin 1gm IM Injection of M/s Hoffman
LA Roche (USFDA Approved).
For generic drugs (me-too status) AVENTRIAX 1 gm IM injection
Shanxi, China.
Module-II (Quality Overall Summary) The firm has submitted QOS as per WHO
and stability studies of drug substance and drug
controls, specifications, analytical procedures
months
months
Batches: (011302001, 011302002, 011302003)
Aventrix 1g Injection by Sanofi Aventis
Pharma by performing quality tests
(Identification, assay, dissolution, uniformity
of dosage form).
specificty.
Manufacturer of API M/s Sinopharm Weiqida Pharmaceutical Co., Ltd.
API Lot No. Q0121039028
Batch No. 016 017 018
No. of Batches 03

wherein the permission to import different
APIs ceftriaxone as sodium for the purpose of
AHPAO505150 dated 04/05/2021
1. Copies of the Drug substance specifications Copies of drug substance specifications and
and analytical procedures used for routine analytical procedures were provided by drug
testing of the Drug substance /Active substance manufacturer.
required.
2. Analytical method verification studies The submitted analytical method verification
including specificity, accuracy and studies were performed by drug substance
repeatability (method precision) performed by manufacturer. Method verification studies were not
the Drug Product manufacturer for both performed by drug product manufacturer.
3. The tests for crystallinity and particulate Not submitted.
matter are not performed by drug product Assay limit as specified by drug substance
manufacturer. The assay limit specified by manufacturer > 84% is according to CP 2010 as
drug substance manufacturer (>84.0%) is provided by Sinopharm.
different from that specified by drug product While QC department of Alpenglow has followed
manufacturer (NLT 79%). Justification is USP 43 which specifies assay limit = NLT 79%.
required.
actually used in the analysis of drug substance.manufacturer, the firm has provided CoA of
be performed as per the instructions provided
in individual label of the drug product.
9. Provide detailed testing method for the The firm has provided detailed testing method for
applied drug product instead of submitting the applied drug product.
copy of USP monograph.
studies.
11. Specify the details of the accuracy and Not submitted
concertation of 80%, 100% and 120%
solutions.
studies.
submitted.
The peak area of standard solution Not submitted.
concentration in analytical method
verification studies is approximately 6472293
while the peak area of the standard solution of
same concentration in stability studies is
436282 approximately. Clarify the difference
in peak areas.
13. Provide COA of reference standard actually The firm has submitted COA of working standard
used in the analysis of drug product. from drug product manufacturer.
14. • In-use studies for drug products Not submitted
which are to be reconstituted before use, along
with proposed in-use storage statement and in-
use shelf-life shall be provided.
• The tests for water contents,
profile.
software 21CFR & audit trail reports on system is not 21 CFR compliant, we will try to
product testing. upgrade our system as soon as possible.
Reference of previous approval of
firm (if any).
15. • Pharmaceutical equivalence of the The firm has submitted pharmaceutical equivalence
developed formulation and the innovator / data against Rocephin 1g IM injection (batch #
reference / comparator product including the 6121z015) by performing quality tests.
results of all the quality tests shall be
submitted.
Deferred for submission of following

No.
3.2.S.4.3 of Form-5F.
> 84%.
79.5%.
powder for injections as per the instructions recommended diluent for IM injection of
provided in individual label of the drug product. ceftriaxone sodium prior to administration. The
results of compatibility and reconstitution
study.
Decision: Approved.
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name CIAXON 1 gm IV Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone as Sodium………….1 gm
Pharmacotherapeutic Group of (API) Antibacterials for systemic use, Third-
The status in reference regulatory authorities Rocephin 1gm IV Injection of M/s Hoffman
LA Roche (USFDA Approved).
For generic drugs (me-too status) AVENTRIAX 1 gm IV Injection
Name and address of API manufacturer. Sinopharm Weiqida Pharmaceutical Co., Ltd.
Address: First Medical Zone, Economic &
Shanxi, China Tel: 0352-7698888 Fax: 0352-
7695555 Post Code: 037300 E-mail:
[email protected]
submitted.
Module III (Drug Substance) Official monograph of Ceftrioxone Sodium is
controls, specifications, analytical procedures
months
months
Batches: (011302001, 011302002, 011302003)
product.
Aventrix 250mg Injection by Sanofi Aventis
Pharma by performing quality tests
of dosage form).
specificty.
Manufacturer of API M/S Sinopharm Weiqida Pharmaceutical Co., Ltd.
API Lot No. Q0121039028
Frequency Accelerated: 0, 2, 4, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. 013 014 015
No. of Batches 03
wherein the permission to import different APIs
ceftriaxone as sodium for the purpose of
AHPAO505150 dated 04/05/2021

manufacturer for both compendial as well as non- not performed by drug product manufacturer.
compendial drug substance(s) shall be submitted.
3. The tests for crystallinity and particulate matter are
Not submitted.
not performed by drug product manufacturer. Assay limit as specified by drug substance
The assay limit specified by drug substance manufacturer > 84% is according to CP 2010 as
manufacturer (>84.0%) is different from that provided by Sinopharm.
specified by drug product manufacturer (NLT While QC department of Alpenglow has
79%). Justification is required. followed USP 43 which specifies assay limit =
NLT 79%.
injections and dry powder for suspension shall be
performed as per the instructions provided in
7. Justify your process validation protocols without Not submitted
any process for optimization of sterilization
process and sealing of vials etc.
8. Specifications of the drug product does not include Not submitted
tests as recommended by USP including test for
constituted solution, crystallinity and complete
assay test.
9. Provide detailed testing method for the applied The firm has provided detailed testing method
drug product instead of submitting copy of USP for the applied drug product.
monograph.
10. Provide standard and sample preparation method Not submitted.
used in analytical method verification studies.
11. Specify the details of the accuracy and specificity Not submitted
test including the details of concertation of 80%,
100% and 120% solutions. Test method for
Empazin 25mg Tablet is provided in analytical
method verification studies.
repeatability (method precision) performed by the
Drug Product manufacturer shall be submitted.
The peak area of standard solution concentration
in analytical method verification studies is Not submitted.
approximately 6472293 while the peak area of the
standard solution of same concentration in
stability studies is 436282 approximately. Clarify
the difference in peak areas.
13. Provide COA of reference standard actually used The firm has submitted COA of working
in the analysis of drug product. standard from drug product manufacturer.
14. • In-use studies for drug products which are Not submitted
to be reconstituted before use, along with proposed
in-use storage statement and in-use shelf-life shall
be provided.
• The tests for water contents, constituted
solution etc are not performed during stability Not provided
assessment of the stability profile.
• Submit compliance Record of HPLC
software 21CFR & audit trail reports on product The firm has submitted that our current HPLC
testing. system is not 21 CFR compliant, we will try to
Reference of previous approval of applications upgrade our system as soon as possible.
• Pharmaceutical equivalence of the The firm has submitted pharmaceutical
developed formulation and the innovator / equivalence data against Rocephin 1g IV

No.
3.2.S.4.3 of Form-5F.
> 84%.
79.5%.
provided.
study.
and before assay, the injection was checked for
Decision: Approved.
Deferred cases (New License):

The Central Licensing Board in its 271st meeting held on 12th September, 2019 has considered and approved the
grant of Drug Manufacturing License to M/s Himark Laboratories Pvt Ltd. Plot 37-A, Sundar Industrial Estate,
Lahore by way of Formulation vide approval letter No. F. 1-67/2005-Lic dated 29th Sep, 2019 with following
(06) sections.
Name of Section Considered till 313th RB Freshly applied

meeting
No of No of No of No of
molecules products molecules products
Tablet (General & General Antibiotic) Section 2 5 2 2
Capsule (General & General Antibiotic) Section 4 9 1 2
Dry Powder Suspension (General & General 3 5 1 1
Antibiotic) Section
Sachet (General) Section - - 1 1
Oral Liquid Syrup Section 2 3 2 3
Cream/Ointment (General) Section - - - -
465. Name, address of Applicant / Marketing M/s Himark Laboratories Private Limited, Plot 37-
Authorization Holder A, Sunder Industrial Estate Lahore.
Name, address of Manufacturing site. M/s Himark Laboratories Private Limited, Plot 37-
A, Sunder Industrial Estate Lahore.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No.30582; Dated: 08-11-2021
PKR 10,000/- Duplicate challan date not mentioned
manufacturer Capsule (General & General Antibiotic) section
approved.
The proposed proprietary name / brand name Dicmark 50 mg DR capsule
Pharmaceutical ingredient (API) per unit Diclofenac sodium (as Diclofenac sodium EC
Pellets 24%)………………50 mg
Pharmaceutical form of applied drug Hard Gelatin capsule
Proposed Pack size 2 ×10’s
The status in reference regulatory authorities Deflamat 50 mg – Kapseln, Astellas Pharma GmbH
Linzer Straße 221/E02 1140 Vienna Austria, AGES
(Austria) Approved.
For generic drugs (me-too status) Phlogin 50 mg cap (Enteric coated pellets) by M/s
Brookes Pharma, Reg. No. 009128
Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt.) Ltd.,
Plot No. 22-23, Industrial Triangle, Kahuta Road,
Islamabad-
process and controls, Identification, water
determination, Assay and tests for total impurities,
months
Batches:(DE-161, DE-469, DE-597)
and process control, process validation protocols
and report, control of drug product, specifications,
dissolution profile against the brand leader that is Phlogin 50 mg
capsule by Brookes Pharma by performing quality
tests (Identification, Assay, Dissolution, Uniformity
of dosage form).
specificity.
Manufacturer of API M/s Vision Pharmaceuticals (Pvt.) Ltd.,
Plot No. 22-23, Industrial Triangle, Kahuta Road, Islamabad- Pakistan
API Lot No. DE706
Description of Pack
Alu-PVC blister packed in unit carton (2 x 10’s)
No. of Batches 03
467. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate
API manufacturer issued by concerned issued by Additional Director DRAP, Islamabad. It
regulatory authority of country of origin. is valid till 10-02-2022.
468. Documents for the procurement of API with The firm has submitted copy of invoice for the
approval from DRAP (in case of import). purchase of Diclofenac sodium EC pellets 24 %
(Batch # DE706, 1Kg) dated 11-03-2020.
469. Data of stability batches will be supported by Data of stability batches have been submitted by UV
attested respective documents like method alongwith respective documents like COA,
470. Compliance Record of HPLC software 21CFR The firm has submitted that testing of Dicmark 50mg
& audit trail reports on product testing DR capsule has been performed on UV
spectrophotometer.
471. Record of Digital data logger for temperature Record of data logger for temperature and humidity
and humidity monitoring of stability chambers monitoring of stability chambers (real time and
(real time and accelerated) accelerated) has been submitted.
Sr. Observations Response by the firm

No.
1. Copies of the Drug substance specifications The firm has submitted copies of the Drug
and analytical procedures used for routine substance specifications and analytical procedures
testing of the Drug substance / Active used for routine testing of the Drug substance by
Pharmaceutical Ingredient by both Drug both Drug substance & Drug Product
substance & Drug Product. manufacturer.
2. Analytical method verification reports of The firm has submitted analytical method
parameters like specificity, accuracy and verification reports of drug substance performed
repeatability (method precision) performed by by drug product manufacturer. However, relevant
the Drug Product manufacturer for both chromatograms of tested parameters were not
compendial as well as non-compendial drug provided.
3. Provide results of analysis of relevant batch(es) The firm has provided results of analysis of
of Drug Substance performed by Drug Product relevant batch(es) of Drug Substance performed by
manufacturer used during product Drug Product manufacturer used during stability
development and stability studies, along with studies, along with certificate of analysis (CoA) of
Certificate of Analysis (CoA) of the same the same batch.
batch from Drug Substance / /Active
Pharmaceutical Ingredient manufacture.
4. Pharmaceutical equivalence of the applied The firm has submitted pharmaceutical
drug shall be established with the innovator equivalence data of developed formulation (batch
product and results of all the quality tests of the
# T-49) against comparator brand Phlogin DR
developed formulation and the innovator 50mg Capsule (Batch # 09519) of M/s Brookes
product shall be submitted and discussed. pharma. Reference of WHO technical report series
No. 902, 2002 has been given to justify the
selection of market brand leader if innovator is not
available.
5. Details of batch numbers of applicant and The firm has provided details of applicant and
comparator product in pharmaceutical comparator product.
equivalence are required to be provided.
6. Justification is required for performing assay Dicmark 50mg DR Capsule is a non-compendial
testing by UV method instead of HPLC product. We have performed method validation on
method. UV spectrophotometer, hence we performed assay
testing by UV method.
7. Justification is required for setting dissolution The firm has submitted that 70% in 45min is a
limit in phosphate buffer stage as NLT 70% in typographic mistake. Actual limit is NLT 80% in
45 min which is different from that mentioned 45 min in phosphate buffer in Dissolution test as
in Stability study protocol i.e., NLT 80% in 45 written in stability protocol.
min.
8. Analytical method verification of drug product The firm has submitted revised reports of
includes performance of test of Detection limit performance of test of Detection limit and
and Quantitation limit by HPLC method. Quantitation limit by UV method.
9. Documents for the procurement of the API The firm has submitted copy of invoice for the
including purchase invoice from M/s M/s purchase of Diclofenac sodium EC pellets 24 %
Vision Pharmaceuticals (Pvt.) Ltd. (Batch # DE706, 1Kg) dated 11-03-2020.
10. Compliance Record of HPLC software 21CFR The firm has submitted that testing of Dicmark
& audit trail reports on product testing. 50mg DR capsule has been performed on UV
spectrophotometer.
11. Record of Digital data logger for temperature Record of data logger for temperature and
and humidity monitoring of stability chambers humidity monitoring of stability chambers (real
(real time and accelerated). time and accelerated) has been submitted.

No.
substance performed by drug product validation reports of drug substance by
manufacturer as per requirement of section performing precision, linearity, accuracy and
3.2.S.4.3 of Form-5F. specificity parameters.
2. Justification of adopting UV-visible Dicmark 50mg DR Capsule is a non-
spectrophotometric method for assay testing pharmacopoeial product. The UV method for
of applied formulation. assay testing was adopted because BP adopts UV
method for Diclofenac sodium prolonged release
capsule and moreover manufacturer of API (i.e.
Vision Pharma) also uses UV method for assay
testing.
3. Performance of pharmaceutical equivalence The firm has submitted pharmaceutical
and CDP studies with innovator/reference equivalence data of developed formulation
product. (batch # T-49) against comparator brand Phlogin
DR 50mg Capsule (Batch # 09519) of M/s
Brookes pharma.
Reference of WHO technical report series No.
902, 2002 has been given to justify the selection
of market brand leader if innovator is not
available.
4. Analytical method verification reports of drug Analytical method validation reports of drug
product performed by drug product product have been provided by performing
manufacturer. precision, linearity, accuracy and specificity
parameters.
Decision: Approved.
472. Name, address of Applicant / Marketing M/s Himark Laboratories Private Limited, Plot 37-A,
Authorization Holder Sunder Industrial Estate Lahore.
Name, address of Manufacturing site. M/s Himark Laboratories Private Limited, Plot 37-A,
Sunder Industrial Estate Lahore.
☐ Importer
☐ Export sale
GMP status of the Finished product New license granted on 26-09-2019.
approved.
Dy. No. and date of submission Dy. No.30581: Dated 08-11-2021
PKR 10,000/-: Duplicate challan date not mentioned
The proposed proprietary name / brand name Lorak 10 mg Tablet
Pharmaceutical ingredient (API) per unit Loratadine ...................10 mg
Pharmaceutical form of applied drug White to off white round uncoated tablet
Pharmacotherapeutic Group of (API) Antihistamines –H1 antagonists
Proposed Pack size 1 ×10’s
The status in reference regulatory authorities Clarityn Allergy 10mg Tablets by M/s UCB Pharma,
(MHRA Approved).
For generic drugs (me-too status) Softin 10 mg Tablet by M/s Werrick Pharmaceuticals,
(Reg # 012026)
Name and address of API manufacturer. M/s. Vasudha Pharma Chem Limited., 78/A,
VENGALRAO NAGAR, HYDERABAD –500038,
INDIA.
process and controls, Identification, Assay and tests
for total impurities, specifications, analytical
substance
Accelerated: 40°C ± 2°C / 75% ± 5% RH for 6 months
(BLRD/001/11, BLRD/002/11, BLRD/003/11)
Module-III (Drug Product): The firm has submitted data of drug product including
and process control, process validation protocols and
report, control of excipients, control of drug product,
Pharmaceutical equivalence and Pharmaceutical equivalence has been established
comparative dissolution profile against the brand leader that is Tirlor Tablet of
Novartis Pharma by performing quality tests
dosage form).
is Tirlor Tablet by Novartis Pharma in Acid media
(pH 1.0-1.2), phosphate buffer (pH 4.5 & pH 6.8).
Manufacturer of API M/s Vasudha Pharma Chem Limited.,
78/A, Vengalrao Nagar, Hyderabad – 500038, India.
API Lot No. BLRD/1911023
Description of Pack
No. of Batches 03
1. Reference of previous approval of The firm has not submitted any document.
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate No.
API manufacturer issued by concerned L. Dis. No. 5741/P&B/2001 issued by Drugs Control
regulatory authority of country of origin. Administration (Govt. of Andhra Pradesh) India valid
till 20-11-2022.
3. Documents for the procurement of API with The firm has submitted copy of letter No.17133/2019/
approval from DRAP (in case of import). DRAP-AD-CD(I&E) dated 26-12-2019 is submitted
wherein the permission to import different APIs
Loratadine for the purpose of test/analysis and stability
studies is granted.
4. Data of stability batches will be supported by The firm has submitted stability data supported by
attested respective documents like respective documents like chromatograms, and
chromatograms, raw data sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software Not submitted.
testing
6. Record of Digital data logger for temperature The firm has submitted record of data logger sheets for
and humidity monitoring of stability temperature and humidity monitoring of stability
chambers (real time and accelerated) chambers (real time and accelerated.
No.
1. Copies of the Drug substance specifications The firm has submitted copies of the Drug
testing of the Drug substance / Active used for routine testing of the Drug substance by
Pharmaceutical Ingredient by both Drug both Drug substance & Drug Product manufacturer.
substance & Drug Product.
parameters like specificity, accuracy and verification parameter of drug substance performed
repeatability (method precision) performed by by drug product manufacturer. However, the
the Drug Product manufacturer for both specificity results were not presented. The relevant
compendial as well as non-compendial drug chromatograms of tested parameter were not
substance(s) shall be submitted. provided.
3. Provide results of analysis of relevant The firm has provided results of analysis of relevant
batch(es) of Drug Substance performed by batch(es) of Drug Substance performed by Drug
Drug Product manufacturer used during Product manufacturer used during stability studies,
product development and stability studies, along with certificate of analysis (CoA) of the same
along with Certificate of Analysis (CoA) of batch.
the same batch from Drug Substance
manufacturer.
4. Pharmaceutical equivalence of the applied Pharmaceutical equivalence has been established
drug shall be established with the innovator against the brand leader that is Tirlor Tablet of
product and results of all the quality tests of Novartis Pharma by performing quality tests
the developed formulation and the innovator (Identification, Assay, Dissolution, Uniformity of
product shall be submitted and discussed. dosage form).
5. Details of batch numbers of applicant and Applicant batch no. Comparator batch no.
comparator product in pharmaceutical Lorak 10 mg Tablet Tirlor 10mg tablet of M/s
equivalence are required to be provided. = T-28 Novartis pharma = 102
6. Submit date of analysis of pharmaceutical The firm has stated date of analysis 27-01-2020 and
equivalence and comparative dissolution relevant chromatograms / spectra were not
profile alongwith chromatograms / spectra. provided.
7. Control of excipients is missing. The firm has submitted that excipients used in the
formulation are of pharmacopoeial grade and we are
using BP specifications.
8. Justification of method of specificity test in The firm has not submitted results for specificity
analytical method verification studies shall be test.
submitted. Clarification is required.
9. Analytical method verification reports of each The firm has submitted raw data sheets for the assay
parameter like specificity, accuracy and test.
the Drug Product manufacturer for drug
product shall be submitted.
10. The submitted chromatograms in stability The firm has not submitted chromatograms of all
studies (3.2.P.8) do not differentiate between time points of real time and accelerated stability
real time or accelerated stability studies time studies.
points of different batches.
11. Submit copies of Batch Manufacturing The firm has submitted copies of BMRs for three
Record (BMR) for all the batches of drug batches.
product for which stability studies data is
provided in Module 3 section 3.2.P.8.3.
12. Record of Digital data logger for temperature The firm has submitted record of data logger for
chambers (real time and accelerated). chambers (real time and accelerated.

No.
substance performed by drug product verification reports of drug substance by
manufacturer as per requirement of section performing precision, linearity, accuracy,
3.2.S.4.3 of Form-5F. specificity and system suitability studies.
2. HPLC chromatograms of all time points of real The firm has provided HPLC chromatograms
time and accelerated stability studies. of real time and accelerated stability studies for
0, 3 and 6-month time point.
3. Analytical method verification reports of drug The firm has submitted analytical method
product performed by drug product verification reports of drug product by
manufacturer. performing precision, linearity, accuracy,
specificity and system suitability studies.
Decision: Approved.
473. Name, address of Applicant / Marketing M/s Himark Laboratories Private Limited, Plot 37-
Authorization Holder A, Sunder Industrial Estate Lahore.
Name, address of Manufacturing site. M/s Himark Laboratories Private Limited, Plot 37-
A, Sunder Industrial Estate Lahore.
☐ Importer
☐ Export sale
manufacturer Oral Liquid Syrup section approved.
Dy. No. and date of submission Dy. No. 30580: Dated 08-11-2021
The proposed proprietary name / brand name Lorak 5 mg / 5 mL oral solution
Strength / concentration of drug of Active Each 5 ml contains:
Pharmaceutical ingredient (API) per unit Loratadine….................5 mg
Pharmaceutical form of applied drug Transparent to yellowish sweet taste orange flavor
oral solution
Pharmacotherapeutic Group of (API) Anti-histamine
Proposed Pack size 1 × 60 mL
The status in reference regulatory authorities Loratadine 5 mg / 5 ml syrup by M/s Generics [UK]
Limited t/a Mylan, MHRA Approved.
For generic drugs (me-too status) Lorel 1mg/mL Syrup by M/s Standpharm (Reg #
020951)
Name and address of API manufacturer. M/s Vasudha Pharma Chem Limited.,78/A,
VENGALRAO NAGAR, HYDERABAD –
500038, INDIA
Module III (Drug Substance) Official monograph of Loratadine is present in USP.
for total impurities, specifications, analytical
drug substance
months
(BLRD/001/11, BLRD/002/11, BLRD/003/11)
Module-III (Drug Product): The firm has submitted data of drug product
including its description, composition,
pharmaceutical development, manufacture,
manufacturing process and process control, process
validation protocols and report, control of
dissolution profile against the brand leader that is Lorel Syrup by
Standpharm by performing quality tests
(Identification, Assay, pH, microbial enumeration
tests & tests for specified micro-organisms).
specificity.
Manufacturer of API M/s Vasudha Pharma Chem Limited.,
78/A, Vengalrao Nagar, Hyderabad – 500038, INDIA
API Lot No. BLRD/1911023
Description of Pack Clear & transparent solution with sweet taste & tutti-fruiti flavor filled in
(Container closure system) amber glass bottles in packs of 60 mL, further packed in unit carton provided
with leaflet insert and a spoon.
No. of Batches 03
API manufacturer issued by concerned 5741/P&B/2001 issued by Drugs Control
regulatory authority of country of origin. Administration, Government of Andhra Pradesh,
approval from DRAP (in case of import). No.17133/2019/ DRAP-AD-CD(I&E) dated
26/12/2019 is submitted wherein the permission to
import different APIs Loratadine for the purpose of
4. Data of stability batches will be supported by The firm has submitted stability data supported by
attested respective documents like respective documents like chromatograms, and
chromatograms, Raw data sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR Not submitted.
& audit trail reports on product testing.
6. Record of Digital data logger for temperature The firm has submitted record of data logger sheets
(real time and accelerated) chambers (real time and accelerated.
No.
1. Copies of the Drug substance specifications and The firm has submitted copies of the Drug
analytical procedures used for routine testing of substance specifications and analytical
the Drug substance / Active Pharmaceutical procedures used for routine testing of the Drug
Ingredient by both Drug substance & Drug substance by both Drug substance & Drug
Product. Product manufacturer.
parameters like specificity, accuracy and verification parameter of drug substance
repeatability (method precision) performed by performed by drug product manufacturer.
the Drug Product manufacturer for both However, the specificity results were not
compendial as well as non-compendial drug presented. The relevant chromatograms of tested
substance(s) shall be submitted. parameter were not provided.
3. Provide results of analysis of relevant batch(es) The firm has provided results of analysis of
of Drug Substance performed by Drug Product relevant batch(es) of Drug Substance performed
manufacturer used during product development by Drug Product manufacturer used during
and stability studies, along with Certificate of stability studies, along with certificate of analysis
Analysis (CoA) of the same batch from Drug (CoA) of the same batch.
Substance manufacturer.
4. Pharmaceutical equivalence of the applied drug The firm has performed pharmaceutical
shall be established with the innovator product equivalence studies with comparator product.
and results of all the quality tests of the The details are below:
developed formulation and the innovator
product shall be submitted and discussed.
comparator product in pharmaceutical Lorak 5 mg /5ml Lorel 5mg /5ml oral
equivalence are required to be provided. Oral solution = T- solution of M/s
31 StandPharma = 004G
6. Submit date of analysis of pharmaceutical The firm has stated date of analysis 12-02-2020,
equivalence and comparative dissolution profile however relevant chromatograms / spectra were
alongwith chromatograms / spectra. not provided.
formulation are of pharmacopoeial grade and we
are using BP specifications.
9. Analytical method verification reports of each The firm has not submitted analytical method
parameter like specificity, accuracy and verification reports of parameters like specificity,
repeatability (method precision) performed by accuracy and repeatability (method precision) for
the Drug Product manufacturer for drug product drug product.
shall be submitted.
10. The submitted chromatograms in stability The firm has not submitted chromatograms of all
studies (3.2.P.8) do not differentiate between time points of real time and accelerated stability
real time or accelerated stability studies time studies.
points of different batches.
11. Submit copies of Batch Manufacturing Record The firm has submitted copies of BMRs for three
(BMR) for all the batches of drug product for batches.
which stability studies data is provided in
Module 3 section 3.2.P.8.3.
(real time and accelerated). chambers (real time and accelerated.

No.
5. HPLC chromatograms of all time points of real The firm has submitted HPLC chromatograms
product performed by drug product verification reports of drug substance by
specificity and system suitability studies.
Decision: Approved.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 30579: Dated: 08-11-2021
PKR 10,000/-: Date not mentioned
The proposed proprietary name / brand name Hitran Paediatric Suspension
Strength / concentration of drug of Active Each 5 mL suspension contains:
Pharmaceutical ingredient (API) per unit Trimethprim........................40 mg
Sulfamethoxazole...............200 mg
Pharmaceutical form of applied drug Clear sweet strawberry flavored homogeneous oral
suspension filled in amber glass bottle sealed with
aluminium cap and packed in printed unit cartons.
Pharmacotherapeutic Group of (API) Antibiotic
The status in reference regulatory authorities Bactrim Suspension by M/s Sun Pharm industries,
(USFDA Approved).
For generic drugs (me-too status) Septran Paediatric Suspension by M/s GSK Pharma
(Reg. No. 000384)
Name and address of API manufacturer. M/s Shouguang Fukang Pharmaceutical company
Ltd.,
North-East of Dongwaihuan Road, Dongcheng
Industrial Area, Shouguang City, Shandong Province,
China.
Module-II (Quality Overall Summary) The firm has submitted QOS as per WHO QOS-PD
Module III (Drug Substance) Trimethoprim:
The firm has submitted details of nomenclature,
for related substances, specifications, analytical
substance.
Sulfamethoxazole:
The firm has submitted details of nomenclature,
for related substances, specifications, analytical
substance.
Batches of Trimethoprim:
(201103504, 201103505, 201103506)
Batches of Sulfamethoxazole:
Accelerated: (200604001, 200604002, 200604003)
Real Time: (2007706001, 2007706002, 2007706003)
and process control, process validation protocols and
Pharmaceutical equivalence and Pharmaceutical equivalence has been established
comparative dissolution profile against the brand leader that is Septran Paediatric
Suspension by GSK Pharma by performing quality
tests (Identification, Assay, pH, Deliverable volume).
Manufacturer of API M/s Shouguang Fukang Pharmaceutical company Ltd.,
North-East of Dongwaihuan Road, Dongcheng Industrial Area, Shouguang
City, Shandong Province, People’s Republic of China.
API Lot No. Trimethoprim: A-50112007004-0500
Sulfamethoxazole: A-50212005029
Description of Pack Hitran Paediatric Suspension is filled in amber glass bottle sealed with pilfer
(Container closure system) proof aluminium cap and packed in a box board unit carton.
No. of Batches 03
firm (if any)
API manufacturer issued by concerned (Certificate # 20190888) for M/s Shouguang Fukang
regulatory authority of country of origin. Pharmaceutical Co. Ltd. issued by China Food and
Drug Administration valid till 12-03-2024.
approval from DRAP (in case of import). No.17133/2019/DRAP-AD-CD (I&E) dated 26-12-
2019 wherein the permission to import different APIs
Trimethoprim & Sulfamethoxazole for the purpose of
test/analysis and stability studies is granted. Invoice
for the purchase of materials is not submitted.
4. Data of stability batches will be supported by The firm has submitted data of stability batches
attested respective documents like alongwith raw data sheets, COA, summary data sheets.
chromatograms, Raw data sheets, COA, Relevant UV scans were not provided.
5. Compliance Record of HPLC software The testing of applied product is performed on UV
21CFR & audit trail reports on product spectrophotometer and audit trail reports not
testing submitted.
chambers (real time and accelerated) chambers (real time and accelerated).
The firm has claimed BP specifications however, the product is also present in USP monograph.
No.
1. Copies of the Drug substance specifications and The firm has submitted copies of the Drug
analytical procedures used for routine testing of substance specifications and analytical
the Drug substance / Active Pharmaceutical procedures used for routine testing of the Drug
Ingredient by both Drug substance & Drug substance by both Drug substance & Drug
Product. Product manufacturer.
2. Submit evidence of equipments required for The firm has not provided evidence of
potentiometric titration and electrometric titration availability of potentiometer.
required for analysis of trimethoprim and
sulfamethoxazole, respectively.
parameters like specificity, accuracy and verification parameter of drug substance
repeatability (method precision) performed by the performed by drug product manufacturer.
Drug Product manufacturer for both compendial However, the specificity results were not
as well as non-compendial drug substance(s) shall presented. The relevant chromatograms of
be submitted. tested parameters were not provided.
4. Provide results of analysis of relevant batch(es) of The firm has provided results of analysis of
Drug Substance performed by Drug Product relevant batch(es) of Drug Substance performed
manufacturer used during product development by Drug Product manufacturer used during
and stability studies, along with Certificate of stability studies, along with certificate of
Analysis (CoA) of the same batch from drug analysis (CoA) of the same batch.
substance manufacturer.
comparator product in pharmaceutical Hitran Paediatric Septran paediatric
equivalence are required to be provided. suspension = T-88 Suspension = KR5B
6. Discussion of microbiological attributes of the The firm has not submitted preservative
Drug Product (e.g. preservative effectiveness effectiveness studies as recommended by
studies to be performed as per recommendations Pharmacopoeia.
of pharmacopoeia) shall be provided.
7. Control of excipients is missing. The firm has submitted that excipients used in
the formulation are of pharmacopoeial grade
and we are using BP specifications and
analytical methods for all tests except Flavor
Banana & Flavor Vanilla for which analytical
procedures are attached.
9. Analytical method verification reports of each The firm has not submitted analytical method
parameter like specificity, accuracy and verification reports of parameters like
repeatability (method precision) performed by the specificity, accuracy and repeatability (method
Drug Product manufacturer for drug product shall precision) for drug product.
be submitted.
10. Provide raw data sheets wherein details of sample The firm has submitted raw data sheets for the
solution preparation and standard solution and assay test.
calculation formula for the assay test shall be
mentioned
11. Submitted DHL invoice is for M/s Scilife Pharma The firm has submitted that M/s Scilife Pharma
(Pvt.) Ltd. Clarification is required. (pvt.) Ltd was written mistakenly by DHL. The
materials were directly delivered to our plant.
12. Supportive documents like chromatograms / The testing of Hitran Pediatric Suspension has
spectra are not submitted. Clarification is been performed on UV-Spectrophotometer.
required. However, relevant UV scans have not been
submitted.
13. Submit copies of Batch Manufacturing Record The firm has submitted copies of BMRs for
(BMR) for all the batches of drug product for three batches.
which stability studies data is provided in Module
3 section 3.2.P.8.3.
14. Record of Digital data logger for temperature and The firm has submitted record of data logger for
humidity monitoring of stability chambers (real temperature and humidity monitoring of
time and accelerated). stability chambers (real time and accelerated.

No.
substance performed by drug product verification reports for both
manufacturer as per requirement of section sulphamethoxazole and trimethoprim by
3.2.S.4.3 of Form-5F. performing precision, linearity, accuracy,
specificity.
2. Preservative effectiveness studies performed as The firm has submitted performance of
per recommendations of pharmacopoeia. microbiological attributes of the drug product.
3. Evidence of availability potentiometer Copy of invoice for the purchase of
including purchase invoice and IQ, OQ, PQ of potentiometric titrator (Model # HI901) is
the equipment. attached.
The firm has submitted installation
qualification and operational qualification of
potentiometer.
product performed by drug product verification reports of drug product by
specificity.
5. Relevant UV spectra for assay testing as Our UV-spectrophotometer (Insmark 300/2)
recommended by the BP monograph of applied was not software base due to which prints
formulation. cannot be taken. Now we have purchased new
software of UV-spectrophotometer with print
option. Now the firm has submitted UV spectra
of dissolution testing of stability batches.
6. Evidence of procurement of drug substance with The firm has submitted copy of invoice
approval from DRAP. specifying import of Sulphamethoxazole
(2.0Kg) and Trimethoprim (0.5 Kg) attested by
Assistant Director (I & E) dated 03-08-2020.
Decision: Approved.
☐ Importer
☐ Export sale
GMP status of the Finished product New license granted on 26-09-2019
The proposed proprietary name / brand name Hitran DS Suspension
Strength / concentration of drug of Active Each 5 mL suspension contains:
Pharmaceutical ingredient (API) per unit Trimethprim ........................80 mg
Sulfamethoxazole ...............400 mg
Pharmaceutical form of applied drug Clear sweet strawberry flavored homogeneous oral
suspension filled in amber glass bottle sealed with
aluminium cap and packed in printed unit cartons
along with a patient information leaflet.
Pharmacotherapeutic Group of (API) Antibiotic
The status in reference regulatory authorities Sulfatrim Suspension by M/s Pharm Assoc, (USFDA
Approved).
For generic drugs (me-too status) Septran DS Suspension by M/s GSK Pharma (Reg #
008752)
Name and address of API manufacturer. M/s Shouguang Fukang Pharmaceutical company
Ltd.
North-East of Dongwaihuan Road, Dongcheng
Industrial Area, Shouguang City, Shandong
Province, People’s Republic of China
Module III (Drug Substance) Official monograph of Trimethoprim and
Sulfamethoxazole is present in BP.
Trimethoprim:
for related substances, impurity K, heavy metals,
Sulfamethoxazole:
for related substances (impurities A, C, D, E) &
impurity B, impurity F, unspecified impurities and
total impurities, specifications, analytical
substance
Batches of Trimethoprim:
(201103504,201103505, 201103506)
Batches of Sulfamethoxazole:
Accelerated: (200604001,200604002, 200604003
Real Time: (2007706001, 2007706002,
2007706003)
validation protocols and report, control of excipients,
procedures, validation of analytical procedures,
dissolution profile against the brand leader that is Septran DS
Suspension by GSK Pharma by performing quality
tests (Identification, Assay, pH, Uniformity of
dosage unit).
Analytical method validation/verification of Analytical method verification reports have not been
product submitted including linearity, accuracy, precision,
specificity.
Manufacturer of API M/s Shouguang Fukang Pharmaceutical company Ltd.,
North-East of Dongwaihuan Road, Dongcheng Industrial Area, Shouguang
City, Shandong Province, People’s Republic of China
API Lot No. Trimethoprim: A-50112007004-0500
Sulfamethoxazole: A-50212005029
Description of Pack Hitran DS Suspension is filled in amber glass bottle sealed with pilfer proof
(Container closure system) aluminium cap and packed in a in box board unit carton.
No. of Batches 03
firm (if any)
API manufacturer issued by concerned (Certificate # 20190888) for M/s Shouguang Fukang
regulatory authority of country of origin. Pharmaceutical Co. Ltd. issued by China Food and
Drug Administration valid till 12-03-2024.
approval from DRAP (in case of import). No.17133/2019/DRAP-AD-CD (I&E) dated 26-12-
2019 wherein the permission to import different APIs
Trimethoprim & Sulfamethoxazole for the purpose of
test/analysis and stability studies is granted. Invoice
for the purchase of materials is not submitted.
attested respective documents like alongwith raw data sheets, COA, summary data
chromatograms, Raw data sheets, COA, sheets. Relevant UV scans were not provided.
5. Compliance Record of HPLC software The testing of applied product is performed on UV
21CFR & audit trail reports on product testing spectrophotometer and audit trail reports not
submitted.
(real time and accelerated) chambers (real time and accelerated).
The firm has claimed BP specifications while the product is also present in available USP.
Evidence of approval of applied formulation in reference regulatory authority could not be confirmed.
No.
1. Copies of the Drug substance specifications The firm has submitted copies of the Drug substance
and analytical procedures used for routine specifications and analytical procedures used for
testing of the Drug substance / Active routine testing of the Drug substance by both Drug
Pharmaceutical Ingredient by both Drug substance & Drug Product manufacturer.
2. Submit evidence of equipments required for The firm has not provided evidence of availability of
potentiometric titration and electrometric potentiometer.
titration required for analysis of
trimethoprim and sulfamethoxazole,
respectively.
repeatability (method precision) performed by drug product manufacturer. However, the
by the Drug Product manufacturer for both specificity results were not presented. The relevant
compendial as well as non-compendial drug chromatograms of tested parameters were not
4. Provide results of analysis of relevant The firm has provided results of analysis of relevant
batch(es) of Drug Substance performed by batch(es) of Drug Substance performed by Drug
Drug Product manufacturer used during Product manufacturer used during stability studies,
product development and stability studies, along with certificate of analysis (CoA) of the same
along with Certificate of Analysis (CoA) of batch.
the same batch from Drug Substance
manufacturer.
comparator product in pharmaceutical Hitran DS Septran DS Suspension
equivalence are required to be provided. suspension = T-88 = HR8P
6. Discussion of microbiological attributes of The firm has not submitted preservative effectiveness
the Drug Product (e.g. preservative studies as recommended by Pharmacopoeia.
effectiveness studies to be performed as per
recommendations of pharmacopoeia) shall
be provided.
using BP specifications and analytical methods for
all tests except Flavor Banana & Flavor Vanilla for
which analytical procedures are attached.
8. Justification of method of specificity test in The firm has not submitted results for specificity test.
analytical method verification studies shall
be submitted. Clarification is required.
9. Analytical method verification reports of The firm has not submitted analytical method
each parameter like specificity, accuracy and verification reports of parameters like specificity,
repeatability (method precision) performed accuracy and repeatability (method precision) for
by the Drug Product manufacturer for drug drug product.
10. Provide raw data sheets wherein details of The firm has submitted raw data sheets for the assay
sample solution preparation and standard test.
solution and calculation formula for the
assay test shall be mentioned
11. Submitted DHL invoice is for M/s Scilife The firm has submitted that M/s Scilife Pharma (pvt.)
Pharma (Pvt.) Ltd. Clarification is required. Ltd was written mistakenly by DHL. The materials
were directly delivered to our plant.
12. Supportive documents like chromatograms / The testing of Hitran DS Suspension has been
spectra are not submitted. Clarification is performed on UV-Spectrophotometer. However,
required. relevant UV scans have not been submitted.
13. Submit copies of Batch Manufacturing The firm has submitted copies of BMRs for three
Record (BMR) for all the batches of drug batches.
14. Record of Digital data logger for The firm has submitted record of data logger for
temperature and humidity monitoring of temperature and humidity monitoring of stability
stability chambers (real time and chambers (real time and accelerated.
accelerated).

No.
substance performed by drug product verification reports for both
manufacturer as per requirement of section sulphamethoxazole and trimethoprim by
3.2.S.4.3 of Form-5F. performing precision, linearity, accuracy,
specificity.
2. Preservative effectiveness studies performed as The firm has submitted performance of
per recommendations of pharmacopoeia. microbiological attributes of the drug product.
3. Evidence of availability potentiometer Copy of invoice for the purchase of
including purchase invoice and IQ, OQ, PQ of potentiometric titrator (Model # HI901) is
the equipment. attached.
The firm has submitted installation
qualification and operational qualification of
potentiometer.
4. Analytical method verification reports of drug Analytical method verification reports of drug
product performed by drug product product by performing precision, linearity,
manufacturer. accuracy, specificity have been submitted.
5. Relevant UV spectra for assay testing as Our UV-spectrophotometer (Insmark 300/2)
formulation. cannot be taken. Now we have purchased new
software of UV-spectrophotometer with print
6. Evidence of procurement of drug substance with The firm has submitted copy of invoice
approval from DRAP. specifying import of Sulphamethoxazole
(2.0Kg) and Trimethoprim (0.5 Kg) attested by
Decision: Approved.
☐ Importer
☐ Export sale
manufacturer Sachet (General) section approved.
Dy. No. and date of submission Dy. No. 24083: Dated: 01-09-2021
The proposed proprietary name / brand name Oestolos 2 g Sachet
Strength / concentration of drug of Active Each Sachet contains:
Pharmaceutical ingredient (API) per unit Strontium Ranelate……..... 2 g
Pharmaceutical form of applied drug Granules in sachet pack
Pharmacotherapeutic Group of (API) Anti-osteoporosis
Proposed Pack size 1 × 7’s
The status in reference regulatory authorities Strontium ranelate Aristo 2 g granules for oral
suspension by M/s Aristo Pharma GmbH
Wallenroder Straße 8-10 13435 Berlin Germany,
MHRA Approved.
For generic drugs (me-too status) ONITA SACHET by M/s PHARM-EVO (PVT)
LTD,
(Reg. No. 057746)
Name and address of API manufacturer. M/s Suntril Pharmaceuticals Pvt. Ltd.,
Plot # 219, Phase-1, HSIIDC, Alipur Tehsil Barwala
District Panchkula (Haryana), India.
for related substances (unspecified and total
impurities), specifications, analytical procedures and
Batches:
(STRHB 170001, STRHB 170002, STRHB 170003)
dissolution profile against the brand leader that is Osstium sachet by
Atco Pharma by performing quality tests
(Identification, Assay, pH, Uniformity of dosage unit
& loss on Drying).
specificity.
Manufacturer of API M/s Suntril Pharmaceuticals Pvt. Ltd.,
Plot # 219, Phase-1, HSIIDC, Alipur Tehsil Barwala District Panchkula
(Haryana), India.
API Lot No. STRHB200003
Description of Pack
Aluminium Foil, 1 × 7’s
Batch No. T-100 T-101 T-102
No. of Batches 03
firm (if any)
API manufacturer issued by concerned 1/151-2 Drug-1-2019/7839 issued by Food and Drug
regulatory authority of country of origin. Administration Haryana Panchkula (India) valid till
22-10-2021.
3. Documents for the procurement of API with The firm has submitted copy of letter No.
approval from DRAP (in case of import). 17133/2019/DRAP-AD-CD(I&E) dated 26-12-2019
is submitted wherein the permission to import
different API Strontium Ranelate for the purpose of
attested respective documents like alongwith chromatograms, Raw data sheets, COA,
6. Record of Digital data logger for temperature The firm has submitted record of digital data logger
(real time and accelerated). chambers (real time and accelerated).
No.
3. Provide results of analysis of relevant The firm has submitted analytical method
batch(es) of Drug Substance performed by verification parameter of drug substance performed
Drug Product manufacturer used during by drug product manufacturer. However, the
product development and stability studies, specificity results were not presented. The relevant
along with Certificate of Analysis (CoA) of chromatograms of tested parameters were not
the same batch from Drug Substance / provided.
/Active Pharmaceutical Ingredient
manufacture.
4. The reference formulation states granules for Granules are prepared in-house by sieving the
oral suspension for applied formulation. materials from appropriate mesh.
Clarification is required in manufacturing
process and process control whether
granules will be prepared in-house or
otherwise.
5. Pharmaceutical equivalence of the applied The firm has submitted pharmaceutical equivalence
drug shall be established with the innovator with comparator product Osstium Sachet of M/s Atco
product and results of all the quality tests of Labs.
the developed formulation and the innovator
comparator product in pharmaceutical Oestolos 2g Sachet Osstium Sachet =
equivalence are required to be provided. = T-100 UJ006FM1
using BP specifications
assay test shall be mentioned
10. Submitted invoice for the procurement of The firm has not submitted invoice for the
drug substance is not attested by AD (I & E). procurement of drug substance.
11. Justification is required for submission of The firm has not submitted chromatograms for real
single chromatogram as test result of each time and accelerated stability studies at different time
batch at different time intervals. intervals. Instead, single chromatogram for each test
interval is submitted.

No.
substance performed by drug product verification reports of strontium ranelate by
3. Analytical method verification reports of drug Analytical method verification reports of
product performed by drug product strontium ranelate by performing precision,
manufacturer. linearity, accuracy, and specificity have been
submitted.
4. Evidence of procurement of drug substance with The firm has submitted copy of letter No.
approval from DRAP. 17133/2019/DRAP-AD-CD(I&E) dated 26-
12-2019 is submitted wherein the permission to
import different API Strontium Ranelate for
is granted.
The firm submitted that material was directly
received at the plant. Import invoice is attached
specifying import of Strontium ranelate 0.70
Kg (batch # STRHB200003).
Decision: Deferred for submission of documents confirming import of API i.e, Goods declaration/
Airway bill/Courier receipt etc.
☐ Importer
☐ Export sale
GMP status of the Finished product New license granted on 26-09-2019.
approved.
Dy. No. and date of submission Dy. No. 24085 Dated: 01-09-2021
Details of fee submitted PKR 30,000/-: Dated 21/06/2021
The proposed proprietary name / brand name Trox 10 mg Tablet
Pharmaceutical ingredient (API) per unit Cetirizine Dihydrochloride……………….. 10 mg
Pharmaceutical form of applied drug White to off white round shaped without any score
film coated tablet
Pharmacotherapeutic Group of (API) Anti-histamine
Proposed Pack size 1 × 10’s
The status in reference regulatory authorities Zirtek Allergy Relief 10 mg film-coated tablets by
M/s UCB Pharma, MHRA Approved.
For generic drugs (me-too status) Avec 10mg Tablet by M/s Platinum Pharma, (Reg #
025506)
Name and address of API manufacturer. M/s Supriya Life sciences Ltd., Mumbai, INDIA. A-
5/2, Lote Parshuram Industrial Area, M.I.D.C Taluka
– Khed, District – Ratnagiri, Maharashtra, India 415
722.
substance.
Accelerated: 40°C ± 2°C / 75% ± 5% RH for 6 months
Batches: (SLL/CTR/0309047, SLL/CTR/0309048,
SLL/CTR/0309047).
Module-III (Drug Product): The firm has submitted details of manufacturers,
product.
dissolution profile against that is Zyrtec 10 mg Tab by GSK Pharma by
is Zyrtec 10 mg Tab by GSK Pharma in acidic
media (pH 1.2) & phosphate buffer (pH 4.5 & 6.8).
The values for f2 are in the acceptable range.
specificity.
Manufacturer of API M/s Supriya Lifescience Ltd., Mumbai, INDIA. A-5/2, Lote Parshuram
Industrial Area, M.I.D.C Taluka – Khed, District – Ratnagiri, Maharashtra,
India 415 722.
API Lot No. CTZ/083/20-21
Description of Pack
No. of Batches 03
firm (if any)
API manufacturer issued by concerned NEW-WHO-
regulatory authority of country of origin. GMP/CERT/KD/67649/2018/11/25185 issued by
Food and Drug Administration India valid till 04-10-
2021.
approval from DRAP (in case of import). No.17133/2019/DRAP-AD-CD(I&E) dated
different APIs Cetirizine Dihydrochloride for the
granted.
attested respective documents like alongwith chromatograms, Raw data sheets, COA,
No.
3. Provide results of analysis of relevant The firm has submitted analytical method
batch(es) of Drug Substance performed by verification parameter of drug substance performed
Drug Product manufacturer used during by drug product manufacturer. However, the
product development and stability studies, specificity results were not presented. The relevant
along with certificate of Analysis (CoA) of chromatograms of tested parameters were not
the same batch from Drug Substance / provided.
/Active Pharmaceutical Ingredient
manufacture.
4. Pharmaceutical equivalence of the applied The firm has submitted pharmaceutical equivalence
drug shall be established with the innovator with comparator product Osstium Sachet of M/s Atco
product and results of all the quality tests of Labs.
the developed formulation and the innovator
5. Details of batch numbers of applicant and Applicant batch Comparator batch no.
comparator product in pharmaceutical no.
equivalence are required to be provided. Trox 10mg Tab = Zyrtec 10mg Tab = 354 E
T-94
using BP specifications
assay test shall be mentioned.
9. Submitted invoice for the procurement of Not submitted.
drug substance is not attested by AD (I & E).
10. UV spectra of dissolution data are required Not submitted.
to be provided.
11. Justification is required for submission of The submitted chromatograms do not differentiate
single chromatogram as test result for each between real time or accelerated stability studies time
batch at different time intervals. points of different batches.

No.
3. UV spectra of dissolution testing, as Our UV-spectrophotometer (Insmark 300/2)
formulation, at all time points of stability study cannot be taken. Now we have purchased new
data. software of UV-spectrophotometer with print
4. Analytical method verification reports of drug Analytical method verification reports of drug
product performed by drug product product have been provided by performing
manufacturer. precision, linearity, accuracy, specificity and
system suitability studies.
5. Evidence of procurement of drug substance with The firm has submitted copy of letter
approval from DRAP. No.17133/2019/DRAP-AD-CD(I&E) dated
different APIs Cetirizine Dihydrochloride for
is granted.
The firm submitted that material was directly
received at the plant. Import invoice is attached
specifying import of Cetirizine
dihydrochloride 0.07 Kg (batch # CTZ/083/20-
21).
Decision: Deferred for submission of documents confirming import of API i.e, Goods declaration/
Airway bill/Courier receipt etc.
.
Case no. 05: Registration applications of locally manufacturing drugs (human) submitted on Form 5F
format (New Section):
On the recommendations of panel of experts, the CLB in its 274th meeting held on 07th April, 2020 has considered
and approved the grant of following six (06) additional sections/facilities of your firm M/s Ferozsons
Laboratories Ltd, Amangarh, Nowshera, KPK
Ground Floor
1. Tablet Section (General)
2. Ointment / Cream / Gel Section (General)
3. Bottle filling area for Tablets and Capsules
4. Raw Material Store
478. Name, address of Applicant / Marketing M/S Ferozsons Laboratories Limited,

Authorization Holder PO Ferozsons, Nowshera - Pakistan.
Name, address of Manufacturing site. M/S Ferozsons Laboratories Limited,
PO Ferozsons, Nowshera - Pakistan.
Status of the applicant  Manufacturer
☐ Importer
 Generic Drug Product (GDP)
☐ Export sale
 Domestic and Export sales
Details of fee submitted PKR 30,000/-: Dated: 07-04-2022
The proposed proprietary name / brand name Acylex 5% Cream
Strength / concentration of drug of Active Each gram contains:
Pharmaceutical ingredient (API) per unit Acyclovir……………...50mg
Pharmaceutical form of applied drug Cream
Pharmacotherapeutic Group of (API) Antiviral for topical use
(ATC code: J05AB01)
Reference to Finished product specifications B.P. Specifications
Proposed Pack size 5gm and 10gm tube
The status in reference regulatory authorities Zovirex 5% cream by M/s GlaxoSmithkline
Approved by USFDA
For generic drugs (me-too status) Zovirex 5% cream by M/s GlaxoSmithkline
Pakistan Reg.No 010333
GMP status of the Finished product Firm has submitted copy of GMP certificate valid
manufacturer till 10-08-2023.
Ointment/Cream (General) section approved.
Name and address of API manufacturer. Name: M/s Zhejiang Zhebei Pharmaceutical Co.,
Ltd-China
Address. No.66 Guo Shantou, Xinshi Town,
Deqing County, Zhejiang., China
manufacturers, Characterization, impurities,
The firm has summarized information of drug
product including its description, composition,
manufacturing process and process control,
Module III (Drug Substance) Official monograph of Acyclovir is present in B.P.
Firm has submitted detailed drug substance data
months
months
Batches: (20120901M, 0120902M, 0120903M)
analytical procedures, batch analysis, justification
of specifications, reference standard or materials,
Pharmaceutical equivalence. The Firm has performed pharmaceutical
equivalence of their developed formulation Acylex
5% cream (B # AVCream-001) with innovator
product Zovirex 5% Cream (B # U389) of M/s
GlaxoSmithkline. Quality tests of both products
including description, identification, pH, viscosity,
Uniformity of container, assay and related
substances were performed and compared.
product report of drug substance.
Firm has submitted analytical method validation
report of applied product.
Manufacturer of API M/s Zhejiang Zhebei Pharmaceutical Co., Ltd-China
Address; No.66 Guo Shantou, Xinshi Town, Deqing County, Zhejiang.,
China
API Lot No. A200802
Description of Pack
Aluminum tube
Batch No. AVCream-001 AVCream-002 AVCream-003
No. of Batches 03
1. Reference of previous approval of applications The firm has submitted reference of already
with stability study data of the firm (if any) conducted inspection dated 26-07-2019 for
registration application of Hexigard Gel 4%
approved in 291st meeting of RB.
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of DML of M/s
manufacturer issued by concerned regulatory Zhejiang Zhebei Pharmaceutical Co., Ltd.-China
authority of country of origin. issued by Zhejiang province FDA valid till 06-01-
2026.
3. Documents for the procurement of API with The firm has submitted copy of commercial
approval from DRAP (in case of import). invoice No.20200824001 specifying import of
Acyclovir (1200Kg) dated 28-08-2020 duly
attested by Assistant Director DRAP (I&E),
Peshawar dated 23-09-2020.
4. Data of stability batches will be supported by Firm has submitted record of testing of all batches
attested respective documents like along with chromatograms, raw data sheets, COA
chromatograms, Raw data sheets, COA, and summary data sheets.
Audit trail on testing reports of product submitted.
6. Record of Digital data logger for temperature Firm has submitted record of data logger for
and humidity monitoring of stability chambers temperature and humidity monitoring of real time
(real time and accelerated) and accelerated stability chambers.

No.
1. Clarify why you have tested a USP grade drug The firm has submitted declaration from drug
substance by applying BP monograph. substance manufacturer showing that our
Acyclovir (Batch NO.: A200802) meets the
requirement of both USP and BP.
2. You have mentioned test of particle size which is We have performed particle size test as per our
not included in BP monograph. internal specifications to control the API.
Decision: Approved.
Case no. 06: Registration applications of locally manufacturing drugs (human) submitted on Form 5 F
format
a. New cases
479. Name, address of Applicant / Marketing M/s Getz Pharma (Pvt.) Limited
Authorization Holder 29-30/27, Korangi Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Getz Pharma (Pvt.) Limited
29-30/27, Korangi Industrial Area, Karachi.
☐ Importer
☐ Export sale
PKR 10,000/-: Dated 22-07-2022
The proposed proprietary name / brand name LOPICARD Tablets 5mg
Pharmaceutical ingredient (API) per unit Amlodipine as besylate…….5mg
Pharmaceutical form of applied drug Light yellow colored, octagonal shaped tablet
engraved "GETZ" on one side and plain on the other
side.
Pharmacotherapeutic Group of (API) Calcium Channel Blocker
Reference to Finished product specifications USP Specification.
Proposed Pack size 20’s & 30’s
Proposed unit price As per DPC
The status in reference regulatory authorities NORVASC Tablet 5mg marketed by M/s Pfizer,
USA. USFDA Approved.
For generic drugs (me-too status) NORVASC Tablet 5mg marketed by M/s Pfizer,
Karachi.
(Registration No.: 011825)
GMP status of the Finished product Last GMP Inspection dated 03-12-2021 concludes that
manufacturer M/s Getz Pharma Pvt. Ltd. is considered to be
operating at an acceptable level of compliance of GMP
requirements. Tablet (General & General Antibiotic)
section approved.
Name and address of API manufacturer. M/s Cadila Pharmaceuticals Limited.
294, G.I.D.C. Industrial Estate Ankleshwar - 393 002
.Gujarat, INDIA
system and stability studies of drug substance is
submitted.
Module III (Drug Substance) Official monograph of Amlodipine Besylate is
available in USP pharmacopeia. The firm has
tests for impurities, specifications, analytical
substance
Accelerated: 40°C±2°C / 75% ± 5%RH for 6 months
Batches: (19AD023, 19AD024, 19AD025)
Module-III (Drug Product): The firm has submitted details of drug product
Pharmaceutical equivalence and comparative The firm has submitted pharmaceutical equivalence
dissolution profile and CDP against the innovator product Norvasc Tablet
5mg (Batch # by M/s Pfizer Australia Pty Ltd in
Acidic media (pH 1.2), Acetate Buffer (pH 4.5) &
Phosphate Buffer (pH 6.8). The f2 values are in the
acceptable range.
product System suitability, Specificity, linearity and Precision
repeatability.
Manufacturer of API M/s Cadila Pharmaceuticals Limited.,
294, G.I.D.C. Industrial Estate, Ankleshwar - 393 002, Gujarat, India
API Lot No. 0000184914 & 0000186073
Description of Pack
Alu-Alu blister packed in unit carton along with leaf insert.
Batch No. 010T77 011T77 012T77
Batch Size 400,000 Tablets 400,000 Tablets 400,000 Tablets
Manufacturing Date 12.03.2021 12.03.2021 15.04.2021
No. of Batches 03
1. Reference of previous approval of applications Onsite inspection report of Getz Pharma product
with stability study data of the firm (if any) Emclide (Empagliflozin & Linagliptin) Tablets 10mg
+ 5mg was discussed and approved in 316th RB
Meeting held on March 15-18, 2022. The inspection
report confirms following points:
• The HPLC software is 21CFR Compliant as per
record available with the firm. The firm have
number of HPLC with Empower 3 and DB
software having following features:
✓ Have Audit trail
✓ Have backup system
✓ Have Data traceability
✓ Have Data achieving system
✓ Have data integrity
✓ Have Data security
✓ System Security Policy
• Audit trail on the testing reports is available.
• Adequate monitoring and control are available for
stability chamber. Chambers are controlled and
monitored through software having alarm system
for alerts as well.
• Related manufacturing area, equipment, personnel
and utilities are in compliance.
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate (No.
manufacturer issued by concerned regulatory 21102987) for M/s Cadila Pharmaceuticals ltd, India
authority of country of origin. issued by Food and Drug control administration,
Gujarat State, India. It is valid till 20-10-2024.
3. Documents for the procurement of API with Copy of commercial invoice attested by AD (I&E)
approval from DRAP (in case of import). DRAP, Karachi, has been submitted.
Quantit
Date of
Invoice y
Batch No. approval
No. Importe
by DRAP
d
20ADL00 320204071 31-12-
50.0 Kg
8 6 2020
20ADL00 320214001 150.0 02-02-
5 3 Kg 2021
4. Data of stability batches will be supported by Firm has submitted data of stability batches along with
attested respective documents like batch manufacturing record, analytical record and
chromatograms, Raw data sheets, COA, attested documents like chromatograms, Raw data
summary data sheets etc. sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR & Firm has submitted compliance certificate of HPLC
audit trail reports on product testing. software and audit trail reports on product testing.
6. Record of Digital data logger for temperature and Firm has submitted record of digital data logger for
humidity monitoring of stability chambers (real temperature & humidity monitoring of stability
time and accelerated). chambers (real time and accelerated).

No.
1. Analytical method verification studies of The firm has submitted analytical method
drug substance including specificity, verification studies from drug product
accuracy and repeatability (method manufacturer by performing system suitability
precision) performed by the Drug Product studies, linearity, specificity and precision. We
manufacturer in both module 2 and module 3 have used 100% API without any placebo in
shall be submitted. analytical method verification studies, therefore
requirement for accuracy is not applicable.
Further, we have performed linearity to check
area response of the sample as the concentration
of sample raised within working range of
sample i.e., 50% to 150%.
2. The storage conditions under which stability Stability study data of three batches of drug
studies of the API conducted were not as per substance has been submitted as per Zone IVA
Zone IVA. Clarification is required. conditions.
3. The copies of complete analysis of at least Copies of complete analysis of three batches of
two batches shall be provided under section Amlodipine 5mg tablet has been submitted.
3.2.P.5.4.
4. The batch numbers and date mentioned in The analytical report of stability batches has
stability summary and conclusions are been provided.
different from that mentioned in section
3.2.P.5.4. Clarification is required.
API manufacturer issued by concerned (No. 21102987) for M/s Cadila Pharmaceuticals
regulatory authority of country of origin. ltd, India issued by Food and Drug control
administration, Gujarat State, India. It is valid
till 20-10-2024.
6. Documents for the procurement of API with Copy of commercial invoice attested by AD
approval from DRAP (in case of import). (I&E) DRAP, Karachi, has been submitted.
Quantit
Date of
Batch Invoice y
approval
No. No. Importe
by DRAP
d
20ADL 3202040 31-12-
50.0 Kg
008 716 2020
20ADL 3202140 150.0 02-02-
005 013 Kg 2021
7. Data of stability batches supported by Firm has submitted data of stability batches
attested respective documents like along with batch manufacturing record,
chromatograms, Raw data sheets, COA, analytical record and attested documents like
summary data sheets shall be submitted. chromatograms, Raw data sheets, COA,
8. Compliance Record of HPLC software Firm has submitted compliance certificate of
21CFR & audit trail reports on product HPLC software and audit trail reports on
testing. product testing.
9. Record of Digital data logger for temperature Firm has submitted record of digital data logger
and humidity monitoring of stability for temperature & humidity monitoring of
chambers (real time and accelerated). stability chambers (real time and accelerated).
Decision: Approved.
• Manufacturer will perform accuracy studies as part of verification studies of analytical method of
drug substance before issuance of registration letter.
480. Name, address of Applicant / Marketing M/s Getz Pharma (Pvt.) Limited
Authorization Holder 29-30/27, Korangi Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Getz Pharma (Pvt.) Limited
29-30/27, Korangi Industrial Area, Karachi.
☐ Importer
☐ Export sale
PKR 10,000/-: Dated 22-07-2022
The proposed proprietary name / brand name LOPICARD Tablets 10mg
Pharmaceutical ingredient (API) per unit Amlodipine as besylate …….10mg
Pharmaceutical form of applied drug Light pink colored, oval shaped tablet engraved
"GETZ" on one side and "10" on the other side
Pharmacotherapeutic Group of (API) Calcium Channel Blocker
The status in reference regulatory authorities NORVASC Tablet 10mg marketed by M/s Pfizer,
USA. (USFDA Approved).
For generic drugs (me-too status) NORVASC Tablet 10mg marketed by M/s Pfizer,
Karachi (Reg # 011826)
GMP status of the Finished product Last GMP Inspection dated 03-12-2021 concludes that
manufacturer M/s Getz Pharma Pvt. Ltd. is considered to be
operating at an acceptable level of compliance of GMP
requirements. Tablet (General & General Antibiotic)
section approved.
Name and address of API manufacturer. M/s Cadila Pharmaceuticals Limited.,
294, G.I.D.C. Industrial Estate Ankleshwar - 393 002,
Gujarat, India.
submitted.
Module III (Drug Substance) Official monograph of Amlodipine Besylate is
available in USP pharmacopeia. The firm has
tests for impurities, specifications, analytical
substance
Accelerated: 40°C±2°C/ 75% ± 5%RH for 6 months
Batches: (19AD023, 19AD024, 19AD025)
Pharmaceutical equivalence and comparative The firm has submitted pharmaceutical equivalence
dissolution profile and CDP against the innovator product Norvasc Tablet
10mg (Batch # by M/s Pfizer Australia Pty Ltd in
Acidic media (pH 1.2), Acetate Buffer (pH 4.5) &
Phosphate Buffer (pH 6.8). The f2 values are in the
acceptable range.
product System suitability, Specificity, linearity and Precision
repeatability.
Manufacturer of API M/s Cadila Pharmaceuticals Limited.,
294, G.I.D.C. Industrial Estate Ankleshwar - 393 002, Gujarat, India.
API Lot No. 0000184914
Description of Pack
Alu-Alu blister packed in unit carton along with leaf insert.
Batch No. 023T78 024T78 025T78
Manufacturing Date 06.03.2021 06.03.2021 27.04.2021
No. of Batches 03
1. Reference of previous approval of applications Onsite inspection report of Getz Pharma product
with stability study data of the firm (if any) Emclide (Empagliflozin & Linagliptin) Tablets 10mg
+ 5mg was discussed and approved in 316th RB
Meeting held on March 15-18, 2022. The inspection
report confirms following points:
• The HPLC software is 21CFR Compliant as per
record available with the firm. The firm have
number of HPLC with Empower 3 and DB
software having following features:
✓ Have Audit trail
✓ Have backup system
✓ Have Data traceability
✓ Have Data achieving system
✓ Have data integrity
✓ Have Data security
✓ System Security Policy
• Audit trail on the testing reports is available.
stability chamber. Chambers are controlled and
monitored through software having alarm system
for alerts as well.
• Related manufacturing area, equipment, personnel
and utilities are in compliance.
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate (No.
manufacturer issued by concerned regulatory 21102987) for M/s Cadila Pharmaceuticals ltd, India
authority of country of origin. issued by Food and Drug control administration,
Gujarat State, India. It is valid till 20-10-2024.
3. Documents for the procurement of API with Copy of commercial invoice attested by AD (I&E)
approval from DRAP (in case of import). DRAP, Karachi, has been submitted.
Quantity Date of
Invoice
Batch No. Importe approval
No.
d by DRAP
20ADL00 3202040
50.0 Kg 31-12-2020
8 716
4. Data of stability batches will be supported by Firm has submitted data of stability batches along with
attested respective documents like batch manufacturing record, analytical record and
chromatograms, Raw data sheets, COA, attested documents like chromatograms, Raw data
summary data sheets etc. sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR & Firm has submitted compliance certificate of HPLC
audit trail reports on product testing software and audit trail reports on product testing.
6. Record of Digital data logger for temperature and Firm has submitted Record of Digital data logger for
humidity monitoring of stability chambers (real temperature & humidity monitoring of stability
time and accelerated) chambers (real time and accelerated).

No.
1. Analytical method verification studies of The firm has submitted analytical method
drug substance including specificity, verification studies from drug product
accuracy and repeatability (method manufacturer by performing system suitability
precision) performed by the Drug Product studies, linearity, specificity and precision. We
manufacturer in both module 2 and module 3 have used 100% API without any placebo in
shall be submitted. analytical method verification studies, therefore
requirement for accuracy is not applicable.
Further, we have performed linearity to check
area response of the sample as the concentration
of sample raised within working range of
sample i.e., 50% to 150%.
2. The storage conditions under which stability Stability study data of three batches of drug
studies of the API conducted were not as per substance has been submitted as per Zone IVA
Zone IVA. Clarification is required. conditions.
3. The copies of complete analysis of at least Copies of complete analysis of three batches of
two batches shall be provided under section Amlodipine 10mg tablet has been submitted.
3.2.P.5.4.
4. The batch numbers and date mentioned in The analytical report of stability batches has
stability summary and conclusions are been provided.
different from that mentioned in section
3.2.P.5.4. Clarification is required.
API manufacturer issued by concerned (No. 21102987) for M/s Cadila Pharmaceuticals
regulatory authority of country of origin. ltd, India issued by Food and Drug control
administration, Gujarat State, India. It is valid
till 20-10-2024.
6. Documents for the procurement of API with Copy of commercial invoice attested by AD
approval from DRAP (in case of import). (I&E) DRAP, Karachi, has been submitted.
Quantit
Date of
Batch Invoice y
approval
No. No. Importe
by DRAP
d
20ADL 3202040 31-12-
50.0 Kg
008 716 2020
20ADL 3202140 150.0 02-02-
005 013 Kg 2021
7. Data of stability batches supported by Firm has submitted data of stability batches
attested respective documents like along with batch manufacturing record,
chromatograms, Raw data sheets, COA, analytical record and attested documents like
summary data sheets shall be submitted. chromatograms, Raw data sheets, COA,
8. Compliance Record of HPLC software Firm has submitted compliance certificate of
21CFR & audit trail reports on product HPLC software and audit trail reports on
testing. product testing.
9. Record of Digital data logger for temperature Firm has submitted record of digital data logger
and humidity monitoring of stability for temperature & humidity monitoring of
chambers (real time and accelerated). stability chambers (real time and accelerated).
Decision: Approved.
• Manufacturer will perform accuracy studies as part of verification studies of analytical method of
drug substance before issuance of registration letter.
481. Name, address of Applicant / Marketing M/s Axis Pharmaceuticals,
Authorization Holder 3-B, Value Addition City, 1.5-Km, Khurrianwala-
Sahianwala Road, Faisalabad.
Name, address of Manufacturing site. M/s Axis Pharmaceuticals,
3-B, Value Addition City, 1.5-Km, Khurrianwala-
Sahianwala Road, Faisalabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Axicart Cream
Strength / concentration of drug of Active Each gram contains:
Pharmaceutical ingredient (API) per unit Isoconazole Nitrate………….10mg
Diflucortolone Valerate…….…1mg
Pharmaceutical form of applied drug Cream (Topical)
Pharmacotherapeutic Group of (API) Isoconazole: Imidazole Antifungals
Diflucortolone: Corticosteroids
Reference to Finished product specifications Manufacturer’s Specifications
Proposed Pack size 10 gm
The status in reference regulatory authorities Travocort 0.1 + 1% w/w Cream by M/s Bayer
Limited (HPRA Approved)
For generic drugs (me-too status) Travocort 0.1 + 1% w/w Cream by M/s Bayer
Healthcare (Reg#005830)
GMP status of the Finished product manufacturer The firm is granted GMP certificate based on
inspection conducted on09-06-2020.
Name and address of API manufacturer. Isoconazole nitrate: M/s Gufic Biosciences
Limited, National highway No. 8, Near Grid,
Kabilpore , Navsari – 396 424
Dist: Navsari, Gujarat State, India.
Diflucortolone valerate: M/s Farmabios S.p.A.
Via Pavia, 1 27027 Gropello Cairoli, (PV) , Italy.
Module III (Drug Substance) The firm has submitted details of nomenclature,
process and controls, tests for impurity d, g & related
substances (impurity a & unspecified),
Stability studies of drug substances Isoconazole nitrate:
Real time: 30°C±2°C/65% ± 5%RH for 24 months
Accelerated:40°C±2°C/75% ± 5%RH for 6 months
Batches: 135, 136, 137.
Diflucortolone valerate:
Accelerated:40°C±2°C/75% ± 5%RH for 6 months
Batches: 0030122, 0010222, 002022.
validation protocols, control of excipients, control of
drug product, specifications, analytical procedures,
justification of specifications, reference standard or
dissolution profile against the reference product Travocort cream
(Batch # MP06068) of M/s Bayer Pharma, Germany
by performing Identification, pH, Assay and average
weight.
CDP not performed.
specificity.
Manufacturer of API Isoconazole nitrate: M/s Gufic Biosciences Limited, National highway No. 8,
Near Grid, Kabilpore, Navsari – 396 424
Dist: Navsari, Gujarat State, India.
Diflucortolone valerate: M/s Farmabios S.p.A.
Via Pavia, 1 27027 Gropello Cairoli, (PV), Italy.
API Lot No. Isoconazole nitrate: API/ISN/201006
Diflucortolone valerate: 2319VMO
Description of Pack Collapsible aluminum tube with lacquered lining having sealed mouth fitted
(Container closure system) with HDPE screw cap, 10gm.
Batch No. T-002 T-003 T-004
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Isoconazole nitrate: The firm has submitted copy of
manufacturer issued by concerned regulatory GMP certificate of M/s Gufic Biosciences Ltd, India
authority of country of origin. issued by Food and Drug Administration, Gujarat
State, India valid till 06-08-2022.
Diflucortolone valerate: The firm has submitted
copy of GMP certificate of M/s Farmabios S.p.A,
Italy issued by AIFA, Italy valid till 19-09-2022.
3. Documents for the procurement of API with Isoconazole nitrate: The firm has submitted copy of
approval from DRAP (in case of import). invoice specifying import of 0.25Kgs of isoconazole
nitrate cleared by Assistant Director (I & E), Lahore
dated 12-02-2021.
Diflucortolone valerate: The firm has submitted
copy of invoice specifying import of 20gm of
Diflucortolone valerate cleared by Assistant
Director (I & E), Lahore dated 18-02-2021.
chromatograms, raw data sheets, COA, summary chromatograms, raw data sheets, COA, summary
data sheets etc. data sheets etc.
5. Compliance Record of HPLC software 21CFR & The firm has submitted audit trail reports on product
audit trail reports on product testing testing.
6. Record of Digital data logger for temperature and The firm has submitted record of data logger for
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability
time and accelerated) chambers.
Sr. Observations Response by the applicant

No.
1. Submit valid copy of GMP certificate of the The firm has submitted copy of GMP certificate
drug substance manufacturer (Isoconazole of M/s Gufic Biosciences Ltd, India issued by
nitrate) issued by relevant regulatory Food and Drug Administration, Gujarat State,
authority of country of origin. India valid till 06-08-2022.
2. The reference literature shows that inactive All the inactive ingredients used in the drug
ingredients for Travocort 0.1 + 1% w/w product are not novel and routinely used in
Cream include Paraffin, white soft Paraffin, development of topical drug products. Moreover,
liquid Cetostearyl alcohol, Polysorbate 60, compatibility studies were performed and
Sorbitan stearate, Disodium edetate dihydrate submitted.
Water, purified. Justify why you have added Spans (Sorbitan stearate & Sorbitan Oleate) are
span 80 (as non-ionic surfactant), propylene functionally non-ionic surfactants having similar
glycol (as humectant) and chlorocresol (as HLB values (4.3 & 4.7 respectively). Due to
preservative) and not adding sorbitan stearate. availability of span 80, it was used instead of span
60. Propylene glycol facilitates in application of
drug product by improving moistness and
preventing dryness when applied. Chlorocresol
was added to help control bio-burden in drug
product during shelf life which are inherently
added during processing of non-sterile drug
product.
3. Justify why pharmaceutical equivalence study Pharmaceutical equivalence study has been
was not performed against innovator product. performed and submitted against innovator
product i.e., Travocort Cream by Bayer.
4. Performance tests of viscosity and Viscosity and homogeneity are not considered
homogeneity were not included in performance test for topical dosage form.
specifications required for evaluation of Moreover, viscosity is formulation dependent
topical formulation. parameter and can vary from manufacturer to
manufacturer based on availability of difference
measuring techniques and instruments and there is
no specific limit defined for it in pharmacopoeia.
Hence it was not included in the specification.
Homogeneity was done through visual inspection
as part of physical description of the drug product.
5. Submit stability study results of initial time The firm has submitted stability study results of
point alongwith raw data sheets, COA and initial time point alongwith raw data sheets, COA.
summary sheets.
6. Submit stability study data of 6-month time The firm has submitted stability study data of 6-
point alongwith chromatograms, raw data month time point alongwith chromatograms, raw
sheets, COA and summary sheets. data sheets, COA and summary sheets.
7. Clarify the submitted chromatograms dated The chromatograms dated 05-04-2021 are
05-04-2021 pertains to which study. pertaining to initial testing of stability batch trial
(T-003 & T-004) respectively.
“Preservative effectiveness studies” at the next time point of long-term stability studies.
Manufacturer will place first three production batches on long term stability studies throughout
• Firm shall be submit fee of 7500/- fee revision of specifications as per notification No.F.7-11/2012-
482. Name, address of Applicant / Marketing M/s Nabiqasim Industries (Pvt) Ltd. 17 / 24, Korangi
Authorization Holder Industrial Area, Karachi – Pakistan.
Name, address of Manufacturing site. M/s Nabiqasim Industries (Pvt) Ltd. 17 / 24, Korangi
Industrial Area, Karachi – Pakistan.
☐ Importer
Status of application ☐New Drug Product (NDP)
☐ Export sale
Dy. No. and date of submission Dy. No.26412 Dated: 23-09-2021
PKR 10,000/-: Dated 11-08-2021
The proposed proprietary name / brand name ES-LOPROT 10mg SACHET
Pharmaceutical ingredient (API) per unit Esomeprazole magnesium trihydrate eq. to
Esomeprazole ………..….10 mg
Pharmaceutical form of applied drug A white to off-white colored enteric coated spherical
pellets.
Pharmacotherapeutic Group of (API) Proton pump inhibitor
Reference to Finished product specifications Innovator’s Specification
The status in reference regulatory authorities Nexium 10mg gastro resistant granules for oral
suspension, sachet Manufactured and Marketed by
AstraZeneca UK Limited (MHRA).
For generic drugs (me-too status) Esowin Sachet 10mg (Reg. 086891)
Manufacturer: M/s. Winthrox Laboratories (Pvt.)
GMP status of the Finished product The firm is granted GMP Certificate based on
Tablet (General & Antibiotic), Capsule (General &
Cephalosporin), Dry Powder for Suspension (General
Antibiotic &Cephalosporin), Oral Liquid (Syrup)
(Non-Antibiotic & Antibiotic), Cream / Ointment /
Lotion (Non-Antibiotic & Antibiotic & Steroids), Eye
& Ear Drops (Non-Antibiotic & Antibiotic &
Steroids), Liquid Enema (General), Sachet (General),
Small Volume Lyophilized Injectable (Non-
Antibiotic, Antibiotic), Gel & Tablet (Hormones)
sections approved.
Name and address of API manufacturer. M/s Surge Laboratories Pvt. Ltd.,
10th Km Faisalabad Road Bikhi District Sheikhupura-
Pakistan.
Module III (Drug Substance) Official monograph of Esomeprazole is USP. The
firm as submitted detail of nomenclature, structure,
and controls, tests for related substances,
Batches: (EPC-22-WB-001, EPC-22-WB-002, EPC-
22-WB-003)
Accelerated: 40°C±2°C/75%± 5%RH for 6 months
Batches: (EPC-001P, EPC-002P, EPC-003P)
dissolution profile against the comparator product Nexium 10 mg (Batch
# RDWT) by AstraZeneca UK Limited by performing
quality tests of description, pH, Assay and Microbial
limits.
Manufacturer of API M/s. Surge Laboratories Pvt. Ltd.
10th KM Faisalabad Road Bikhi, District Sheikhupura.
API Lot No. EPC-22-WB-119
Description of Pack
28’s Alu Triplex Sachet
Batch No. E001DS01 E001DS02 E001DS03
Batch Size 1.5Kg 1.5Kg 1.5Kg
No. of Batches 03
1. Reference of previous approval of applications Panel Inspection Reports for Tablets Section & Gel
with stability study data of the firm (if any). Sections was approved in DRB 297th meeting and we
got Registration of Solbovir Tablets (Sofosbuvir
400mg) Reg. No.108620,
Navosept Gel (Chlorhexidine Gel) Reg. No.107734
while our Capsule Section was approved in 316th
Meeting and we got registration of Dexloprot 30mg
& 60mg Capsules (Dexlansoprazole) Reg. No.
112582 & 112583).
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 170/2019-DRAP (AD-
manufacturer issued by concerned regulatory 823175-158) issued by Add. Director DRAP, Lahore
authority of country of origin. dated 04-07-2019 valid till 03-07-2022.
3. Documents for the procurement of API with Copy of invoice no 19090324-SG dated 26- Sept-2019
approval from DRAP (in case of import). – Locally purchased from M/s. Surge, Sheikhupura.
chromatograms, raw data sheets, COA, summary chromatograms, raw data sheets, COA, summary data
data sheets etc. sheets.
5. Compliance Record of HPLC software 21CFR & Audit trail reports on product testing were not
audit trail reports on product testing submitted.
6. Record of Digital data logger for temperature Record of Digital data logger for temperature and
and humidity monitoring of stability chambers humidity monitoring of stability chambers (real time
(real time and accelerated). and accelerated) submitted.

No.
1. Submit copy of latest inspection report or The firm has submitted copy of GMP certificate
GMP certificate of finished drug product based on inspection conducted on 19-09-2020.
manufacturer.
2. Justify the quantity of ready-to-fill pellets It is stated that each 4.444mg of Esomeprazole
used in master formulation keeping in view magnesium pellets 22.5% contains 1mg of
label claim and potency of pellets Esomeprazole magnesium.
Each 10mg Sachet contains 45.866mg (round off
46.00) of Esomeprazole magnesium pellets (22.5%
w/w), calculated as below:
10/22.5 × 100 × 1.032 = 45.866mg
3. As per WHO recommendations when As per the WHO recommendations to conduct
delayed release products (e.g. Enteric dissolution of delayed release products (e.g. enteric
coated) are being compared, the coated) in acid media (pH 1.2 for 2 hours) and
recommended conditions are acid medium buffer pH6.8 medium. We have conducted
(pH 1.2 for 2 hours) and buffer pH 6.8 additional studies in pH 4.5 acetate buffer for
medium. Justify your CDP studies in three assurance of our product dissolution profile
media. similarity with innovator product in all three media
covering the physiological range i.e pH 1.2
Hydrochloric acid, pH 4.5 buffer and pH 6.8 buffer.
4. Specify the batch size in terms of number of The firm has stated that batch size in terms of packs
packs prepared instead of providing quantity is 17 packs of 28’s. While batch size in terms of
used to prepare stability batches. bulk weight is 1.50 Kg and in unit quantity 500
sachets.
5. Reference of previous approval of Panel Inspection Reports for Tablets Section & Gel
applications with stability data of the firm (if Sections was approved in DRB 297th meeting and
any). we got Registration of Solbovir Tablets
(Sofosbuvir 400mg) Reg. No.108620,
Navosept Gel (Chlorhexidine Gel) Reg.
No.107734 while our Capsule Section was
approved in 316th Meeting and we got registration
of Dexloprot 30mg & 60mg Capsules
(Dexlansoprazole) Reg. No. 112582 & 112583).
6. Submit compliance record of HPLC software Compliance record of HPLC software 21CFR and
21 CFR & audit trail reports on product audit trail reports on product testing.
testing.
7. Submit record of data logger for temperature Data of logger record for temperature and humidity
and humidity monitoring of stability monitoring of stability chambers (real time and
chambers (real time and accelerated). accelerated) has been submitted.
8. Submit purchase invoice specifying The firm has submitted purchase invoice of
purchase of Esomeprazole delayed release Esomeprazole pellets 22.5% (batch No: EPC-22-
pellets for stability batches. WB-119) from M/s Surge laboratories (Pvt) Ltd,
Lahore.
9.
Decision: Approved.
483. Name, address of Applicant / Marketing M/s Scotmann Pharmaceuticals,
Authorization Holder 5-D, I-10/3, Industrial Area, Islamabad, Pakistan
Name, address of Manufacturing site. M/s Scotmann Pharmaceuticals,
5-D, I-10/3, Industrial Area, Islamabad, Pakistan
☐ Importer
☐ Export sale
Details of fee submitted PKR 30,000/- Dated 06-09-2021
The proposed proprietary name / brand name Fitbit PFS 20mg/2ml
Strength / concentration of drug of Active Each 2ml of pre-filled syringe contains:
Pharmaceutical ingredient (API) per unit Sodium hyaluronate……………20mg
Pharmaceutical form of applied drug Injection
Pharmacotherapeutic Group of (API) Anti-Inflammatory, Anti-arthritis
Reference to Finished product specifications Manufacturer’s specification
Proposed Pack size 1’s, 2’s, 5’s, 10’s
The status in reference regulatory authorities HYALGAN Injection 20mg/2ml by Fidia
Farmaceutici S.p.A (AIFA Approved)
For generic drugs (me-too status) HYALGAN Injection Manufacture by Fidia
Farmaceutici S.p.A
Imported by:
Liakat Pharma, Karachi
Marketed by:
Matrix Pharma Karachi
DRAP Registration no. 031340
GMP status of the Finished product The firm has submitted copy of GMP certificate based
manufacturer on inspection conducted on 09-11-2020.
The firm has provided Biotech (Pre-filled syringe)
section.
Name and address of API manufacturer. Name: M/s Contipro a.s.,
Address: Dolni Dobrouc 401 561 02 Dolni Dobrouc
Czech Republic.
Module-II (Quality Overall Summary) The firm has submitted QOS as per WHO QOS-PD
Module III (Drug Substance) Official monograph of sodium hyaluronate is not
present in any Pharmacopeia. The firm has submitted
detail of nomenclature, structure, general properties,
of manufacturing process and controls, tests for
impurity related substances, specifications, analytical
substance.
Stability studies of drug substance Stability study conditions:
Long term: 5°C ± 3°C for 36 months
Accelerated: 25°C ± 2°C/65% ± 5%RH for 6 months
Batches: (071114, 111207, N120815)
process control, process validation protocols, control
dissolution profile against the reference product HYALGAN PFS
Injection 20mg/2ml (Batch # D01240) of Matrix
Pharma, Karachi by performing quality tests
(Identification, Endotoxin test, Assay. pH).
CDP is not required.
product linearity, Robustness, accuracy, precision
(Repeatability), specificity.
Manufacturer of API Name: M/s Contipro a.s.
Address: Dolni Dobrouc 401 561 02 Dolni Dobrouc Czech Republic.
API Lot No. SH-200129-F3
Description of Pack Sterile prefilled syringe with Luer Lock System (Rigid cap), highly resistant
(Container closure system) borosilicate tubing glass (Type I) (1’s, 2’s ,5’s,10’s)
Frequency Accelerated: Initial, 3, 6 (Months)
Real time: Initial, 3, 6 (Months)
Batch Size 500 PFS 500 PFS 500 PFS
No. of Batches 03
1. Reference of previous approval of applications The firm has referred to onsite inspection report of their
with stability study data of the firm (if any) product DASCOT 30mg & 60mg Tablet which was
conducted on 26-01-2018, and was presented in 278th
Following was reported in the report:
checked.
The firm has data loggers for recording of temperature
and humidity.
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. sukls72897/2019 issued
API manufacturer issued by concerned by Ministerstvo spravedlnosti CR Ministry of Justice
regulatory authority of country of origin. of the Czech Republic.
Issue & Valid Upto Dt: 15-07-2019 – 15-07-2022.
3. Documents for the procurement of API with The firm has submitted copy of invoice specifying
approval from DRAP (in case of import). import of 0.15 kg of sodium hyaluronate attested by
chromatograms, Raw data sheets, COA, chromatograms, raw data sheets, COA, summary data
summary data sheets etc. sheets.
5. Compliance Record of HPLC software 21CFR The firm has submitted audit trail reports on product
& audit trail reports on product testing. testing.
6. Record of Digital data logger for temperature Record of data logger for temperature and humidity
and humidity monitoring of stability chambers monitoring of stability chambers (real time and
(real time and accelerated). accelerated) was submitted.
Sr. Observations Response by the Firm
No.
1. Submit valid copy of GMP certificate of the Copy of GMP certificate (No. sukls72897/2019)
drug substance manufacturer issued by issued by Ministerstvo spravedlnosti CR Ministry
relevant regulatory authority of country of of Justice of the Czech Republic has been
origin. submitted.
Issue & Valid Upto Dt: 15-07-2019 – 15-07-2022.
2. Confirmation of manufacturing facility /
section for the applied formulation.
3. Copies of the drug substance specifications The firm has submitted copies of the Drug
testing of the Drug substance /Active for drug substance by drug product manufacturer.
required.
4. Analytical method verification studies The firm has submitted analytical method
including specificity, accuracy and verification protocol and report of the test method
repeatability (method precision) performed for determination of sodium hyaluronate by
by the Drug Product manufacturer for both performing specificity, linearity, accuracy and
compendial as well as non-compendial drug precision.
5. Provide copy of Batch Manufacturing The firm has submitted copies of batch
Record (BMR) for all the batches of drug manufacturing record of stability batches of drug
product for which stability studies data is product.
6.
• Confirmation of required manufacturing facility / section from Licensing Division.
• Evidence of approval of applied formulation either as pharmaceutical drug product or medical
device in reference regulatory authorities/agencies which were adopted by the Registration Board.
• Clarification of source of drug substance whether Biological or synthetic.
484. Name, address of Applicant / Marketing M/s Global Pharmaceuticals (Pvt) Ltd Plot # 204-205,
Authorization Holder Industrial Triangle, Kahuta Road, Islamabad"
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt) Ltd Plot # 204-205,
Industrial Triangle, Kahuta Road, Islamabad"
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Protole 20mg Capsule
Pharmaceutical ingredient (API) per unit Omeprazole enteric coated pellets eq. to
omeprazole……………20mg
Pharmacotherapeutic Group of (API) Proton Pump Inhibitor
Reference to Finished product specifications USP Specifications
Proposed Pack size 14’s, 28’s, 56’s
The status in reference regulatory authorities Omeprzole 20mg Capsule by LANNETT CO INC
(USFDA Approved)
For generic drugs (me-too status) Opra 20mg Cap by Heal Pharmaceuticals – Peshawar
(Reg No: 046135).
GMP status of the Finished product GMP certificate issued on 04-01-2022 on the basis of
manufacturer inspection conducted on 03-01-2022
General Capsule Section Approved.
Name and address of API manufacturer. M/s Vision Pharmaceuticals Pvt. Ltd
Plot # 22-23, Industrial Triangle, Kahuta Road,
Islamabad.
process and controls, tests for impurity D, G & related
Real time: 30°C ± 2°C/ 65% ± 5%RH for 24 months
Accelerated: 40°C±2°C/ 75% ± 5%RH for 6 months
Batches: (21E271, 21F243 & 21G104)
dissolution profile against the reference product Risek 20mg Capsules by
Getz Pharmaceuticals Pvt. Ltd (Batch No 4-163852 &
Mfg 08-2019), by performing quality tests
dosage form).
is Risek 20mg Capsules by Getz Pharmaceuticals Pvt.
Ltd (Batch No 4-163852 & Mfg 08-2019), in Acid
media (pH 1.0-1.2) & Phosphate Buffer (pH 6.8). The
values for f1 and f2 are in the acceptable range.
Manufacturer of API M/s Vision Pharmaceuticals Pvt. Ltd
Plot # 22-23, Industrial Triangle, Kahuta Road, Islamabad- Pakistan
API Lot No. OMP561, OMP571 & OMP564
Description of Pack
02 Alu-Alu blisters, 7 capsules/blister, along with leaflet in a unit carton
Frequency Accelerated: 0, 3 & 6 (Months)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Protole 20mg Capsule
Batch No. 21A152 20K220 20K218
Batch Size 50,000 Packs 50,000 Packs 50,000 Packs
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API
The firm has submitted Copy of GMP certificate
No.F.3/262019-Addl.Dir. (QA&L-I) issued on 31st July
manufacturer issued by concerned regulatory
authority of country of origin. 2019, based on evaluation conducted on 10th February
2019.
3. Documents for the procurement of API with Not Applicable as API Manufacturer is Local
chromatograms, Raw data sheets, COA, chromatograms, Raw data sheets, COA, summary data
5. Compliance Record of HPLC software 21CFR The firm has submitted audit trail reports on product
& audit trail reports on product testing. testing.
6. Record of digital data logger for temperature The firm has submitted record of digital data logger for
(real time and accelerated). chambers.

No.
1. Submit data in section 3.2.S.4.1 and The firm has submitted method verification data for
3.2.S.4.2 as per the guidance document assay of Omeprazole 8.5% pellets by using HPLC
approved by Registration Board which with UV detector. The test method was validated for
specifies that “Analytical method specificity, linearity, precision, accuracy range,
verification studies including specificity, system suitability and robustness.
accuracy and repeatability (method
precision) performed by the Drug Product
manufacturer for both compendial as well
as non-compendial drug substance(s) shall
be submitted”.
2. Justify why pharmaceutical equivalence Innovator product Losec 20mg Capsule was not
and CDP studies were not performed commercially available in Pakistan. Therefore,
against innovator product (Losec 20mg pharmaceutical equivalence and CDP were
Capsule). preformed with locally available brand leader Risek
capsule of Getz as per DRAP guidelines.
3. As per WHO recommendations, when CDP was performed in 0.1 N HCl for 2 hours
delayed-release products (e.g. enteric followed by buffer pH 6.8. CDP in another buffer pH
coated) are being compared, the 4.5 was also performed for separate set of capsules in
recommended conditions are acid medium order to get additional dissolution profile of drug
(pH 1.2) for 2 hours and buffer pH 6.8 product.
medium. Justify your CDP studies in three
media.
4. Justify/Clarify the development of We have submitted the commercial batches data of
commercial scale batches before our export registered product “Prozole 20mg
registration of applied product. Capsule” Registration # 002575-EX, registered in
2010 for our local registration of Protole 20mg
capsule.
5. Submit purchase invoice specifying The firm has submitted invoices of omeprazole
purchase of omeprazole delayed release delayed release pellets 8.5% from M/s Vision
pellets for stability batches. Pharmaceuticals for following batches:
OMP561
OMP564
OMP571
Decision: Approved.
• Manufacturer shall perform pharmaceutical equivalence and Comparative Dissolution Profile
(CDP) against the innovator’s product i.e. Losec 20mg Capsule before issuance of Registration
Letter.
485. Name, address of Applicant / Marketing M/s Atco Laboratories Limited,
Authorization Holder Address: B-18, S.I.T.E., Karachi -75700, Karachi.
Name, address of Manufacturing site. M/s Atco Laboratories Limited,
Address: B-18, S.I.T.E., Karachi -75700, Karachi.
☐ Importer
☐ Export sale
Dated 17- 09-2021 (with three month stability)
Dated 11-11-2021 (with six months stability)
The proposed proprietary name / brand name TOFACITINIB TABLET 5 MG
Pharmaceutical ingredient (API) per unit Tofacitinib as Citrate……..………..5mg
Pharmaceutical form of applied drug Film coated Tablet
Pharmacotherapeutic Group of (API) Selective immunosuppressants
Reference to Finished product specifications Innovator’s specifications.
Proposed Pack size 7’s, 10’s, 14’s, 20’s, 28’s, 30’s, 56’s, 60’s, 180’s.
The status in reference regulatory authorities XELJANZ 5mg Tablet of M/s PF PRISM CV
(USFDA approved).
For generic drugs (me-too status) Importer Name: M/s Pfizer Pakistan Limited, 12
Dockyard Road, West Wharf, Karachi.
Name and address of manufacturer: Pfizer
Manufacturing Deutschland GmbH, Betriebsstatte
Freiburg Mooswaldallee 1 79090 Freiburg, Germany
Final Packaging & Release: Pfizer Pharmaceuticlas
LLC Road 689, Km 1.9 Vega Baja, Peurto rico 00693,
USA
Brand Name: Xelijanz 5mg tablet
Registration No: Approved in DRB 276th,
Dated: 22-25 November, 2017
GMP status of the Finished product The firm has submitted copy of inspection report
manufacturer conducted on 05-04-2022 wherein the panel
manufacturing license of the firm as well as
regularization of sections as per layout plan.
Name and address of API manufacturer. M/s Kaifeng Pharmaceutical (Group) Company
Limited.,
Manufacturing Site: No.1, Yunan Street, Kaifeng,
Henan Province, China
product.
Real time:30°C±2°C/65% ± 5%RH for 6 months
Accelerated:40°C±2°C/75%±5%RH for 6 months
Batches: (15012401, 15020201, 15020301)
dissolution profile against the brand leader that is Xeljanz 5mg Tablet
(Batch # DE4156) by Pfizer Laboratories Ltd by
Dissolution and related substances).
is Xeljanz 5mg Tablet by Pfizer Laboratories Ltd in
Acid media (pH 1.0-1.2), acetate buffer (pH 4.5) &
Phosphate Buffer (pH 6.8). The values for f1 and f2 are
in the acceptable range.
Manufacturer of API M/s Kaifeng Pharmaceutical (Group) Company Limited.,
Manufacturing Site: No.1, Yunan Street, Kaifeng, Henan Province, China.
API Lot No. HF201230
Description of Pack
1 × 10’s tablets packed in Alu-Alu blister
Batch No. MA109C MA110C MA111C
No. of Batches 03
1. Reference of previous approval of applications The firm has submitted reference of previous approval
with stability study data of the firm (if any) of application “Rofl 500mg tablet” Approved in DRB
277 held on 27-29 December 2017.
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate of M/s
manufacturer issued by concerned regulatory Kaifeng pharmaceutical (Group) issued by CFDA
authority of country of origin. valid till 25-06-2024.
approval from DRAP (in case of import). import of 0.8 Kgs of Tofacitinib citrate (batch #
HF201230) attested by Assistant Director (I & E),
Karachi dated 28-09-2024.
5. Compliance Record of HPLC software 21CFR & The firm has submitted compliance Record of HPLC
audit trail reports on product testing software 21CFR & audit trail reports on product
testing.
(real time and accelerated) chambers.

No.
1. Last GMP inspection report conducted The firm has submitted copy of inspection report
within 3 years is required to be submitted. conducted on 05-04-2022 wherein the panel
2. Analytical method verification studies Analytical method verification studies including
including specificity, accuracy and specificity, accuracy, and repeatability performed
repeatability (method precision) by drug product manufacturer for drug substance
performed by the Drug Product Tofacitinib citrate has been submitted.
be submitted.
3. Submit stability study data of 6-month The firm has submitted stability study data of 06-
time point alongwith chromatograms, raw month time point alongwith chromatograms, raw
data sheets, COA and summary sheets. data sheets, COA and summary sheets.
Decision: Approved.
486. Name, address of Applicant / Marketing M/s Atco Laboratories Limited.,
Authorization Holder Address: B-18, S.I.T.E., Karachi -75700, Karachi.
Name, address of Manufacturing site. M/s Atco Laboratories Limited,
Address: B-18, S.I.T.E., Karachi -75700, Karachi.
☐ Importer
☐ Export sale
Dated 09-09-2021 (with three month stability)
Dated 11-11-2021 (with six months stability)
The proposed proprietary name / brand name EXEMESTANE TABLET 25 MG
Pharmaceutical ingredient (API) per unit Exemestane…………………25mg
Pharmaceutical form of applied drug Film coated Tablet
Pharmacotherapeutic Group of (API) Aromatase inhibitors; WHO ATC code: L02BG06
Proposed Pack size 7’s, 10’s, 14’s, 15’s, 20’s, 28’s, 30’s, 60’s.
The status in reference regulatory authorities Exemestane 25 mg Film-coated Tablets of Accord
Healthcare Limited United Kingdom (MHRA
approved)
For generic drugs (me-too status) Aromasin 25mg tablet of M/s Pfizer Laboratories.
GMP status of the Finished product The firm has submitted copy of inspection report
manufacturer conducted on 05-04-2022 wherein the panel
Name and address of API manufacturer. M/s Shandong Anhong Pharmaceutical Co., Ltd.
No.29 Huayuan Street Linyi County, Dezhou,
Shandong, China.
product.
Real time: 30°C±2°C/ 65% ± 5%RH for 24 months
Accelerated: 40°C±2°C / 75% ± 5%RH for 6 months
Batches: (8024P71A, 8025P71A, 8026P71A).
dissolution profile against the reference product Aromasin 25mg tablet
(batch # AN4319) of Pfizer Laboratories Ltd by
is Aromasin 25mg tablet by Pfizer Laboratories Ltd in
Acid media (pH 1.0-1.2), acetate buffer (pH 4.5) &
Phosphate Buffer (pH 6.8). The values for f1 and f2 are
in the acceptable range.
specificity.
Manufacturer of API M/s Shandong Anhong Pharmaceutical Co., Ltd.
No.29 Huayuan Street Linyi County, Dezhou, Shandong, China
API Lot No. 0020P71A
Description of Pack
1 × 10’s tablets packed in Alu-Alu blister
Frequency Accelerated: 0, 2, 4, 6 (months)
Real Time: 0,3,6,9,12,18,24 (months)
Batch No. MA092C MA093C MA094C
No. of Batches 03
1. Reference of previous approval of applications The firm has submitted reference of previous approval
with stability study data of the firm (if any) of application “Rofl 500mg tablet” Approved in DRB
277 held on 27-29 December 2017.
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate of M/s
manufacturer issued by concerned regulatory Qilu Antibiotics (Linyi) Pharmaceutical Co. Ltd,
authority of country of origin. China issued by CFDA valid till 25-06-2024.
approval from DRAP (in case of import). import of 0.75 Kg of Exemestane (batch # 0020P71A)
attested by Assistant Director (I & E), Karachi dated
22-01-2022.
5. Compliance Record of HPLC software 21CFR & The firm has submitted compliance Record of HPLC
audit trail reports on product testing software 21CFR & audit trail reports on product
testing.

No.
1. Last GMP inspection report conducted The firm has submitted copy of inspection report
within 3 years is required to be submitted. conducted on 05-04-2022 wherein the panel
2. Analytical method verification studies Analytical method verification studies including
including specificity, accuracy and specificity, accuracy, and repeatability performed
repeatability (method precision) by drug product manufacturer for the assay method
performed by the Drug Product of drug substance Exemestane has been submitted.
be submitted.
3. Provide copy of Batch Manufacturing Copies of Batch manufacturing record of all the
Record (BMR) for all the batches of drug batch drug product have been provided.
4. Justify performance of comparative As per NDA 20-753 Assessment report (Clinical
dissolution study in three media in the pharmacology and Biopharmaceutics review) of
presence of sodium lauryl sulphate Aromasin 25mg Tablet, Exemestane is poorly
soluble in all aqueous media simulating
gastrointestinal fluids such that sink conditions
cannot be reached even at ___ minutes (Hidden in
innovator’s assessment report) from the 25mg
Tablet in water, simulated gastric fluid pH 1.2 and
phosphate buffer 6.8. The sponsor then investigated
the possibility of enhancing the solubility of
Exemestane in aqueous media by addition of sodium
lauryl sulphate. However, the referred literature is
for selection of dissolution method and
specification.
5. The submitted copy of GMP certificate of Shandong Qilu Pharmaceutical Group has changed
API manufacturer is from Qilu Antibiotics their name from Qilu Antibiotics Pharmaceutical
(Linyi) Pharmaceutical Co. Ltd, China Co., Ltd to Shandong Anhong pharmaceutical Co.,
while COA is from M/s Shandong Anhong Ltd effective from February 1, 2020. According to
Pharmaceutical Co., Ltd. China. previous CFDA regulation, the original GMP
certificates are still in valid and there is no need to
be revised. Change approval / change notification
with original GMP certificate have been attached.
6. Submit stability study data of 6-smonth The firm has submitted stability study data of 06-
time point alongwith chromatograms, raw month time point alongwith chromatograms, raw
data sheets, COA and summary sheets. data sheets, COA and summary sheets.
Decision: Approved.
487. Name, address of Applicant / Marketing M/s Martin Dow Marker Limited, 7-Jail Road, Quetta
Name, address of Manufacturing site. M/s Martin Dow Marker Limited, 7-Jail Road, Quetta
☐ Importer
☐ Export sale
PKR 10,000/-: Dated: 30-06-2021
The proposed proprietary name / brand name Lodopin-VHCT 10mg+160mg+25mg Tablet
Pharmaceutical ingredient (API) per unit Amlodipine as Besylate……...10mg
Valsartan Potassium……….160mg
Hydrochlorothiazide………..25mg
Pharmaceutical form of applied drug Brown Color, Oblong Biconvex film coated tablets on
one side engraved with M-D and plain from another side.
Pharmacotherapeutic Group of (API) Calcium channel blocker
Angiotensin II receptor blocker (ARB)
Thiazide diuretic (Anti-hypertensive)
The status in reference regulatory authorities Exforge HCT 10+160+25mg tablet by M/s Novartis
Pharmaceuticals Corporation, USFDA Approved.
For generic drugs (me-too status) Exforge HCT 10+160+25mg tablet by M/s Novartis
(Pakistan) Limited, DRAP Approved.
GMP status of the Finished product Certificate No:015/2021-DRAP (Q)/K issued on 10th
manufacturer September 2021.
Tablet (General & Psychotropic), Capsule (General),
Oral Liquid Syrup (General), Sterile Liquid
Injection/Ampoule, Ointment/Cream, Dry Powder
Sachet (General), Dry Powder Suspension (General)
section approved.
Name and address of API manufacturer. Amlodipine: M/s Prudence Pharma chem,
Plot No. 7407, Behind lakya lab, GIDC Ind. Estate,
Ankleshwar -393 002 Dist. Bharuch, Gujarat, INDIA.
Valsartan: M/s Zhuhai Rundu Pharmaceutical Co., Ltd.
No. 6, North Airport Road, Sanazao Town, Jinwan
District, Zhuhai City, Guangdong province, 519041,
P.R. of China.
Hydrochlorothiazide: M/s Changzhou Pharma,
No.518 Laodong East Road, Changzhou, Jiangsu
Province, P.R. China
submitted.
Module III (Drug Substance) The firm has submitted detail of nomenclature, structure,
Accelerated: 40°C ± 2°C / 75%±5%RH for 6 months
Batches:
NPD-T-659-P, NPD-T-632-L, NPD-T-658-P
dissolution profile between test formulation (Batch # BMJ 27) against the
reference product Exforge HCT 5/160/25 mg tablet
(Batch # NPD-T-1348-T) by M/s Novartis Farmaceutica
S.A., Barcelona Spain by performing quality tests
CDP has been performed against Exforge HCT
10+160+25mg tablet by M/s Novartis Farmaceutica
S.A., Barcelona Spain in Acidic media (pH 1.2), Acetate
Buffer (pH 4.5) & Phosphate Buffer (pH 6.8). The
values for f1 and f2 are in the acceptable range.
Analytical method validation/verification of Method validation studies have been submitted
specificity.
Manufacturer of API Amlodipine: M/s Prudence Pharmachem, Gujarat (India).
Valsartan: M/s Zhuhai Rundu Pharmaceutical Co. Ltd. China.
Hydrochlorothiazide: M/s Changzhou Pharmaceutical, China.
API Lot No. Amlodipine: AMB/081/07/19 & AMB/082/07/19
Valsartan: 67819100605
Hydrochlorothiazide: EH180407
Description of Pack
Lodopin-VHCT 10mg+160mg+25mg Tablet
Batch No. NPD-T-658-P NPD-T-632-L NPD-T-659-P
No. of Batches 03
1. Reference of previous approval of applications The firm has submitted registration letter of Glucovance
with stability study data of the firm (if any) Tablet 1000mg/5mg.
2. Approval of API/ DML/GMP certificate of M/s Prudence Pharmachem: The firm has submitted
API manufacturer issued by concerned copy of retention of license to manufacture for sale of
regulatory authority of country of origin. drugs. License in Form-25, No No G/25/1656 has been
retained from 08-04-2020 to 07-04-2025.
M/s Zhuhai Rundu: Copy of GMP certificate for M/s
Zhuhai Rundu Pharmaceutical Co. Ltd., China issued by
China Food and Drug Administration has been
submitted. It is valid till 10-04-2024.
M/s Changzhou Pharmaceutical: GMP Certificate No
JS20180848 issued by CFDA valid till 09-07-2023.
3. Documents for the procurement of API with Amlodipine besylate: The firm has submitted copy of
approval from DRAP (in case of import). invoice specifying import of Amlodipine besylate
(Batch#AMB/082/04/19, 300Kg) attested by Assistant
Director (I &E) DRAP, Quetta dated 09-07-2019.
Valsartan: The firm has submitted copy of invoice
specifying import of Valsartan (Batch#67819100605,
150Kg) attested by Assistant Director (I &E) DRAP,
Quetta dated 26-02-2020.
Hydrochlorothiazide: The firm has submitted copy of
invoice specifying import of Hydrochlorothiazide
(EH180407, 15Kg) attested by Assistant Director (I &E)
DRAP, Quetta dated 02-04-2019.
attested respective documents like alongwith chromatograms, Raw data sheets and
5. Compliance Record of HPLC software 21CFR The firm has submitted audit trail record for dissolution
& audit trail reports on product testing and assay testing of drug product.

No
1. The label claim of applied formulation does not The firm has corrected the label claim of amlodipine
define the equivalency of salt form of besylate in applied formulation.
amlodipine besylate. Corrrection / clarification
is required.
2. Analytical method verification studies The firm has submitted method verification study of
including specificity, accuracy and testing method of Lodopin VHCT Tablet by
repeatability (method precision) performed by performing parameters like precision, linearity and
the Drug Product manufacturer for both accuracy.
3. The reference literature shows that inactive The firm replied that some of the excipients are not
ingredients for all strengths of the tablets being used in the formulation like, Hypromellose,
include microcrystalline cellulose; Macrogol 4000 & Talc. The mentioned excipients
crospovidone; colloidal anhydrous silica; are used for coating purpose only. Therefore, we
magnesium stearate; hypromellose, macrogol have used the ready-made film coating materials to
4000 and talc. Justify your formulation make the film process simpler, easier to automate
development in line with innovator product and enhances the elegance and glossy appearance of
without addition of Hypromellose, macrogol the coated tablets.
4000 and talc.
4. Clarify the use of nomenclature process The firm has submitted process validation protocol
performance qualification protocol instead of of Lodopin VHCT Tablets.
adopting process validation protocol.
5. Justify why accuracy parameter was not studied The firm has submitted analytical method validation
in analytical method validation study for assay studies of testing method of Lodopin VHCT Tablet
testing of drug product. Moreover, results of by performing linearity, accuracy precision.
analytical method validation studies are
required to be tabulated properly for Module 3.
6. In this section, only summary of batch analysis Complete analysis details of three batches has been
release results of two batches has been submitted.
submitted. Provide complete analysis details of
two batches for which stability study has been
conducted.
7. The results of batch analysis and stability data The firm has submitted performance of content
reflect that test of uniformity of dosage unit has uniformity test by individual assay of 10 tablets of
not been performed. Lodopin VHCT tablets for each amlodipine as
besylate, valsartan and hydrochlorothiazide by
HPLC.
8. Justify the manufacturing of stability batches Valsartan:
on 05-2019 since amlodipine besylate and The firm has submitted that M/s. Martin Dow
Valsartan are cleared on 07-2019 and 02-2020, Marker Limited & M/s. Martin Dow limited perform
respectively as per the documents for import of function under the umbrella of Martin Dow group
drug substances submitted. (same management). So, when we were developing
formulation of Lodopin VHCT in May 2019 at
Martin Dow Marker limited, 7-Jail road Quetta, we
procured Valsartan from M/s Martin Dow Limited,
Karachi only for development purpose (ADC
invoice) attached for reference.
Here, we undertake that in future for
commercialization of above product we will procure
Valsartan from same source.
purchase of Valsartan (90Kg) attested by AD (I&E),
Amlodipine:
We, M/s Martin Dow Marker limited apologize for
mistakenly putting the wrong invoice in the dossier,
the correct invoice is attached to this file.
purchase of Amlodipine besylate (100Kg) attested
by AD (I&E), Quetta dated 26-03-2019.
9. Provide copy of Batch Manufacturing Record The firm has submitted copies of BMR of the
(BMR) for the batches of drug product for stability batches for the drug product. However,
which stability studies data is provided in manufacturing date on BMR was 04-2020 while
Module 3 section 3.2.P.8.3. initially submitted stability data showed
manufacturing date of 05-2019.
The firm again submitted that there is some typo
error in BMR, so we will provide revised BMR
accordingly.
10. Submit updated copy of GMP certificate of The firm has submitted copy of GMP certificate for
drug substance manufacturer of Valsartan. M/s Zhuhai Rundu Pharmaceutical Co. Ltd., China
issued by China Food and Drug Administration. It is
Decision: Approved.
• Registration Board further decided that registration letter will be issued after submission of 7500/-
fee for revision of label claim as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
☐ Importer
☐ Export sale
PKR 10,000/-: Dated: 30-06-2021
The proposed proprietary name / brand name Lodopin-VHCT 10mg+160mg+12.5mg Tablet
Pharmaceutical ingredient (API) per unit Amlodipine as Besylate...…...10mg
Valsartan …….…………..160mg
Hydrochlorothiazide……..12.5mg
Pharmaceutical form of applied drug White to off white, Oblong Biconvex film coated tablets
on one side engraved with M-D and plan from another
side
The status in reference regulatory authorities Exforge HCT 10+160+12.5mg tablet by M/s Novartis
For generic drugs (me-too status) Exforge HCT 10+160+12.5mg tablet by M/s Novartis
section approved.
P.R. of China.
submitted.
Batches:
NPD-T-655-P, NPD-T-631-L, NPD-T-657-P
dissolution profile against the brand leader that is Exforge HCT 5/160/25
mg tablet by M/s Novartis Farmaceutica S.A.,
Barcelona Spain by performing quality tests
Exforge HCT 10+160+12.5mg tablet by M/s Novartis
Farmaceutica S.A., Barcelona Spain in Acid media
(pH 1.2), Acetate Buffer (pH 4.5) & Phosphate Buffer
(pH 6.8). The values for f1 and f2 are in the acceptable
range.
Manufacturer of API Amlodipine: M/s Prudence Pharmachem, Gujarat (India)
Valsartan: M/s Zhuhai Rundu Pharmaceutical Co. Ltd. China
Hydrochlorothiazide: M/s Changzhou Pharmaceutical, China
Description of Pack
Lodopin-VHCT 10mg+160mg+12.5mg Tablet
No. of Batches 03
retained from 08-04-2020 to 07-04-2025.

No
is required.
development in line with innovator product
without addition of Hypromellose, macrogol and enhances the elegance and glossy appearance of
4000 and talc. the coated tablets.
conducted.
HPLC.
Amlodipine:
accordingly.
Decision: Approved.
489. Name, address of Applicant / Marketing M/s Martin Dow Marker Limited, 7-Jail Road, Quetta.
Name, address of Manufacturing site. M/s Martin Dow Marker Limited, 7-Jail Road, Quetta.
☐ Importer
☐ Export sale
PKR 10,000/-: Dated: 30-06-2021
Pharmaceutical ingredient (API) per unit Amlodipine as Besylate.……….....10mg
Valsartan………….....………....320mg
Hydrochlorothiazide….……….25mg
Pharmaceutical form of applied drug Dark Brown Color, Oblong Biconvex film coated tablets
on one side engraved with M-D and plain from another
side
The status in reference regulatory authorities Exforge HCT 10+320+25mg tablet by M/s Novartis
For generic drugs (me-too status) Exforge HCT 10+320+25mg tablet by M/s Novartis
manufacturer September 2021
section approved.
P.R. of China.
submitted.
Batches:
Real Time: NPD-T-660-P, NPD-T-633-L,
NPD-T-661-P,
Accelerated Time: NPD-T-660-P, NPD-T-633-L,
NPD-T-661-P,
Exforge HCT 10+320+25mg tablet by M/s Novartis
range.
Manufacturer of API Amlodipine: M/s Prudence Pharmachem, Gujarat, India.
Valsartan: M/s Zhuhai Rundu Pharmaceutical Co. Ltd. China.
Hydrochlorothiazide: M/s Changzhou Pharmaceutical, China.
Description of Pack
No. of Batches 03
retained from 08-04-2020 to 07-04-2025.
No
is required.
4000 and talc.
conducted.
HPLC.
Amlodipine:
accordingly.
Decision: Approved.
490. Name, address of Applicant / Marketing M/s Martin Dow Marker Limited, 7-Jail Road, Quetta.
Name, address of Manufacturing site. M/s Martin Dow Marker Limited, 7-Jail Road, Quetta.
☐ Importer
☐ Export sale
PKR 10,000/-: Dated: 30-06-2021
The proposed proprietary name / brand name Lodopin-VHCT 5mg+160mg+12.5mg Tablet
Pharmaceutical ingredient (API) per unit Amlodipine as besylate….…...5mg
Valsartan…………………....160mg
Hydrochlorothiazide……....12.5mg
Pharmaceutical form of applied drug White to Off white, Oblong Biconvex film coated tablets
on one side engraved with M-D and plan from another
side
The status in reference regulatory authorities Exforge HCT 5/160/12.5 mg tablet by M/s Novartis
For generic drugs (me-too status) Exforge HCT 5/160/12.5 mg tablet by M/s Novartis
section approved.
P.R. of China.
submitted.
Stability studies of Drug Substance Stability study conditions:
Amlodipine besylate:
Valsartan:
Hydrochlorothiazide:
Pharmaceutical equivalence and comparative Pharmaceutical equivalence has been established against
dissolution profile the reference product, Exforge HCT 5/160/12.5 mg
tablet by M/s Novartis Farmaceutica S.A., Barcelona
Spain by performing quality tests (Identification, Assay,
Dissolution).
Exforge HCT 5/160/12.5 mg tablet by M/s Novartis
Farmaceutica S.A., Barcelona Spain in Acid media (pH
1.2), Acetate Buffer (pH 4.5) & Phosphate Buffer (pH
6.8). The values for f1 and f2 are in the acceptable range.
Description of Pack
Lodopin-VHCT 5mg+160mg+12.5mg Tablet
No. of Batches 03
1. Reference of previous approval of applications
The firm has submitted registration letter of Glucovance
Tablet 1000mg/5mg.
regulatory authority of country of origin.drugs. License in Form-25, No No G/25/1656 has been
retained from 08-04-2020 to 07-04-2025.

No
is required.
4000 and talc.
conducted.
7. The results of batch analysis and stability data
The firm has submitted performance of content
reflect that test of uniformity of dosage unit has
uniformity test by individual assay of 10 tablets of
HPLC.
function under the umbrella of Martin Dow group
respectively as per the documents for import of (same management). So, when we were developing
drug substances submitted. formulation of Lodopin VHCT in May 2019 at
Amlodipine:
accordingly.
Decision: Approved.
☐ Importer
☐ Export sale
PKR 10,000/-: Dated: 30-06-2021
Pharmaceutical ingredient (API) per unit Amlodipine as Besylate……..5mg
Valsartan…………..…......160mg
Hydrochlorothiazide…......25mg
Pharmaceutical form of applied drug Light Yellow, Oblong Biconvex film coated tablets on
one side engraved with M-D and plan from another side
The status in reference regulatory authorities Exforge HCT 5/160/25 mg tablet by M/s Novartis
For generic drugs (me-too status) Exforge HCT 5/160/25 mg tablet by M/s Novartis
manufacturer September 2021
section approved.
P.R. of China.
submitted.
Batches:
Real Time: NPD-T-654-P, NPD-T-630-L,
NPD-T-655-P
Accelerated Time: NPD-T-654-P, NPD-T-630-L,
NPD-T-655-P
Exforge HCT 5/160/25 mg tablet by M/s Novartis
range.
Description of Pack
No. of Batches 03
retained from 08-04-2020 to 07-04-2025.

No
is required.
4000 and talc.
conducted.
HPLC.
Amlodipine:
accordingly.
Decision: Approved.
492. Name, address of Applicant / Marketing M/s Genix Pharma Private Limited., 44-45B Korangi
Authorization Holder creek road Karachi
Name, address of Manufacturing site. M/s Genix Pharma Private Limited., 44-45B Korangi
creek road Karachi
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 23538 Dated 27/08/2021
PKR 25,000/- Dated: 26-07-2021
The proposed proprietary name / brand name Movcol Jar Powder for Solution 510g
Strength / concentration of drug of Active Each dose contains:
Pharmaceutical ingredient (API) per unit Polyethylene glycol……………..17g
Pharmaceutical form of applied drug White to off white color powder filled in HDPE bottle.
Pharmacotherapeutic Group of (API) Osmotic Laxative
Reference to Finished product specifications Innovator Specification
The status in reference regulatory authorities Miralax Powder 510g by M/s Bayer, USFDA
Approved.
manufacturer Sachet section (General) approved.
Name and address of API manufacturer. M/s Avesta Pharma pvt. Ltd., Shivam chambers,
106/108, First Floor, S.V. Road, Goregaon west,
Mumbai – 400 062, Maharashtra, India
Module III (Drug Substance) Official monograph of Polyethylene glycol is present
in USP. The firm as submitted detail of nomenclature,
Batches: (AP0912002, AP0912003 & AP0912004)
product.
dissolution profile against the brand leader that is Miralax 510g Jar by
… Bayer by performing quality tests (Appearance,
Identification, Filling weight, Moisture content &
Assay).
CDP is N/A
Manufacturer of API M/s Avesta Pharma pvt. Ltd., Shivam chambers, 106/108, First Floor, S.V.
Road, Goregaon west, Mumbai – 400 062, Maharashtra, India
API Lot No. AP0919009
Description of Pack
HDPE Bottles 1’s
Frequency Accelerated: 1, 2, 3, 4 & 6(Months)
Real Time: 3, 6, 9 & 12 (Months)
Batch No. 19SB-146-01 19SB-147-02 19SB-148-03
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate of
manufacturer issued by concerned regulatory M/s. Avesta Pharma Pvt. Ltd, Maharashtra state, India
authority of country of origin. issued by Food and Drug Administration, Maharashtra
state, India. It is valid upto 15-09-2023.
3. Documents for the procurement of API with The firm has submitted copy of invoice for the import
approval from DRAP (in case of import). of polyethylene glycol-3350 (5000Kg, Batch #
AP0919009) attested by AD (I & E) DRAP, Karachi
dated 18-04-2019.
attested respective documents like along with chromatograms, raw data sheets, COA and
chromatograms, summary data sheets.
5. Compliance Record of HPLC software 21CFR & The firm has submitted compliance record of HPLC
audit trail reports on product testing software from Waters Corporation.
Audit trail on testing of product has been submitted.
and humidity monitoring of stability chambers temperature and humidity monitoring of real time and
(real time and accelerated) accelerated stability chambers.

#
including specificity, accuracy and verification report for Assay by GPC (HPLC). The
repeatability (method precision) performed by parameters include specificity and system suitability,
the Drug Product manufacturer for both linearity, precision and accuracy parameters from
compendial as well as non-compendial drug drug substance manufacturer. Analytical method
substance(s) shall be submitted. verification was also performed by drug product
manufacturer.
2. Evidence of approval of formulation in applied The firm has submitted evidence of approval of
pack size i.e., 578g shall be required since formulation in applied pack size. Unit dose
bottle of three pack sizes mentioned in compliance is achieved via measuring cap of the jar,
chemistry and biopharmaceutics review are which is engraved with the unit dose of 17g from
119g, 238g and 527g and unit dose foil pouch inside.
of 17g.
3. Scientific justification is required for not Initially, we had performed stability studies at
performing assay testing by HPLC method till interval of 1,2,3,4 in spectrophotometric method.
6-month time point in all batches and adoptingAfter purchasing RI Detector and column L 25
HPLC method from 6 month onward. (Waters, Ultrahydrogel 120, 7.8 × 300 mm part No.
WaT011520 Lot 002D190651). We had validated the
method in HPLC. So 6th month interval and onward
testing were conducted in HPLC.
4. Provide copy of Batch Manufacturing Record The firm has submitted copy of batch manufacturing
(BMR) for all the batches of drug product for records for all the batches.
5. Compliance Record of HPLC software 21CFR The firm has submitted compliance record of HPLC
& audit trail reports on product testing. software from Waters Corporation.
6. Documents for the procurement of drug The firm has submitted copy of invoice for the import
substance with approval from DRAP is of polyethylene glycol-3350 (5000Kg, Batch #
required. AP0919009) attested by AD (I & E) DRAP, Karachi
dated 18-04-2019.
• Confirmation of required facility where manufacturing and packaging in Jar can be carried out.
• Clarification how the applied product is similar in terms of packaging material, unit dose and
total dose per pack in comparison with the innovator’s product.
• Evidence of HPLC system along with RI detector which is used for product testing.
493. Name, address of Applicant / Marketing M/s Genix Pharma Private Limited
Authorization Holder 44-45B Korangi creek road Karachi
Name, address of Manufacturing site. M/s Genix Pharma Private Limited
44-45B Korangi creek road Karachi
☐ Importer
☐ Export sale
Details of fee submitted PKR 50,000/-: Dated 18/01/2021
PKR 25,000/- Dated: 26/07/2021
Approved.
Name and address of API manufacturer. AVESTA PHARMA PVT. LTD.
Shivam chambers, 106/108,
First Floor, S.V. Road,
Goregaon west,
Mumbai – 400 062
Maharashtra, India
Batches: (AP0912002, AP0912003 & AP0912004)
product.
dissolution profile against the brand leader that is Miralax 765g Jar by
Bayer by performing quality tests (Appearance,
Assay).
CDP is N/A
Manufacturer of API AVESTA PHARMA PVT. LTD.
Shivam chambers, 106/108, First Floor, S.V. Road, Goregaon west,
Mumbai – 400 062 Maharashtra, India
Description of Pack
HDPE Bottles 1’s
Batch No. 19SB-171-01 19SB-172-02 19SB-173-03
No. of Batches 03
dated 18-04-2019.
chromatograms, summary data sheets.

#
manufacturer.
of 17g.
dated 18-04-2019.
494. Name, address of Applicant / Marketing M/s Genix Pharma Private Limited., 44-45B Korangi
Authorization Holder creek road Karachi.
Name, address of Manufacturing site. M/s Genix Pharma Private Limited., 44-45B Korangi
creek road Karachi
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 23536 Dated 27/08/2021
PKR 25,000/- Dated: 26-07-2021
Approved.
Name and address of API manufacturer. AVESTA PHARMA PVT. LTD.
Shivam chambers, 106/108, First Floor, S.V. Road,
Goregaon west, Mumbai – 400 062 Maharashtra,
India
Batches: (AP0912002, AP0912003 & AP0912004)
product.
dissolution profile against the brand leader that is Miralax 119g Jar by …
Bayer by performing quality tests (Appearance,
Assay).
CDP is N/A
Manufacturer of API AVESTA PHARMA PVT. LTD.
Shivam chambers, 106/108, First Floor, S.V. Road, Goregaon west,
Mumbai – 400 062 Maharashtra, India
Description of Pack
HDPE Bottles 1’s
Batch No. 19SB-133-01 19SB-134-02 19SB-135-03
No. of Batches 03
dated 18-04-2019.

#
manufacturer.
of 17g.
6-month time point in all batches and adopting After purchasing RI Detector and column L 25
dated 18-04-2019.

495. Name, address of Applicant / Marketing M/s Cunningham Pharmaceuticals (Pvt.) Ltd.
Authorization Holder Plot No. 81, Sunder industrial Estate Raiwind Road,
Lahore, Pakistan
Name, address of Manufacturing site. M/s Cunningham Pharmaceuticals (Pvt.) Ltd.
Plot No. 81, Sunder industrial Estate Raiwind Road,
Lahore, Pakistan
☐ Importer
☐ Export sale
The proposed proprietary name / brand name NU-ORS Sachet (Orange Flavor)
Strength / concentration of drug of Active Each sachet Contains:
Pharmaceutical ingredient (API) per unit Sodium chloride………………...2.60gm
Potassium chloride…………..….1.50gm
Tri-sodium citrate dihydrate….....2.90gm
Dextrose anhydrous……………..13.50gm
Pharmaceutical form of applied drug Granule to be reconstituted for oral administration
Pharmacotherapeutic Group of (API) Oral Rehydration Salts
Proposed Pack size 1 x 20’s Sachets
The status in reference regulatory authorities WHO Approved.
For generic drugs (me-too status) OEM Orange Flavour, Indus Pharma Karachi (Reg #
067312)
GMP status of the Finished product The firm is granted GMP certificate based on
The firm has provided sachet section.
Name and address of API manufacturer. Sodium Chloride:
M/s Dominion salt Ltd., Totara street, Mount
Maunganui, New Zealand.
Potassium Chloride:
M/s K+S KALI GmbH Germany, Am Kaliwerk 6,
36119 Neuhof, Germany
Trisodium Citrate:
M/s. Weifang Ensign Industry Co., Ltd. No. 1567,
Changsheng Street, Changle, Weifang, shandong
province, China.
Dextrose Anhydrous:
M/s Xiwang pharmaceutical., No. 237, Tongfu Road,
Handian Town, Zouping Country, Binzhou city,
Shandong Province, P.R. China.
submitted.
Module III (Drug Substance) Official monograph of oral rehydration salts is present
in BP. The firm has submitted detail of nomenclature,
process and controls, analytical procedures and its
system and stability studies of drug substances.
Stability studies Sodium chloride: Firm has submitted stability study
data of 3 batches of drug substance at both accelerated
as well as real time conditions. The accelerated
stability data is conducted at 40°C ± 2°C / 75% ± 5%
RH for 6 months. The real time stability data is
conducted at 30°C ± 2°C / 65 ± 5% RH for 60 months.
Potassium chloride: Firm has submitted stability
study data of 3 batches of drug substance at both
accelerated as well as real time conditions. The
accelerated stability data is conducted at 40°C ± 2°C /
75% ± 5% RH for 6 months. The real time stability
data is conducted at 30°C ± 2°C / 65 ± 5% RH for 60
months.
Trisodium citrate dihydrate:
Firm has submitted stability study data of 3 batches of
drug substance at both accelerated as well as real time
conditions. The accelerated stability data is conducted
at 40°C ± 2°C / 75% ± 5% RH for 6 months. The real
time stability data is conducted at 30°C ± 2°C / 65 ±
5% RH for 36 months.
Glucose anhydrous: Firm has submitted stability
study data of 3 batches of drug substance at both
accelerated as well as real time conditions. The
accelerated stability data is conducted at 40°C ± 2°C /
75% ± 5% RH for 6 months. The real time stability
data is conducted at 30°C ± 2°C / 65 ± 5% RH for 24
months.
dissolution profile against the comparator product OEM (ORS) orange
flavour (Batch # OR-4043) by M/s Indus Pharma,
Karachi by performing quality tests (Description,
LOD, Average weight and Assay).
product linearity, accuracy, precision and specificity.
Manufacturer of API Sodium Chloride:
M/s Dominion salt Ltd., Totara street, Mount Maunganui, New Zealand.
Potassium Chloride:
M/s K+S KALI GmbH Germany, Am Kaliwerk 6, 36119 Neuhof, Germany
Tri Sodium Citrate:
M/s. Weifang Ensign Industry Co., Ltd. No. 1567, Changsheng Street, Changle,
Weifang, shandong province, China.
Dextrose Anhydrous:
M/s Xiwang pharmaceutical., No. 237, Tongfu Road, Handian Town, Zouping
Country, Binzhou city, Shandong Province, P.R. China.
API Lot No. Sodium Chloride: 24042018
Potassium Chloride: 711800743
Trisodium Citrate: ST1803283
Glucose Anhydrous (Dextrose): 211901315
Description of Pack
Aluminium Foil Sachets packed in unit carton (1×20’s)
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (Months)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. OT001 OT002 OT003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of Sodium Chloride:
API manufacturer issued by concerned The firm has submitted copy of GMP certificate (No.
regulatory authority of country of origin.TT60-565-16-3) of M/s Dominion Salt Limited, New
Zealand issued by Ministry of health, New Zealand.
Potassium Chloride:
The firm has submitted copy of GMP certificate of M/s
K+S Kali GmbH issued by Regierungsprasidium,
Darmstadt Germany. The certificate is valid till 06-03-
2021.
Tri Sodium Citrate:
The firm has submitted document of verification of
compliance certificate of M/s Weifang Ensign Industry
Co., Ltd., China issued by SGS-CSTC Standards
Technical services Co. ltd. The certificate is valid till
28-06-2024.
Dextrose Anhydrous:
Firm has submitted copy of GMP certificate (No.
SD2020170644) of M/s Xiwang Pharmaceutical Co.,
ltd. China issued by China Food and Drug
Administration. The certificate is valid till 11-01-2023.
3. Documents for the procurement of API with Sodium Chloride:
approval from DRAP (in case of import). Firm has submitted copy of invoice from Mak
Kemikal, Karachi specifying purchase of 25Kg of
sodium chloride dated 17-09-2019.
Potassium Chloride:
Firm has submitted copy of invoice from Mak
potassium chloride dated 17-09-2019.
Tri Sodium Citrate:
sodium citrate dated 17-09-2019.
Dextrose Anhydrous:
Dextrose anhydrous dated 17-09-2019.
chromatograms, raw data sheets, COA, chromatograms, raw data sheets, COA, summary data
5. Compliance Record of HPLC software 21CFR Not applicable.
& audit trail reports on product testing.
6. Record of Digital data logger for temperature The firm has submitted record of Digital data logger
Sr. Observations Response by the Firm

No.
1. Copy of GMP inspection report/ GMP The firm has submitted request for renewal of GMP
certificate of the manufacturing unit issued certificate to Director General (E & M), Lahore.
within the last three years shall be submitted.
2. Submit data of verification of analytical The firm has submitted analytical method
procedure of each drug substance in section verification studies for each drug substance.
3.2.S.4.3 as per the guidance document
approved by Registration Board which
specifies that “Analytical method verification
studies including specificity, accuracy and
repeatability (method precision) performed
by the Drug Product manufacturer for both
substance(s) shall be submitted.”
3. Submit evidence of availability of atomic The firm has submitted copy of invoice for the
emission spectroscopy / flame photometer purchase of Flame photometer (Model: PFP7) from
which is required in the testing of the drug Western Analytical services dated 06-11-2019
product as per BP monograph. (Invoice # 01119/097).
4. Submit evidence of purchase / import Sodium Chloride:
documents of each drug substance. Firm has submitted copy of invoice from Mak
sodium chloride dated 17-09-2019.
Potassium Chloride:
potassium chloride dated 17-09-2019.
Tri Sodium Citrate:
sodium citrate dated 17-09-2019.
Dextrose Anhydrous:
Dextrose anhydrous dated 17-09-2019.
Decision: Registration Board referred the case to QA & LT division seeking opinion regarding use of
API imported by the indentor not having valid DML.
496. Name, Address of Applicant / Marketing M/s Bio-Labs (Pvt.) Ltd, Plot No. 145, Industrial
Authorization Holder Triangle Kahuta Road Islamabad.
Name, address of Manufacturing site. M/s Bio-Labs (Pvt.) Ltd, Plot No. 145, Industrial
Triangle Kahuta Road Islamabad.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No.17785: Dated 25-06-2021
The proposed proprietary name / brand name Colicraft Injection I.V 2MIU
Pharmaceutical ingredient (API) per unit Colistimethate Sodium…….……..2MIU
Pharmaceutical form of applied drug Glass vial filled with almost white to off-white
colored Lyophilized Powder for Injection.
Pharmacotherapeutic Group of (API) Antibacterial agent
The status in reference regulatory authorities Colistimethate sodium for injection of M/s Mukhtar
Enterprises Lahore (Reg#094757).
For generic drugs (me-too status) Colistimethate sodium 2 MIU, powder for solution
for injection by M/s PANMEDICA (MHRA
Approved).
Name and address of API manufacturer. M/s Mac-Chem Products (India) Pvt. Ltd.,
N-211/2/10, MIDC. Boisar, District –Thane, Pin –
401 506, Maharashtra, India.
solubility, physical form, manufacturers,
drug product.
Module III (Drug Substance) The firm has submitted detailed data for drug
substance related to nomenclature, structure,
Real time: 30°C ± 2 °C / /65% ± 5%RH RH for 12
months
Accelerated: 40°C ± 2°C /75% ± 5%RH for 6
months
Batches: (CLS0219006, CLS0219008,
CLS0219009).
validation protocols, control of excipients, control
of drug product, specifications, analytical
dissolution profile equivalence of trial formulation (Batch # T001)
against reference product Colistimethate Sodium
2MIU Injection (Lot No. 3056579) of M/s Xellia
Pharmaceuticals by performing Biological assay by
zone of inhibition method.
Analytical method validation/verification of Firm has submitted report of verification of
product analytical method for the drug product.
Manufacturer of API M/s Mac-Chem Products (India) Pvt. Ltd.,
N-211/2/10, MIDC. Boisar, District –Thane, Pin – 401 506,
Maharashtra, India.
API Lot No. CLS0218009
Description of Pack
Glass vial
Real Time: 0, 3, 6 ,9,12,18,24 (Months)
Batch No. T001 T002 T003
Batch Size 1000 Vials 1000 Vials 1000 vials
No. of Batches 03
DOCUMENTS / DATA REQUIRED ALONGWITH APPLICATION
Copy of GMP certificate No. NEW-WHO-
GMP/CERT/KD/74238/2018/11/24897 issued by
authority of country of origin. Food and Drug Administration, Maharashtra State,
3. Documents for the procurement of API with Copy of commercial invoice (Invoice # 67533/2020
approval from DRAP (in case of import). dated 27-01-2020 with received quantity of 5Kg) for
the purchase of Colistimethate sodium for Injection.
The invoice is cleared by Assistant director (I & E),
DRAP, Islamabad.
4. Data of stability batches will be supported by Firm has submitted analytical record of testing of all
attested respective documents like chromatograms, batches along with raw data sheets, COA and
Raw data sheets, COA, summary data sheets etc. summary data sheets.
5. Compliance Record of HPLC software 21CFR & N.A.
humidity monitoring of stability chambers (real temperature and humidity monitoring of real time
time and accelerated) and accelerated stability chambers.

No.
1. Analytical method verification studies The firm has submitted Bioassay test method
including specificity, accuracy and validation protocol and reports for the
repeatability (method precision) performed by determination of colistimethate sodium by
the drug product manufacturer for both performing accuracy, precision, Linearity, range,
compendial as well as non-compendial drug ruggedness and specificity parameters.
2. Valid copy of GMP certificate of drug
substance manufacturer issued by country of
origin.
3. COA of primary / secondary reference standard The firm has submitted certificate of analysis
including source and lot number shall be showing working standard calibration report.
provided.
4. Submit master formulation including The firm has submitted master formulation
theoretical fill weight per vial. showing quantity of fill weight per vial.
5. Justify why pharmaceutical equivalence Firm has submitted revised pharmaceutical
studies do not include all the tests as equivalence against reference product
recommended by USP. Instead the test for Colistimethate Sodium 2MIU Injection (Lot No.
microbiological has been performed only. 3056579) of M/s Xellia Pharmaceuticals by
performing identification, pH, uniformity of
dosage unit, particulate matter, Biological assay,
sterility and Endotoxin.
6. Scientific justification of manufacturing of The firm has submitted that the bulk and raw
applied formulation by way of lyophilization material of colistimethate sodium was available in
using pre-lyophilized Colistimethate for lyophilized powder form. The raw material is then
Injection from M/s Mac-Chem Products (India) formulated into solution which is filled and
Pvt. Ltd. lyophilized.
7. Provide detailed method of analysis of the drug The firm has submitted method of analysis of the
product instead of providing copy of USP drug product.
monograph.
8. Provide detailed protocols how validation of The firm has submitted Bioassay test method
analytical procedures of the drug product was validation protocol and reports for the
carried out and further justify how the determination of colistimethate sodium.
recovered concentration (mg/ml) was Accuracy is determined by standard addition
calculated in accuracy and recovery. method, previously analyzed sample with
concentration of 0.2mg/ml were spiked with 50,
100, and 150% API and the mixtures were
analyzed by the proposed method.
9. Provide COA of reference standard actually The firm has submitted copy of USP primary
used in the analysis of drug product. reference standard with lot no. H3J047.
10. Provide copy of Batch Manufacturing Record The firm has submitted copies of batch
(BMR) for all the batches of drug product for manufacturing records for all the batches of drug
which stability studies data is provided in product for which stability studies data is
Module 3 section 3.2.P.8.3. provided.
• Valid GMP certificate or DML of drug substance manufacturer issued by relevant regulatory
authority of the country of origin since submitted GMP certificate was valid till 10-9-2021.
• Scientific justification for using prelyophilized drug substance for formulation of the finished
drug product by way of lyophilization.
497. Name, address of Applicant / Marketing M/s SAMI Pharmaceuticals (Pvt.) Ltd. F-95, Off
Authorization Holder Hub River Road, S.I.T.E. Karachi.
Name, address of Manufacturing site. M/s SAMI Pharmaceuticals (Pvt.) Ltd. F-95, Off
Hub River Road, S.I.T.E. Karachi.
☐ Importer
☐ Export sale
manufacturer inspection conducted on 28-08-2020
Dy. No. and Date of submission Dy. No. 23869 Dated 31-08-2021
Balance fee: PKR 25,000/-: Dated 31-07-2021
The proposed proprietary name / brand name BALOXA 10mg Sachet
Pharmaceutical ingredient (API) per unit Baloxavir Marboxil…….…….10mg
Pharmaceutical form of applied drug White to pale yellow white granules
Pharmacotherapeutic Group of (API) Anti-viral
ATC Code: J05AX25
Reference to Finished product specifications Innovator’s Specification
The status in reference regulatory authorities Xofluza granules 2% Sachet by M/s. Shionogi &
Co Ltd, Japan (PMDA Approved)
For generic drugs (me-too status) Not applicable
Name and address of API manufacturer. M/s Fujian Jinshan Zhundian Pharmaceutical
Co.,Ltd. Jintang Industry zone, Shaown city,
Fujian Province, China.
drug substance
Real time: 30°C±2°C/65%± 5%RH for 24 months
Accelerated: 40°C±2°C/75%±5%RH for 6 months
Batches: (180801, 180802, 180803)
Module-III (Drug Product): The firm has submitted details of manufacturers,
its validation studies, batch analysis and
container closure system and stability studies of the
drug product.
Pharmaceutical equivalence and comparative It may please be noted that despite of our
dissolution profile contacting M/s Genetech and Shionagi, we could
not obtain required number of sachets for
conducting comparative dissolution profile and
Pharmaceutical equivalence.
Since Xofluza 2% granules are neither available in
the local market, nor could be procured from
abroad nor is mentioned in any pharmacopeia, we
have considered and ensured the quality
parameters which give us the confidence that in-
vitro parameter of our product is comparable with
the innovator.
Formulation of our product is qualitatively similar
to innovator product.
Analytical method validation/validation of Method validation studies have been submitted
product including linearity, accuracy, precision
(repeatability and intermediate), robustness and
specificity.
Manufacturer of API M/s Fujian Jinshan Zhundian Pharmaceutical Co. Ltd.,
Address: Jintang Industry Zone, Shaowu City, Fujian Province, China
API Lot No. 200101
Description of Pack
Aluminum Foil (Unprinted Triplex)
Frequency Accelerated: 0,1,2,3,4,6 (Months)
Batch No. Lab-1 Lab-2 Lab-3
Batch Size 1000 sachet 1000 sachet 1000 sachet
No. of Batches 03
DOCUMENTS / DATA REQUIRED ALONGWITH APPLICATION
1. Reference of previous approval of applications Firm has referred to onsite inspection report of their
with stability study data of the firm (if any) product “RECADA (Racecadotril) 10mg & 30mg
Sachet” which was presented in 290th meeting of
Registration Board wherein the Board decided to
approve registration of this product.
Date of inspection: 10th May, 2019
According to inspection report, following points
were confirmed:
• The firm has 21CFR compliant HPLC software.
stability chambers.
manufacturer issued by concerned regulatory No. FJ20160009 issued by Food and Drug
authority of country of origin. Administration of China valid
till 22-02-2021.
As per Chinese Government website no more GMP
certificates are being issued after December 2019.
3. Documents for the procurement of API with Copy of commercial invoice (Invoice#WIS200028
approval from DRAP (in case of import). dated March 18, 2020 with received quantity of
300gm) for the purchase of Baloxavir marboxil
from M/s Fujian Jinshan Zhundian Pharmaceutical
Co. Ltd., Jintand Industry zone, Shaown city,
Fujian Province, China with attestation of DRAP
dated 31st March 2020.
4. Data of stability batches will be supported by Firm has submitted complete record of testing of all
attested respective documents like batches along with chromatograms, raw data
chromatograms, Raw data sheets, COA, sheets, COA and summary data sheets.
5. Compliance Record of HPLC software 21CFR & Firm has submitted audit trail record of product
audit trail reports on product testing testing of HPLC for all test intervals.

No.
1. Valid copy of DML / GMP certificate of API As per the current law of People’s Republic of
manufacturer issued by concerned regulatory China of the administration of the drug, the GMP
authority shall be submitted. and GSP certificates of medicine have been
cancelled and will no longer be issued from
December 1 2019. This notice can be verified on
their website online link is below:
http://english.nmpa.gov.cn/2019-11/29/c_
456284.htm
2. Elaborate the manufacturing process and The chosen method of preparation is dry mixing.
method by which Baloxavir granules have been The manufacturing steps comprises of well-
prepared in Section 3.2.P.2. known processes like dispensing, sieving,
blending, sieving, blending, filling and
packaging. The process is considered to be the
standard manufacturing process. In processes,
controls are adequate for these types of
manufacturing processes.
3. Justify the product development studies without The reference product is not available in Japan.
performing pharmaceutical equivalence and We have tried to arrange it from the country of
CDP studies with innovator/ reference product. origin but unfortunately not succeeded.
Please also note that our formulation is similar to

the innovator in the following,
1. API: Same as that of Reference listed drug.
2. Dosage form: Same as that of Reference
listed drug.
3. Indication: Same as that of Reference listed
drug.
4. Excipients: Same as that of Reference listed
drug.
5. Label claim: Same as that of Reference listed
drug.
However, for assay, dissolution and other

chemical / microbiological attributes, we have
tested the product according to the general
guidelines of FDA and USP and complied.
In 295th DRB meeting of DRAP Registration

Board, same case of M/s. PharmEvo (pvt.)
Limited was discussed and approved by Drug
Registration Board. The product named Treow
(Trelagliptin) 50mg Tablet and Treow
(Trelagliptin) 100mg Tablet in which the firm
did not perform comparative dissolution profile
against innovator because they were unable to
arrange the innovator packs from Japan without
Japanese prescription which is only available in
Japan.
4. Justification is required for adopting the two The firm replied that we have adopted the two
time point study for dissolution test. Moreover, time point dissolution test from 293rd meeting
provide the basis for selection of dissolution test minutes of DRAP “Guidance document for
conditions. Setting Dissolution Specifications of Immediate
Release Solid Oral Dosage Form” and from
FDA guideline “Guidance for Industry
Dissolution Testing of Immediate Release Solid
Oral Dosage Forms” which states that “For
slowly dissolving or poorly water soluble drugs
(BCS class 2), a two-point dissolution
specification, one at 15 minutes to include a
dissolution range (a dissolution window) and the
other at a later point (30, 45, or 60 minutes) to
ensure 85% dissolution, is recommended to
characterize the quality of the product”.
• Valid GMP certificate or DML of drug substance manufacturer issued by relevant regulatory
authority of the country of origin since submitted GMP certificate was valid till 22-02-2021.
• Pharmaceutical equivalence and Comparative Dissolution Profile (CDP) against the
innovator’s product.
Case No.07: Registration applications of local manufacturing of human drugs submitted on CTD format
a. Deferred Cases
498. Name, address of Applicant / Marketing M/s Genix Pharma (Pvt) Ltd, 44-45-B, Korangi
Authorization Holder Creek Road, Karachi
Name, address of Manufacturing site. M/s Genix Pharma (Pvt) Ltd, 44-45-B, Korangi
Creek Road, Karachi
☐ Importer
GMP status of the firm The firm is inspected on 02-07-2020 wherein the
firm was found to be operating at good level of GMP
compliance.
Evidence of approval of manufacturing facility The firm has provided Sachet (General) section from
confirmed from approved layout plan from licensing
division.
☐ Export sale
The proposed proprietary name / brand name Movcol Jar 238g
Pharmaceutical ingredient (API) per unit Polyethylene glycol 3350…………….17g
Pharmaceutical form of applied drug White to off white color powder filled in HDPE
bottle.
Pharmacotherapeutic Group of (API) Osmotic laxative
Reference to Finished product specifications Manufacturer’s specifications
The status in reference regulatory authorities Miralax for oral solution of M/s Bayer Healthcare
LLC (USFDA Approved, over the counter)
For generic drugs (me-too status) Not available
Name and address of API manufacturer. M/s Avesta Pharma Pvt Ltd., Shivam chambers,
Mumbai – 400 062 Maharashtra India.
Characterization, impurities, specifications,
The firm has summarized information of drug
product including its description, composition,
validation protocols, control of excipients, control of
drug product, specifications, analytical procedures,
justification of specifications, reference standard or
Module-III Drug Substance: The firm has submitted detailed drug substance data
Minutes of of 321 meeting of Registration Board (20 -22nd September, 2022)
st th
672
substance.
(Conditions & duration of Stability studies) of drug substance at both accelerated as well as real
time conditions. The accelerated stability data is
conducted at 40°C ± 2°C / 75% ± 5% RH for 6
months. The real time stability data is conducted at
30°C ± 2 °C / 65% ± 5% RH for 36 months.
Module-III Drug Product: The firm has submitted data of drug product
Pharmaceutical Equivalence The firm has performed pharmaceutical equivalence
of Movcol 238g Jar (B#19SB-143-01) of M/s Genix
pharma with Miralax 238g Jar (B # 0C20PU) of M/s
Bayer. Quality tests of both products including
description, identification, filled weight, moisture
content and assay were compared.
product report of applied product.
Manufacturer of API M/s Avesta Pharma Pvt Ltd., Shivam chambers, 106/108, First Floor, S.V.
Road, Goregaon west, Mumbai – 400 062 Maharashtra India.
Description of Pack
HDPE Bottle
Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RH
Movcol Jar 238g
Batch No. 19SB-143-01 19SB-144-02 19SB-145-03
No. of Batches 03
# Documents To Be Provided Status
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate of M/s.
manufacturer issued by concerned regulatory Avesta Pharma PVT LTD, Maharashtra state, India
issued by Food and Drug Administration, Maharashtra
3. Documents for the procurement of API with The firm has submitted copy of invoice for the import of
approval from DRAP (in case of import). polyethylene glycol-3350 (5000Kg, Batch #
dated 18-04-2019.
attested respective documents like with chromatograms, raw data sheets, COA and
Audit trail of testing of product has not been submitted.
(real time and accelerated). stability chambers.

No.
repeatability (method precision) performed by parameters include specificity and system
the Drug Product manufacturer for both suitability, linearity, precision and accuracy
compendial as well as non-compendial drug parameters from drug substance manufacturer.
substance(s) shall be submitted. Analytical method verification was also performed
by drug product manufacturer.
2. Evidence of approval of formulation in The firm has submitted evidence of approval of
applied pack size i.e., 578g shall be required formulation in applied pack size. Unit dose
since bottle of three pack sizes mentioned in compliance is achieved via measuring cap of the jar,
of 17g.
6-month time point in all batches and adoptingAfter purchasing RI Detector and column L 25.
WaT011520 Lot 002D190651). We had validated
the method in HPLC. So 6th month interval and
onward testing were conducted in HPLC.
5. Compliance Record of HPLC software The firm has submitted compliance record of HPLC
21CFR & audit trail reports on product software from Waters Corporation.
testing.
6. Documents for the procurement of drug The firm has submitted copy of invoice for the
substance with approval from DRAP is import of polyethylene glycol-3350 (5000Kg, Batch
required. # AP0919009) attested by AD (I & E) DRAP,
Registration Board deferred the case for following (M-313):
Sr.# Decision of 316th meeting Response by the firm

1. Scientific justification of using Jar container The firm has submitted that we have used same
closure system instead of using foil pouch as container closure system as per reference product
per reference product i.e., Miralax of M/s Miralax by M/s Bayer. It is available in jar in which
Bayer for achieving unit dose dispensing of unit dose compliance is achieved via measuring cap
applied product. of the jar, engraved with the unit dose of 17g from
inside.
2. Evidence of availability of drug product in Miralax jar is also available in applied pack size of
applied container closure system in reference 238g jar in the same container closure system.
regulatory authorities.
499. Name, address of Applicant / Marketing M/s Genix Pharma (Pvt) Ltd, 44-45-B, Korangi Creek
Authorization Holder Road, Karachi
Name, address of Manufacturing site. M/s Genix Pharma (Pvt) Ltd, 44-45-B, Korangi Creek
Road, Karachi
☐ Importer
GMP status of the firm The firm is inspected on 02-07-2020 wherein the firm
was found to be operating at good level of GMP
compliance.
Evidence of approval of manufacturing facility The firm has provided Sachet (General) section from
confirmed from approved layout plan from licensing
division.
☐ Export sale
proposed proprietary name / brand name Movcol Jar 578g
Pharmaceutical ingredient (API) per unit Polyethylene glycol 3350…………….17g
Pharmacotherapeutic Group of (API) Osmotic laxative
Reference to Finished product specification Manufacturer’s specifications
The status in reference regulatory authorities Miralax for oral solution of M/s Bayer Healthcare LLC
(USFDA Approved, over the counter)
For generic drugs (me-too status) Not available
Name and address of API manufacturer. M/s Avesta Pharma Pvt Ltd., Shivam chambers,
Mumbai–400 062 Maharashtra India.
(Conditions & duration of Stability studies) drug substance at both accelerated as well as real time
conditions. The accelerated stability data is conducted
at 40°C ± 2°C / 75% ± 5% RH for 6 months. The real
time stability data is conducted at 30°C ± 2 °C / 65% ±
5% RH for 36 months.
control, process validation protocols and report, control
Pharmaceutical Equivalence The firm has performed pharmaceutical equivalence
and comparative dissolution profile of Movcol 578g Jar
(B#19SB-149-01) and Miralax 578g Jar (B # TN00RM)
of M/s Bayer. Quality tests of both products including
description, identification, filled weight, moisture
content and assay were compared.
Analytical method validation/verification of Firm has submitted analytical method validation report
product of applied product.
Manufacturer of API M/s Avesta Pharma Pvt Ltd., Shivam chambers, 106/108, First Floor, S.V. Road,
Goregaon west, Mumbai – 400 062 Maharashtra India.
Description of Pack
HDPE Bottle
Movcol Jar 578g
Batch No. 19SB-149-01 19SB-150-02 19SB-151-03
No. of Batches 03
1. Reference of previous approval of applications NA
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate of M/s.
manufacturer issued by concerned regulatory Avesta Pharma Pvt. Ltd, Maharashtra state, India issued
authority of country of origin. by Food and Drug Administration, Maharashtra state,
India. It is valid upto 15-09-2023.
dated 18-04-2019.
Audit trail of testing of product has not been submitted.
(real time and accelerated). accelerated stability chambers.
S# Observations communicated Response by the firm

manufacturer.
of 17g.
dated 18-04-2019.
Deferred for following submission:

1. Scientific justification of using Jar container
The firm has submitted that we have used same
closure system instead of using foil pouch as container closure system as per reference product
per reference product i.e., Miralax of M/s Miralax by M/s Bayer. It is available in jar in which
Bayer for achieving unit dose dispensing of unit dose compliance is achieved via measuring cap
applied product. of the jar, engraved with the unit dose of 17g from
inside.
2. Evidence of availability of drug product in Miralax jar is also available in applied pack size of
applied container closure system in reference 578g jar in the same container closure system.
regulatory authorities.
500. Name, address of Applicant / Marketing M/s Vision Pharmaceuticals (Pvt.) Ltd.,
Authorization Holder Plot # 22-23, Industrial triangle, kahuta road,
Islamabad-44000.
Name, address of Manufacturing site. M/s Vision Pharmaceuticals (Pvt.) Ltd.
Plot # 22-23, Industrial triangle, kahuta road,
Islamabad-44000.
☐ Importer
☐ Export sale
manufacturer The firm has provided Liquid Ampoule General
section.
The proposed proprietary name / brand name Vision DS Injection 600mg/2ml
Strength / concentration of drug of Active Each 2ml contains:
Pharmaceutical ingredient (API) per unit Lincomycin as hydrochloride………….600mg
Pharmaceutical form of applied drug Clear to slightly yellow colour liquid injection
Pharmacotherapeutic Group of (API) Antibiotics
st
678
Proposed Pack size 10’s, 50’s & 100’s
The status in reference regulatory authorities LINCOMYCIN SXP 600mg/2ml solution for injection
ampoule by M/s Southem XP IP Pty Ltd, (TGA
Approved).
For generic drugs (me-too status) Olinc 600mg/2ml Injection by M/s Bosch Karachi,
Reg. No. 025416
Name and address of API manufacturer. M/s Topfond Pharmaceutical Co., Ltd., No.2,
Guangming Road, Zhumadian City, 463000, Henan
P.R. China.
Real time: 30°C ± 2°C / 65%±5%RH for 48 months
Accelerated: 40°C ± 2°C /75%±5%RH for 6 months
Batches: (081101, 081102, 081103)
process control, process validation protocols and
Pharmaceutical equivalence and comparative The firm has submitted comparative assay data of trial
dissolution profile formulation (Batch # NPD 213 T-01) against the
comparator product Lincocin Injection (Batch # C151)
by Sanofi – Aventis Pakistan Ltd. Karachi by
performing quality tests (Physical appearance, Assay,
pH, Liquid Particle Count).
Manufacturer of API M/s Topfond Pharmaceutical Co., Ltd., No.2, Guangming Road, Zhumadian
City, 463000, Henan P.R. China.
API Lot No. 1907025
Description of Pack 2 ml ampoule,
(Container closure system) Type II glass
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%RH Accelerated: 40°C ± 2°C / 75% ±
5%RH
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. NPD213-T01 NPD213-T02 NPD213-T03
Batch Size 1587 Amp 1587 Amp 1587 Amp
No. of Batches 03
1. Reference of previous approval of The firm has referred to onsite inspection report of their
applications with stability study data of the product Calador 400mg/100ml Infusion which was
firm (if any) conducted on 24-08-2021 and was presented in 312th
meeting of Registration Board held on 14-16th
September, 2021.
confirmed.
•The firm has 21 CFR compliant HPLC software
•The firm has audit trail reports available.
loggers.
API manufacturer issued by concerned HA20160021 issued by CFDA valid till 17-10-2021.
3. Documents for the procurement of API with The firm has submitted copy of commercial Invoice to
approval from DRAP (in case of import). import Lincomycin HCl (Invoice # XX17026) dated
Jul-28-2017 attested by AD (I & E) DRAP Islamabad
dated 20-09-2019.
4. Data of stability batches will be supported by The firm has submitted Data of stability batches
chromatograms, raw data sheets, COA, chromatograms, raw data sheets, COA, summary data
summary data sheets etc. sheets etc.
5. Compliance Record of HPLC software 21CFR The firm has submitted Compliance Record of HPLC
testing.
6. Record of Digital data logger for temperature The firm has submitted record of digital data logger for
(real time and accelerated). chambers (real time and accelerated)

1. Copies of the drug substance specification and Copies of the drug substance specification and
analytical procedures used for routine testing analytical procedures used for routine testing of the
of the Drug substance / Active Pharmaceutical Drug substance / Active Pharmaceutical Ingredient by
Ingredient by both Drug substance & Drug both Drug substance & Drug Product manufacturer
Product manufacturer. are attached.
2. Submitted drug substance specifications are as As we have used material by Topfond pharmaceutical
per Indian Pharmacopoeia while monograph Co. Ltd which is as per USP monograph. We have
of drug substance is available in USP. revised documents and complete DMF & QOS is
attached here. Initially the firm had provided DMF
from Henan Xinxiang Huaxing Pharmaceutical
factory. However, the limits provided by FPP
manufacturer for pH, specific optical rotation, water
contents and assay are different from API
manufacturer.
3. Analytical method verification reports of Analytical method verification reports of parameters
parameters like specificity, accuracy & like specificity, accuracy & repeatability (method
repeatability (method precision) performed by precision) performed by the drug product
the drug product manufacturer for both manufacturer are attached.
4. Submitted certificate of analysis is from API used for manufacturing & testing is by Topfond
Topfond pharmaceutical Co. Ltd while drug pharmaceutical Co. Ltd. accidently DMF of Henan
substance manufacturer is M/s Henan Xinxiang Huaxing Pharmaceutical factory is provided
Xinxiang Huaxing Pharmaceutical Factory. in dossier.
5. Reference standard was not from drug Not submitted.
6. Details of batch numbering of reference The firm has submitted comparative assay profile
product and test formulation used for protocol as well as report of trial formulation with
Pharmaceutical equivalence are required. comparator product Linocin Injection 600mg/2ml.
Pharmaceutical equivalence should contain However, pharmaceutical equivalence results
results of all the quality tests mentioned in containing all the tests have not been submitted.
official pharmacopoeia of the developed
formulation and the reference product.
7. In section 3.2.P.2.4, type II glass vial has been It is a typing error, container closure used is Glass
chosen as container closure system while in ampoule
manufacturing process development glass
ampoule has been mentioned
8. Justification/Clarification is required It is error occurred during typing, the actual quantity
regarding target fill weight of Lincomycin dispensed is 1.031kg instead of 1031.0kg. As per trial
hydrochloride as 1031.0kg in batch formula card, the quantity dispensed is 1.119 Kg.
for preparing 1587 ampoules.
9. Justification shall be submitted for not The firm has submitted that we performed the
performing terminal sterilization in applied autoclave on all trials.
injection. Moreover, step of aseptic filling Highlighted trial card is also attached.
process has also not been mentioned.
10. Justify the weight taken for Lincomycin As per USP, standard concentration is 1.2 mg per ml,
hydrochloride in different sets of accuracy so we have prepared the sample also as 2ml containing
parameter in analytical method validation 600mg of Lincomycin so we pipette 2 ml and transfer
studies. Moreover, basis for setting 100% to 50ml volumetric flask. In second dilution, we
theoretical contents are required to be transfer 5ml from it to another 50ml volumetric flask,
clarified. making final concentration of 1.2mg / ml. For other
concentration spiking was done as per protocol.
11. Chromatograms of Lincomycin injection Chromatograms of Lincomycin injection samples
samples contain two principle peaks. contain two principle peaks.
Clarification is required for these two peaks As this finished product only containing API
(Lincomycin HCl) and excipient (Benzyl Alcohol)
Peak at 16.443 minutes is of LINCOMYCIN and peak
on 11.396 minutes is of BENZYL ALCOHOL.
Secondly, 210nm of wavelength is used for analysis.

1. Clarification of dispensed quantity of The firm has submitted that the difference is just due
Lincomycin hydrochloride for manufacturing to rounding off during calculation.
of 1587 ampoules of each trial batch since the For 3.3 L, the ampoules prepared should be 1571.
quantity mentioned on master formulation is While calculation, we take 3.33 L for which ampoules
different from trial card. will be 1587.
• Calculation of API per ampoule.
3.3 Liters = 3300ml.
3300ml x 300mg = 990000mg
(600mg is present in 2ml so for 1 ml 300mg as
mentioned above.)
By converting mg to Kg.
990000mg / 1000 = 990 grams
990grams / 1000 = 0.99 Kg
So, 0.99 x 100/88.51 = 1.1185 Kg
By calculating for 2.1ml per ampoule the calculation
is as below.
3300/2.1 = 1571 Ampoules
Per Ampoule 600mg x 2.1/2 = 630mg
630 mg 100/88.51 = 711.78mg
So, for 1571 Ampoules we will require API as
1571 Ampoules x 711.78mg = 1.1182
By rounding 1.1182 it becomes 1.119 Kg
2. Provide COA of primary / secondary reference The firm has submitted copy of COA of working
standard including source and lot number. standard from drug substance manufacturer (M/s
Topfond Pharmaceutical Co. Ltd) with lot number of
19070024.
Decision: Approved.
• Registration Board further directed the firm to dispense the drug substance for commercial batch
manufcaturing on the basis of actual potency of drug substance determined durinig drug substance
analysis.
501. Name, address of Applicant / Marketing M/s Arsons Pharmaceutical Industries (Pvt) Ltd., 22 Km
Authorization Holder Multan Road off, 2.5 Km, Defence Road, Lahore
Name, address of Manufacturing site. M/s Arsons Pharmaceutical Industries (Pvt) Ltd., 22 Km
Multan Road off, 2.5 Km, Defence Road, Lahore
☐ Importer
☐ Export sale
GMP status of the firm The firm is granted GMP certificate based on inspection
The proposed proprietary name / brand name Peflam 50mg Tablet
Pharmaceutical ingredient (API) per unit Diclofenac potassium………….50mg
Pharmaceutical form of applied drug Light brown colored round biconvex film coated tablet
Pharmacotherapeutic Group of (API) NSAIDs
Reference to Finished product specifications USP Specifications
st
682
The status in reference regulatory authorities Cataflam 50mg Tablet of M/s Novartis (USFDA
approved)
For generic drugs (me-too status) Voltaflam Tablet of M/s Platinum pharma (Reg#
021621)
Name and address of API manufacturer. M/s Henan Dongtai Pharm Co. Ltd., East Changhong
Road, Tangyin, Henan, China.
and its validation, batch analysis and justification of
structure, general properties, solubility, physical form,
controls, specifications, analytical procedures and its
specification, working standard, container closure
Batches: (131118-5, 131118-6, 131119-5)
Module-III (Drug Product): The firm has submitted data of drug product including its
procedures, validation of analytical procedures, batch
analysis, justification of specifications, reference
stability.
Pharmaceutical equivalence and comparative The firm has submitted comparative dissolution studies
dissolution profile Peflam 50mg Tablet (B#PF001) with comparator product
Caflam 50mg tablet (B#PK3R) in three media pH 1.2,
acetate buffer pH 4.5 and phosphate buffer pH 6.8.
Analytical method validation/verification of Method validation studies have been submitted including
product accuracy, precision, robustness and specificity studies.
Manufacturer of API M/s Henan Dongtai Pharmaceutical Co. Ltd.,
No. 2, East Kangtai Road, Tangyin County, Anyang city, China.
API Lot No. 0303191005-5
Description of Pack
Alu-PVC blister packed in unit carton (2 × 10’s)
Peflam-50 Tablet
Batch No. PF-001 PF-002 PF-003
No. of Batches 03
1. Reference of previous approval of
applications with stability study data of the The firm has not submitted any document.
firm (if any)
API manufacturer issued by concerned (Certificate # HA20190077) of M/s Henan Dongtai
regulatory authority of country of origin.Pharmaceutical Co., Ltd. China issued by He Nan
Province Drug administration, China. It is valid till 05-
11-2024.
4. Data of stability batches will be supported by Firm has submitted complete record of testing of all
attested respective documents like batches along with chromatograms, raw data sheets,
chromatograms, Raw data sheets, COA, COA and summary data sheets.
5. Compliance Record of HPLC software The firm has submitted compliance record of HPLC
21CFR & audit trail reports on product software and audit trail record of product testing.
testing.
chambers (real time and accelerated). chambers (real time and accelerated).
1. Copies of the drug substance specifications and The firm has submitted that drug substance
analytical procedures used for routine testing of specifications are part of analytical procedure.
the drug substance / active pharmaceutical The firm has submitted copies of analytical
ingredient by both drug substance & drug procedure from both drug substance and drug
Product manufacturer. Moreover, analytical product manufacturer.
procedure for assay testing has not been
provided.
parameters like specificity, accuracy and verification protocol and reports for assay method
repeatability (method precision) performed by by titration method. The verification study does
the Drug Product manufacturer for both not include accuracy and specificity parameters.
3. Provide results of analysis of relevant batch(es) The firm has submitted certificate of analysis of
of Drug Substance performed by drug Product drug substance from both drug substance and drug
manufacturer used during product development product manufacturer.
and stability studies, along with certificate of
Analysis (CoA) of the same batch from Drug
Substance manufacturer.
4. Pharmaceutical equivalence of the applied drug The firm has provided comparative dissolution
shall be established with the innovator / profile studies with Anti-flam Tablet 50mg.
reference / comparator product and results of all The performance of pharmaceutical equivalence
the quality tests of the developed formulation studies with innovator product was not provided.
and the innovator / reference / comparator
5. Submit acceptance criteria for release and shelf The firm has submitted that release limit and shelf
life specifications. life specifications comply USP monograph. Both
the limits are exactly the same.
6. Justify method verification studies without The firm has submitted performance of linearity
performance of specificity studies. Moreover, and precision studies.
relevant chromatograms for each studied
parameter are required.
7. Reference of previous approval of applications No approvals have been granted so far with
with stability study data of the firm (if any). stability studies, however, we have 21 CFR
compliant HPLC alongwith audit trail enabled.
Further our stability chambers are also attached
with UPS and 24-h monitoring record.
manufacturer issued by concerned regulatory (Certificate # HA20190077) of M/s Henan
authority of country of origin. Dongtai Pharmaceutical Co., Ltd. China issued by
HeNan Province Drug administration, China. It is
9. Documents for the procurement of API with Not submitted.

1. Submission of complete analytical method The firm has submitted results of accuracy and
verification studies including results of specificity parameters alonwith relevant
specificity and accuracy parameters as per chromatograms.
requirement of section 3.2.S.4.3 of Form-5F.
2. Justification for adopting same acceptance The firm has not submitted any justification for
criteria for release and shelf life specifications. adopting same acceptance criteria for release and
shelf life specifications.
3. Performance of pharmaceutical equivalence and The firm has submitted comparative dissolution
CDP studies with innovator/reference product. studies Peflam 50mg Tablet (B#PF001) with
comparator product Caflam 50mg tablet
(B#PK3R) in three media pH 1.2, acetate buffer
pH 4.5 and phosphate buffer pH 6.8.
The performance of pharmaceutical equivalence
studies was not provided.
4. Analytical method verification protocol and The firm has submitted analytical method
reports of drug product as per requirements of verification protocol and reports of drug product
section 3.2.P.5.3 of Form-5F. by performing system suitability, specificity,
linearity, precision and accuracy parameters.
5. Evidence of procurement of API with approval The firm has submitted copy of invoice specifying
from DRAP. import of Diclofenac potassium 1000 Kgs attested
by Assistant Director (I & E), lahore dated 02-10-
2019.
Decision: Approved.
• Registration Board further deciced that registration letter will be issued upon subsmission of
Pharmaceutical equivalence studies against the innovator product.
502. Name, address of Applicant / Marketing M/s Standpharm Pakistan Pvt. Ltd., 20-km, Ferozepur
Authorization Holder Road, Lahore
Name, address of Manufacturing site. M/s Vision Pharmaceuticals (Pvt.) Ltd, Plot # 22-23,
Industrial triangle, Kahuta Road, Islamabad
☐ Importer
GMP status of the firm M/s Standpharm Pakistan: Panel inspection
conducted on 18-02-2020 wherein the panel
recommended the renewal of DML.
M/s Vision Pharmaceuticals: The firm is granted GMP
certificate based on inspection conducted on 23-04-
2019.
Evidence of approval of manufacturing M/s Vision Pharmaceuticals: The firm has provided
facility sterile Dry powder injection vials (General).
☐ Export sale
The proposed proprietary name / brand name CISEC 40mg IV Injection
Pharmaceutical ingredient (API) per unit Omeprazole sodium eq. to Omeprazole (as lyophilized
powder) …………….40mg
The status in reference regulatory authorities Omeprazole 40mg powder for solution for infusion of
M/s Sandoz Novartis (MHRA approved)
For generic drugs (me-too status) Risek Injection 40mg of M/s Getz Pharma Pakistan
Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt.) Ltd. Semi-basic Plant
(DML # 000806). Plot No. 22-23, Industrial Triangle
Kahuta Road, Islamabad.
Module-II (Quality Overall Summary) Firm has summarized information related to
40°C ± 2°C / 75% ± 5% RH for 6 months. The real time
stability data is conducted at 30°C ± 2 °C / 65% ± 5%
RH for 36 months.
Pharmaceutical Equivalence The firm has performed pharmaceutical equivalence of
the developed formulation Rapid 40mg Injection
(B#2005707) and comparator product Risek Injection
40mg (B # 789P06) of M/s GETZ Pharma. Quality tests
of both products including physical appearance,
solubility, water content, pH and assay were compared.
product of drug substance.
Firm has submitted analytical method validation report
of applied product.
Manufacturer of API M/s Vision Pharmaceuticals (Pvt.) Ltd. Semi-basic Plant (DML # 000806).
Plot No. 22-23, Industrial Triangle Kahuta Road, Islamabad.
API Lot No. 1702901
1702902
1702903
Description of Pack
Glass vial
Rapid 40mg I.V Injection
Batch No. 1803707 1803708 1803709
Batch Size 10,000 vials 10,000 vials 10,000 vials
No. of Batches 03
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate issued
API manufacturer issued by concerned by Additional Director DRAP, Islamabad. It is valid till
regulatory authority of country of origin. 10-02-2022.
3. Documents for the procurement of API with The firm has procured material from their semi basic
approval from DRAP (in case of import). manufacturing facility.
5. Compliance Record of HPLC software 21CFR The firm has submitted audit trail on testing reports of
& audit trail reports on product testing. product.

No.
1. Analytical method verification studies including The firm has submitted analytical method
specificity, accuracy and repeatability (method verification report from M/s Vision
precision) performed by the Drug Product Pharmaceuticals Pvt, Ltd. Islamabad.
manufacturer for both compendial as well as
submitted.
2. Certificate of analysis of both drug substance The firm has submitted COAs of 3 batches of
manufacturer and drug product manufacturer omeprazole lyophilized powder. The firm stated
are required. that we have a combined QC of both Formulation
(000517) and Semi-Basic (000806) facility having
same equipment and analysts for both facilities.
3. Pharmaceutical equivalence of the applied drug The firm has performed pharmaceutical
shall be established with the innovator / equivalence of the developed formulation Rapid
reference / comparator product and results of all 40mg Injection (B#2005707) and Risek 40mg
the quality tests of the developed formulation Injection (B # 789P06) manufactured by M/s
and the innovator / reference / comparator GETZ Pharma. Quality tests of both products
product shall be submitted and discussed. including physical appearance, solubility, water
content, pH and assay were compared.
4. Scientific justification is required for As the stability studies of the Bulk lyophilized
performing assay testing by UV method instead material is performed by the Bulk manufacturer in
of HPLC method. the same QC lab with the same instrument (on
HPLC) so just for verification purpose we
performed the stability of the said product by UV.
The firm has not submitted stability study data
performed by HPLC alongwith raw data sheets,
chromatograms and summary data sheets.
5. Provide copy of Batch Manufacturing Record The firm has submitted copy of batch
(BMR) for all the batches of drug product for manufacturing record of 3 batches for which
which stability studies data is provided in stability studies were carried out.
6. Compliance Record of HPLC software 21CFR Stability testing is performed by UV
& audit trail reports on product testing. spectrophotometry therefore audit trail is not
required.
7. Documents for the procurement of drug We have procured omeprazole sodium lyophilized
substance with approval from DRAP is ready to fill powder our own Semi-basic facility.
required.
8. Summary of additional stability studies (if The firm has not submitted the details of
applicable) e.g. in-use studies for drug products reconstitution diluents with which dilution was
which are to be reconstituted before use, along carried.
with proposed in-use storage statement and in-
use shelf-life shall be provided.
9. Compatibility studies for the dry powder for Compatibility studies were not provided with
injections and dry powder for suspension shall required diluents.
Evaluation by PEC:

No.
1. Justification of adopting UV-visible • As we have the facility for semi basic preparation
spectrophotometric method for assay & we are lyophilizing the omeprazole and
testing of applied formulation. conduct the testing on HPLC.
• In Omeprazole 40 mg Injection (commercial
batch) we are filling the same lyophilized powder
tested in our quality control laboratory.
• We performed the final month Stability testing on
HPLC. Testing for 36th month is attached in
Annexure I.
2. Submission of results of in-use stability Testing after reconstitution shows satisfactory
studies of the drug product to be results
reconstituted before use, along with Reconstituted Storage In-Use
proposed in-use storage statement and in- Diluent Condition Shelf Life
use shelf-life. NaCl 0.9% 2 – 8 ºC 24 Hours
solution 25 ºC 12 Hours
Testing Reports with brief summary of results are

attached in Annexure II.
3. Submission of compatibility studies for the Omeprazole Dry Powder for Injection in
dry powder for injections to be performed reconstituted with 10ml of NaCl 0.9% solution and
as per the instructions provided in shows satisfactory results after 8 hours under
individual label of the drug product. storage condition 2 – 8 ºC.
Testing Reports are attached in Annexure III
4. Capacity assessment of manufacturing and Capacity Assessment of manufacturing and testing
testing facility of M/s Vision facility of M/s Vision Pharma has been carried out.
Pharmaceuticals Pvt. Ltd.
Decision: RegistrationBoard noted the fact that firm had initially submitted stability studies data by UV
spectrophotometric method ofor Assay test, while HPLC method was adopted for the 36th month time
point of long term stability studies hence Registration Board deferred the case for submission of batch
release data of recently manufactured commercial batches by M/s Visio npharmaceuticals wherein assay
testing shall be performed using HPLC method.
503. Name, address of Applicant / Marketing M/s Carer Pharmaceutical Industries.
Authorization Holder Plot No. 27 Main Road, Rawat Industrial Estate, Rawat,
Pakistan.
☐ Importer
GMP status of the firm M/s Carer pharmaceutical Industries: The firm is
granted new license on 18/03/2021.
2019.
☐ Export sale
The proposed proprietary name / brand name Desan 40mg IV Injection
RH for 36 months.
(B#2005707) and Risek 40mg Injection (B # 789P06)
manufactured by M/s GETZ Pharma. Quality tests of
both products including physical appearance, solubility,
water content, pH and assay were compared.
of applied product.
API Lot No. 1702901
1702902
1702903
Description of Pack
Glass vial
Batch No. 1803707 1803708 1803709
No. of Batches 03

No.
including specificity, accuracy and verification report from M/s Vision
repeatability (method precision) performed Pharmaceuticals Pvt, Ltd. Islamabad.
compendial as well as non-compendial
drug substance(s) shall be submitted.
2. Certificate of analysis of both drug The firm has submitted COAs of 3 batches of
substance manufacturer and drug product omeprazole lyophilized powder. The firm
manufacturer are required. stated that we have a combined QC of both
Formulation (000517) and Semi-Basic
(000806) facility having same equipment and
analysts for both facilities.
3. Pharmaceutical equivalence of the applied The firm has performed pharmaceutical
drug shall be established with the innovator equivalence of the developed formulation
/ reference / comparator product and results Rapid 40mg Injection (B#2005707) and Risek
of all the quality tests of the developed 40mg Injection (B # 789P06) manufactured by
formulation and the innovator / reference / M/s GETZ Pharma. Quality tests of both
comparator product shall be submitted and products including physical appearance,
discussed. solubility, water content, pH and assay were
compared.
performing assay testing by UV method material is performed by the Bulk
instead of HPLC method. manufacturer in the same QC lab with the
same instrument (on HPLC) so just for
verification purpose we performed the
stability of the said product by UV.
performed by HPLC alongwith raw data
sheets, chromatograms and summary data
sheets.
5. Provide copy of Batch Manufacturing The firm has submitted copy of batch
Record (BMR) for all the batches of drug manufacturing record of 3 batches for which
product for which stability studies data is stability studies were carried out.
6. Compliance Record of HPLC software Stability testing is performed by UV
21CFR & audit trail reports on product spectrometry therefore audit trail is not
testing. required.
7. Documents for the procurement of drug We have procured omeprazole sodium
substance with approval from DRAP is lyophilized ready to fill powder our own
required. Semi-basic facility.
st th
692
applicable) e.g. in-use studies for drug reconstitution diluents with which dilution
products which are to be reconstituted was carried.
before use, along with proposed in-use
storage statement and in-use shelf-life shall
be provided.
9. Compatibility studies for the dry powder Compatibility studies were not provided with
for injections and dry powder for required diluents.
suspension shall be performed as per the
instructions provided in individual label of
the drug product.
Evaluation by PEC:

No.
Annexure I.

individual label of the drug product. storage condition 2 – 8 ºC.
Testing Reports are attached in Annexure III
Decision: Deferred for submission of data of recently manufactured commercial batches in which assay
testing has been performed using HPLC method.
504. Name, address of Applicant / Marketing M/s Nagarsons Pharmaceuticals (Pvt) Ltd, Plot # 34,
Authorization Holder Street No. NS-2, National Industrial Zone, Rawat,
Islamabad.
☐ Importer
GMP status of the firm M/s Nagarsons Pharmaceuticals: The firm is inspected
on 23-05-2019 which concluded that overall GMP
compliance could be graded as Good for visited sections
as of today. The firm has provided 8 sections.
2019.
☐ Export sale
The proposed proprietary name / brand name Nagzole 40mg IV Injection
st
694
RH for 36 months.
(B#2005707) and comparator product (B # 789P06) of
M/s GETZ Pharma. Quality tests of both products
including physical appearance, solubility, water content,
pH and assay were compared.
of applied product.
API Lot No. 1702901
1702902
1702903
Description of Pack
Glass vial
Batch No. 1803707 1803708 1803709
No. of Batches 03

No.
including specificity, accuracy and verification report from M/s Vision
repeatability (method precision) performed Pharmaceuticals Pvt, Ltd. Islamabad.
compendial as well as non-compendial
drug substance(s) shall be submitted.
2. Certificate of analysis of both drug The firm has submitted COAs of 3 batches of
substance manufacturer and drug product omeprazole lyophilized powder. The firm
manufacturer are required. stated that we have a combined QC of both
Formulation (000517) and Semi-Basic
(000806) facility having same equipment and
analysts for both facilities.
3. Pharmaceutical equivalence of the applied The firm has performed pharmaceutical
drug shall be established with the innovator equivalence of the developed formulation
/ reference / comparator product and results Rapid 40mg Injection (B#2005707) and Risek
of all the quality tests of the developed 40mg Injection (B # 789P06) manufactured by
formulation and the innovator / reference / M/s GETZ Pharma. Quality tests of both
comparator product shall be submitted and products including physical appearance,
discussed. solubility, water content, pH and assay were
compared.
performing assay testing by UV method material is performed by the Bulk
instead of HPLC method. manufacturer in the same QC lab with the
same instrument (on HPLC) so just for
verification purpose we performed the
stability of the said product by UV.
performed by HPLC alongwith raw data
sheets, chromatograms and summary data
sheets.
5. Provide copy of Batch Manufacturing The firm has submitted copy of batch
Record (BMR) for all the batches of drug manufacturing record of 3 batches for which
product for which stability studies data is stability studies were carried out.
6. Compliance Record of HPLC software Stability testing is performed by UV
21CFR & audit trail reports on product spectrometry therefore audit trail is not
testing. required.
7. Documents for the procurement of drug We have procured omeprazole sodium
substance with approval from DRAP is lyophilized ready to fill powder our own
required. Semi-basic facility.
st th
696
applicable) e.g. in-use studies for drug reconstitution diluents with which dilution
products which are to be reconstituted was carried.
before use, along with proposed in-use
storage statement and in-use shelf-life shall
be provided.
9. Compatibility studies for the dry powder Compatibility studies were not provided with
for injections and dry powder for required diluents.
suspension shall be performed as per the
instructions provided in individual label of
the drug product.
Evaluation by PEC:

No.
Annexure I.

individual label of the drug product. storage condition 2 - 8 °C.
Decision: RegistrationBoard noted the fact that firm had initially submitted stability studies data by UV
spectrophotometric method ofor Assay test, while HPLC method was adopted for the 36th month time
point of long term stability studies hence Registration Board deferred the case for submission of batch
release data of recently manufactured commercial batches by M/s Visio npharmaceuticals wherein assay
testing shall be performed using HPLC method.
Agenda of Evaluator PEC-XV
Cases of New Sections & New License

505. Name, address of Applicant / Marketing M/s Citi Pharma Private Limited
Name, address of Manufacturing site. M/s Citi Pharma Private Limited Factory: 3 K.M, Hea
Balloki Road, Phool Nagar, Distt. Kasur
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. dated 11/04/2022
The proposed proprietary name / brand name Cef-Sulb Injection 1gm
Strength / concentration of drug of Active Sterile Powder Cefoperazone sodium MS equivalent t
Pharmaceutical ingredient (API) per unit Cefoperazone……..500mg
Sterile Powder Sulbactam sodium MS equivalent t
Sulbactam…….500mg
Pharmaceutical form of applied drug Intra-venous / Intra-muscular Injection
Pharmacotherapeutic Group of (API) Broad-spectrum cephalosporin antibiotic
The status in reference regulatory authorities Sulperazone Injection 1gm
by M/s Pfizer Ltd. USA,
USFDA Approved.
For generic drugs (me-too status) Toxirid Injection 1gm by Global Pharmaceuticals, Reg. N
042552
Cephalosporin section approved.
Name and address of API manufacturer. M/s Shandong Luoxin Pharmaceutical Co.,Ltd China
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD templat
Summarized information related to nomenclatur
structure, general properties, solubilities, physical form
manufacturers, description of manufacturing process an
controls, impurities, specifications, analytical procedure
and its verification, batch analysis and justification o
and stability studies of drug substance and drug product
submitted.
Module III (Drug Substance) Official monograph of Cefoperazone sodium /Sulbactam
sodium eq to Cefoperazone /Sulbactam not present in an
pharmacopeia. The firm has submitted detail o
nomenclature, structure, general properties, solubilitie
physical form, manufacturers, description of manufacturin
process and controls, tests for impurity D, G & relate
substances (impurity A & unspecified), specification
analytical procedures and its verification, batch analys
and justification of specification, reference standar
container closure system and stability studies of dru
substance
Batches: (T-CSP001, T-CSP002, T-CSP003)
Module-III (Drug Product): The firm has submitted detail of manufacturers, descriptio
of manufacturing process and controls, impuritie
specifications, analytical procedure (including dissolutio
testing at acidic and buffer medium) and its verificatio
studies, batch analysis and justification of specification
reference standard, container closure system and stabilit
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been established again
dissolution profile the brand leader that is Toxirid Injection 1gm by Glob
Pharmaceuticals Pakistan performing quality tes
(Identification, Assay, Constituted Solution, Uniformity o
dosage form).
Analytical method validation/verification of Method verification studies have submitted includin
Manufacturer of API M/s Shandong Luoxin Pharmaceutical Co.,Ltd China
API Lot No. CEFP17/023/06/21
Description of Pack One clear glass vial 15ml with LDPE ampoule of WFI along with leafl
(Container closure system) in unit carton.
Batch No. T-CSP001 T-CSP002 T-CSP003
Batch Size (Scientifically rational batch 1000 Vials 1000 Vials 1000 Vials
size)
No. of Batches 03
8. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. SD20191025 issued by
manufacturer issued by concerned regulatory CFDA valid till 10/12/2024.
9. Documents for the procurement of API with Letter No. 11160/2021/DRAP Dated: 27-07-2021
approval from DRAP (in case of import). B/L No. 176-6445-291 dated: 31-07-2021

Shortcomings communicated to the Firm:
• You have mentioned USP specification in section 1.5.6 in module 1, while the drug product monograph is not availab
in USP, but present in JP. Revise the specifications along with submission of requisite fee.
• The drug substance manufacturer has claimed both USP and in-house standards for the drug substance, provid
scientific justification in this regard.
• Justify, how you have claimed USP specification for drug substance cefoperazone sodium+Sulbactum30-May-2
sodium, when the monograph has not been present in USP.
• Submit data in section 3.2.S.4.1 as per the guidance document approved by Registration Board which specifies th
“Copies of the Drug substance specifications and analytical procedures used for routine testing of the Drug substanc
/Active Pharmaceutical Ingredient by both Drug substance manufacturers.”
• Submit data in section 3.2.S.4.3 as per the decision of 293rd meeting of Registration Board, which states th
“Analytical Method Verification studies including specificity, accuracy and repeatability (method precision) performe
by the Drug Product manufacturer for both compendial as well as non-compendial drug substance(s) shall b
submitted”. Further justify how the analysis of drug substance was conducted without performing verification studie
of the analytical method of drug substance.
• Stability study data of 3 batches of drug substances till the assigned shelf life needs to be submitted, since stability da
of 3 months has submitted despite the batch had been manufactured in 2017.
• Submit data in section 3.2.P.1 (c) as per the decision of 293rd meeting of Registration Board, which states that “Provid
information including type of diluent, its composition, quantity or volume, specifications (as applicable) and regulator
status in Pakistan (as applicable) for the diluent which is to be provided along with the applied drug”.
• Justify the use of 4ml printed glass vial for packaging of drug product with reference to the volume of diluent used fo
reconstitution of dry powder for injection as per innovator product.
• Justify how you have performed pharmaceutical equivalence studies using the reference product of different strength
• Submit data in section 3.2.P.2.3 (Manufacturing process development) as per the decision of 293rd meeting o
Registration Board, which states that “The selection and optimization of the manufacturing process described
3.2.P.3.3, in particular its critical aspects, shall be explained. Any specific manufacturing process development sha
be provided e.g., sterilization shall be explained and justified. Where relevant, justification for the selection of asept
processing or other sterilization methods over terminal sterilization shall be provided”.
• Submit the data of compatibility studies in section 3.2.P.2.6 as per the decision of 293rd meeting of Registration Boar
which states that “Compatibility studies for the dry powder for injections and dry powder for suspension should b
performed as per the instructions provided in individual label of the drug product”
• Batch formula mentioned in section 3.2.P.3.1 evident that only the active ingredient is the part of batch formula, whi
manufacturing procedure specified in section 3.2.P.3.3 stated that “solution has been prepared in 50-liter pyrogen fre
water by dissolving the 1.5kg Citi-Taxime 250mg IM and later add propylene glycol, sodium chloride and sodiu
hydroxide. Clarification is required either the applied product is dry powder for injection or a solution for injection a
evident from the detail manufacturing procedure given in section 3.2. P.3.3.
• Justify the weight variation limit of filled vial from1107-1152mg with reference to the claimed potency of both active
• Provide the Pharmacopeial reference of finished product specifications, since USP specs are mentioned in module
and USP does not contain any monograph for Cefoperazone Sodium and Sulbactam Sodium for Injection. Howeve
monograph for Cefoperazone Sodium and Sulbactam Sodium for Injection is present in Japanese Pharmacopeia.
• Provide COA of primary / secondary reference standard including source and lot number in section 3.2. P.6.
• According to the document submitted in section 3.2.P.8 batch no. T-CSP-002 and T-CSP-003 has been manufacture
on 02-2021, while stability study data sheet submitted in section 3.2.P.8.3 stated these batches were manufactured
sep-2021. Clarification required in this regard.
• Specify the batch size of all three stability batches.
• Justify the pH acceptance criteria (6.0-8.0) and water content acceptance limit (8.0-11%) set for drug product with th
acceptance criteria mentioned on COA of drug substance by drug substance manufacturer i.e. 4.5-6.5 and NMT 3.0%
Elevation of pH and water content of drug product without any further processing of formulation needs to be justif
with the pharmacopeial reference and innovator product.
• Assay content of both active should be separately calculated and mentioned as per pharmacopeial reference an
innovator product.
• As per release specification of drug product acceptance criteria of assay is 90-110% while the stability data she
represents that assay content should be between 90-115%. Justification is required regarding the variation in acceptanc
limit of assay content in various section of module-III.
• Justify why the sterility test is not included in the stability studies of the product.
• Provide details that which lot number of drug substance has been used in manufacturing of each batch of drug produc
Also provide documents confirming evidence of import of each lot of drug substance used in manufacturing of thes
batches of drug product.
• Provide data of stability batches properly arranged and supported by respective documents including analytical repo
/ COA, raw data sheet and respective chromatograms separately for each time point.
• Provide Reference of previous approval of applications with stability study data of the firm (if any)
• Documents for the procurement of API with approval from DRAP (in case of import).
• Provide compliance Record of HPLC software 21CFR & audit trail reports on product testing.
• Provide Record of Digital data logger for temperature and humidity monitoring of stability chambers (real time an
accelerated).
In-use stability studies of reconstituted suspension is required along with proposed in-use storage statement and in-use
shelf-life.
Remarks of the Evaluator:
In response of above shortcomings, firm has submitted a complete new CTD dossier with fee of Rs.7500/- in which dru
substance was imported from a new source and accordingly data of trial batches of drug product manufactured from ne
source of drug substance has submitted. Newly submitted dossier has again evaluated and presented before the Board fo
its consideration.
Name, address of Applicant / Marketing M/s Citi Pharma Private Limited
Name, address of Manufacturing site. M/s Citi Pharma Private Limited Factory: 3 K.M, Head
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Cef-Sulb Injection IV/IM
Strength / concentration of drug of Active Sterile Powder Cefoperazone sodium JP equivalent to
Pharmaceutical ingredient (API) per unit Cefoperazone…….500mg
Sterile Powder Sulbactam sodium JP equivalent to
Sulbactam…….500mg
Pharmaceutical form of applied drug Dry powder for injection
Reference to Finished product specifications JP Specifications
USFDA Approved.
For generic drugs (me-too status) Toxirid Injection 1gm by Global Pharmaceuticals, Reg.
No. 042552
Name and address of API manufacturer. M/s Qilu Antibiotics Pharmaceutical Co. Ltd. China
submitted.
Module III (Drug Substance) Official monograph of cefoperazone sodium /sulbactam
sodium Injection is present in JP pharmacopeia. The
firm has submitted detail of nomenclature, structure,
substance.
Batches: (2003FJ81NH, 2002FJ81NH, 2001FJ81NH)
product.
dissolution profile against the comparator product 2SUM (Cefoperazone
Sodium + Sulbactam Sodium) 1g Injection of M/s.
Healthtek Pvt. Ltd. Karachi, performing quality tests
(Identification, Assay, constituted solution, BET &
sterility test).
Manufacturer of API Qilu Antibiotic Pharmaceutical Co. Ltd. China
API Lot No. 2001FJ81NH
Description of Pack One clear glass vial 15ml with LDPE ampoule of WFI along with leaflet in unit
(Container closure system) carton.
Batch No. TRI003-01 TRI003-02 TRI003-03
Batch Size (Scientifically Not mentioned Not mentioned Not mentioned
rational batch size)
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has not submitted the requisite document.
3. Documents for the procurement of API with Form-6 grant permission for license to import from M/s.
approval from DRAP (in case of import). Qilu Antibiotics Pharmaceuticals Co. Ltd., China vide
Dy. No. 11160/2021 DRAP Dated: 27-12-2021.
Invoice attested vide Dy.no. 11160/2021 DRAP dated:
27-12-2021in which shipper was M/s. Shandong Luoxin
Pharmaceuticals, China.
4. Data of stability batches will be supported by Raw data sheets and chromatograms attached.

Sr.no. Section Shortcomings/Observations
1. 3.2. S.4.1 Acceptance criteria of assay mentioned in specification of drug was not in
accordance with JP monograph.
Assay limit mentioned in COA and Assay acceptance criteria in
specification of drug substance by accordance with JP monograph is
both drug substance manufacturer “It contains not less than 90.0% and
and drug product manufacturer was not more than 110.0% of the labeled
Cefoperazone on anhydrous basis potency of cefoperazone
≥43.5% and sulbactam on (C25H27N9O8S2: 645.67), and not
anhydrous basis ≥44.5%. less than 95.0% and not more than
110.0% of the labeled potency of
sulbactam (C8H11NO5S: 233.24)”.
2. 3.2. S.4.3 Firm has not submitted the analytical method verification report of drug
substance performed by drug product manufacturer.
3. 3.2. S.5 Firm has not submitted the COA of primary / secondary reference standard
including source and lot number used for testing of drug substance.
4. 3.2. S.7 Firm has submitted only 6 months long term stability data of all three batches
of drug substance.
5. 3.2P.2.1(a)(b) Firm has not provided any details related to weight of powder filled per vial
keeping in view the sodium content of both active substances.
6. 3.2.P.2.1(C) Firm has not provided any details regarding the type of diluent, its
composition, quantity or volume, specifications (as applicable) in which drug
product has to be reconstitute before administration.
7. 3.2. P.2.2.1 Firm has submitted the pharmaceutical equivalence report in which the
acceptance criteria of all the quality test was not in accordance with JP
monograph:
Acceptance criteria in Acceptance criteria in JP monograph
pharmaceutical equivalence report
pH (6.0-8.8) pH (4.5-6.5)
Assay (90%-110%) Assay (It contains not less than 90.0
and not more than 110.0% of the
labeled potency of cefoperazone
(C25H27N9O8S2: 645.67), and not
less than 95.0% and not more than
sulbactam (C8H11NO5S: 233.24).)
Bacterial Endotoxin Test (NMT 0.2 Bacterial Endotoxin Test (Less than
USP Endotoxin unit per mg) 0.060 EU/mg (potency).)
Further firm has not performed water content test and clarity and color of
solution test which are also included in JP monograph.
8. 3.2. P.5.2 Firm has not submitted the analytical procedure used for testing of drug
product.
9. 3.2.P.5.3 Analytical method verification report reflects that the assay has performed on
UV method while the JP monograph recommends the HPLC method for assay
of drug product.
10. 3.2.P.6 Firm has not submitted the COA of primary / secondary reference standard
including source and lot number used for testing of drug product.
11. 3.2.P.8 Firm has not submitted following documents to support the stability data of
drug product:
• Reference of previous approval of applications with stability study data of
the firm (if any)
• Documents for the procurement of API with approval from DRAP (in case
of import).
• Details that which lot number of drug substance has been used in
manufacturing of each batch of drug product. Also provide documents
confirming evidence of import of each lot of drug substance used in
manufacturing of these batches of drug product.
• Valid Good Manufacturing Practice (GMP) certificate of the Drug
Substance manufacturer issued by relevant regulatory authority of country
of origin.
• Firm submitted the invoice of import of drug substance according to which,
supplier of the drug substance was M/s. Shandong Luoxin Pharmaceutical
Co., Ltd China and quantity of 5kg has been imported and clearance granted
on 27-12-2021 vide dy.no.11160/2021 DRAP. While the firm has also
submitted Form-6 along with the invoice in which license to import drug
from Qilu Antibiotics Pharmaceuticals Co. Ltd. China has given on 27-12-
2021 vide Dy.no. 11160/2021 DRAP.
12. Firm has not submitted the copy of Batch Manufacturing Record (BMR) for
all the batches of drug product for which stability studies data is provided in
Module 3 section 3.2. P.8.3.
• Submit analytical method verification studies including results of specificity and accuracy parameters
as per requirement of section 3.2.S.4.3 of Form-5F.
• Justification for adopting the acceptance criteria of assay of drug substance different from that specified
in JP monograph.
• COA of primary / secondary reference standard including source and lot number used for testing of
drug substance.
• Submit long term stability data of drug substance till the claimed shelf life.
• Submit weight of powder filled per vial keeping in view the sodium content of both active substances,
under section 3.2.P.2.1.
• Submit pharmaceutical equivalence report, in which all the quality test should performed in compliance
with JP monograph.
• Submit analytical procedure used for testing of drug product under section 3.2.P.5.2.
• Submit analytical method verification report of assay testing performed on HPLC in compliance with
JP monograph.
• COA of primary / secondary reference standard including source and lot number used for testing of
drug product.
• Details that which lot number of drug substance has been used in manufacturing of each batch of drug
product. Also provide documents confirming evidence of import of each lot of drug substance used in
• Valid Good Manufacturing Practice (GMP) certificate of the Drug Substance manufacturer issued by
relevant regulatory authority of country of origin.
• Copy of Batch Manufacturing Record (BMR) for all the batches of drug product for which stability
studies data is provided in Module 3 section 3.2. P.8.3.
• Full fee of Rs. 30,000 for revision of stability data as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021.
Name, address of Manufacturing site. M/s Citi Pharma Private Limited Factory: 3 K.M, Hea
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Cef-Slub Injection IV/IM
Strength / concentration of drug of Active Sterile Powder of Cefoperazone sodium MS equivalent t
Pharmaceutical ingredient (API) per unit Cefoperazone 1g
Sterile Powder of Sulbactam sodium MS equivalent t
Sulbactam 1g
USFDA Approved.
For generic drugs (me-too status) Toxirid Injection 2gm by Global Pharmaceuticals, Reg. N
042555
Name and address of API manufacturer. M/s Shandong Luoxin Pharmaceutical Co.,Ltd China
submitted.
Module III (Drug Substance) Official monograph of Cefoperazone sodium /Sulbactam
sodium eq to Cefoperazone /Sulbactam is present no
present in any pharmacopeia. The firm as submitted deta
of nomenclature, structure, general properties, solubilitie
substance
Batches: (T-CSP001, T-CSP002, T-CSP003)
dissolution profile the brand leader that is Toxirid Injection 2gm by Glob
dosage form).
Manufacturer of API M/s Shandong Luoxin Pharmaceutical Co.,Ltd China
API Lot No. CEFP17/023/06/21
Description of Pack One clear glass vial 15ml with LDPE ampoule of WFI along with leafl
(Container closure system) in unit carton.
Batch No. T-CSP001 T-CSP002 Batch No.
Batch Size (Scientifically rational batch 1000 Vials 1000 Vials Batch Siz
size) (Scientifically
rational batc
size)
Manufacturing Date 09-2021 09-2021 Manufacturin
Date
Date of Initiation Date o
28-09-2021 28-09-2021
Initiation
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. SD20191025 issued by
manufacturer issued by concerned regulatory CFDA valid till 10/12/2024.
3. Documents for the procurement of API with Letter No. 11160/2021/DRAP Dated: 27-07-2021
approval from DRAP (in case of import). B/L No. 176-6445-291 dated: 31-07-2021


Shortcomings communicated to the Firm:
• You have mentioned USP specification in section 1.5.6 in module 1, while the drug product monograph is not availab
in USP, but present in JP. Revise the specifications along with submission of requisite fee.
• The drug substance manufacturer has claimed both USP and in-house standards for the drug substance, provid
scientific justification in this regard.
• Justify, how you have claimed USP specification for drug substance cefoperazone sodium+Sulbactum30-May-2
sodium, when the monograph has not been present in USP.
• Submit data in section 3.2.S.4.1 as per the guidance document approved by Registration Board which specifies th
“Copies of the Drug substance specifications and analytical procedures used for routine testing of the Drug substanc
/Active Pharmaceutical Ingredient by both Drug substance manufacturer.”
• Submit data in section 3.2.S.4.3 as per the decision of 293rd meeting of Registration Board, which states th
“Analytical Method Verification studies including specificity, accuracy and repeatability (method precision) performe
by the Drug Product manufacturer for both compendial as well as non-compendial drug substance(s) shall b
submitted”. Further justify how the analysis of drug substance was conducted without performing verification studi
of the analytical method of drug substance.
• Stability study data of 3 batches of drug substances till the assigned shelf life needs to be submitted, since stability da
of 3 months has submitted despite the batch had been manufactured in 2017.
• Submit data in section 3.2.P.1 (c) as per the decision of 293rd meeting of Registration Board, which states that “Provid
information including type of diluent, its composition, quantity or volume, specifications (as applicable) and regulator
status in Pakistan (as applicable) for the diluent which is to be provided along with the applied drug”.
• Justify the use of 4ml printed glass vial for packaging of drug product with reference to the volume of diluent used fo
reconstitution of dry powder for injection as per innovator product.
• Justify how you have performed pharmaceutical equivalence studies using the reference product of different strength
• Submit data in section 3.2.P.2.3 (Manufacturing process development) as per the decision of 293rd meeting
Registration Board, which states that “The selection and optimization of the manufacturing process described
3.2.P.3.3, in particular its critical aspects, shall be explained. Any specific manufacturing process development sha
be provided e.g., sterilization shall be explained and justified. Where relevant, justification for the selection of asept
processing or other sterilization methods over terminal sterilization shall be provided”.
• Submit the data of compatibility studies in section 3.2.P.2.6 as per the decision of 293rd meeting of Registration Boar
which states that “Compatibility studies for the dry powder for injections and dry powder for suspension should b
performed as per the instructions provided in individual label of the drug product”
• Batch formula mentioned in section 3.2.P.3.1 evident that only the active ingredient is the part of batch formula, whi
manufacturing procedure specified in section 3.2.P.3.3 stated that “solution has been prepared in 50-liter pyrogen fre
water by dissolving the 1.5kg Citi-Taxime 250mg IM and later add propylene glycol, sodium chloride and sodiu
hydroxide. Clarification is required either the applied product is dry powder for injection or a solution for injection a
evident from the detail manufacturing procedure given in section 3.2. P.3.3.
• Justify the weight variation limit of filled vial from1107-1152mg with reference to the claimed potency of both active
• Provide the Pharmacopeial reference of finished product specifications, since USP specs are mentioned in module
and USP does not contain any monograph for Cefoperazone Sodium and Sulbactam Sodium for Injection. Howeve
monograph for Cefoperazone Sodium and Sulbactam Sodium for Injection is present in Japanese Pharmacopeia.
• Provide COA of primary / secondary reference standard including source and lot number in section 3.2. P.6.
• According to the document submitted in section 3.2.P.8 batch no. T-CSP-002 and T-CSP-003 has been manufacture
on 02-2021, while stability study data sheet submitted in section 3.2.P.8.3 stated these batches were manufactured
sep-2021. Clarification required in this regard.
• Specify the batch size of all three stability batches.
• Justify the pH acceptance criteria (6.0-8.0) and water content acceptance limit (8.0-11%) set for drug product with th
acceptance criteria mentioned on COA of drug substance by drug substance manufacturer i.e. 4.5-6.5 and NMT 3.0%
Elevation of pH and water content of drug product without any further processing of formulation needs to be justi
with the pharmacopeial reference and innovator product.
• Assay content of both active should be separately calculated and mentioned as per pharmacopeial reference an
innovator product.
• As per release specification of drug product acceptance criteria of assay is 90-110% while the stability data she
represents that assay content should be between 90-115%. Justification is required regarding the variation in acceptanc
limit of assay content in various section of module-III.
• Justify why the sterility test is not included in the stability studies of the product.
• Provide details that which lot number of drug substance has been used in manufacturing of each batch of drug produc
Also provide documents confirming evidence of import of each lot of drug substance used in manufacturing of thes
• Provide data of stability batches properly arranged and supported by respective documents including analytical repo
/ COA, raw data sheet and respective chromatograms separately for each time point.
• Provide Reference of previous approval of applications with stability study data of the firm (if any)
• Provide compliance Record of HPLC software 21CFR & audit trail reports on product testing.
• Provide Record of Digital data logger for temperature and humidity monitoring of stability chambers (real time an
accelerated).
In-use stability studies of reconstituted suspension is required along with proposed in-use storage statement and in-use
shelf-life.
Remarks of the Evaluator:
In response of above shortcomings, firm has submitted a complete new CTD dossier with fee of Rs.7500/- in which dru
substance was imported from a new source and accordingly data of trial batches of drug product manufactured from ne
source of drug substance has submitted. Newly submitted dossier has again evaluated and presented before the Board fo
its consideration.
Name, address of Applicant / Marketing M/s Citi Pharma Private Limited
Name, address of Manufacturing site. M/s Citi Pharma Private Limited Factory: 3 K.M, Head
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Cef-Slub Injection
Strength / concentration of drug of Active Sterile Powder of Cefoperazone sodium JP equivalent to
Pharmaceutical ingredient (API) per unit Cefoperazone 1g
Sterile Powder of Sulbactam sodium JP equivalent to
Sulbactam 1g
Pharmaceutical form of applied drug Dry Powder for Injection
Reference to Finished product specifications JP Specifications
USFDA Approved.
For generic drugs (me-too status) Toxirid Injection 2gm by Global Pharmaceuticals, Reg.
No. 042555
Name and address of API manufacturer. M/s Qilu Antibiotics Pharmaceutical Co. Ltd. China
Module III (Drug Substance) Official monograph of cefoperazone sodium /sulbactam
sodium Injection is present in JP pharmacopeia. The firm
has submitted detail of nomenclature, structure, general
description of manufacturing process and controls, tests
for impurity D, G & related substances (impurity A &
unspecified), specifications, analytical procedures and
Batches: (2003FJ81NH, 2002FJ81NH, 2001FJ81NH)
product.
dissolution profile against the comparator product 2SUM (Cefoperazone
Sodium + Sulbactam Sodium) 2g Injection of M/s.
Healthtek Pvt. Ltd. Karachi, performing quality tests
(Identification, Assay, constituted solution, BET &
sterility test).
Manufacturer of API Qilu Antibiotic Pharmaceutical Co. Ltd. China
API Lot No. 2001FJ81NH
Description of Pack One clear glass vial 15ml with LDPE ampoule of WFI along with leaflet in unit
(Container closure system) carton.
Batch No. TRI004-01 TRI004-02 TRI004-03
Batch Size (Scientifically Not mentioned Not mentioned Not mentioned
rational batch size)
No. of Batches 03
9. Documents for the procurement of API with Form-6 grant permission license to import from M/s.
approval from DRAP (in case of import). Qilu Antibiotics Pharmaceuticals Co. Ltd., China vide
Dy. No. 11160/2021 DRAP Dated: 27-12-2021.
Invoice attested vide Dy.no. 11160/2021 DRAP dated:
27-12-2021in which shipper was M/s. Shandong Luoxin
Pharmaceuticals, China.

Sr.no. Section Shortcomings/Observations
1. 3.2. S.4.1 Acceptance criteria of assay mentioned in specification of drug was not in
accordance with JP monograph.
Assay limit mentioned in COA and Assay acceptance criteria in
specification of drug substance by accordance with JP monograph is
both drug substance manufacturer “It contains not less than 90.0% and
and drug product manufacturer was not more than 110.0% of the labeled
Cefoperazone on anhydrous basis potency of cefoperazone
≥43.5% and sulbactam on (C25H27N9O8S2: 645.67), and not
anhydrous basis ≥44.5%. less than 95.0% and not more than
sulbactam (C8H11NO5S: 233.24)”.
2. 3.2. S.4.3 Firm has not submitted the analytical method verification report of drug
substance performed by drug product manufacturer.
3. 3.2. S.5 Firm has not submitted the COA of primary / secondary reference standard
including source and lot number used for testing of drug substance.
4. 3.2. S.7 Firm has submitted only 6 months long term stability data of all three batches
of drug substance.
5. 3.2P.2.1(a)(b) Firm has not provided any details related to weight of powder filled per vial
keeping in view the sodium content of both active substances.
6. 3.2.P.2.1(C) Firm has not provided any details regarding the type of diluent, its
composition, quantity or volume, specifications (as applicable) in which drug
product has to be reconstitute before administration.
7. 3.2. P.2.2.1 Firm has submitted the pharmaceutical equivalence report in which the
acceptance criteria of all the quality test was not in accordance with JP
monograph:
Acceptance criteria in Acceptance criteria in JP monograph
pharmaceutical equivalence report
pH (6.0-8.8) pH (4.5-6.5)
Assay (90%-110%) Assay (It contains not less than 90.0
and not more than 110.0% of the
labeled potency of cefoperazone
(C25H27N9O8S2: 645.67), and not
less than 95.0% and not more than
sulbactam (C8H11NO5S: 233.24).)
Bacterial Endotoxin Test (NMT 0.2 Bacterial Endotoxin Test (Less than
USP Endotoxin unit per mg) 0.060 EU/mg (potency).)
Further firm has not performed water content test and clarity and color of
solution test which are also included in JP monograph.
8. 3.2. P.5.2 Firm has not submitted the analytical procedure used for testing of drug
product.
9. 3.2.P.5.3 Analytical method verification report reflects that the assay has performed on
UV method while the JP monograph recommends the HPLC method for assay
of drug product.
10. 3.2.P.6 Firm has not submitted the COA of primary / secondary reference standard
including source and lot number used for testing of drug product.
11. 3.2.P.8 Firm has not submitted following documents to support the stability data of
drug product:
• Reference of previous approval of applications with stability study data of
the firm (if any)
• Documents for the procurement of API with approval from DRAP (in case
of import).
• Details that which lot number of drug substance has been used in
manufacturing of each batch of drug product. Also provide documents
confirming evidence of import of each lot of drug substance used in
• Valid Good Manufacturing Practice (GMP) certificate of the Drug
Substance manufacturer issued by relevant regulatory authority of country
of origin.
• Firm submitted the invoice of import of drug substance according to which,
supplier of the drug substance was M/s. Shandong Luoxin Pharmaceutical
Co.,Ltd China and quantity of 5kg has been imported and clearance granted
on 27-12-2021 vide dy.no.11160/2021 DRAP. While the firm has also
submitted Form-6 along with the invoice in which license to import drug
from Qilu Antibiotics Pharmaceuticals Co. Ltd. China has given on 27-12-
2021 vide Dy.no. 11160/2021 DRAP.
12. Firm has not submitted the copy of Batch Manufacturing Record (BMR) for
all the batches of drug product for which stability studies data is provided in
• Submit analytical method verification studies including results of specificity and accuracy parameters as per
requirement of section 3.2.S.4.3 of Form-5F.
• Justification for adopting the acceptance criteria of assay of drug substance different from that specified in
JP monograph.
• COA of primary / secondary reference standard including source and lot number used for testing of drug
substance.
• Submit long term stability data of drug substance till the claimed shelf life.
• Submit weight of powder filled per vial keeping in view the sodium content of both active substances, under
section 3.2.P.2.1.
• Submit pharmaceutical equivalence report, in which all the quality test should performed in compliance with
JP monograph.
• Submit analytical procedure used for testing of drug product under section 3.2.P.5.2.
• Submit analytical method verification report of assay testing performed on HPLC in compliance with JP
monograph.
• COA of primary / secondary reference standard including source and lot number used for testing of drug
product.
• Details that which lot number of drug substance has been used in manufacturing of each batch of drug
product. Also provide documents confirming evidence of import of each lot of drug substance used in
• Valid Good Manufacturing Practice (GMP) certificate of the Drug Substance manufacturer issued by
relevant regulatory authority of country of origin.
• Copy of Batch Manufacturing Record (BMR) for all the batches of drug product for which stability studies
data is provided in Module 3 section 3.2. P.8.3.
• Full fee of Rs. 30,000 for revision of stability data as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
Name, address of Manufacturing site. M/s Citi Pharma Private Limited
Factory: 3 K.M, Head Balloki Road, Phool Nagar, Dist
Kasur
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No.11609 dated 13/05/2022
The proposed proprietary name / brand name Citi-Pime Injection 1gm
Strength / concentration of drug of Active Sterile Powder of Cefepime HCL with L- Arginine Eq. t
Pharmaceutical ingredient (API) per unit Cefepime 1g
The status in reference regulatory authorities Maxipime Injection 1g
by M/s Hospira Inc. USA,
USFDA Approved.
For generic drugs (me-too status) Zepime Injection 1g by Global Pharmaceuticals, Reg. No
046016
Name and address of API manufacturer. M/s Kopran Research Laboratories Ltd India
submitted.
Module III (Drug Substance) Official monograph of Cefepime HCL with L- Arginine
present in USP. The firm has submitted detail o
substance
Batches: (CEIV/B1203011, CEIV/B120301
CEIV/B1203013)
studies, batch analysis and justification of specificatio
dissolution profile the comparator brand that is Zepime Injection 1g by Glob
dosage form).
Manufacturer of API M/s Kopran Research Laboratories Ltd India
API Lot No. CFM-2104004
Description of Pack One clear glass vial 15ml with LDPE ampoule of WFI or 1% Lidocain
(Container closure system) along with leaflet in unit carton.
Batch No. TC006-001 TC006-002 TC006-003
Batch Size (Scientifically rational batch Not Not mentioned Not mentione
size) mentioned
No. of Batches 03
3. Documents for the procurement of API with Form-6 grant permission for license to import from M/
approval from DRAP (in case of import). Kopran Research laboratories,India vide Dy. No. 617
Dated: 16-04-2021.
Invoice attested vide Dy.no. 6017/2021 DRAP dated: 22
04-2021in which exporter was M/s. Kopran Researc
laboratories, India

Sr.no. Section Observations/Shortcomings Reply of the Firm
1. 3.2.S.4.1 Submit specifications as well Firm has not submitted the specifications and
3.2. S.4.2 as analytical method of the analytical procedure of drug substance by drug
drug substance from the drug product manufacturer.
product manufacturer in
section 3.2.S.4.1 and 3.2.
S.4.2.
2. 3.2. S.4.3 Submit data in section Firm has not submitted the analytical method
3.2.S.4.3 as per the guidance verification report of drug substance
document approved by performed by drug product manufacturer.
Registration Board which
specifies that “Analytical
Method Verification studies
including specificity,
accuracy and repeatability
(method precision) performed
by the Drug Product
manufacturer for both
compendial as well as non-
compendial drug substance(s)
shall be submitted”
3. 3.2. S.7 Submit complete long-term Firm has not submitted the long-term stability
stability data of all three data of batch no. CEIV/B1203013.
batches of drug substance,
since only the complete data
of batch no. CEIV/B1203011
has been submitted in section
3.2. S.7.
4. 3.2. P.2.6 Submit the data of Firm has not submitted the reply in response of
compatibility studies in this query.
section 3.2.P.2.6 as per the
decision of 293rd meeting of
Registration Board, which
states that “Compatibility
studies for the dry powder for
injections and dry powder for
suspension should be
performed as per the
instructions provided in
individual label of the drug
product”
5. 3.2. P.3.1 Batch formula mentioned in Firm has submitted the amended document in
section 3.2.P.3.1 evident that which cefepime HCl with L-arginine is
only the active ingredient is mentioned as the only active ingredient.
the part of batch formula, However, the information regarding the
while manufacturing quantity of dry powder filled per vial has not
procedure specified in section been given. Further, the flow chart of
3.2.P.3.3 stated that “solution manufacturing process submitted in the reply
has been prepared in 50-liter of section 3.2.P.3.3 is of ceftriaxone.
pyrogen free water by
dissolving the 1.5kg Citi-
Taxime 250mg IM and later
add propylene glycol, sodium
chloride and sodium
hydroxide. Clarification is
required either the applied
product is dry powder for
injection or a solution for
injection as evident from the
detail manufacturing
procedure given in section 3.2.
P.3.3.
6. 3.2.P.5.2 Provide complete analytical Firm again submit the copy of monograph of
procedure used for routine USP in section 3.2.P.5.2 and in section
testing of drug product since 3.2.P.4.2 submit the analytical procedure of
submitting the copy of USP cefotaxime injection.
monograph did not fulfil the
requirement of section 3.2.
P.5.2.
7. 3.2.P.5.3 Analytical method of drug Firm has not given the reply in response of
product verified in section this query.
3.2.P.5.3 is different from that
specified in USP monograph.
Justify, for using different
analytical method for
8. 3.2.P.5.4 Scientific justification for not firm has submitted batch analysis report of
performing test of three trail batches TRA-001, TRA-002, TRA-
completeness and clarity of 003 which were not the batch numbers of trial
solution, bacterial endotoxin batches used for stability studies as evident
test, testing of pH, water from the submitted stability data sheets.
determination test and sterility Further, the test of completeness and clarity of
test during the batch release of solution, bacterial endotoxin test, testing of pH,
the drug product water determination test and sterility test was
not been included in batch analysis report nor
given any justification.
Furthermore, the firm submitted the same

batch analysis report for cefepime 500mg
injection and cefepime 1gm injection.
9. 3.2.P.6 Provide COA of primary / Firm has submitted the reply in response of
secondary reference standard this query.
including source and lot
number in section 3.2. P.6.
10. 3.2.P.8 Submit the stability data sheet Firm stated that rectified and corrected
of cefepime injection, since stability data sheets are submitted.
the submitted sheets are of
ceftriaxone.
11. 3.2.P.8 According to the document Firm stated that rectified and corrected stability
submitted in section 3.2. P.8 data sheets are submitted. However, the firm
batch no. Cef-P-004, Cef-P- submitted the raw data sheets of batch no.
005and Cef-P-006 has been TC006-01, TC006-02, TC006-03.
manufactured on 09-2021,
while the dossier submitted in
R&I of DRAP on 13th
May,2022i.e. after 8 months
of manufacturing of trial
batches, clarification is
required how you have
submitted the stability data of
real time study till 24month.
12. 1. Provide details that which Firm has only submitted the chromatograms
lot number of drug and 21 CFR audit trail report of instant product.
substance has been used in Remaining documents has not been provided
manufacturing of each by the firm.
batch of drug product. Also
provide documents
confirming evidence of
import of each lot of drug
substance used in
manufacturing of these
2. Provide data of stability
batches properly arranged
and supported by
respective documents
including analytical report /
COA, raw data sheet and
respective chromatograms
separately for each time
point.
3. Provide Reference of
previous approval of
applications with stability
study data of the firm (if
any)
4. Documents for the
case of import).
5. Provide compliance
Record of HPLC software
21CFR & audit trail reports
on product testing.
6. Provide Record of Digital
data logger for temperature
and humidity monitoring of
7. In-use stability studies of
reconstituted injection is
required along with
proposed in-use storage
statement and in-use shelf-
life.
8. Provide copy of Batch
Manufacturing Record
(BMR) for all the batches
of drug product for which
stability studies data is
provided in Module 3
section 3.2. P.8.3.
• Specifications as well as analytical method of the drug substance from the drug product manufacturer i
section 3.2.S.4.1 and 3.2. S.4.2.
• Analytical method verification report of drug substance performed by drug product manufacturer.
• Long-term stability data of batch no. CEIV/B1203013 of drug substance till the claimed shelf life/re-te
period.
• Compatibility study data of drug product with its diluent under the requirement of section 3.2.P.2.6.
• Complete batch formula along with quantity of filled weight per vial in section 3.2.P.3.
• Complete analytical procedure used for routine testing of applied drug product in section 3.2. P.5.2.
• Analytical method verification report of assay testing of drug product,in compliance of USP monograph
Cefepime Injection.
• Clarification regarding the trial batches which were actually manufactured for the stability study of applie
product.
• Batch analysis report of all three trial batches, in which all the quality test should be included that ar
specify in USP monograph of Cefepime injection.
• Provide details that which lot number of drug substance has been used in manufacturing of each batch o
drug product. Also provide documents confirming evidence of import of each lot of drug substance used
• Provide data of stability batches properly arranged and supported by respective documents includin
analytical report / COA, raw data sheet and respective chromatograms separately for each time point.
• Provide copy of Batch Manufacturing Record (BMR) for all the batches of drug product for which stabilit
studies data is provided in Module 3 section 3.2. P.8.3.
Kasur
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Citi-Pime Injection
Strength / concentration of drug of Active Sterile Powder of Cefepime HCL with L-Arginine Eq. t
Pharmaceutical ingredient (API) per unit Cefepime 500mg
Pharmaceutical form of applied drug Dry powder for injection
The status in reference regulatory authorities Maxipime Injection 500mg
by M/s Hospira Inc. USA,
USFDA Approved.
For generic drugs (me-too status) Zepime Injection 500mg by Global Pharmaceuticals, Reg
No. 046015
Name and address of API manufacturer. M/s Kopran Research Laboratories Ltd,Maharashtra, Indi
submitted.
Module III (Drug Substance) Official monograph of Cefepime for injection is present i
USP. The firm has submitted detail of nomenclatur
controls, tests for impurity D, G & related substance
(impurity A & unspecified), specifications, analytic
procedures and its verification, batch analysis an
justification of specification, reference standard, containe
Real time: 30°C ± 2°C / 65% ± 5%RH
Batches: (CEIV/B1203011, CEIV/B120301
CEIV/B1203013)
dissolution profile the brand leader that is Zepime Injection 500mg by Glob
dosage form).
Manufacturer of API M/s. Kopran Research Laboratories Ltd India
API Lot No. CFM-2104004
Description of Pack One clear glass vial 15ml with LDPE ampoule of WFI or 1% Lidocain
(Container closure system) along with leaflet in unit carton.
Batch No. TC007-001 TC007-002 TC007-001
size) mentioned
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API not submitted
3. Documents for the procurement of API with Form-6: Letter No. 6176/2021 DRAP dated: 22-04-2021
approval from DRAP (in case of import). Invoice: bearing two different dy.no. and date 6017/2021
DRAP (22-04-2021) & 6176 (16-04-2021)


1. 3.2.S.4.1 Submit specifications as well Firm has not submitted the specifications and
3.2. S.4.2 as analytical method of the analytical procedure of drug substance by drug
drug substance from the drug product manufacturer.
product manufacturer in
section 3.2.S.4.1 and 3.2.
S.4.2.
2. 3.2. S.4.3 Submit data in section Firm has not submitted the analytical method
3.2.S.4.3 as per the guidance verification report of drug substance performed
document approved by by drug product manufacturer.
(method precision) performed
by the Drug Product
manufacturer for both
compendial as well as non-
compendial drug substance(s)
shall be submitted”
3. 3.2. S.7 Submit complete long-term Firm has not submitted the long-term stability
stability data of all three data of batch no. CEIV/B1203013.
batches of drug substance,
since only the complete data
of batch no. CEIV/B1203011
has been submitted in section
3.2. S.7.
4. 3.2. P.2.6 Submit the data of Firm has not submitted the reply in response of
compatibility studies in this query.
section 3.2.P.2.6 as per the
decision of 293rd meeting of
Registration Board, which
states that “Compatibility
studies for the dry powder for
injections and dry powder for
suspension should be
performed as per the
instructions provided in
individual label of the drug
product”
5. 3.2. P.3.1 Batch formula mentioned in Firm has submitted the amended document in
section 3.2.P.3.1 evident that which cefepime HCl with L-arginine is
only the active ingredient is mentioned as the only active ingredient.
the part of batch formula, However, the information regarding the
while manufacturing quantity of dry powder filled per vial has not
procedure specified in section been given. Further, the flow chart of
3.2.P.3.3 stated that “solution manufacturing process submitted in the reply
has been prepared in 50-liter of section 3.2.P.3.3 is of ceftriaxone.
pyrogen free water by
dissolving the 1.5kg Citi-
Taxime 250mg IM and later
add propylene glycol, sodium
chloride and sodium
hydroxide. Clarification is
required either the applied
product is dry powder for
injection or a solution for
injection as evident from the
detail manufacturing
procedure given in section 3.2.
P.3.3.
6. 3.2.P.5.2 Provide complete analytical Firm again submit the copy of monograph of
procedure used for routine USP in section 3.2.P.5.2 and in section
testing of drug product since 3.2.P.4.2 submit the analytical procedure of
submitting the copy of USP cefotaxime injection.
monograph did not fulfil the
requirement of section 3.2.
P.5.2.
7. 3.2.P.5.3 Analytical method of drug Firm has not given the reply in response of
product verified in section this query.
3.2.P.5.3 is different from that
specified in USP monograph.
Justify, for using different
analytical method for
8. 3.2.P.5.4 Scientific justification for not firm has submitted batch analysis report of
performing test of three trail batches TRA-001, TRA-002, TRA-
completeness and clarity of 003 which were not the batch numbers of trial
solution, bacterial endotoxin batches used for stability studies as evident
test, testing of pH, water from the submitted correct stability data sheets.
determination test and sterility Further, the test of completeness and clarity of
test during the batch release of solution, bacterial endotoxin test, testing of pH,
the drug product water determination test and sterility test was
not been included in batch analysis report nor
given any justification.
Furthermore, the firm submitted the same

batch analysis report for cefepime 500mg
injection and cefepime 1gm injection.
9. 3.2.P.6 Provide COA of primary / Firm has not submitted the reply in response of
secondary reference standard this query.
including source and lot
number in section 3.2. P.6.
10. 3.2.P.8 Submit the stability data sheet Firm submitted the rectified and corrected
of cefepime injection, since stability data sheets.
the submitted sheets are of
ceftriaxone.
11. 3.2.P.8 According to the document Firm stated that rectified and corrected stability
submitted in section 3.2. P.8 data sheets are submitted and the corrected
batch no. Cef-P-004, Cef-P- stability trial batches were of batch no. TC007-
005and Cef-P-006 has been 01, TC007-02, TC007-03.
manufactured on 09-2021,
while the dossier submitted in
R&I of DRAP on 13th
May,2022i.e. after 8 months
of manufacturing of trial
batches, clarification is
required how you have
submitted the stability data of
real time study till 24month.
12. 1. Provide details that which Firm has only submitted the chromatograms
lot number of drug and 21 CFR audit trail report of instant product.
substance has been used in Remaining documents has not been provided
manufacturing of each by the firm.
st
721
batch of drug product. Also
provide documents
confirming evidence of
import of each lot of drug
substance used in
manufacturing of these
2. Provide data of stability
batches properly arranged
and supported by
respective documents
including analytical report /
COA, raw data sheet and
respective chromatograms
separately for each time
point.
3. Provide Reference of
previous approval of
applications with stability
study data of the firm (if
any)
4. Documents for the
case of import).
5. Provide compliance
Record of HPLC software
21CFR & audit trail reports
on product testing.
6. Provide Record of Digital
data logger for temperature
and humidity monitoring of
7. In-use stability studies of
reconstituted injection is
required along with
proposed in-use storage
statement and in-use shelf-
life.
8. Provide copy of Batch
Manufacturing Record
(BMR) for all the batches
of drug product for which
stability studies data is
provided in Module 3
section 3.2. P.8.3.
• Specifications as well as analytical method of the drug substance from the drug product manufacturer
in section 3.2.S.4.1 and 3.2. S.4.2.
• Long-term stability data of batch no. CEIV/B1203013 of drug substance till the claimed shelf life/re-
test period.
• Compatibility study data of drug product with its diluent under the requirement of section 3.2.P.2.6.
• Complete batch formula along with quantity of filled weight per vial in section 3.2.P.3.
• Complete analytical procedure used for routine testing of applied drug product in section 3.2. P.5.2.
• Analytical method verification report of assay testing of drug product,in compliance of USP
monograph of Cefepime Injection.
• Clarification regarding the trial batches which were actually manufactured for the stability study of
applied product.
• Batch analysis report of all three trial batches, in which all the quality test should be included that are
specify in USP monograph of Cefepime injection.
• Provide details that which lot number of drug substance has been used in manufacturing of each batch
of drug product. Also provide documents confirming evidence of import of each lot of drug substance
used in manufacturing of these batches of drug product.
• Provide data of stability batches properly arranged and supported by respective documents including
analytical report / COA, raw data sheet and respective chromatograms separately for each time point
• Provide copy of Batch Manufacturing Record (BMR) for all the batches of drug product for which
stability studies data is provided in Module 3 section 3.2. P.8.3.
Kasur
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Cefask Capsule 200mg
Pharmaceutical ingredient (API) per unit Cefixime as Trihydrate .....200mg
Pharmaceutical form of applied drug Oral Capsule
Pharmacotherapeutic Group of (API) Third generation cephalosporin antibiotic
Reference to Finished product specifications Manufacturer’s Specification
Proposed Pack size 2x5’s
The status in reference regulatory authorities SUPRAX 200 mg CAPSULE by SANOFI Aventis Spain
Approved
For generic drugs (me-too status) Cefiget 200 mg Capsule by M/s GETZ Pharma
Name and address of API manufacturer. M/s Citi Pharma Private Limited
Kasur
submitted.
Module III (Drug Substance) Official monograph of cefixime drug substance is presen
in USP. The firm has submitted detail of nomenclatur
Real time: 30°C ± 2°C / 65% ± 5%RH for 36th month
Batches: (CFM1602001, CFM1602002, CFM1602003)
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been established agains
dissolution profile the comparator brand Product: Maxophine 200mg Capsul
Manufacturer: Global Pharmaceutical (Pvt.) Ltd.
Batch no: 20H097
Mfg Date: 08-2020
Manufacturer of API M/s Citi Pharma Private Limited
Factory: 3 K.M, Head Balloki Road, Phool Nagar, Distt. Kasur
API Lot No. Not mentioned
Description of Pack Hard gelatin shell capsule, blistered in alu-pvc packed in standard un
(Container closure system) carton in 2x5s provided with leafinsert inside.
Batch No. TRA-001 TRA-002 TRA-003
size) mentioned
No. of Batches 03



1. 1.5.7 • In section 1.5.7, you have Firm replied that We have to revised
claimed USP specification for the specification of drug product as
drug product while in section approved by DRAP, but firm has not
3.2.P.5.2 JP monograph for submitted the fee for change of
cefixime capsule has been specification.
attached which revealed that
product is comply with JP
specification. Clarify, how
200mg potency capsule comply
dissolution acceptance criteria
of JP monograph, since it is
applicable for 50mg and 100mg.
• Revised the specification of
drug product along with
requisite fee as per the
monograph of cefixime capsule
approved by DRAP dated 22nd
March,2022 copy of monograph
available on DRAP official
website.
2. 3.2.S.4.3 Submit data in section 3.2.S.4.3 as Firm submitted the reply in which it is
per the guidance document stated that “As mentioned in section 4.2
approved by Registration Board the analytical methods applied in
which specifies that “Analytical course of release testing of Cefixime
Method Verification studies are based on the monograph of
including specificity, accuracy and Cefixime of USP 42. These methods
repeatability (method precision) are followed without any deviation”.
manufacturer for both compendial
as well as non-compendial drug
3. 3.2. S.4.4 Submit data in section 3.2.S.4.4 as Firm submitted the COA of three
per the guidance document batches of API.
approved by Registration Board
which specifies that “Provide
results of analysis of relevant
batch(es) of Drug Substance
manufacturer used during product
Ingredient manufacture, since the
submitted COA of three batches of
API are of different batches than
that used in the manufacturing of
stability batches.
4. 3.2.S.5 Submit COA of reference standard Firm has submitted the requisite
actually used in the analysis of drug information.
substance in section 3.2. S.5.
5. 3.2.S.7 The manufacturing date of API In the reply Firm submitted the stability
batches was feb,2016 while the data of different batches of drug
approval of cefixime API was substance which were manufactured in
granted on 24th July, 2018 by October,2018 and having batch no.
DRAP as evident from the (CFM1602001, CFM1602002,
submitted approval letter. Clarify CFM1602003)
the manufacturing of cefixime API
prior grant of approval from
DRAP.
6. 3.2.P.2.2.1 Conclusion of comparative Firm in their reply stated that “it was
dissolution profile of cefixime typographic error and rectified,” but
capsule specified the f2 values of not submitted the correct CDP report.
paracetamol and caffeine,
clarification is required in this
regard.
7. 3.2.P.5.1 • Scientific justification is Firm replied that they have now
required for using different switches over to the monograph of
assay method from that cefixime capsule approved by DRAP.
specified in JP monograph with However, the specifications of drug
reference to the product given in the reply was not
chromatographic condition and comply with the said monograph of
preparation of standard and cefixime capsule
sample solutions.
• According to JP monograph the
assay limit should be not less
than 90.0% and not more than
105.0% of the labelled potency
of cefixime, justify, for keeping
the wider acceptance criteria for
assay of drug product than JP
specifications i.e. 90% to 110%.
8. 3.2.P.5.2 Firm again submitted the copy of monograph of JP instead of submitting the
analytical procedure in accordance with DRAP approved monograph of
cefixime capsule.
9. 3.2.P.5.3 Analytical method validation report submitted in the reply was also not
complying the claim pharmacopeial reference of drug product i.e. DRAP’s
approved monograph of cefixime capsule.
10. 3.2.P.5.4 Firm submitted the batch analysis report which evident that the
specifications of quality test were not in accordance claimed pharmacopeial.
Further the results of dissolution test were also included in batch analysis
report.
11. 3.2.P.8 Provide details that which lot Firm has not submitted the requisite
number of drug substance has been information.
used in manufacturing of each
batch of drug product. Also provide
documents confirming evidence of
import of each lot of drug substance
used in manufacturing of these
12. 3.2P.8 Provide data of stability batchesFirm submitted the supportive
properly arranged and supported by
documents of different stability
respective documents including batches of drug product. Stability
analytical report / COA, raw datasummary data sheets were of batch no.
sheet and respective
(TRA-001,TRA-002,TRA-003),while
chromatograms separately for eachsupportive documents
time point. (chromatogram, raw data sheets&
COA) were of TRC-001,TRC-
002,TRC-003.
13. 3.2.p.8 • Documents for the procurement Firm has not submitted these
of API with approval from documents.
• Provide copy of Batch
Manufacturing Record (BMR)
for all the batches of drug
product for which stability
studies data is provided in
• Approval of API/ DML/GMP
certificate of API manufacturer
• Fee of Rs. 7,500 for revision of specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021
• Revised CDP report of drug product, performed against the innovator product.
• Complete analytical procedure used for routine testing of applied drug product in section 3.2. P.5.2 according
the monograph approved by DRAP.
• Analytical method validation report of assay testing of drug product.
• Batch analysis report of all three trial batches of drug, in which all the quality test should be included that ar
the part of approved monograph of cefixime capsule.
product and provide the supporting document of same batches.
• Details that which lot number of drug substance has been used in manufacturing of each batch of drug produc
Also provide documents confirming evidence of import of each lot of drug substance used in manufacturing o
these batches of drug product.
• Copy of Batch Manufacturing Record (BMR) for all the batches of drug product for which stability studies dat
is provided in Module 3 section 3.2. P.8.3.
• Approval of API/ DML/GMP certificate of API manufacturer issued by concerned regulatory authority o
country of origin.
Kasur
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Cefask DS Suspension
Strength / concentration of drug of Active Each 5ml reconstituted suspension contains:
Pharmaceutical ingredient (API) per unit Cefixime as Trihydrate .....200mg
Pharmaceutical form of applied drug Oral suspension
Pharmacotherapeutic Group of (API) Third generation cephalosporin antibiotic
Proposed Pack size 1X30ml
The status in reference regulatory authorities SUPRAX Suspension USFDA Approved
For generic drugs (me-too status) Cefiget 200 mg/5ml Suspension by M/s GETZ Pharma
Name and address of API manufacturer. M/s Citi Pharma Private Limited
Kasur
submitted.
Module III (Drug Substance) Official monograph of cefixime drug substance is presen
in USP. The firm has submitted detail of nomenclatur
Real time: 30°C ± 2°C / 65% ± 5%RH for 36th month
Batches: (CFM1602001, CFM1602002, CFM1602003)
dissolution profile the comparator brand REFFERENCE PRODUCT
CEFIGET DS SUSPENSION
Manufacturer: GETZ Pharma
Batch NO.: 865
MFG Date: 11-2020
Manufacturer of API M/s Citi Pharma Private Limited
Factory: 3 K.M, Head Balloki Road, Phool Nagar, Distt. Kasur
API Lot No. Not mentioned
Description of Pack 1 x 30ml (after reconstitution) Filled in amber glass bottle; labelled an
(Container closure system) packed in standard unit carton provided with leaflet inside.
Batch No. TRS-004 TRS-005 TRS-006
size) mentioned
No. of Batches 03



1. 3.2.S.4.3 Submit data in section 3.2.S.4.3 as Firm submitted the reply in which it is
per the guidance document stated that “As mentioned in section 1.4.2
approved by Registration Board the analytical methods applied in course
which specifies that “Analytical of release testing of Cefixime are based
Method Verification studies on the monograph of Cefixime of USP
including specificity, accuracy and 42. These methods are followed without
repeatability (method precision) any deviation”.
manufacturer for both compendial
as well as non-compendial drug
2. 3.2. S.4.4 Submit data in section 3.2.S.4.4 as Firm submitted the COA of three batches
per the guidance document of API.
approved by Registration Board
which specifies that “Provide
results of analysis of relevant
batch(es) of Drug Substance
manufacturer used during product
(CoA) of the same batch from
Drug Substance /Active
Pharmaceutical Ingredient
manufacture, since the submitted
COA of three batches of API are
of different batches than that used
in the manufacturing of stability
batches.
3. 3.2.S.5 Submit COA of reference standard Firm has submitted the requisite
actually used in the analysis of information.
drug substance in section 3.2. S.5.
4. 3.2.S.7 The manufacturing date of API In the reply Firm submitted the stability
batches was feb,2016 while the data of different batches of drug
approval of cefixime API was substance which were manufactured in
granted on 24th July, 2018 by October,2018 and having batch no.
DRAP as evident from the (CFM1602001, CFM1602002,
submitted approval letter. Clarify CFM1602003)
the manufacturing of cefixime API
prior grant of approval from
DRAP.
5. 3.2. P.3.1 The bottle fill weight mentioned in Firm clarified that 1266mg of
section 3.2.P.3.1 is 1266mg while suspension powder filled per bottle.
the objective weight per bottle
mentioned in process validation
report is 6.56mg. Justification is
required in this regard.
6. 3.2. P.5.1 Justify why weight variation test, Firm submitted the specification of drug
test of uniformity of dosage unit product in which again not including the
and deliverable volume were not weight variation test, test of uniformity
included in the specification of of dosage unit and deliverable volume
drug product. test neither submitted justification.
7. 3.2. P.5.2 Provide complete analyticalFirm has submitted the copy of USP
procedure used for routine testing monograph of cefixime drug substance
of drug product, submitting the in section 3.2.P.5.2 instead detailed
copy of USP monograph did not analytical procedure of cefixime
fulfil the requirement of section suspension in compliance of USP
3.2. P.5.2. monograph of cefixime for oral
suspension.
8. 3.2. P.5.3 Following observations have been Firm did not submit any reply in
found in the analytical method response of this query.
verification report, clarification is
required in this regard:
1. Assay method which has been
verified is not in line with USP
monograph, justify how the
drug product comply with USP
specification.
2. How the verification report of
cefixime capsule be applied on
cefixime suspension, since the
st
730
submitted analytical method
verification report is of
cefixime capsule.
9. 3.2.P.5.4 Batch analysis report in section Firm submitted the batch analysis report
3.2. P.5.4. reflect that filled weight of three trail batches in which the weight
was 65.6 mg ±5% while the COA of filled powder varied between 211mg
of drug product on page 263 to 213mg, while the average filled
specified that average weight weight of powder per bottle in
should be 17.5g±2.5%, accordance with data given in section
justification is required in this 3.2.P.3.1.should be 1266mg.
regard.
10. 3.2.P.8 • Clarification is required either Firm has not submitted any
the dissolution testing is clarification/justification regarding these
included in the specification of queries and submitted the new stability
drug product, since the result of data sheet along with supportive
dissolution testing was documents of trail batches (TRS-004,
included in the stability data TRS-005, TRS-006).
sheets of all three trial batches.
• Justify for changing the assay
limits in the long-term stability
data of drug product.
11. 3.2.P.8 • Provide data of stability Firm submitted the requisite documents.
batches properly arranged and
supported by respective
documents including analytical
report / COA, raw data sheet
and respective chromatograms
separately for each time point.
• Provide compliance Record of
HPLC software 21CFR & audit
trail reports on product testing.
• Provide Record of Digital data
and accelerated).
12. 3.2.P.8 • Documents for the procurement Firm has not submitted these documents.
of API with approval from
• Provide copy of Batch
Manufacturing Record (BMR)
for all the batches of drug
product for which stability
studies data is provided in
• Approval of API/ DML/GMP
certificate of API manufacturer
• Fee of Rs. 7,500 for revision of specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021
• Revised CDP report of drug product, performed against the innovator product.
• Complete analytical procedure used for routine testing of applied drug product in section 3.2. P.5.2 according t
the USP monograph.
• Analytical method verification report of assay testing of drug product according to the USP monograph o
cefixime suspension.
• Clarification regarding the disparity observed in the bottle fill weight both in section 3.2. P.3.1. and 3.2. P.5.4.
product and provide the supporting document of same trial batches.
• Details that which lot number of drug substance has been used in manufacturing of each batch of drug produc
Also provide documents confirming evidence of import of each lot of drug substance used in manufacturing
• Copy of Batch Manufacturing Record (BMR) for all the batches of drug product for which stability studies dat
is provided in Module 3 section 3.2. P.8.3.
Approval of API/ DML/GMP certificate of API manufacturer issued by concerned regulatory authority o
country of origin.
511. Name, address of Applicant / Marketing Variant Pharmaceuticals (Pvt.) Ltd
Name, address of Manufacturing site. Plot # 5, M-2, Pharmazone, 26 Km Main Sharaqpur Roa
District Sheikhupura.
☐ Importer
☐ Export sale
☒Domestic and Export sales
Details of fee submitted PKR 30,000/- dated 01/02/2022
The proposed proprietary name / brand name VILDAMET 50/500mg Tablet
Strength / concentration of drug of Active Each Film coated tablet contains
Pharmaceutical ingredient (API) per unit Metformin HCl …..500mg
Vildagliptin ………..50mg
Pharmacotherapeutic Group of (API) Biguanide/Dipeptidyl peptidase-4 inhibitor
The status in reference regulatory authorities Vildagliptin/Metformin 50mg/850mg film coated tabl
by Teva Nederland BV, Swensweg 5, Haarlem, 2031GA
Netherlands. MHRA Approved.
For generic drugs (me-too status) Galvus Met 50/500 mg TABLET by M/s Novart
Pharmaceuticals Ltd., Reg. No. 066107
manufacturer General Tablet, General Capsule, General Sachet an
General dry powder injectable (pre-lyophilized)
Name and address of API manufacturer. METFORMIN
AARTI DRUGS LIMITED.
Plot No. 211-213, Road No. 2 G.I.D.C., Sarigam, Dist.:
Valsad-396 155 Gujarat. INDIA.
VILDAGLIPTIN
Fuxin Long Rui Pharmaceutical Co. Ltd
Fluoride Industrial Park, Fumeng County (Yi Ma Tu),
Fuxin City,
Liaoning Province -123000, China
specification, reference standard, container closur
system and stability studies of drug substance and dru
Module III (Drug Substance) Official monograph of Metformin HCl and Vildagliptin
present in both USP/BP. The firm as submitted detail o
physical form, manufacturers, description o
manufacturing process and controls, tests for impurity &
related substances, specifications, analytical procedure
Batches: METFORMIN
(MEF/1410027, MEF/1410028, MEF/1410029)
Vildagliptin
20160927,20161031,20161123
Module-III (Drug Product): The firm has submitted detail of manufacturer
description of manufacturing process and control
impurities, specifications, analytical procedure (includin
dissolution testing at acidic and buffer medium) and i
verification studies, batch analysis and justification o
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been establishe
dissolution profile against the innovator brand that is Galvus Met 50/500 m
Tablet by M/s Novartis Pharmaceuticals Ltd., Reg. N
066107 by performing quality tests includ
(Identification, Assay, Dissolution,).
Galvus Met 50/500 mg Tablet by M/s Novart
Pharmaceuticals Ltd., in Acid media (pH 1.2), Aceta
buffer (pH 4.5) & Phosphate Buffer (pH 6.8). The value
for f1 and f2 are in the acceptable range.

Manufacturer of API METFORMIN HCL
Plot No. 211-213, Road No. 2 G.I.D.C., Sarigam, Dist.: Valsad-396 15
Gujarat. INDIA
VILDAGLIPTIN
Fluoride Industrial Park, Fumeng County (Yi Ma Tu), Fuxin City,
API Lot No. MEF/11010279 (METFORMIN)
WT-20200314-D01-WT03-02 (VILDAGLIPTIN)
Description of Pack
Batch No. T-001 T-002 T-003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API METFORMIN
manufacturer issued by concerned regulatory Copy of GMP certificate No. 20031933 FDA INDIA
authority of country of origin. issued by FDA INDIA valid till 19-03-2023.
VILDAGLIPTIN
Copy of GMP certificate issued by Fuxin FDA China
valid till 27-09-2020
3. Documents for the procurement of API with • Copy of letter No.4111/2020/DRAP-AD-CD(I&E)
approval from DRAP (in case dated 18/03/2020 is submitted wherein the permission
of import). to import different APIs including METFORMIN HC
for the purpose of test/analysis and stability studies is
granted.
• Invoice # EXP/1023/20-21 AD date 23-07-2020
• Invoice # HN200812-Q AD date 09-10-2020
chromatograms,
S.no. Sections Observations/Deficiencies/ Reply of the firm
Short-comings
1. 3.2. S.4 Provide detailed analytical Firm has submitted analytical procedures used for testing of
procedures for the testing of both drug substances along with analytical method
drug substance by drug verification reports.
Provide analytical Method
validation studies
performed by the Drug
Product manufacturer.
2. 3.2. S.7 Provide complete stability Firm has submitted the complete stability of drug substance
data of drug substance till till claimed shelf life i.e.36months.
the claimed shelf life since
the submitted data is of 24
months despite the study
had performed in 2016.
3. 3.2. P.1 Justify the choice of Firm has submitted the results of 6month real time stability
excipients in your data of drug product under the head of compatibility analysis
formulation, since the sheet.
excipients used are different
from that of the innovator /
reference product. Further
justify how the formulation
was developed without
performing drug-excipient
compatibility studies.
4. 3.2. Specify details including Firm has submitted following details:
P.2.2 batch number and Brand name Batch Mfg Exp Manufacturer
manufacturing date of the no. Date Date
reference / comparator Galvus Met KAR88 12- 05- Novartis
product against which (Reg.no.786106) 2020 2022 Singapore
pharmaceutical
equivalence is performed.
5. 3.2.P.2.2 • Submit the data of Firm has submitted the complete data of comparative
comparative dissolution dissolution profile in accordance with the decision of 293rd
profile in comply with meeting of Registration Board.
the decision of 293rd
meeting of Registration
Board.
6. 3.2. P.5 Justify the adaptation of Firm replied that they update the acceptance criteria to NLT
dissolution acceptance 85%(Q) in 30 minutes.
criteria as NLT 80% in 30
minutes since the review
documents of MHRA
approved innovator product
specifies the dissolution
criteria as 85% (Q) in 30
minutes for both drug
substance. Dissolution data
of stability study submitted
in the relevant section
i.e.3.2.P.8 supported the
acceptance limit of
innovator product.
7. Submit valid GMP certificate of the Firm submit the valid GMP certificate of drug substance
drug substance vildagliptin Vildagliptin which is valid till 23-08-2023.
manufacturer since the submitted
GMP certificate was valid till 29-07-
2020.
Decision: Approved.
• Manufacturer will place first three production batches on long term stability studies throughout propose
shelf life and on accelerated studies for six months as per the commitment submitted in the registratio
application.
• Manufacturer will perform process validation of first three batches as per the commitment submitted in th
512. Name, address of Applicant / Variant Pharmaceuticals (Pvt.) Ltd
Marketing Authorization Holder
Name, address of Manufacturing Plot # 5, M-2, Pharmazone, 26 Km Main Sharaqpu
site. Road District Sheikhupura.
☐ Importer
☐ Is involved in none of the above (contract giver
The proposed proprietary name /
Vildamet 50/850mg Tablet
brand name
Strength / concentration of drug of Each Film coated tablet contains
Active Pharmaceutical ingredient Metformin HCl ….850mg
(API) per unit Vildagliptin ……….50mg
Pharmacotherapeutic Group of
Biguanide/Dipeptidyl peptidase-4 inhibitor
(API)
Innovator’s specifications
specifications
The status in reference regulatory Vildagliptin/Metformin 50mg/850mg film coate
authorities tablet by Teva Nederland BV, Swensweg
Haarlem, 2031GA, Netherlands. MHRA Approved
manufacturer General Tablet, General Capsule, General Sach
and General dry powder injectable (pre-lyophilized
Name and address of API METFORMIN
manufacturer. AARTI DRUGS LIMITED.
Plot No. 211-213, Road No. 2 G.I.D.C., Sarigam,
Dist.: Valsad-396 155 Gujarat. INDIA.
VILDAGLIPTIN
Fluoride Industrial Park, Fumeng County (Yi Ma
Tu), Fuxin City,
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-P
Summary) template. Summarized information related t
nomenclature, structure, general propertie
solubilities, physical form, manufacturer
impurities, specifications, analytical procedures an
its verification, batch analysis and justification o
system and stability studies of drug substance an
Module III (Drug Substance) Official monograph of Metformin HCl an
Vildagliptin is present in USP/BP. The firm a
submitted detail of nomenclature, structure, gener
properties, solubilities, physical form
manufacturers, description of manufacturing proces
and controls, tests for impurity & related substance
specifications, analytical procedures and i
verification, batch analysis and justification o
Real time: 30°C ± 2°C / 65% ± 5%RH for 48 month
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 month
Batches: Metformin
(MEF/1410027, MEF/1410028, MEF/1410029)
Vildagliptin
20160927,20161031,20161123
impurities, specifications, analytical procedur
(including dissolution testing at acidic and buffe
medium) and its verification studies, batch analys
product.
Pharmaceutical equivalence and Pharmaceutical Equivalence have been establishe
comparative dissolution profile against the innovator brand that is Galvus M
50/850 mg Tablet by M/s Novartis Pharmaceutica
Ltd., Reg. No. 066106 by performing quality tes
CDP has been performed against the same brand th
is Galvus Met 50/850 mg Tablet by M/s Novart
Pharmaceuticals Ltd., in Acid media (pH 1.2
Acetate buffer (pH 4.5) & Phosphate Buffer (p
6.8). The values for f1 and f2 are in the acceptab
range.
Analytical method Method verification studies have submitte
validation/verification of product including linearity, range, accuracy, precisio
specificity.
Gujarat. INDIA
VILDAGLIPTIN
Description of Pack
Batch No. T-001 T-002 T-003
No. of Batches 03
of the firm (if any)
2. Approval of API/ DML/GMP METFORMIN
certificate of API manufacturer Copy of GMP certificate No. 20031933 FDA
issued by concerned regulatory INDIA issued by FDA INDIA valid till 19-03-202
authority of country of origin. VILDAGLIPTIN
Copy of GMP certificate issued by Fuxin FDA
China valid till 27-09-2020
3. Documents for the procurement of • Copy of letter No.4111/2020/DRAP-AD-
API with approval from DRAP (in CD(I&E) dated 18/03/2020 is submitted wherein
case the permission to import different APIs includin
of import). METFORMIN HCl for the purpose of
sheets etc.
5. Compliance Record of HPLC Submitted
on product testing
temperature and humidity monitoring
of stability chambers (real time and
accelerated)
Short-comings
8. 3.2. S.4 Provide detailed analytical Firm has submitted analytical procedures used for testing of
validation studies
pharmaceutical
12. 3.2.P.2.2 • Submit the data of Firm has submitted the complete data of comparative
comparative dissolution dissolution profile in accordance with the decision of 293rd
Board.
documents of MHRA
substance. Dissolution data
of stability study submitted
in the relevant section
i.e.3.2.P.8 supported the
acceptance limit of
innovator product.
2020.
Decision: Approved.
• Manufacturer will place first three production batches on long term stability studies throughout propose
shelf life and on accelerated studies for six months as per the commitment submitted in the registratio
application.
513. Name, address of Applicant / M/s. Variant Pharmaceuticals (Pvt.) Ltd.
☐ Importer
VILDAMET 50/1000mg Tablet
brand name
Strength / concentration of drug of Each Film coated tablet contains
Active Pharmaceutical ingredient Metformin HCl ….1000mg
(API) per unit Vildagliptin ………..50mg
Biguanide/Dipeptidyl peptidase-4 inhibitor
(API)
Innovator’s specifications
specifications
The status in reference regulatory Vildagliptin/Metformin 50mg/1000mg film coate
authorities tablet by Teva Nederland BV, Swensweg
Haarlem, 2031GA, Netherlands. MHRA Approved
manufacturer General Tablet, General Capsule, General Sach
Name and address of API METFORMIN
manufacturer. AARTI DRUGS LIMITED.
Plot No. 211-213, Road No. 2 G.I.D.C., Sarigam,
Dist.: Valsad-396 155 Gujarat. INDIA.
VILDAGLIPTIN
Fluoride Industrial Park, Fumeng County (Yi Ma
Tu), Fuxin City,
Module III (Drug Substance) Official monograph of Metformin HCl an
Vildagliptin is present in USP/BP. The firm a
Batches: METFORMIN
(MEF/1410027, MEF/1410028, MEF/1410029)
Vildagliptin
20160927,20161031,20161123
product.
comparative dissolution profile against the innovator brand that is Galvus M
50/1000 mg Tablet by M/s Novartis Pharmaceutica
Ltd., Reg. No. 066106 by performing quality tes
is Galvus Met 50/1000 mg Tablet by M/s Novart
Pharmaceuticals Ltd., in Acid media (pH 1.2
Acetate buffer (pH 4.5) & Phosphate Buffer (p
6.8). The values for f1 and f2 are in the acceptab
range.
specificity.
Gujarat. INDIA
VILDAGLIPTIN
Description of Pack
Batch No. T-001 T-002 T-003
No. of Batches 03
2. Approval of API/ DML/GMP METFORMIN
authority of country of origin. VILDAGLIPTIN
Copy of GMP certificate issued by Fuxin FDA
China valid till 27-09-2020
of import). METFORMIN HCl for the purpose of
sheets etc.
on product testing
temperature and humidity monitoring
accelerated)
Short-comings
3.2.
1. S.4 Provide detailed analytical Firm has submitted analytical procedures used for testing of
validation studies
pharmaceutical
5. 3.2. • Submit the data of Firm has submitted the complete data of comparative
P.2.2 comparative dissolution dissolution profile in accordance with the decision of 293rd
Board.
documents of MHRA
substances. Dissolution
data of stability study
submitted in the relevant
section i.e.3.2.P.8
supported the acceptance
limit of innovator product.
2020.
Decision: Approved.
• Manufacturer will place first three production batches on long term stability studies throughout proposed she
life and on accelerated studies for six months as per the commitment submitted in the registration application
☐ Importer
AMLOSARTAN 5/80mg Tablet
brand name
Strength / concentration of drug of Each Film coated tablet contains Amlodipin
Active Pharmaceutical ingredient Besylate eq. to Amlodipine …..5mg
(API) per unit Valsartan………….80mg
Pharmaceutical form of applied
Film Coated Tablet.
drug
Pharmacotherapeutic Group of Calcium channel blocker & Angiotensin II recepto
(API) blockers
USP specifications
specifications
The status in reference regulatory Amlodipine/Valsartan Mylan 5 mg/80 mg film
authorities coated tablets by Mylan Germany Gmb
Zweigniederlassung Bad Homburg v. d. Hoeh
Benzstrasse 1, Bad Homburg v. d. Hoehe, Hesse
61352 Germany , MHRA Approved.
For generic drugs (me-too status) Exforge 5/80 mg tablets by by M/s Novart
Pharmaceuticals Ltd, Reg. No. 047569
product manufacturer General Tablet, General Capsule, General Sach
Name and address of API CADILA PHARMACEUTICALS LIMITED.
manufacturer. (Amlodipine Besylate)
294, GIDC Industrial Estate, Ankleshwar-393 002
Gujarat. INDIA.
Zhuhai Rundu Pharmaceutical Co., Ltd. (Valsartan
No.6, North Airport Road, Sanzao Town, Jinwan
District, Zhuhai City, Guangdong Province,
519041, P. R. of China
Module III (Drug Substance) Official monograph of Amlodipine Besylate an
Valsartan is present in USP/BP. The firm a
product.
comparative dissolution profile against the innovator brand that is Exforge 5/80m
Tablet by M/s Novartis Pharmaceuticals Ltd, Re
No. 047569 by performing quality tes
is Exforge 5/80mg Tablet by M/s Novartis, in Aci
media (pH 1.2), Acetate buffer (pH 4.5) &
Phosphate Buffer (pH 6.8). The values for f1 and f
specificity.
Manufacturer of API CADILA PHARMACEUTICALS LIMITED. (Amlodipine Besylate)
294, GIDC Industrial Estate, Ankleshwar-393 002 Gujarat. INDIA.
Zhuhai Rundu Pharmaceutical Co., Ltd. (Valsartan)
No.6, North Airport Road, Sanzao Town, Jinwan District,
Zhuhai City, Guangdong Province, 519041, P. R. of China
API Lot No. 20AD096 (Amlodipine)
67820030604 (Valsartan)
Description of Pack
Batch No. T-001 T-002 T-003
No. of Batches 03
applications with stability study
data of the firm (if any)
2. Approval of API/ DML/GMP AMLODIPINE BESLYLATE:
authority of country of origin. VALSARTAN:
Copy of GMP certificate No. GD20160649 FDA
CHINA issued by FDA CHINA valid till 13-11-
2021.
of import). AMLODIPINE BESYLATE & VALSARTAN
for the purpose of test/analysis and stability
studies is granted.
• Invoice # CPL/BD/SAM/003/20-21 AD date 09
10-2020 FOR AMLODIPINE
• Invoice # RD2020060101-1 AD date 23-07-202
FOR VALSARTAN

data sheets etc.
S.no. Sections Observations/Deficiencies/ Reply of the Firm
Short-comings
1. 3.2. S.4 • Provide detailed Firm has submitted analytical procedures used for testing of
analytical procedures both drug substances along with analytical method
for the testing of both verification reports.
drug substance by drug
• Provide analytical
Method validation
studies of drug
substance amlodipine
performed by the drug
2. 3.2. P.1 • Justify the choice of Firm has submitted the results of 6month real time stability
excipients used are
different from that of the
innovator / reference
product. Further justify
how the formulation was
developed without
performing drug-
excipient compatibility
studies.
reference / comparator Exforge BYH80 12- 11- Novartis
product against which (Reg.no.047569) 2020 2023 Pakistan
pharmaceutical
4. 3.2.P.2.2 Justify, the below 80% (Q) Firm submitted the copy of monograph of USP instead of
release of valsartan of test justification and claimed that they follow Test 2 of
product in pH 6.8 medium monograph for dissolution testing of drug product, in which
with reference to the the acceptance criteria is again NLT 80%(Q) of the labelled
acceptance criteria of USP claim of valsartan.
monograph.
5. 3.2.P.2.2 Submit complete Firm has submitted the complete data of comparative
dissolution profile data in dissolution profile in accordance with the decision of 293rd
line with the decision of meeting of Registration Board.
293rd meeting of
Registration Board.
6. 3.2. P.5 • Justify why content Firm submitted the raw data sheet of content uniformity test,
uniformity test is not which has been performed while stability studies of drug
included in the finished product.
product specification,
further justify why
content uniformity test
was not performed
during the stability
studies.
Decision: Approved.
life and on accelerated studies for six months as per the commitment submitted in the registration applicatio
site. Road District Sheikhupura.Pakistan
☐ Importer
AMLOSARTAN 10/160mg Tablet
brand name
Strength / concentration of drug of Each Film coated tablet contains Amlodipin
Active Pharmaceutical ingredient Besylate eq. to Amlodipine …..10mg
(API) per unit Valsartan………….160mg
Pharmaceutical form of applied
Film Coated Tablet.
drug
Pharmacotherapeutic Group of Calcium channel blocker & Angiotensin II recepto
(API) blockers
USP specifications
specifications
The status in reference regulatory Exforge 10 mg/160 mg film-coated tablets b
authorities Novartis Europharm Limited,Vista Building
Elm Park, Merrion Road.Dublin 4.Ireland
USFDA Approved.
For generic drugs (me-too status) Exforge 10/160 mg tablets by by M/s Novart
Pharmaceuticals Ltd, Reg. No. 047571
product manufacturer General Tablet, General Capsule, General Sach
Name and address of API CADILA PHARMACEUTICALS LIMITED.
manufacturer. (Amlodipine Besylate)
294, GIDC Industrial Estate, Ankleshwar-393 002
Gujarat. INDIA.
Zhuhai Rundu Pharmaceutical Co., Ltd. (Valsartan
No.6, North Airport Road, Sanzao Town, Jinwan
District, Zhuhai City, Guangdong Province,
519041, P. R. of China
Module III (Drug Substance) Official monograph of Amlodipine Besylate an
Valsartan is present in USP/BP. The firm a
product.
comparative dissolution profile against the innovator brand that is Exforg
10/160mg Tablet by M/s Novartis Pharmaceutica
Ltd, Reg. No. 047571 by performing quality tes
is Exforge 10/160mg Tablet by M/s Novartis, i
Acid media (pH 1.2), Acetate buffer (pH 4.5) &
Phosphate Buffer (pH 6.8). The values for f1 and f
specificity.
Manufacturer of API CADILA PHARMACEUTICALS LIMITED. (Amlodipine Besylate)
294, GIDC Industrial Estate, Ankleshwar-393 002 Gujarat. INDIA.
Zhuhai Rundu Pharmaceutical Co., Ltd. (Valsartan)
No.6, North Airport Road, Sanzao Town, Jinwan District,
Zhuhai City, Guangdong Province, 519041, P. R. of China
API Lot No. 20AD096 (Amlodipine)
67820030604 (Valsartan)
Description of Pack
Batch No. T-001 T-002 T-003
No. of Batches 03
applications with stability study
data of the firm (if any)
2. Approval of API/ DML/GMP AMLODIPINE BESLYLATE:
authority of country of origin. VALSARTAN:
Copy of GMP certificate No. GD20160649 FDA
CHINA issued by FDA CHINA valid till 13-11-
2021.
of import). AMLODIPINE BESYLATE & VALSARTAN
for the purpose of test/analysis and stability
studies is granted.
• Invoice # CPL/BD/SAM/003/20-21 AD date 09
10-2020 FOR AMLODIPINE
• Invoice # RD2020060101-1 AD date 23-07-202
FOR VALSARTAN

data sheets etc.
S.no. Sections Observations/Deficiencies/ Reply of the Firm
Short-comings
1. 3.2. S.4 • Provide detailed Firm has submitted analytical procedures used for testing of both
analytical procedures drug substances along with analytical method verification reports.
for the testing of both
drug substance by drug
• Provide analytical
Method validation
studies of drug
substance amlodipine
performed by the drug
2. 3.2. P.1 • Justify the choice of Firm has submitted the results of 6month real time stability data of
excipients in your drug product under the head of compatibility analysis sheet.
formulation, since the
excipients used are
different from that of the
innovator / reference
product. Further justify
how the formulation was
developed without
performing drug-
excipient compatibility
studies.
reference / comparator Exforge BYA65 04- 03- Novartis
product against which (Reg.no.047571) 2021 2024 Pakistan
pharmaceutical
4. 3.2.P.2.2 Justify, the below 80% (Q) Firm submitted the copy of monograph of USP instead of
release of valsartan of test justification and claimed that they follow Test 2 of monograph for
product in pH 6.8 medium dissolution testing of drug product, in which the acceptance criteria
with reference to the is again NLT 80%(Q) of the labelled claim of valsartan.
acceptance criteria of USP
monograph.
5. 3.2.P.2.2 Submit complete Firm has submitted the complete data of comparative dissolution
dissolution profile data in profile in accordance with the decision of 293rd meeting of
line with the decision of Registration Board.
293rd meeting of
Registration Board.
6. 3.2. P.5 • Justify why content Firm submitted the raw data sheet of content uniformity test, which
uniformity test is not has been performed while stability studies of drug product.
included in the finished
product specification,
further justify why
content uniformity test
was not performed
during the stability
studies.
Decision: Approved.
life and on accelerated studies for six months as per the commitment submitted in the registration application.
Cases of Apremilast tablets:
In compliance of decision of Authority taken in its 140th meeting, regarding the out of que consideration of
registration applications of apremilast tablet, following are the cases of apremilast presented before the Board
for its consideration please.
Discussion: Registration Board made thorough deliberations upon the presentations, dosage regimen and pack
sizes of the innovator product. The innovator product i.e. Otezla tablet in USFDA recommended the initial
dosage titration of OTEZLA from Day 1 to Day 5 is shown in the following table. Following the 5-day titration,
the recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6. This titration is
intended to reduce the gastrointestinal symptoms associated with initial therapy.
Dosage titration schedule in innovator brand:
Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 &
thereafter
AM AM PM AM PM AM PM AM PM AM PM
10mg 10mg 10mg 10mg 20mg 20mg 20mg 20mg 30mg 30mg 30mg
The requirement of co-blistering manufacturing facility was also discussed for presentation of tablet in similar
display panel as of innovator product, one of the presentation of supply pack of innovator brand is as under:
According to the available literature of innovator brand, the titration pack is supplied in two different display
panels i.e. 2-week starter pack or 28days starter pack, further separate packaging configuration of only 30mg
tablet is also available for regular use.
Decision: Registration Board deliberated the matter in detail and decided as under:
i. Approved to grant the registration of Apremilast Tablet 10mg, 20mg and 30mg with Innovator’s
Specifications. Furthermore, in order to standardize the drug as per dosage regimen of the
innovator’s drug product as approved by reference regulatory authorities, the Board decided that
the manufacturers may adopt any of the following presentation for starter pack:
a. Presentation / Pack size as per the Innovator’s drug product i.e., Otezla Tablet approved by
USFDA.
OR
b. 14 days Starter Pack:
1st Blister
(4 Tablets, each containing Apremilast 10mg)
Day Morning (A.M.) Evening (P.M.)
1 10mg Tablet -
2 10mg Tablet 10mg Tablet
3 10mg Tablet -
2nd Blister
3 - 20mg Tablet
5 20mg Tablet -
3rd Blister
5 - 30mg Tablet
4th Blister
8-14 30mg Tablet 30mg Tablet
OR
c. 28 days Starter Pack:

1st Blister
1 10mg Tablet -
3 10mg Tablet -
2nd Blister
3 - 20mg Tablet
5 20mg Tablet -
3rd Blister
5 - 30mg Tablet
4th, 5th, 6th Blister

Blister Day Morning (A.M.) Evening (P.M.)
4th 8-14 30mg Tablet 30mg Tablet
ii. A unit carton of 14 days starter pack shall contain:

a. Pouch-I: 1 blister of 4 tablets containing apremilast 10mg.
b. Pouch-II: 1 blister of 4 tablets containing apremilast 20mg.
c. Pouch-III: 2 blisters of 19 tablets containing apremilast 30mg (1 blister with 5 tablets and
1 blister with 14 tablets).
OR
A unit carton of 28 days starter pack shall contain:
a. Pouch-I: 1 blister of 4 tablets containing apremilast 10mg.
b. Pouch-II: 1 blister of 4 tablets containing apremilast 20mg.
c. Pouch-III: 4 blisters of 47 tablets containing apremilast 30mg (1 blister with 5 tablets and
3 blisters with 14 tablets each).
iii. Each blister shall be labelled in accordance with The Drugs (Labeling and Packing) Rules, 1986.
iv. Each type of blister (i.e. 10mg, 20mg or 30mg) shall be contained in a pouch which shall also
contain information including brand name, strength, number of tablets and pouch number etc.
v. Outer unit carton shall contain all the information of blisters packed inside and shall be labelled
in accordance with The Drugs (Labeling and Packing) Rules, 1986.
vi. For continuous use, Routine/ Maintenance Pack of 56 Tablets, each containing Apremilast 30mg,
shall also be registered and marketed.
vii. The dosing schedule, conspicuously stating morning and evening doses, shall be printed on each
blister. For this purpose, manufacturers shall submit proposed labeling / packaging of the product
for approval of Chairman Registration Board before issuance of registration letter.
Name, address of Applicant / M/s Tabros Pharma Pvt. Ltd. L-20/B, Sector-22, Federal
Marketing Authorization Holder B Industrial Area, Karachi
Name, address of Manufacturing site. M/s Tabros Pharma Pvt. Ltd. L-20/B, Sector-22, Federal
B Industrial Area, Karachi
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No.11093 dated 07-05-2022
Details of fee submitted PKR 75,000/- dated 04-2022
Pixel tablet
name
Strength / concentration of drug of Each starter pack contains:
Active Pharmaceutical ingredient (API)
per unit PIXEL 10mg Tablet
Apremilast….10mg
PIXEL 20mg Tablet

Apremilast….20mg
PIXEL 30mg Tablet

Apremilast….30mg
Tabros Specs.
Pharmaceutical form of applied drug PIXEL 10mg Tablet
White to light yellow colour round film coated tablet plain
on both sides.
PIXEL 20mg Tablet
Brown colour round film coated tablet plain on both sides
PIXEL 30mg Tablet
Brown colour round film coated tablet plain on both sides
Pharmacotherapeutic Group of (API) Anti-Psoriatic (PDE 4 Inhibitor)
st
753
Reference to Finished product Tabros Specifications
specifications
Proposed Pack size STARTER PACK OF PIXEL (Apremilast) TABLETS
(4’s Tablets of 10mg, 4’s Tablets of 20mg & 56’s
Tablets of 30mg)
OTEZLA tablet by M/s Celgene, USFDA Approved.
authorities
For generic drugs (me-too status) N/A.
Name and address of API manufacturer. M/s Glenmark Life Sciences Limited, India
A-80, MIDC, KURKUMBH, TAL.DAUND-
413802,Dist. PUNE Zone 4, India
Module-II (Quality Overall Summary) Firm has submitted QOS as per template provided in
293DRB meeting minutes. Firm has summarized
information related to nomenclature, structure, general
properties, isomerism, polymorphism, solubilities,
manufacturing process and controls, Characterization,
stability. Firm has also submitted data for facilities,
equipments and regional information.
Module III (Drug Substance) Firm has submitted detailed drug substance data related to
nomenclature, structure, general properties, isomerism,
polymorphism, manufacturers, description of
manufacturing process and controls, Characterization,
Batches:
D3350116001 (82160888).
D3350116002 (82161041).
D3350116003 (82161086).
Module-III (Drug Product): Firm has submitted information of drug product including
its description, composition, pharmaceutical development,
control of critical steps and intermediate, process
validation protocols, control of excipients, control of drug
product, specifications, analytical procedures, validation
of analytical procedures, batch analysis, justification of
Pharmaceutical equivalence and Pharmaceutical Equivalence have been established against
comparative dissolution profile the brand leader that is OTEZLA tablet 10mg, 20mg &
30mg by Celgene Corporation, USA by performing
quality tests including Identification, water content,
Assay, Dissolution, Disintegration.

OTEZLA tablet by Celgene Corporation, USA in Acid
media (0.1N HCl), acetate buffer pH 4.5 & Phosphate
Buffer pH 6.8. The F2 values are found satisfactory.
validation/verification of product linearity, range, accuracy, precision, specificity, Detection
limit, Quantitation limit, robustness, stability indicating.
Manufacturer of
M/s Glenmark Life Sciences Limited, India
API
API Lot No. 83170813
Description of STARTER PACK
Pack (Container This pack contains the following for titration over 5days up to the prescribed
closure system dose of 30mg:
Four (1x4’s)- 10mg Tablets
Four (1x4’s)- 20mg Tablets
Fifty-Six (4 x 14’s)- 30mg Tablets
Fo ur All above are packed in Alu - Alu Blister.


Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Strength PIXEL 10mg Tablet PIXEL 20mg Tablet PIXEL 30mg Tablet
Batch No. TR001- TR002- TR003- TR001- TR002- TR003- TR001- TR002- TR003-
1/PIX 1/PIX 1/PIX 2/PIX 2/PIX 2/PIX 3/PIX 3/PIX 3/PIX
Batch Size 1100 1000 1000 1000 1000 1000 1000 1000 1000
tablets tablets tablets tablets tablets tablets tablets tablets tablets
Manufacturing
05-2019 05-2019 06-2019
Date
Date of Initiation 28-05-2019 30-05-2019 26/6/19 1/07/19 1/07/19
No. of Batches 03 03 03
the firm (if any) (Apixaban) 2.5mg & 5mg Tablets on 5th January, 2021 by
following panel:
2. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL,
DRAP, Karachi.
14. Approval of API/ DML/GMP certificate The firm has submitted copy of GMP certificate for M/s
of API manufacturer issued by Glenmark life sciences, India The certificate is valid till
concerned regulatory authority of 24th January 2023.
country of origin.
15. Documents for the procurement of API The firm has imported 0.2Kg API consignment Glenmark
with approval from DRAP (in case of life sciences, India, bearing invoice number
import). F2000000116 dated July 28, 2018. ADC signed Form 6
& invoice is available. Form 3 and form 7 also available.
sheets etc.
testing
Submitted
accelerated)
Sr.no. Section Observations/shortcomings Reply of the firm
1. 3.2.S.4.3 Submit data in section Firm submitted the analytical verification
3.2.S.4.3 as per the guidance report of drug substance
document approved by
(method precision)
Product manufacturer for
both compendial as well as
non-compendial drug
substance(s)”
2. 3.2. P.2.2.1 It is evident from the Firm submitted the reply in which it is
comparative dissolution stated that “Initially, they have been
profile data that an expired submitted CDP as per updated USFDA
batch of innovator brand has guideline with the specification of NLT
been used in all three 80(Q) in 45 minutes, these studies were
strengths for comparison. conducted in sep-2020 at that time
The expiry date of Otezla innovator sample was within the expiry.
tablet batch no.H02248A was Later on,01 March 2021, they have
Nov-20 and date of analysis received query from the DRAP on
mentioned on CDP report is dissolution and in response of query, they
17/03/2021.Clarification is again performed CDP in March 2021 with
required in this regard the outdated Innovator samples, because
they cannot wait to procure the innovator
samples from USA immediately, since it is
time taking activity. Hence, on truthful
ground realities they have been seen there
is no significant change in results have
been observed with the same samples,
therefore they used similar innovator
sample for CDP to fulfill the requirements
of DRAP.
3. 3.2. P.5.1 Justify for setting the
acceptance criteria of
dissolution test other than
adapted by
innovator/reference product.
The review report of
innovator brand approved in
USFDA revealed that the
recommended dissolution
criteria should be NLT (Q) in
30 minutes, while the
dissolution criteria adapted
for applied product was NLT
80%(Q) in 45 minutes.
4. 3.2.P.7 The applied starter pack Firm in the reply stated that “Review
presentation mentioned in Report has considered as a Bench Mark “2-
section 3.2.P.7 was consist of week starter pack”, however, this is NOT
4 Alu-Alu blisters of (30mg) FOR SALE, mentioned on innovator pack,
each of 14 film coated tablet the actual innovator commercial pack size
along with one Alu-Alu 28 days. In 28 days, pack, innovator has
blister (10mg) of 4 film presented in one blister 04-tablets
coated tablets as well as one 10mg,04-tablets 20mg and 05-tablets
Alu-Alu blister (20mg) of 4 30mg, and rest of other 3 strips are 14’s x3,
film coated tablets packed in (30mg). Likewise, the same technology we
a unit carton. While as per the don’t have to keep simultaneously
innovator brand the starter, 10mg,20mg and 30mg in one strip.
pack is for 2 weeks which Nevertheless, we adapted same theme as
consist of 13-tablet blister innovator, accommodate, one Alu-Alu
titration pack containing:(4) blister (10mg) of 4 film coated tablets as
10-mg, (4) 20-mg, and (5) well as one Alu-Alu blister 20mg of 4 film
30-mg tablets with an coated tablets along with (30mg) 04 Alu-
additional (14) 30mg tablets. Alu blister in one-unit carton to make it
Justify the rationality of your symmetrical. The innovator and our pack
starter pack presentation with only one difference innovator providing
reference to the innovator. forty-seven tablets of 30mg, while we are
providing fifty-six tablets.
Presentation of display panel of 28 days

starter pack of innovator Brand:
While the Applied pack presentation:

32-days starter Pack
04-Tablet Blister (10mg)
04-Tablets Blister 20mg
With an additional (14’s x4 = 56)30mg
Tablets.
Decision: Approved registration of starter pack (1 pack only) with innovator’s specifications as per
details mentioned in above decision.
• Registration letter will be issued after submission of revised limit of dissolution test in line
with innovator product along with performance data of dissolution in compliance of new
adapted dissolution limits. Further, Firm shall submit the fee of Rs. 7,500 for revision of
specifications per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
• The Board further decided that registration letter for apremilast 30mg (already approved)
will be issued after approval of starter pack.
Name, address of Applicant / Marketing M/s Crystolite Pharmaceuticals
Authorization Holder Plot # 1 & 2, Street S-2, National Industrial
Zone, Rawat, Islamabad.
Name, address of Manufacturing site. M/s Crystolite Pharmaceuticals
Plot # 1 & 2, Street S-2, National Industrial Zone,
Rawat, Islamabad.
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name APREMIST COMBO PACK (10MG, 20MG,
30MG TABLETS)
Strength / concentration of drug of Active APREMIST 10MG TABLETS
Pharmaceutical ingredient (API) per unit Each Film Coated Tablet Contains:
Apremilast …………………10mg
APREMIST 20MG TABLETS

APREMIST 30MG TABLETS

Pharmaceutical form of applied drug 10 mg film-coated tablet
(The tablets are pink, round, biconvex, film
coated tablet, one side smooth and other is
engraved with CRYSTO)
20 mg film-coated tablet
(Brown, round, biconvex, film coated tablet,
one side smooth and other is engraved with
CRYSTO)
30 mg film-coated tablet
(Beige Color, Round, Biconvex, One side
smooth & other is engraved with “CRYSTO”
Film Coated Tablets)
Pharmacotherapeutic Group of (API) Antipsoriatic (Selective Immunosuppressant)
Reference to Finished product specifications Innovator’s specification
Proposed Pack size Combo Pack Contains:
10MG (4’s),
20MG (4’s),
30MG (4x14’s)
56 Tablets
Proposed unit price
As per SRO
The status in reference regulatory authorities Otezla Tablet by M/s Amgen Inc, USFDA
Approved.
For generic drugs (me-too status) NA
GMP status of the Finished product Firm has provided the inspection report for
manufacturer renewal of
DML conducted on 12-11-2018 & 02-01-2019
Name and address of API manufacturer. Apremist 10mg & 20mg Tablets
Glenmark Life Sciences Limited
Address: Plot No. A-80, MIDC, Kurkumbh, Tal-
Daund,
Dist. Pune - 413 802, India.
Apremist 30mg Tablets

Kaifeng Pharmaceutical (Group) Co., Ltd.
No.1 Yunan Street, Kaifeng City, Henan
Province, China
Stability studies Glenmark Life Sciences Limited
months
months
Batches: (83151223, 83151300, 83151315)

months
months
Batches: (HF140718, HF140610, HF140526)
controls, specifications, analytical procedure
medium) and its verification studies, batch
Pharmaceutical equivalence and comparative Data for establishing Pharmaceutical equivalence
dissolution profile by performing all the quality tests and
comparative dissolution profile has been
submitted against the comparator product “Otezla
10mg, 20mg & 30mg combo pack Tablet by
Amgen
Batch number H02495A
Analytical method validation/verification of Protocols along with the complete data of
product validation studies are submitted.
Manufacturer of API Apremist 10mg & 20mg Tablets
Glenmark Life Sciences Limited
Address: Plot No. A-80, MIDC, Kurkumbh, Tal-Daund,
Dist. Pune - 413 802, India.

No.1 Yunan Street, Kaifeng City, Henan Province, China
API Lot No. Glenmark Life Sciences Limited: 82190049
Kaifeng Pharmaceutical (Group) Co., Ltd.: HF151025 & HF151118
Description of Pack Alu/Alu foil blister of 10mg (4’s) tablets, are packed along with Alu/Alu foil
(Container closure system) blister of 20mg (4’s) tablets, Alu/Alu foil blisters of 30mg (4x14’s) tablets
with patient information leaflet into card board outer carton.
Time Period Apremist 10mg & 20mg Tablets
Real time: 6 months

Real time: 24 months
Frequency Apremist 10mg & 20mg Tablets


Accelerated: 0,1,2,3,4,6,8,12,16,20,24 (Weeks)
Real Time: 0,1,2,3,4,6,8,12,16,20,24,36,48 (Weeks), 18,24 (months)
Batch No. Apremist 10mg Tablets Apremist 10mg Tablets Apremist 10mg
004T21 005T21 Tablets
006T21
Apremist 20mg Tablets Apremist 20mg Tablets
007T21 008T21 Apremist 20mg
Tablets
Apremist 30mg Tablets Apremist 30mg Tablets 009T21
007T16 011T16
Apremist 30mg
Tablets
012T16
Batch Size 600 tab for each strength 600 tab for each 600 tab for each
strength strength
Manufacturing Date Apremist 10mg Tablets Apremist 10mg Tablets Apremist 10mg
10-2021 10-2021 Tablets
10-2021
10-21 10-21 Apremist 20mg
Tablets
Apremist 30mg Tablets Apremist 30mg Tablets 10-21
04-2016 04-2016
Apremist 30mg
Tablets
04-2016
Date of Initiation Apremist 10mg
Apremist 10mg Tablets Apremist 10mg Tablets Tablets
004T21 005T21 006T21
(09.10.2021) (10.10.2021) (12.10.2021)
Apremist 20mg Tablets Apremist 20mg Tablets Apremist 20mg

007T21 008T21 Tablets
(13.10.2021) 15.10.2021 009T21
16.10.2021
007T16 011T16 Apremist 30mg
(07.04.2016) (11.04.2016) Tablets
012T16
(12.04.2016)
No. of Batches 03 batches for each strength
1. Reference of previous approval of applications Firm has referred last onsite panel inspection for
with stability study data of the firm (if any) Dapazin-M 5/1000 mg Tablet
Dapagliflozin Propanediol Monohydrate Eq. to
Dapagliflozin 5mg & Metformin HCl 1000mg
which was approved in 307th meeting of
Registration Board
2. Approval of API/ DML/GMP certificate of API Glenmark Life Sciences Limited
manufacturer issued by concerned regulatory Copy of DML certificate No. MH/102855 issued
authority of country of origin. by Food & Drugs Administration (Maharashtra
State) valid till 31/12/2023.
Copy of GMP certificate No. 6104231issued by

Food & Drugs Administration (Maharashtra
State) valid till 24/01/2023.
Copy of DML certificate No. 20150031 issued
by FDA valid till 31/12/2025.
Copy of GMP certificate No. HA20190069

issued CFDA valid till 28/09/2024
3. Documents for the procurement of API with Glenmark Life Sciences Limited
approval from DRAP (in case of import). Firm has submitted copy of invoice (invoice#
F32200000700) cleared by DRAP Islamabad
office dated 28-09-2021 specifying import of
Desloratadine. Firm has submitted undertaking
that firm has purchased commercial quantity of
Desloratadine from manufacturer Glenmark Life
Sciences Limited. Along with Desloratadine
supplier has send free of cost sample of
Apremilast and Apremilast working standard.
Firm has applied ADC of only Desloratadine
dated 28 Sep 2021
Firm has submitted copy of invoices
(No.CIN20151117D01 & CIN20151210D01)
cleared by DRAP Islamabad office dated 22-12-
2015 specifying import Of 40gm Apremilast &
20gm Apremilast respectively
chromatograms,
S.No. Deficiencies/Shortcomings Reply of the Firm
1. Drug Substance Manufacturer (M/s. Glenmark Life Sciences, India)
a) Submit the evidence of availability Firm has submitted revised analytical procedure
of HPLC equipped with quaternary in which HPLC equipped with binary gradient
gradient pumps, variable wavelength pump has been used.
UV detector with data recorder and
integrator software by the drug
product manufacturer, since the said
equipment has been used as evident
from the analytical method
verification report of drug substance
from drug product manufacturer.
b) Justification is required for not Firm has submitted the procedure of
performing the enantiomeric purity enantiomeric purity test along with revised
test while analysing the quality of batch analysis report.
drug substance by drug product
manufacturer. Since, it is the critical
test for apremilast because the active
substance exhibits stereoisomerism
due to presence of a single chiral
centre, with the (S)-enantiomer
being pharmacologically active.
2. c) According to the assay procedure Firm has submitted revised analytical procedure
submitted in section 3.2.S.4.2 by and following chromatographic conditions has
drug product manufacturer, the run been mentioned:
time should be 15minutes, injection Flow rate: 1.0ml/min
volume should keep at 10µl and the Detection wavelength: UV 220nm
apremilast elutes at retention time of Injection volume :20µl
about 7 minutes. While the Retention time and total run time has not been
chromatogram of verification report mentioned in the revised procedure.
from drug product manufacturer
revealed that the run time was
20min, injection volume kept at 20µl
and the main peak elute at 14.319
minutes. Clarification is required in
this regard.
3. Drug Substance Manufacturer (M/s. Kaifeng Pharmaceutical Group, China)
a) Justify of using different assay Firm has submitted revised analytical procedure
method for analysis of drug without any justification.
substance from that given by drug
b) Analytical method verification of Firm has submitted revised analytical method
drug substances performed by drug verification report for both drug substance
product manufacturer, imports from which are import from two different sources.
two different sources exhibit same
results, justify.
c) Justification is required for not Firm in their reply stated that “we have not
performing the enantiomeric purity performed enantiomeric purity test because we
test while analysing the quality by have not purchased impurity standards along
drug product manufacturer. Since, it with the raw material.
is the critical test for apremilast
because the active substance exhibits
stereoisomerism due to presence of a
single chiral centre, with the (S)-
enantiomer being pharmacologically
active
Drug Product
4. Justify the performance of comparative Firm has submitted revised analytical procedure
dissolution profile of using UV method in which the method for performance of
while the procedure of dissolution dissolution test both on HPLC and UV has been
testing specified in section 3.2.P.5.2 included.
stated that the dissolution test should be
performed on HPLC.
5. Scientific justification required that, Firm in their reply stated that “we have done
how an active substance classified as CDP of our all three strengths with innovator
having low solubility and low product at three different pH. The release
permeability according to pattern of our product is comparable with
Biopharmaceutical Classification innovator as mentioned in CDP report. The drug
System (i.e. BCS Class 4) release more products show similar behavior in three
than 85% within 20 minutes in all the different pH mediums.
three BCS medium as evident from the
submitted CDP report of three
strengths.
6. Justify the performance of validation of Firm in their reply stated that “we have used
assay procedure of using UV method HPLC method for the performance of validation
since the analytical procedure given in of assay procedure instead of UV method. The
section 3.2.P.5.2 mentioned that the word absorbance of peak was mistakenly
assay be performed on HPLC. written on the report, revised report has
submitted.
7. Justify for setting the acceptance Firm revised the dissolution acceptance criteria
criteria of dissolution test other than in accordance with innovator product i.e. NLT
adapted by innovator/reference 80% (Q) in 30 minutes.
product. The review report of innovator
brand approved in USFDA revealed
that the recommended dissolution Further the dissolution results of stability study
criteria should be NLT (Q) in 30 were also within limits of revised acceptance
minutes, while the dissolution criteria criteria.
adapted for applied product was NLT
80%(Q) in 45 minutes.
Specify the acceptance criteria of
dissolution test in term of Q value and
with the time point at which NLT 80%
should be achieved, since the
specification given in section 3.2.P.5.1
and batch analysis report in section
3.2.P.5.4 did not mentioned the time
point.
8. The applied starter pack presentation Firm in their reply stated that we have applied
mentioned in section 3.2.P.7 consist of pack size 10mg (4’s),20mg (4’s),30mg (4x14’s)
4 Alu-Alu blisters of (30mg) each of 14 the reason for applying this pack size is because
film coated tablet along with one Alu- our individual product apremist 30mg is already
Alu blister (10mg) of 4 film coated registered with pack size (4x14’s) i.e. 56 tablets
tablets as well as one Alu-Alu blister and the pricing done by DRAP is also for the
(20mg) of 4 film coated tablets packed same pack size. Therefore just because of the
in a unit carton. While as per the pricing done by DRAP we have decided to
innovator brand the starter, pack is for 2 provide product in market with pricing of 56
weeks which consist of 13-tablet blister tablets of 30mg strength along with free of cost
titration pack containing:(4) 10-mg, (4) 4 tablets of 10mg and free of cost 4 tablets of
20-mg, and (5) 30-mg tablets with an 20mg.
additional (14) 30mg tablets. Justify the
rationality of your starter pack
presentation with reference to the
innovator.
9. Justify the quantity of apremilast used Firm submitted the calculation in which factor
for the development of trial batches 1.000300 for calculation.
with reference to its potency adjustment
and water content calculation, since the
submitted BMR of all three strength did
not mentioned the calculation of
dispensing amount of active ingredient
per unit.
10. Weight of tablet of all three strengths of Firm replied that “we have followed innovator
innovator brand increase with empirical product qualitatively and not by quantitatively”.
ratio as per the review report of
USFDA, while the weight of tablet of In innovator product weight of tablet increase
all three applied strength varies with the empirical ration i.e.
irrespective of their increase quantity of 10mg 20mg 30mg
active ingredient. 104.00 208.00 312.00
11. Scientific justification is required Firm in their reply stated that “we have
regarding the variation of retention timesubmitted data of 6months of apremist 10mg
of apremilast observed in the &20mg and 2 years for apremist 30mg ,so the
chromatograms of all three strengths, it test performed in different time period may
varies from 11 minutes till 22 minutes, influenced by the conditions that is change in
justify it with system suitability report.
lots of chemical used, mobile phase
preparations, analyst and column conditions.
12. Provide details that which lot number of drug substance has been used in manufacturing
of each batch of drug product. Also provide documents confirming evidence of import of
each lot of drug substance used in manufacturing of these batches of drug product.
Firm submitted the following information:
Lot No. Batch of Drug Product
Apremist 10mg tablet
82190049 from Glenmark Life 004T21
Sciences Ltd. 004T22
004T23

82190049 from Glenmark Life 007T21
Sciences Ltd. 008T21
009T21

HF151118 from Kaifing 007T16
Pharmaceuticals Co. Ltd.
13. Justify, how the batch no. H02248A of innovator product otezla tablet that was
manufactured in 2021 according to the expiry date of 05-2023 could be available for the
performance of Comparative dissolution testing back in the year 2018, since as per the
submitted CDP report of apremist 30mg Tablet analysis has been done in 2018.
Firm replied that we are again submitting the CDP report of Apremist 30mg tablet in which
expiry date of innovator product is mentioned as Nov.2020.
Otezla 30mg Tablet
Batch no. H02248A
Exp date : Nov-2020
Decision: Approved registration of starter pack (1 pack only) with innovator’s specifications as per
details mentioned in above decision
• Registration letter will be issued after submission of revised and scientifically rationale CDP
report by keeping in view the BCS classification of active ingredient.
• Firm shall submit the fee of Rs. 7,500 for revision of specifications per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
• The Board further decided that registration letter for apremilast 30mg (already approved)
will be issued after approval of starter pack.
Cases of Diclofenac Potassium:

In compliance of decision of Authority taken in its 140th meeting, regarding the out of que consideration of
registration applications of diclofenac potassium and famotidine, following are the registration applications of
diclofenac potassium received in DRAP were evaluated out of que and shortcoming letters have communicated
to the firms but reply has not received yet, cases presented before the Board for its consideration please.
516. Name, address of Applicant / Marketing M/s Quaper Pvt. Ltd.
Name, address of Manufacturing site. 26-A Small Industrial Estate Lahore Road
Sargodha.
☐ Importer
(contract giver)
☐ Export sale
Details of fee submitted PKR 30,000/-: dated
KAYMAX Sachet 50 mg
name
Strength / concentration of drug of Active Each Sachet contains:
Pharmaceutical ingredient (API) per unit Diclofenac Potassium 50 mg
Pharmaceutical form of applied drug Sachet
Pharmacotherapeutic Group of (API) Non-steroidal anti-inflammatory Drug (NSAID)
Reference to Finished product specifications USP Specs
Proposed Pack size 1×10’s & 1×30’s
The status in reference regulatory Voltfast 50 mg Sachet by Novartis Pharma AG,
authorities Basel, Switzerland USFDA Approved.
For generic drugs (me-too status) Voltfast 50 mg Sachet by Novartis Pharma
GMP status of the Finished product GMP certificate No. 161/2019-DRAP(AD732485-
manufacturer 5132)
Copy of GMP certificate Issued by DRAP is
attached.
Name and address of API manufacturer. Name of API: Diclofenac Potassium
M/s AARTI DRUGS LIMITED (G-60). PLOT NO.
G-60,
MIDC, TARAPUR, BOISAR TAL.PALGHAR,
DIST: THANE.MAHARASHTRA. INDIA.
Module III (Drug Substance) Monograph of Diclofenac Potassium exist in USP
pharmacopeia. The firm has submitted detail of
tests for impurity D, G & related substances
Diclofenac Potassium Batches:
(DFK/10070024, DFK/10070025, DFK/10070026 )
product.
comparative dissolution profile against the brand leader that is Voltfast 50 mg Sachet
by Novartis Pharma AG, Basel, Switzerland by
is Voltfast 50 mg Sachet by Novartis Pharma AG,
Basel, Switzerland. in Acid media 0.1N HCl (pH
1.2), Buffer (pH 4.5) & Buffer (pH 6.8). The values
for f2 are in the acceptable range.
Manufacturer of API Name of API: Diclofenac Potassium
M/s AARTI DRUGS LIMITED (G-60). PLOT NO. G-60,
MIDC, TARAPUR, BOISAR TAL.PALGHAR,
DIST: THANE.MAHARASHTRA. INDIA.
API Lot No. Diclofenac Potassium Batch No.DFK/10120182
Description of Pack
Aluminum foil sachet packed in unit carton (1×10’s)
Batch No. T1/21 T2/21 T3/21
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of For Diclofenac Potassium
API manufacturer issued by concerned Copy of GMP certificate No.NEW-WHO-
regulatory authority of country of origin.GMP/CERT/KD/84387/2019/11/29412
issued by Food & Drug administration Maharashtra
state India.
3. Documents for the procurement of API with Submitted
chromatograms,
etc.
5. Compliance Record of HPLC software Firm informed that their HPLC system has not in
21CFR & audit trail reports on product compliant with 21CFR SOFTWARE.
testing
and humidity monitoring of stability Submitted
S.No. Deficiencies/ Short-comings Reply of the Firm
1. Submit data in section 3.2.S.4.3 as per the Firm submitted the analytical method
guidance document approved by Registration verification report of drug substance performed
Board which specifies that “Analytical Method by drug product manufacturer.
Verification studies including specificity,
accuracy and repeatability (method precision)
performed by the Drug Product manufacturer
for both compendial as well as non-compendial
drug substance(s)”
2. Justification is required for not including theFirm in their reply stated that: “Microbial & Ph
microbial enumeration test, test for specified determination tests as specified in USP
microorganism and pH determination test monograph for diclofenac potassium for oral
while analysis of trial batches of drug product,
solution were performed during stability
since these tests are the part of USP monographstudies of all three trial batches but erroneously
of diclofenac potassium for oral solution. it could not be submitted with dossier. We are
submitting the microbial test report.
3. Justify for not performing the test for Firm in their reply stated that “pH
determination of pH while stability study of determination test as specified in USP
trail batches of drug product. monograph for diclofenac potassium for oral
solution were performed during stability
studies of all three trial batches but erroneously
it could not be submitted with dossier in the
stability summary sheet.
Correct summary report are submitted.
517. Name, address of Applicant / Marketing M/s. Sunshine Pharmaceuticals Emanabad, G.T.
Authorization Holder Road, Gujranwala
Name, address of Manufacturing site. M/s. Sunshine Pharmaceuticals Emanabad, G.T.
Road, Gujranwala
☐ Importer
(contract giver)
☐ Export sale
The proposed proprietary name / brand name Detran-P 50 mg Film coated Tablet
Pharmaceutical ingredient (API) per unit Diclofenac Potassium……50 mg
Pharmaceutical form of applied drug Oral tablet
The status in reference regulatory authorities USFDA Approved.
For generic drugs (me-too status) Artinil-K Tablet of M/s. Global Pharmaceuticals
(Reg.no.005982)
GMP status of the Finished product Copy of GMP certificate Issued by DRAP is
manufacturer attached.
Name and address of API manufacturer. Name of API: Diclofenac Potassium
M/s. Henan Dongtai Pharm Co. Ltd. East
Changhong Road,Tangyin Henan,China
Module III (Drug Substance) Monograph of Diclofenac Potassium exist in BP
pharmacopiea. The firm has submitted detail of
(131118-5, 131118-6, 131118-7)
product.
dissolution profile against the comparator brand that is Diclorep 50 mg
tablet by M/s. Sami Pharmaceuticals by performing
quality tests (Identification, Assay, Dissolution,
CDP has been performed against the same brand in
Acid media 0.1N HCl (pH 1.2), Buffer (pH 4.5) &
Buffer (pH 6.8). The values for f2 are in the
acceptable range.
Manufacturer of API Name of API: Diclofenac Potassium
M/s. Henan Dongtai Pharm Co. Ltd. East Changhong Road,Tangyin
Henan,China
API Lot No. Diclofenac Potassium Batch No. 20200329,20200330,20200331
Description of Pack
Detran-P Tablets are packed in Alu-PVC packing.
Batch No. Trial-001 Trial-002 Trial-003
No. of Batches 03
firm (if any)
API manufacturer issued by concerned Copy of GMP certificate No. HA20170001 issued
regulatory authority of country of origin. by China Food and Drug Administration

chromatograms,
etc.
& audit trail reports on product testing Submitted
1. Provide compatibility studies of the drug Firm submitted the summary report of
Substance(s) with excipients as the qualitative compatibility testing study in which it was
composition of the formulation is not similar stated that FTIR spectral and HPLC analysis
to innovator / reference product in section 3.2. showed that there is no appearance or
P.2.1.1. disappearance of any characteristic peaks of
pure drug Diclofenac Potassium and in the
physical mixture of all other excipients which
confirms the absence of chemical interaction
between drug substance and excipient.
2. As per the USP monograph of diclofenac Firm in their reply stated that in analytical
potassium tablet the recommended dissolution testing method the word simulated intestinal
medium should be Simulated intestinal fluid fluid was missing due to typographical error.
(without enzyme), while the dissolution Correct copy of analytical procedure has
medium of drug product mentioned in section resubmitted.
3.2. P.5.2 was buffer solution pH 6.8. Justify Further, the firm stated, we have used exactly
for not complying the USP monograph in same composition of dissolution medium as
terms of selection of dissolution medium. specified in USP (Intestinal Fluid, simulated)
as evident from the submitted analytical
procedure.
However, USP monograph do not specify the

composition of dissolution medium.
Reference literature revealed that the pH of
simulated intestinal fluid is between 6.50-6.60
(25 °C, after dilution)
3. According to the dissolution data of stability Firm rectify the acceptance limit of dissolution
batches of drug product more than 95% drug test in terms of Q value and revised the criteria
release within 60 minutes, then justify the to “NLT 75% (Q) of the labeled amount
setting of broader acceptance criteria for dissolved in 60 minutes.” Further, the firm did
dissolution testing i.e. NLT 75% within 60 not give any justification of setting of broader
minutes. Further, the acceptance criteria of acceptance criteria for dissolution testing i.e.
dissolution recommended by USP is in term of NLT 75% within 60 minutes, despite of
Q value, justify for not adapting the achieving 95% drug release within 60
acceptance limit with the Q value. minutes.
518. Name, address of Applicant / Marketing M/s. Batala Pharmaceuticals 23/B, Small Industrial
Authorization Holder Estate No.2 Gujranwala
Name, address of Manufacturing site. M/s. Batala Pharmaceuticals 23/B, Small Industrial
Estate No.2 Gujranwala
☐ Importer
(contract giver)
☐ Export sale
The proposed proprietary name / brand name Beflam 50mg Tablet
Strength / concentration of drug of Active Each sugar-coated tablet contains:
Pharmaceutical ingredient (API) per unit Diclofenac Potassium……50 mg
Pharmaceutical form of applied drug Oral tablet
The status in reference regulatory authorities USFDA Approved.
For generic drugs (me-too status) Ariflam Tablet of M/s. Aries Pharmaceuticals
(Reg.no.054526)
GMP status of the Finished product Copy of GMP certificate not attached.
manufacturer
Name and address of API manufacturer. M/S Aarti Drugs Limited (G-60). Plot No. G-60,
Midc, Tarapur, Boisar Tal. Palghar,
Dist:Thane.Maharashtra. India.
Module III (Drug Substance) Monograph of Diclofenac Potassium exist in USP
pharmacopeia. The firm has submitted detail of
(DFK/10070024, DFK/10070025, DFK/10070026)
product.
dissolution profile against the comparator brand that is Caflam 50mg
tablet by performing quality tests (Identification,
Assay, Dissolution, Uniformity of dosage form).
CDP has been performed against the same brand in
Acid media 0.1N HCl (pH 1.2), Buffer (pH 4.5) &
Buffer (pH 6.8). The values for f2 are in the
acceptable range.
Manufacturer of API M/S Aarti Drugs Limited (G-60). Plot No. G-60, Midc, Tarapur, Boisar
Tal.Palghar, Dist: Thane. Maharashtra. India.
API Lot No. Diclofenac Potassium Batch No. DFK/18070058
Description of Pack
Tablets are packed in Alu-PVC packing.
Batch No. DP21-001 DP21-002 DP21-003
No. of Batches 03
firm (if any)
API manufacturer issued by concerned Copy of GMP certificate No. HA20170001 issued
regulatory authority of country of origin. by China Food and Drug Administration

chromatograms,
etc.
1. Submit specifications as well as analytical Firm submitted the specification and analytical
method of drug substance from the drug procedure of drug substance in accordance
product manufacturer in section 3.2.S.4.1 and with USP.
3.2. S.4.2.
2. Submit data in section 3.2.S.4.3 as per the Firm submitted the verification report of drug
guidance document approved by Registration product instead of drug substance as evident
Board which specifies that “Analytical Method from the sample preparation of submitted
Verification studies including specificity, report.
accuracy and repeatability (method precision)
performed by the Drug Product manufacturer
for both compendial as well as non-compendial
drug substance(s)”
3. Composition of drug product given in section Firm in their reply stated that “it was clerical
3.2.P.1 mentioned chloroform in the sugar- mistake we are using IPA 70% as an organic
coating material, please elaborate the role of solvent instead of chloroform for dissolving
chloroform in the applied composition and waxes.
provide scientific rational of its usage, along
with the international literature reference.
4. Provide compatibility studies of the drug Firm in their reply stated that we have done
Substance(s) with excipients as the qualitative placebo analysis in method verification in
composition of the formulation is not similar to section 3.2.S.4.3,which did not show any
innovator / reference product in section 3.2. interference of excipients with drug substance.
P.2.1.1.
5. Provide results of all quality test specify in the Firm submitted the pharmaceutical
USP monograph of diclofenac potassium tablet equivalence report with caflam 50mg Tablet of
to establish the pharmaceutical equivalence M/s. Novartis with the result of assay,
between reference and test product since the dissolution and disintegration.
results are not mentioned.
6. Justify how your product is comparable to Firm submitted the revised CDP report without
reference product when the similarity factor f2 any justification.
was below 50 as evident from the submitted
CDP report of drug product.
7. BMR of drug product revealed the source of Firm in their reply stated that it was mistakenly
active ingredient was China, while, as per the written China in BMR, correct copy of BMR
S-part of CTD dossier, source of drug has submitted.
substance was AARTI Drug Limited, India,
clarification is required in this regard.
8. Scientific justification is required for using Firm submitted the reply that it was a clerical
completely different method for assay of drug mistake that was submitted in section
product then specified in USP monograph. 3.2.P.5.3.Further, they stated that “we have
Similarly, the analytical procedure verified in performed all test during stability study in
section 3.2.P.5.3 was also not in accordance accordance with USP monograph.
with the method of assay recommended by But, firm did not submit any documented
USP monograph of diclofenac potassium evidence neither submitted the correct
tablet. procedure.
Further, the raw data sheet of stability data
submitted in the reply again revealed that the
assay procedure was not in accordance with
USP in terms of chromatographic condition
and the calculations.
9. In section 1.5.6 you have specified that the Firm stated that their drug product comply USP
pharmacopoeial reference of drug product was specification and they rectified the information
USP while in section 3.2.P.5 it is mentioned in section 3.2.P.5.
that the product complies inhouse
specification, clarification is required either
drug product complies pharmacopoeial
reference or the in-house specification.
10. Provide detailed composition and preparation Firm submitted the dissolution medium details
method of simulated intestinal fluid that is the according to which pH 6.8 buffer medium has
recommended dissolution medium of been prepared under the head of simulated
diclofenac potassium tablet. intestinal fluid.
11. Clarify the acceptance criteria of dissolution in Firm submitted the document which concluded
term of time point at which NLT 75% should that value of Q is 75% at time T 30 minutes.
be achieved, as the time point has not Firm neither correct the specification in section
mentioned on stability data sheet. Further set 3.2 P.5.1 nor in stability summary sheet.
the acceptance criteria of dissolution in term of
Q, since the USP monograph specify the limit
with Q value i.e. NLT 75% (Q) of the labeled
amount of diclofenac potassium dissolved.
12. • Provide details that which lot number of Firm submitted the COA of API of batch no.
drug substance has been used in DFK/11010013 along with documented
manufacturing of each batch of drug evidence of procurement of API.
product. Also provide documents
confirming evidence of import of each lot Further, firm submitted the audit trail report
of drug substance used in manufacturing of and digital data logger record.
• Provide Reference of previous approval of
firm (if any)
• Documents for the procurement of API
with approval from DRAP (in case of
import).
• Provide compliance Record of HPLC
software 21CFR & audit trail reports on
product testing.
• Provide Record of Digital data logger for
accelerated).
Decision: Approved. Firm shall submit following before issuance of registration letter:
• Analytical method verification report of drug substance performed by drug product manufacturer
as per requirement of section 3.2.S.4.3 of Form-5F.
• Submission of revised method for assay testing of drug product in accordance with USP
monograph of “Diclofenac potassium tablet” and accordingly performance of assay in compliance
with USP on next time point of stability.
• Submission of revised dissolution limits in terms of %age released and time point from that
recommended by the US FDA for innovator product and in compliance of USP monograph.
Further, performance of dissolution testing in line with revised specification on next time point.
• Firm shall submit the fee of Rs. 7,500 for revision of specifications per notification No.F.7-11/2012-
Cases of Form 5-F

519. Name, address of Applicant / M/s SAMI Pharmaceuticals (Pvt) Ltd. F-95, Off Hub
Marketing Authorization Holder River Road, S.I.T.E. Karachi.
Name, address of Manufacturing site. M/s SAMI Pharmaceuticals (Pvt) Ltd. F-95, Off Hub
River Road, S.I.T.E. Karachi.
☐ Importer
☐ Export sale
BISTIN 2.5mg/ml Oral Solution
name
Strength / concentration of drug of Each ml contains:
Active Pharmaceutical ingredient Bilastine…….…2.5mg
(API) per unit
Pharmaceutical form of applied drug Clear colorless to slightly colored Oral Solution
Pharmacotherapeutic Group of (API) Antihistamines
ATC Code: RO6AX29
Innovator’s Specs
specifications
Proposed Pack size 60ml & 120ml
The status in reference regulatory Ilaxten / Bilaxten 2.5mg/ml oral solution M/s. Menarini
authorities International Operations Luxembourg S.A
Spain Approved.
For generic drugs (me-too status) Not applicable
GMP status of the Finished product GMP certificate issued dated: 11-08-2020
manufacturer
Name and address of API manufacturer. Virupaksha Organics Limited
Address: Survey No. 10 Gaddapototharam Village
Jinnaram, Mandal, Sangareddy District – 502319,
Telangana, India.
manufacturing process and controls, specifications,
analytical procedures and its validation, batch analysis
and controls, specifications, analytical procedures and
months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for
6 months
Batches: (ABSTC0120001, ABSTC0120002,
ABSTC0120003)
impurities, individual impurity and total impurity,
specifications, analytical procedure and its validation
Pharmaceutical equivalence and It may please be noted that despite of our contacting
comparative dissolution profile M/s. Menarini Farmaceutica Internazionale SRL as well
as local distributor, we could not obtain samples for
conducting Pharmaceutical Equivalence.
Due to the above fact w.r.t. its procurement, we are
unable to perform Pharmaceutical Equivalence but
despite of that we have considered and ensured that our
formulation comply with the innovator & all our quality
tests i.e. Identification, Assay, pH, Preservatives test,
Degradation products and Microbial Enumeration Test
comply the references/general guidelines and validated
as per USP guidelines which ensures the quality and
safety of our product
CDP not applicable

validation/verification of product Linearity, Accuracy, Precision including Repeatability
& Intermediate Precision, Robustness and Specificity.
Manufacturer of API Virupaksha Organics Limited, Telangana India
API Lot No. ABSNC1119001
Description of Pack
Amber Glass Bottle packed in unit carton (60ml & 120ml)
Frequency Accelerated: 0, 1,2,3,4 & 6 (Months)
Batch No. Lab-01 Lab-02 Lab-03
Batch Size 4 Liters 4 Liters 4 Liters
No. of Batches 03
1. Reference of previous approval of Reference of our last onsite panel inspection for instant
applications with stability study data of dosage form conducted during last three years LAGITA
the firm (if any) Double Action Suspension (Sodium Alginate + Sodium
Bicarbonate + Calcium Carbonate) 500mg + 213mg +
325mg on 30th January 2020
The inspection report confirms following points The
HPLC software is 21CFR Compliant
1. Audit trail on the testing reports is available.
2. Adequate monitoring and control are available
for stability chamber. Chambers are controlled
and monitored through software having alarm
system for alerts as well.
3. Related manufacturing area, equipment,
personnel and utilities are GMP compliant.
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. 5884/E1/2018
of API manufacturer issued by issued by DRUGS CONTROL ADMINISTRATION
concerned regulatory authority of Government of Telangana valid till 27/03/2022
country of origin.
3. Documents for the procurement of API Copy of commercial invoice (Invoice# AEX/085/2019‐
with approval from DRAP (in case of 20 dated 27th November 2019
import).
with received quantity i.e. 400gm) for the purchase of
Bilastine from M/s Virupaksha Organics Ltd. India with
attestation of DRAP dated 03‐12‐2019
4. Data of stability batches will be Firm has submitted complete record of testing of
supported by attested respective all batches along with chromatograms, raw data
documents like chromatograms, Raw sheets, COA and summary data sheets
etc.
5. Compliance Record of HPLC software Firm has submitted audit trail record of product testing
21CFR & audit trail reports on product of HPLC for all test intervals.
testing
6. Record of Digital data logger for Firm has submitted record of digital data logger for
temperature and humidity monitoring of temperature and humidity monitoring of real time and
stability chambers (real time and accelerated stability chambers.
accelerated)
Sr.no. Shortcomings/Deficiencies Response of the Firm
1. Provide Valid Good Manufacturing Firm has submitted the copy of GMP certificate of
Practice (GMP) certificate of the drug substance manufacturer i.e. M/s. Virupaksha
Drug Substance manufacturer issued Organic Limited, Telangana state which is valid
by relevant regulatory authority of up till 29/01/2022.
country of origin since the submitted
GMP certificate was valid till 2021.
2. Justification is required for not Since, the testing facility of P-XRD is not
performing the powder x-ray available in Pakistan therefore we rely on drug
diffraction test by drug product substance manufacturer COA.
manufacturer to confirm the
polymorphic state of drug substance,
since the bilastine has three different
polymorphic forms. Further, the test
has been included in the COA of the
drug substance manufacturer.
3. Formulation contain preservative, so Firm submitted preservative effectiveness studies
preservative effectiveness studies to of drug product.
be performed as per
recommendations of pharmacopoeia
and shall be submit.
4. Justification is required for not Firm submitted the API- Excipient compatibility
performing compatibility studies of study report of bilastine oral solution.
excipient with active ingredient,
since the solubilizing agent of
innovator is betadex and you have
using β-Cyclodextrin
sulfobutylether, sodium salt as a
solubilizer.
5. Provide data of pharmaceutical Firm submitted the reply that the reference
equivalence against the innovator product is not available in Pakistan, they have
product to justify your formulation tried to arrange it from the country of origin but
development as per the requirement unfortunately not succeeded.
of section 3.2. P.2.2.1.
Decision: Deferred for submission of pharmaceutical equivalence report against the innovator drug
product.
520. Name, address of Applicant / Marketing M/s Martin Dow Limited, Plot no. 37, Sector 19,
Authorization Holder Korangi Industrial Area, Karachi
Name, address of Manufacturing site. M/s Martin Dow Limited, Plot no. 37, Sector 19,
Korangi Industrial Area, Karachi
☐ Importer
☐ Export sale
Details of fee submitted PKR 30,000/-dated 29-07-2021 slip no.
5849810042
Solidow Tablets 10mg
name
Strength / concentration of drug of Active Each Film Coated Tablet contains:
Pharmaceutical ingredient (API) per unit Solifenacin Succinate …………10mg
Pharmacotherapeutic Group of (API) Anti-muscarinic
As per innovator’s specifications
specifications
The status in reference regulatory Product is registered in FDA-USA, with brand
authorities name “VESICARE TABLET” by Astellas Pharma
US, Inc.
For generic drugs (me-too status) Solifen Tablets 10mg by Getz Pharma
(Registration No. 061203)
GMP status of the Finished product GMP certificate issued 11-6-2020
manufacturer
Name and address of API manufacturer. Zhejiang Guobang Pharmaceuticals Co., Ltd.
Address:
No. 6, Weiwu Road, Hangzhou Gulf Shangyu
Economic and Technological Development
Zone, Zhejiang, PR China.
Module-II (Quality Overall Summary) Firm has submitted QOS details as per WHO
QOS PD template.
substances, specifications, analytical procedures
substance
months
months
Batches: (170501,170502,170503)
medium) and its validation studies, batch analysis
comparative dissolution profile against the Innovator product that is VESICARE
TABLETS 10mg by Astellas Pharma by
performing quality tests (Identification,
Disintegration, Assay, Dissolution, Uniformity of
dosage form).
that is VESICARE TABLETS 10mg by Astellas
Pharma, in Acid media (pH 1.2) F2= 63.1, Acetate
buffer (pH 4.5) F2 =71.1 & Phosphate Buffer (pH
6.8) F2=54.6. The values for f1 and f2 are in the
acceptable range.
Analytical method validation/verification of Method Validation studies have submitted
specificity.
Manufacturer of API Zhejiang Guobang Pharmaceuticals Co., Ltd.
Address:
No. 6, Weiwu Road, Hangzhou Gulf Shangyu Economic and
Technological Development Zone, Zhejiang, PR China.
API Lot No. 2011000080 (200501)
Description of Pack
Batch No. NPD-T-1395-S NPD-T-1429-S NPD-T-1430-S
No. of Batches 03
1. Reference of previous approval of Firm has referred to their product Empator Tablets
applications with stability study data of the 10mg which was approved in 291st Meeting of
firm (if any) Registration Board held on 2nd - 4th September
2019.
confirmed.
• The firm has 21 CFR compliant HPLC
software
• The firm possesses stability chambers
with digital data loggers.
2. Approval of API/ DML/GMP certificate of Copy of DML for Zhejiang Guobang
API manufacturer issued by concerned Pharmaceuticals Co., Ltd. issued by Zhejiang Food
regulatory authority of country of origin. and Drug Administration & valid up to 08-12-2024
is submitted
3. Documents for the procurement of API with Firm has submitted copy of invoice (invoice#
approval from DRAP (in case of import). GBPH2020-2023) Dated: 02-11-2020 from
Zhejiang Guobang Pharmaceuticals Co., Ltd.
cleared by DRAP Karachi office dated 03-11-
2020.
testing
Decision: Approved with innovator’s specifications as per Policy for inspection of Manufacturer
abroad and verification of local storage facility.
Finished import product received on Form 5-F:

521. Name, address of Applicant / Importer M/s Himmel Pharmaceuticals (Pvt.) Ltd.
793-D, Block ‘’C’’, Faisal Town Lahore.
Details of Drug Sale License of importer License No: 05-352-0065-016174-D
Address: 793-D, Block-C, Faisal Town Lahore
Address of Godown: NA Validity: 06. Feb.2022
Name and address of marketing authorization M/s BEACON Pharmaceuticals Limited
holder (abroad) Plant address: Kathali, Bhaluka, Mymensingh
Bangladesh
Office address: 9/B/2, Toynbee Circular Road,
Motijheel Dhaka, Bangladesh
Name, address of manufacturer(s) M/s BEACON Pharmaceuticals Limited
Plant address: Kathali, Bhaluka, Mymensingh
Bangladesh
Office address: 9/B/2, Toynbee Circular Road,
Motijheel Dhaka, Bangladesh
Name of exporting country Bangladesh
Detail of certificates attached (CoPP, Free sale CoPP: Original legalized COPP (Certificate#
certificate, GMP certificate) DA/6-110/2016/3300 issued on 01-06-2020 by
Government of the people’s republic of
Bangladesh, Ministry of Health & Family
welfare, Directorate General of Drug
Administration, Oushad Bhaban, Mohkhali
Dhaka-1212, Bangladesh.
GMP: Firm has submitted Legalized GMP
certificate (Certificate No. DA/6-110/06/10002)
issued by M/s Beacon Pharmaceuticals limited.
Also, Renewal certificate is submitted
(Certificate No. DA/6-110/06/4950).
Details of letter of authorization / sole agency Firm has submitted copy of letter of distribution
agreement certificate from Beacon Pharmaceuticals limited.
The letter specifies that the manufacturer
appoints M/s Himmel Pharmaceuticals Pvt. Ltd.
to register their products in Pakistan. The
authorization letter is valid till June, 2025.
☒ Importer
giver)
☐ Export sale
purpose only
Dy. No. and date of submission Dy. No.16561 Date:15.06.2021
Details of fee submitted PKR: 100,030/- Date: Dec-2020
The proposed proprietary name / brand name Pazonix 200mg Tablet
Strength / concentration of drug of Active Each tablet contains
Pharmaceutical ingredient (API) per unit Pazopanib Hydrochloride INN….200mg
Pharmacotherapeutic Group of (API) Anti-cancer
Proposed Pack size 30’s (HDPE Bottle)
Proposed unit price As per current pricing policy of DRAP
The status in reference regulatory authorities Votrient 200mg Tablet
For generic drugs (me-too status) Votrient (Novartis)
Name, address of drug substance manufacturer Ace bright (India) Pharma Private Limited
Address: No. 77D &116/117, KIADB Industrial
Area Jigani, Bangalore - 560 105
Karnataka, India.
for both sources related to nomenclature,
substance.
Stability Studies of Drug Substance Firm has submitted long term stability study data
(Conditions & duration of Stability studies) of 3 batches of drug substance at 25°C ± 2°C /
60 ± 5% RH for 12 months. The accelerated
stability data is conducted at 40°C ± 2°C / 75 ±
5% RH for 6 months
Module-III Drug Product: Firm has submitted data of drug product
manufacturing process and process control,
process validation protocols, control of
excipients, control of drug product,
specifications, analytical procedures, validation
of analytical procedures, batch analysis,
stability.
Pharmaceutical Equivalence and Comparative Comparative analysis Studies against the
Dissolution Profile reference product Votrient 200mg (Novartis) has
been submitted
product studies for the applied product.
Container closure system of the drug product HDPE Bottle
Stability study data of drug product, shelf life and Firm has submitted stability study data of 3
storage conditions batches.
Accelerated stability studies have been
conducted at 40oC±2oC and 75%±5% RH for 6
months.
Real time stability studies conducted at
30oC±2oC and 65% ± 5% for 24 months
Evaluation by PEC:
Sr.no. Shortcomings/Deficiencies Response of the Firm
1. Submit data of analytical Method Firm has submitted analytical method validation
verification studies including studies of drug substance performed by drug
specificity, accuracy and product manufacturer.
repeatability (method precision).
2. Justify acceptance criteria set for Firm has submitted the reply, in which it is stated
dissolution test i.e. NLT 70% (Q) in that “The dissolution time for pazonix 200mg
60 minutes, which is not as per the tablet has been selected 60 minutes as per the FDA
international guidelines as well as the dissolution database. In the database, USP
decision of Registration Board i.e. apparatus Type-II and 10,20,30,45 and 50 min has
“For all type of drug products, the been mentioned for profiling. For the immediate
value of “Q” should not be less than release tablet, we have selected 60 mins as a single
75% in any case as per the time point.
recommendations of United States Firm has not given any scientific justification for
Pharmacopoeia (USP) General selecting the extreme time point i.e. 60 minutes for
Chapter <711> Dissolution, dissolution of drug product, while the FDA review
Dissolution testing in BP finished document of innovator product reveals that the
products monographs for solid oral dissolution criteria should be Q= at 30 minutes
dosage forms and The International using the following conditions. Apparatus: USP
Pharmacopoeia Ninth Edition, 2019 Apparatus 2 Volume: 900 mL Medium: 50 mM
-Dissolution testing of tablets and sodium acetate buffer, pH 4.5, containing 0.75%
capsules”. SDS Agitation: Paddle speed of 75 rpm. Analysis:
As per the submitted data percentage UV at 270 nm with a background correction at 400
of drug release at 30 minutes was nm. Temperature: 37°C.
55.09% in the USFDA recommended
release media. Justify, how your
formulation can be considered
equivalent to the innovator product
which shows release more than
Q+5% in 30 minutes.
3 • Justify how the results of all Firm has not provided any justification regarding
quality tests for every batch in these queries, instead submit the stability data of
stability studies are same at all commercial batches. (batch no.
time points. 3860005,3860006,3860007)
• Justification is required regarding
the out of specification assay
results i.e. 46.5mg content of
pazopanib per tablet at 6-month
time interval during the
accelerated stability studies of
batch no. 3860003 and 3860004.
4 Provide copy of Batch Firm has submitted the Batch Manufacturing
Manufacturing Record (BMR) for all Record of batch no. 3860002, 3860003 and
the batches of drug product under 3860004.
section 2.3.R.1.1, for which stability
studies data is provided in Module 3
section 3.2. P.8.
5 Firm has submitted the differential fee of Rs. 50,000 vide Challan no.78134245317 dated
22-08-2022 for finished import drug product, as per notification No.F.7-11/2021-
Decision: Deferred for Scientific justification regarding difference in dissolution limits in terms of
%age released and time point from that recommended by the US FDA for innovator product .
Previously Deferred Cases of Form 5-F:

522. Name, Address of Applicant / M/s Bio-Next Pharmaceuticals Plot No. 50, Street No. S-10, RCCI
Marketing Authorization Holder Industrial Estate, Rawat Islamabad- Pakistan
Name, address of Manufacturing M/s Bio-Labs (Pvt). Ltd Plot No. 145industrial Triangle Kahuta road
site. Islamabad.
Status of the applicant ☐Manufacturer
☐ Importer
Intended use of pharmaceutical ☐Domestic sale
Nextcraft 1MIU Injection IV
brand name
Active Pharmaceutical ingredient Colistimethate Sodium….1MIU
(API) per unit
Pharmaceutical form of applied Glass vial filled with almost white to off-white coloured Lyophilized
drug Powder.
Antibiotics
(API)
USP
specifications
MHRA Approved
authorities
For generic drugs (me-too status) Colistim Injection by Pharmasol (Pvt) Ltd
GMP status of the Finished GMP certificate issued based upon inspection conduct 23-4-2019, valid
product manufacturer upto 22-4-2022.
Name and address of API Mac-Chem Products (India)Pvt.Ltd
manufacturer. N-211/2/10, midc, Boisar District –Thane.
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD template. Firm has
Summary) summarized information related to nomenclature, structure, general
properties, solubility, physical form, manufacturers, description of
analytical procedures and its validation, batch analysis and justification
stability studies of drug substance and drug product.
Module III (Drug Substance) Firm has submitted detailed data for both drug substance data related
to nomenclature, structure, general properties, solubilities, physical
form, manufacturers, description of manufacturing process and
controls, impurities, specifications, analytical procedures and its
substance.
Real time: 6oC ± 2 oC, RH for 48 months
Accelerated: 25oC ± 2 o C/60% ± 5%RH for 6 months
Batches:(CLS0219006, CLS0219008, CLS0219009)
Module-III (Drug Product): Firm has submitted data of drug product including its description,
composition, pharmaceutical development, manufacture,
manufacturing process and process control, process validation
protocols, control of excipients, control of drug product, specifications,
analytical procedures, validation of analytical procedures, batch
analysis, justification of specifications, reference standard or materials,
Pharmaceutical equivalence and Firm has submitted results of pharmaceutical equivalence for all the
comparative dissolution profile quality tests for their product against the comparator i.e. Colistim
Injection by Pharmasol (Pvt) Ltd.
Analytical method Firm has submitted report of verification of analytical method for the
validation/verification of product drug product.
Manufacturer of API Mac-Chem Products (India)Pvt.Ltd
N-211/2/10, midc, Boisar District –Thane.
API Lot No. A1680997, A1681004, A1600290
Description of Pack
Glass vial
Real Time: 0, 3, 6 ,9,12,18,24(Months)
Batch No. L-159 L-182 L-199
Batch Size 18200 Vials 28000 Vials 30000vials
No. of Batches 03
1. Reference of previous approval Empaglif 10mg & 25mg tablet in 296th meeting (Bio-Labs (Pvt). Ltd,
of applications with stability Islamabad).
2. Approval of API/ DML/GMP Firm has submitted copy of GMP certificate (NEW-WHO
certificate of API manufacturer GMP/CERT/KD/74238/2018/11/24897) issued by Maharashtra food
issued by concerned regulatory and drug administration dated 11-09-2018.
authority of country of origin. The certificate is valid till 10-09-2021.
3. Documents for the procurement Firm has submitted copy of Form 6 “License to import drugs for clinical
of API with approval from trial, examination, test or analysis” for import of Colistimethate sodium
DRAP (in case of import). 5Kg from Mac-Chem Products (India)Pvt.Ltd N-211/2/10, midc,
Boisar District –Thane. The license was issued on 14-02-2020.
• Firm has submitted copy of commercial invoice dated 14-02-2020
specifying import of Colistimethate sodium 5Kg. The invoice is signed
by AD (I&E) DRAP.
4. Data of stability batches will be Firm has submitted record of testing of all batches including COA and
supported by attested respective summary data sheets.
data sheets etc.
5. Compliance Record of HPLC The product specifications of colistimethate sodium injection based on
software 21CFR & audit trail USP and there is no application of HPLC in testing method because the
reports on product testing assay method based on microbial assay therefore compliance record of
HPLC is not applicable here.
6. Record of Digital data logger for Firm has submitted record of digital data logger for temperature and
temperature and humidity humidity monitoring of real time and accelerated stability chambers.
• Provide detailed analytical procedures for Firm submitted the analytical procedure for the testing of
the testing of drug substance by the drug drug substance but the microbial assay method is not in
product manufacturer. accordance with USP in terms of composition of media,
• Provide analytical Method Verification volume of media, method of analysis, incubation
studies including specificity, accuracy and temperature and potency calculation.
repeatability performed by the Drug Product Firm submitted the analytical method verification studies.
manufacturer. Verification has been done on assay procedure which is also
not as per the USP.
Justify 90.1mg filled weight of colistimethate Nominal potency of colistimethate sodium used for
sodium per vial against the labelled claim of calculation of filled weight is not correct, according to the
colistin activity as per the USP monograph of innovator product of Colistimethate sodium 1MIU the
“colistimethate for injection”. nominal potency of the drug substance =12,500 IU/mg. So,
using of 90.1 filled weight is still not scientifically rationale.
All quality test as per USP monograph has not Test for uniformity of dosage unit, loss on drying, and free
been performed while establishing the colistin under Colistimethate Sodium are not performed
pharmaceutical equivalence against the while establishing pharmaceutical equivalence with the
reference product. Provide results of all quality reference product, while these tests are included in the USP
test of applied and reference product as per USP monograph of colistimethate sodium injection.
to establish pharmaceutical equivalence.
Details of type and quantity of diluents used for According to the submitted information, to reconstitute the
reconstitution for of applied product is required. injection, use 3ml 0.9% sodium chloride solution.
While the international reference product including the
innovator, use the range of 7ml-10ml of water for injection
or 0.9% sodium chloride for reconstitution of colistimethate
injection.
Provide detailed analytical procedures used to Firm submitted the analytical procedure for the testing of
evaluate the quality of drug product by the drug substance but the microbial assay method is not in
Manufacturer M/s. Bio-Lab Pvt. Ltd. accordance with USP in terms of composition of media,
volume of media, method of analysis, incubation
temperature and potency calculation.
Further, the test for uniformity of dosage unit, loss on
drying, heavy metals, and free colistin under Colistimethate
Sodium are not included in finished product specification,
since these tests are included in the USP monograph.
According to the filled BMR batch size of Batch Firm submitted the reply that “Batch sizes mentioned on
L-159, L-199 and L-182 is 11090vials,11,000 stability was written mistakenly. Please consider BMR batch
vials and 11050 vials respectively. While sizes (11,111 packs) as valid batch size. Correct stability
according to the stability data sheet batch size of data has been submitted.
all three batches are L-159 18,200 vials, L-199
30,000 vials and L-182 28,000 vials.
Justification is required regarding the disparity
observed in the batch sizes of the same batch.
Decision of 316th meeting of Registration Board:
Deferred for the submission of following:
• Scientific justification for using microbial assay procedure of drug substance and drug product different from that
specified in relevant USP monograph.
• Scientific justification using fill weight of 90.1 mg with respect to nominal potency of 1MIU Colistimethate sodium
i.e.12,500IU/mg.
• Scientific justification for not performing critical tests like “test for uniformity of dosage unit”, “loss on drying” and
“free colistin” during the pharmaceutical equivalence studies.
“free colistin” during the stability studies.
• For further deliberation regarding the label claim of Colistimethate sodium in line with the product approved in
reference regulatory agencies and pharmacopeia.
Response of the Firm:
Scientific justification for using microbial assay procedure of drug substance and drug product different from that
Firm has submitted the revised microbial assay method which is again not in accordance with USP general chapter
microbial assay <81> in terms of analysis and calculations.
Scientific justification using fill weight of 90.1 mg with respect to nominal potency of 1MIU Colistimethate sodium
i.e.12,500IU/mg.
Firm has submitted the calculation, according to which quantity of 87.144mg of colistimethate injection has been filled
per vial after adjustment of water content and sodium factor. Further, firm set the internal fill weight ±4% i.e. 83.65mg
to 90.62 mg and fill weight set at 90mg/vial.
Scientific justification for not performing critical tests like “test for uniformity of dosage unit”, “loss on drying” and
Firm has submitted revised pharmaceutical equivalence report in which only test for uniformity of dosage unit has been
added but test for loss on drying and free colistin still not been included.
Firm has submitted the revised stability data and COA of relevant stability batches, in which test for loss on drying and
free colistin was still not included neither any scientific justification has been submitted.
Decision: Registration Board deferred the case for following points:
• submission of batch manufacturing details of most recent commercial batch from M/s Bio Labs Pvt Ltd.,
for applied formulation to confirm the fact whether Colistimethate injection is formulated from pre-
lyophilised drug substance or otherwise.
• Performance of microbial assay of drug substance and drug product in accordance with USP general
chapter of microbial assay <81>.
• Submission of Pharmaceutical equivalence report in which all the quality test should be included in
accordance with USP monograph of colistimethate injection.
• Performance of loss on drying test for drug product as per USP monograph of colistimethate injection.
523. Name, Address of Applicant / Marketing M/s. Benson Pharmaceuticals Plot #3 Mai Road
Authorization Holder National Industrial Zone RCCI Rawat Pakistan.
Name, address of Manufacturing site. M/s Bio-Labs (Pvt). Ltd Plot No. 145industrial
Triangle Kahuta road Islamabad.
☐ Importer
Intended use of pharmaceutical product ☐Domestic sale
☐ Export sale
Details of fee submitted PKR 50,000/-: vide slip no. 1913592 dated
08/03/2021
The proposed proprietary name / brand name Coliben 1MIU Injection IV
Pharmaceutical ingredient (API) per unit Colistimethate Sodium………...…….1MIU
Pharmaceutical form of applied drug Glass vial filled with almost white to off-white
colored Lyophilized Powder.
The status in reference regulatory authorities MHRA Approved
For generic drugs (me-too status) Colistim Injection by Pharmasol (Pvt) Ltd
GMP status of the Finished product manufacturer GMP certificate issued based upon inspection
conduct 23-4-2019, valid upto 22-4-2022.
Name and address of API manufacturer. Mac-Chem Products (India)Pvt.Ltd
solubility, physical form, manufacturers, description
drug product.
Module III (Drug Substance) Firm has submitted detailed data for both drug
substance.
Real time: 6°C ± 2 °C, RH for 48 months
Accelerated: 25°C ± 2 °C/60% ± 5%RH for 6 months
dissolution profile equivalence for all the quality tests for their product
against the comparator i.e. Colistim Injection by
Pharmasol (Pvt) Ltd.
Analytical method validation/verification of Firm has submitted report of verification of analytical
product method for the drug product.
Manufacturer of API Mac-Chem Products (India)Pvt.Ltd
API Lot No. A1680997, A1681004, A1600290
Description of Pack
Glass vial
Real Time: 0, 3, 6 ,9,12,18,24(Months)
Batch No. L-159 L-182 L-199
No. of Batches 03
1. Reference of previous approval of applications
Empaglif 10mg & 25mg tablet in 296th meeting
(Bio-Labs (Pvt). Ltd, Islamabad).
Firm has submitted copy of GMP certificate (NEW-
WHO GMP/CERT/KD/74238/2018/11/24897)
authority of country of origin. issued by Maharashtra food and drug administration
dated 11-09-2018.The certificate is valid till 10-09-
2021.
3. Documents for the procurement of API with Firm has submitted copy of Form 6 “License to
approval from DRAP (in case of import). import drugs for clinical trial, examination, test or
analysis” for import of Colistimethate sodium 5Kg
from Mac-Chem Products (India)Pvt.Ltd N-
211/2/10, midc, Boisar District –Thane. The license
was issued on 14-02-2020.
• Firm has submitted copy of commercial invoice
dated 14-02-2020 specifying import of
Colistimethate sodium 5Kg. The invoice is signed by
AD (I&E) DRAP.
attested respective documents like including COA and summary data sheets.
chromatograms, Raw data sheets, COA, summary
data sheets etc.
5. Compliance Record of HPLC software 21CFR & NA
• Provide detailed analytical procedures for Firm submitted the analytical procedure for the testing of drug
the testing of drug substance by the drug substance but the microbial assay method is not in accordance
product manufacturer. with USP in terms of composition of media, volume of media,
• Provide analytical Method Verification method of analysis, incubation temperature and potency
studies including specificity, accuracy and calculation.
manufacturer. Verification has been done on assay procedure which is also
not as per the USP.
been performed while establishing the colistin under Colistimethate Sodium are not performed while
pharmaceutical equivalence against the establishing pharmaceutical equivalence with the reference
reference product. Provide results of all quality product, while these tests are included in the USP monograph
test of applied and reference product as per USP of colistimethate sodium injection.
innovator, use the range of 7ml-10ml of water for injection or
0.9% sodium chloride for reconstitution of colistimethate
injection.
Provide detailed analytical procedures used to Firm submitted the analytical procedure for the testing of drug
evaluate the quality of drug product by the substance but the microbial assay method is not in accordance
Manufacturer M/s. Bio-Lab Pvt. Ltd. with USP in terms of composition of media, volume of media,
method of analysis, incubation temperature and potency
calculation.
Further, the test for uniformity of dosage unit, loss on drying,
heavy metals, and free colistin under Colistimethate Sodium
are not included in finished product specification, since these
tests are included in the USP monograph.
L-159, L-199 and L-182 is 11090vials,11,000 stability was written mistakenly. Please consider BMR batch
vials and 11050 vials respectively. While sizes (11,111 packs) as valid batch size. Correct stability data
according to the stability data sheet batch size of has been submitted.
30,000 vials and L-182 28,000 vials.
i.e.12,500IU/mg.
i.e.12,500IU/mg.
524. Name, address of Applicant / M/s Novartana Pharmaceuticals (Pvt). Ltd 87-B Plot of Sundar
Marketing Authorization Holder Industrial Area, Raiwind Road, Lahore Pakistan.
Name, address of Manufacturing M/s Bio-Labs (Pvt). Ltd Plot No. 145industrial Triangle Kahuta road
site. Islamabad.
☐ Importer
Intended use of pharmaceutical ☐Domestic sale
Details of fee submitted PKR 50,000/-: vide slip no. 1913592 dated 08/03/2021
ColiNova 1MIU Injection IV
brand name
Active Pharmaceutical ingredient Colistimethate Sodium……….…….1MIU
(API) per unit
Pharmaceutical form of applied drug Glass vial filled with almost white to off-white colored Lyophilized
Powder.
USP
specifications
MHRA Approved
authorities
For generic drugs (me-too status) Colistim Injection 80mg by Pharmasol (Pvt) Ltd. Reg.no. 089922
GMP status of the Finished product GMP certificate no. F.3-19/2019-Addl.Dir. (QA&LT-I) issued based
manufacturer upon inspection conducted on 23-04-2019, valid up to 22-04-2022.
Section Approval Status Firm has Lyophilized vial section as per the GMP certificate issued
based upon inspection conducted on 23-04-2019, valid up to 22-04-
2022.
Name and address of API DMF Holder Address:
manufacturer. Mac Chem Products (India) Pvt. Ltd. 304, Town Centre, Andheri-
Kurla Road, Andheri East Mumbai
Manufacturing and Testing Facilities:
Mac-Chem Products (India)Pvt.Ltd
N-211/2/10, MIDC, Boisar District –Thane. Maharashtra, India
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD template. Firm has
Summary) summarized information related to nomenclature, structure, general
analytical procedures and its validation, batch analysis and justification
stability studies of drug substance and drug product.
Module III (Drug Substance) Firm has submitted detailed data for both drug substance data related
substance.
Module-III (Drug Product): Firm has submitted data of drug product including its description,
composition, pharmaceutical development, manufacture,
manufacturing process and process control, process validation
protocols, control of excipients, control of drug product, specifications,
analytical procedures, validation of analytical procedures, batch
analysis, justification of specifications, reference standard or materials,
Pharmaceutical equivalence and Firm has submitted results of pharmaceutical equivalence Biological
comparative dissolution profile Assay for their product against the comparator i.e. Colistim Injection
80mg by Pharmasol (Pvt) Ltd.
Analytical method Firm has submitted report of verification of analytical method for the
validation/verification of product drug product.
Manufacturer of API Mac-Chem Products (India)Pvt.LtdN-211/2/10, MIDC, Boisar District
–Thane.
API Lot No. A1680997, A1681004, A1600290
Description of Pack
Glass vial
Real Time: 0, 3, 6 ,9,12,18,24(Months)
Batch No. L-159 L-182 L-199
Date of Initiation 29-05-18 03-10-18 21-12-
2018
No. of Batches 03
1. Reference of previous approval of Empaglif 10mg & 25mg tablet in 296th meeting (Bio-Labs (Pvt). Ltd,
applications with stability study data Islamabad).
2. Approval of API/ DML/GMP Firm has submitted copy of GMP certificate (NEW-WHO
certificate of API manufacturer issued GMP/CERT/KD/74238/2018/11/24897) issued by Maharashtra food
by concerned regulatory authority of and drug administration dated 11-09-2018.
country of origin. The certificate is valid till 10-09-2021.
3. Documents for the procurement of Firm has submitted copy of Form 6 “License to import drugs for clinical
API with approval from DRAP (in trial, examination, test or analysis” for import of Colistimethate sodium
case of import). 5Kg from Mac-Chem Products (India)Pvt.Ltd N-211/2/10, midc,Boisar
District –Thane. The license was issued on 14-02-2020.
• Firm has submitted copy of commercial invoice dated 14-02-2020
specifying import of Colistimethate sodium 5Kg. The invoice is signed
by AD (I&E) DRAP.
4. Data of stability batches will be Firm has submitted record of testing of all batches including COA and
supported by attested respective summary data sheets.
data sheets, COA, summary data
sheets etc.
5. Compliance Record of HPLC NA
on product testing
6. Record of Digital data logger for Firm has submitted record of digital data logger for temperature and
temperature and humidity monitoring humidity monitoring of real time and accelerated stability chambers.
accelerated)
• Provide detailed analytical procedures for Firm submitted the analytical procedure for the testing of
the testing of drug substance by the drug drug substance but the microbial assay method is not in
product manufacturer. accordance with USP in terms of composition of media,
• Provide analytical Method Verification volume of media, method of analysis, incubation
studies including specificity, accuracy and temperature and potency calculation.
manufacturer.
Verification has been done on assay procedure which is also
not as per the USP.
been performed while establishing the colistin under Colistimethate Sodium are not performed
pharmaceutical equivalence against the while establishing pharmaceutical equivalence with the
reference product. Provide results of all quality reference product, while these tests are included in the USP
test of applied and reference product as per USP monograph of colistimethate sodium injection.
innovator, use the range of 7ml-10ml of water for injection
or 0.9% sodium chloride for reconstitution of colistimethate
injection.
Provide detailed analytical procedures used to Firm submitted the analytical procedure for the testing of
evaluate the quality of drug product by the drug substance but the microbial assay method is not in
Manufacturer M/s. Bio-Lab Pvt. Ltd. accordance with USP in terms of composition of media,
volume of media, method of analysis, incubation
temperature and potency calculation.
Further, the test for uniformity of dosage unit, loss on
drying, heavy metals, and free colistin under Colistimethate
Sodium are not included in finished product specification,
since these tests are included in the USP monograph.
L-159, L-199 and L-182 is 11090 vials, 11,000 stability was written mistakenly. Please consider BMR batch
vials and 11050 vials respectively. While sizes (11,111 packs) as valid batch size. Correct stability
according to the stability data sheet batch size of data has been submitted.
30,000 vials and L-182 28,000 vials.
i.e.12,500IU/mg.
i.e.12,500IU/mg.
525. Previously Deferred case of Finished Import Product of Form5-F

Name, address of Applicant / Importer M/s. Martin Dow Limited Plot no. 37, Sector 19, Korangi Industrial
Area, Karachi.
Details of Drug Sale License of importer License No: 521
Address: Plot No.37 Sector 19 K.I.A. Karachi
Godown Addresses:1. 1st Floor Plot no.211 Sector 23 K.I.A. Karachi
Plot no. 302 Sector 16 K.I.A. Karachi
Validity: 16/06/2022
Status: by way of wholesale
Name and address of marketing M/s. Duopharma (M) SDN.BHD. Lot 2599, JALAN SERULING 59
authorization holder (abroad) KAWASAN 3, TAMAN KLANG JAYA 41200 KLANG, Selangor,
Malaysia.
Name, address of manufacturer(s) M/s. Duopharma HAPI Sdn. Bhd. No.2, Jalan Saudagar U1/16, Zon
Perindustrian HICOM Glenmarie, Seksyen U1,40150 Shah Alam,
Selangor, Malaysia.
Name of exporting country Malaysia
Detail of certificates attached (CoPP, Free sale certificate, GMP certificate)
• Original legalized & marketed COPP (Certificate# 0095/2021) issued by Pharmaceutical Services Division
Ministry of Health Malaysia.
• Firm has submitted Legalized copy of GMP certificate (Certificate No.1330/19) issued by Competent
authority of “Malaysia” in the name of Duopharma HAPI Sdn. Bhd. No.2, Jalan Saudagar U1/16, Zon
Perindustrian HICOM Glenmarie, Seksyen U1,40150 Shah Alam, Selangor, Malaysia., valid for 3 years
from the date of inspection conducted on 16-17 July 2019.
Details of letter of authorization / sole agency agreement
• “Letter of Authorization” submitted issued by M/s. Duopharma HAPI Sdn. Bhd. No.2, Jalan Saudagar
U1/16, Zon Perindustrian HICOM Glenmarie, Seksyen U1,40150 Shah Alam, Selangor, Malaysia. In
the name of M/s Martin Dow for the applied product of “Lebreta 2.5mg (Letrozole Tablets)”
☒ Importer
Status of application ☐New Drug Product (NDP)
☒Generic Drug Product (GDP)
☐ Export sale
these ☐ Bulk import and local repackaging
☐ Bulk import and local repackaging for export purpose only
Details of fee submitted Rs.50,000/- dated 03-06-2021 slip no. 73776950099
The proposed proprietary name / brand Lebreta 2.5mg (Letrozole Tablets)
name
Strength / concentration of drug of Each film-coated tablet contains
Active Pharmaceutical ingredient (API) 2.5mg of letrozole
per unit
Pharmaceutical form of applied drug Film-coated tablets
Pharmacotherapeutic Group of (API) Anti-neoplastic agents, ATC code: L02BG04
specifications
The status in reference regulatory FDA approved
authorities
For generic drugs (me-too status) Femara Tablet 2.5mg of M/s. Novartis (Pakistan) Limited
(Reg.no.021129)
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template. Firm has
summarized information related to nomenclature, structure, general
analytical procedures and its validation, batch analysis and
system and stability studies of drug substance and drug product.
Name, address of drug substance M/s. Natco Pharma Limited, Chemical Division, Mekaguda Village,
manufacturer Nandigama Mandal, Rangareddy District Telangana, India
(L.Dis.No.758/E/(k)/TS/2018 dated 14-02-2018)
Module-III Drug Substance: Firm has submitted detailed data for both drug substance data related
substance.
Stability Studies of Drug Substance Stability studies has been performed and submitted by the firm.
(Conditions & duration of Stability
studies)
Module-III Drug Product: All the relevant details are submitted by the firm.
Pharmaceutical Equivalence and Firm has performed pharmaceutical equivalence studies and
Comparative Dissolution Profile comparative dissolution with the innovator product Femara tablet.
Analytical method validation/verification Analytical method validation studies for drug product has been
of product performed.
Container closure system of the drug Blisters
product
Stability study data of drug product, shelf Stability studies has been performed and submitted by the firm.
life and storage conditions Real time stability studies have been conducted at 30°C/75 % RH.
Batch Number Status
20181101PB Completed till the claimed shelf
life i.e.2years
20191201 12month data has been
submitted
20200201 12month data has been
submitted
Accelerated stability studies is conducted at 40oC±2oC and 75%±5%

RH for 6 months.
Shelf life: 24month

Sr.# Section# Observations Firm’s response
1. 3.2. S.4 Justify, the verification studies of the The methods for drug substance were adopted
drug substance without performing test from the USP40 Monograph. It is considered as
for accuracy parameter. Method Verification (Compendial Method).
Based on USP General Chapter <1226>, the
verification requirements/parameters that are
considered to be appropriate for verification of
the particular procedure need to be evaluated
during the method verification. The Malaysia,
National Pharmaceutical Regulatory Agency
(NPRA), formerly known as the National
Pharmaceutical Control Bureau (NPCB) had
come out with an Analytical Method
Validation Guideline stating that the Accuracy
parameter and the reliability of these methods
are not required to be validated for monograph
method (compendial method), but merely
verify the methods suitability (System
Suitability Testing) under actual conditions of
use.
Hence, the method verification (compendial
method) was not conducted. The accuracy
parameters were only performed when
validating non-compendial methods.
According to the USP General Chapter
<1226>Verification should include an
assessment of elements such as the effect of the
matrix on the recovery of impurities and drug
substances from the drug product matrix, as
well as the suitability of chromatographic
conditions and
column, the appropriateness of detector signal
response, etc. Recovery studies. This statement
indicates that accuracy parameter is the part of
2. P.2.2.1 Product development studies performed Duopharma HAPI also conducted CDP
by sending unit i.e. Natco Pharma against Femara 2.5mg (Letrozole) (Brand
revealed that after optimization of Leader) and Letrozole Tablets USP, 2.5mg
formulation, the cumulative % of drug (Natco Pharma).
release is not less than 85% within The batch number as below:
15min as evident from the comparative 1. Duopharma HAPI: 20200201
dissolution profile of exhibit batch of 2. Brand Leader: SUH88
Natco Pharma with RLD Femara tablet 3. Natco Pharma: 410120
in all 4 mediums with 75rpm.While the
Comparative dissolution profile of From the report (DH.QC.R.CD.002.AD.01),
receiving unit i.e. DUOPHARMA HAPI the % dissolution for Natco Pharma at 15 mins
SDN.BHD.Malaysia with the product of for all 4 mediums were also less than 85%.
Natco pharma shows that average % The CDP was proven similar by F2
release of both products are less than calculation.
85% in 15minutes. Justify, the The Bioequivalent Study (BE) was also
significant variation observed in conducted for Duopharma HAPI product
cumulative % of drug release. (Batch No.: 20200201) against the Brand
• Provide Pharmaceutical Equivalence Leader (Batch No.: SUH88) and the BE study
report between Lebreta tablet and passed. Therefore, it justifies the variation of
innovator product since the dissolution of < 85% at 15 mins timepoint is
submitted report was between not significant.
letrozole tablet of Natco Pharma and
femara tablet (innovator product).
3. 3.2.P.5.3 Justify, why the accuracy parameter has For Finished Product, the approach of the
been performed only at 100% method was by the Method Transfer
concentration, since the ICH guideline (Comparative Testing Approach) as the
for validation of analytical procedure Duopharma HAPI Sdn Bhd is a Technology
specify that “Accuracy should be Transfer Plant. This Method Transfer is
assessed using a minimum of 9 governed under USP General Chapter <1224>
determinations over a minimum of 3 Transfer of Analytical Procedures. Based on
concentration levels covering the the guideline, the method transfer is a
specified range (e.g., 3 concentrations/3 documented process that qualifies a laboratory
replicates each of the total analytical (the Receiving Unit) to use an analytical test
procedure).” procedure that originated in another laboratory
(the Transferring Unit) to ensure that the
Receiving Unit has the procedural knowledge
and ability to perform the transferred analytical
procedure as intended.
The method validation must be completed prior
to the Method Transfer activity. For these
methods of the Finished Product, the method
validations were conducted by the Transferring
Unit. The accuracy parameter was conducted
by Transferring Unit based on the ICH
Guideline and the USP General Chapter
<1225> Validation of Compendial Procedures.
The details are as below:
1. Assay: 20%, 100%, 200% and 320%
concentration level where each
concentration had triplicate samples
(total = 12 samples)
2. Related Compounds: LOQ%, 50%,
100% and 200% concentration level
where each concentration had triplicate
samples (total = 12 samples)
3. Dissolution: 40%, 100% and 160%
concentration level where each
concentration had triplicate samples
(total = 9 samples)
During the Method Transfer activity, the
accuracy parameter was included at only 100%
concentration to verify the method accuracy at
the actual concentration of testing.
4. 3.2.P.8.2 Justify the out of specification result of The dissolution for 18th month timepoint for
dissolution at 18th month time point i.e. 20181101PB was still passed within the
79% since the acceptance criteria of acceptance criteria at Stage 2. Based on USP
dissolution is NLT 80% (Q) in 30 General Chapter <711>.The first 6 tablets
minutes. (Stage 1) obtained below Q (Q=80%), which
was 79% (minimum result), then Stage 2 was
proceeded. Another 6 tablets were analyzed.
Based on 12 tablets (Stage 1 + Stage 2), the
average reading obtained was 88% which is ≥
Q (Q=80%) and no tablet was < Q-15% (Q-
15% = 65%).
Therefore, the dissolution at 18th month for
20181101PB passed within the acceptance
criteria at Stage 2.
Moreover, the additional timepoints of the
following batches have been completed.
5. 2.3.R.1.1 Provide copy of Batch Manufacturing Firm has provided the BMR of batch no.
Record (BMR) of drug product of batch 20181101PB.
no.20181101PB, since the stability
studies data of the said batch has been
submitted in Module 3 section 3.2. P.8.
• Pharmaceutical equivalence studies data of Lebreta 2.5mg tablet manufactured by M/s. Duopharma HAPI
Sdn. Bhd. No.2, Jalan Saudagar U1/16, Zon Perindustrian HICOM Glenmarie, Seksyen U1,40150 Shah
Alam, Selangor, Malaysia against the innovator product/reference product, since the submitted
pharmaceutical equivalence data was between letrozole tablet of M/s Natco Pharma and Femara tablet
(innovator product).
• Analytical verification studies of drug product in accordance with relevant guidelines.
Pharmaceutical equivalence studies data of Lebreta 2.5mg tablet manufactured by M/s. Duopharma HAPI Sdn.
Bhd. No.2, Jalan Saudagar U1/16, Zon Perindustrian HICOM Glenmarie, Seksyen U1,40150 Shah Alam,
Selangor, Malaysia against the innovator product/reference product, since the submitted pharmaceutical
equivalence data was between letrozole tablet of M/s Natco Pharma and Femara tablet (innovator product).
Firm has submitted pharmaceutical equivalence data, which incudes only the result of content of active
ingredient of test product (Letronat 2.5 mg Tablet of M/s. Duopharma HAPI Sdn. Bhd., Malaysis and reference
product (Femara 2.5mg Tablet manufactured by Novartis Pharma Stein, Switzerland).
Further, firm submitted the bioequivalence study report of Letronat 2.5 mg Tablet of M/s. Duopharma HAPI
Sdn. Bhd., Malaysia with Femara 2.5mg Tablet manufactured by Novartis Pharma Stein, Switzerland.
Analytical verification studies of drug product in accordance with relevant guidelines.

• Firm submitted the reply in which it is stated that “the assay method was validated by Natco Pharma Limited
and successfully transferred from Natco Pharma Limited to Duopharma HAPI via method transfer based on
guidance from USP General Chapter <1224>”. There are several approaches to the method transfer, for this
method transfer, comparative testing approach has been adopted.
• Duopharma HAPI has performed the accuracy parameter at 100% concentration and Natco Pharma has
performed it on 4 different concentrations and since Duopharma was comparing all the results with Natco
Pharma Limited as the Method Transferrer. There is no requirement to test accuracy at 3 different
concentrations.
Comparative testing approach in USP General Chapter <1224> stated that “Comparative testing requires the
analysis of a predetermined number of samples of the same lot by both the sending and the receiving units. Other
approaches may be valid, e.g., if the receiving unit meets a predetermined acceptance criterion for the recovery
of an impurity in a spiked product. Such analysis is based on a preapproved transfer protocol that stipulates the
details of the procedure, the samples that will be used, and the predetermined acceptance criteria, including
acceptable variability. Meeting the predetermined acceptance criteria is necessary to assure that the receiving
unit is qualified to run the procedure”.
Firm has submitted the analytical method transfer report in accordance with the guidance of abovesaid USP
General chapter.
Decision: Approved with USP specifications as per Policy for inspection of Manufacturer abroad and
verification of local storage facility.
Deferred Cases of Form-5:

526. Name and address of M/s. Innvotek Pharmaceuticals, Plot no.35, Industrial Triangle
manufacturer / Applicant Kahuta Road, Islamabad
Brand Name +Dosage Form + Bromycin-D Eye Ointment
Strength
Diary No. Date of R& I & fee (Duplicate Dossier) Dy. No. dated 15-03-2018 Rs. 8,000/-
(photocopy)
With the statement that due to late submission of differential fee
12,000/- there product was not discussed in any Registration
Board so to avoid further delay they withdraw from the fee of rs.
8,000/- i.e. earlier submitted in April, 2005, Dy.no. 570.Now, they
resubmitted Rs. 8,000/- and apply for the registration of product.
Differential fee (photocopy) of Rs.12,000/- submitted on
05/11/2015 Dy.No.1950 (verified from R&I)
Composition Each gram contains:
Tobramycin….3mg (0.3% w/w)
Dexamethasone…1mg (0.1%w/w)
Pharmacological Group Aminoglycoside antibiotic/Corticosteroid
Type of Form Form-5
Finished Product Specification USP Specification
Pack Size & Demanded Price As per SRO
Approval Status of Product in USFDA Approved (Tobradex Ophthalmic Ointment tobramycin
Reference Regulatory 0.3% (3 mg) and dexamethasone 0.1% (1 mg).
Authorities
Me-too Status Obradex Eye Ointment of M/s. Vega Pharmaceuticals, Lahore
(Reg.no.067753)
GMP Status GMP Certificate issued dated 11th January,2021 vide certificate no.
F.3-64/2021-Addl.Dit. (QA&LT-I). Eye ointment & Cream (sterile)
General section is mentioned in the said certificate.
Remarks of the Evaluator. Evidence of availability of separate steroidal dispensing booth is
required.
Decision of 312th meeting of Deferred for clarification regarding status of application.
Registration Board
Response of the Firm Firm submitted the clarification in response of decision of
Registration Board in which it is stated that “It was mistakenly
mentioned in the covering letter of year 2018 which was submitted
with fee of Rs.8,000/-,regarding withdrawal of fee of Rs.8,000/-
which was deposited initially in 2005 along with Form-5.
Decision: Approved.
• Frim shall submit evidence of availability of separate dispensing booth for steroidal drug
substance.
• Firm shall also submit fresh fee of Rs. 30,000/-, as per notification No.F.7-11/2012-
527. Name and address of manufacturer / M/s Jawa Pharmaceuticals Pvt Ltd
Applicant 112/10, Quaid-e-Azam Industrial Area, Kot Lakhpat, Lahore
Brand Name +Dosage Form + M. Brozine Injection
Strength
Diary No. Date of R& I & fee (Duplicate Dossier) Dy. No. dated 16/06/2011 Rs 8,000/-
(photocopy fee challan)
Dy. No. dated 16/12/2015 Rs. 12,000/- (photocopy fee
challan)
(Not verified from R&I)
Composition Each ml contains: -
Promethazine HCl …… 25mg
Pharmacological Group Antihistamine
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price 10 x 2ml’s
Approval Status of Product in Phenergan Injection 25mg/ml Oral by M/s Aventis
Reference Regulatory Pharma Limited, trading as Sanofi, Emc Approved.
Authorities
Me-too Status Phenerzine Injection by EPOCH Pharma (Reg#050476)
GMP Status Panel inspection for renewal of DML conducted on 15-12-
2020,16-12-2020,26-01-2021 concluded with the following
remarks:
“The panel recommends the renewal of Drug Manufacturing
License to M/s. Jawa Pharmaceuticals (Pvt.) Ltd., Lahore by
way of formulation”
Decision of 308th meeting of Deferred for verification of receiving of Registration
Registration Board application from R&I section, DRAP.
Remarks of the Evaluator R&I Section of DRAP verified the receiving of fee of
Rs.8,000 vide Dy.no. 2283 dated 16-06-2011 and Differential
fee of RS.12,000/- received vide Dy.no. 261 dated 16-12-
2015.
Decision: Approved.
Agenda of Evaluator PEC-XVI
A. Registration applications Veterinary (New): -

528. Name and address of manufacturer/ My lab (Pvt) Ltd. Khanqah sharif, Bahawalpur.
Applicant
Brand Name + Dosage Form + Strength THAIBONDOL Suspension
Thiabendazole…………………….133.00 mg
Diary No. Date of R & I & fee Dy. No 12165 dated 06-03-2019; Rs.20,000/- dated 05-03-
2019.
Type of Form Form - 5
Pack size & Demanded Price 50ml,100ml,150ml,250ml,500ml,1000ml,2.5L
Approval status of product in Reference Not Applicable
Me-too status Thiabendazole oral liquid,058716, Selmore
Pharmaceuticals (Pvt) ltd Lahore
GMP status Panel GMP inspection was conducted on 24-02-2021 and
25-02-2021 and concluded as “ In view of above
inspection proceedings and facilities verified such as
company profile, building ,production, in process controls,
quality control testing , machinery/equipment , material
management , air handling, water treatment system ,
personnel and documentation etc. the firm M/s Mylab
(pvt) Ltd. Khanqah sharif Bahawalpur , was found to be
operating at a satisfactory level of GMP compliance for
the following sections only, oral Liquid (General)II and
Aerosol section were under maintenance and were not
functional at time of inspection”:
Liquid Injection Section (General)
Oral Powder Premix Section (General)
Oral Liquid (General)(I)
Liquid Injection (penicillin)
Dry Powder Injection (penicillin)
Oral Powder (penicillin)
Liquid Injection (hormone)
Liquid Injection (Steroid)
Remarks of the Evaluator • Master Formulation with Firm has submitted fee
complete Outline of challan No.1856802411
manufacturing method is dated 16-06-2022 of
required. 30000/= along with
• Complete finished good Composition of API /ml,
testing specifications master formulation,
mentioning assay of manufacturing method,
finished products. finished product testing
• Form 5 prescribed title method and signed title
page dully signed is not page.
provided along with
preregistration variation
fee challan.
• Composition of Active
Ingredients per ML is
required.
Decision: Approved
Applicant
Brand Name + Dosage Form + Strength BIO-AMOXYLLIN Water Soluble Powder
Composition Each 100 gm Contains:
Amoxicillin Trihydrate Equivalent to Amoxicillin
Base……………………………………….70 mg
2019.
Finished product Specification B.P (Vet)
Pack size & Demanded Price 100 g,250 g,500g,1 kg,2 kg,2.5kg,3kg,5,kg.As per SRO
Me-too status PRIMOX 70% WATER SOLUBLE POWDER, 074032,
M/s prix pharmaceutical (Pvt) ltd., plot # 5 pharma city,
30-km Multan Road, Lahore.
manufacturing method is dated 16-06-2022 of 7500/=
required. along with master
• Complete finished good formulation, manufacturing
testing specifications method, finished product
mentioning assay of testing method and signed
finished products. title page.
• Form 5 prescribed title
page dully signed is not
provided along with
preregistration variation
fee challan.
Decision: Approved
Applicant
Brand Name + Dosage Form + Strength TYLAX Injection
Tylosin Tartrate eq to Tylosin …………………...200 mg
2019.
Pack size & Demanded Price 100 ml glass vial type II, As per SRO
Me-too status Positive 200 Injection., 063504, M/s Cherished
Pharmaceuticals (Private) Limited, Lahore
manufacturing method is dated 16-06-2022 of 7500/=
required. along with master
• Complete finished good formulation, manufacturing
testing specifications method, finished product
mentioning assay of testing method,
finished products. Packing/closure and signed
• Pack Size, container and title page.
closure is not provided.
• Pre-registration variation
fee challan.
Decision: Approved
Applicant
Brand Name + Dosage Form + Strength SELMEC Injection
Composition Ivermectin…………………………20 mg
2019.
Pack size & Demanded Price 250 ml,t ype II glass vial.
Me-too status FARMEC-2 INJECTION, 063722, LEADS PHARMA
(PVT) LTD., ISLAMABAD.
Complete Outline of challan No.21841031354
required. 30000/= along with
• Complete finished good composition of API/ml
testing specifications (Each ml Contains
mentioning assay of Ivermectin…20mg),
finished products. master formulation,
• Pack Size, container and manufacturing method,
closure is not provided. finished product testing
method, Packing/closure
and signed title page.
Decision: Approved
Applicant
Brand Name + Dosage Form + Strength DOXYRAL Powder
Composition Each gram Contains:
Doxycycline Hyclate 923.32 mg equivalent to
Doxycycline base…………………………….800 mg
2019.
Pharmacological Group Tricyclic Antibiotics.
Finished product Specification Innovator Specification.
Pack size & Demanded Price 100 gm, 500 gm, 1000 gm, 2000 gm, 5000 gm.
Me-too status DOXYRAL 80% WATER SOLUBLE POWDER FOR
ORAL ROUTE, 082504, "M/S. ORIENT ANIMAL
HEALTH (PVT.) LIMITED, KARACHI
required. 30000/= along with revise
• Complete finished good composition of API, master
testing specifications formulation, manufacturing
mentioning assay of method, finished product
finished products. testing method,
• Form 5 prescribed title Packing/closure and signed
page dully signed is not title page.
provided.
• Pack Size, container and
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength CLIMISOL Injection
Composition Levamisol…………………….75 mg
Closental……………………...50 mg
2019.

Finished product Specification Innovator’s
Pack size & Demanded Price 100 ml,
Me-too status CLOMISOL Injection, 049641, SELMORE
PHARMACEUTICALS, LAHORE.
Remarks of the Evaluator • Master formulation with Firm has submitted fee
required. 30000/= and submiited
• Complete finished good revised dosage form and
testing specifications strength of APIs as under:
mentioning assay of “CLOMISOL Injection
finished products. Each ml Contains:
• Fee Challan mentioned Levamiol as Hcl...75 mg
dosage form as drench Closental……50 mg”.
where as Form -5 Firm has also submitted
mentioned as Injection. revised master formulation,
• Firm did not mention per Pack size, Finished product
ml composition. specification and signed
• Pack Size, container and Form-5.
• Evidence of me-too status
of product already
registered in Pakistan.
Decision: Approved with Innovator Specification with following label claim;
“CLOMISOL Injection 100 ml”
Each ml Contains:
Levamiol as Hcl...............75 mg
Closental………………..50 mg”.
Applicant
Brand Name + Dosage Form + Strength PENISEL-40 mg Injection (Dry Powder)
Procaine Penicillin G………………...3000000 IU
Benzathine Penicillin G……………...1000000 IU
2019.
Pharmacological Group Board Spectrum Antibiotic

Finished product Specification innovator
Pack size & Demanded Price Dry Powder Glass vial of type -II.
Me-too status Penisel-40 Dry Powder Injection, 080956, Selmore
Pharmaceuticals ,Lahore.
Remarks of the Evaluator • Master formulation with • Firm has submitted fee
required. 30000/= and submitted
• Complete finished good revised dosage form as
testing specifications “Dry Powder Vial “along
mentioning assay of with revised Form- 5,
finished products. Manufacturing method,
• Form-5 cover letter dully master formulation, Pack
signed by management. size, and finished product
• Evidence of me-too status specification. The revised
of product registered in composition is as under:
Pakistan. Each Dry Powder Vial
Contains:
Procaine
Penicillin…...3000000 IU
Benzyl
penicillin……10,00,000
IU
Decision: Approved with innovators specification with following label claim;
“Each Dry Powder Vial Contains:
Procaine Penicillin………………….3000000 IU
Benzyl penicillin……………………10,00,000 IU”
Applicant
Brand Name + Dosage Form + Strength UTERICIN Intrauterine Injection
Composition Each syringe of 20 gm Contains:
Benzyl Penicillin (As procaine) …………1000000 IU
Gentamycin (As Sulaphate) ……………...200000 IU
2019.
Pharmacological Group Board Spectrum Antibiotic

Finished product Specification Not provided
Pack size & Demanded Price Pack Size, Container and closure is not provided.
Me-too status UTERICINE INTRAUTERINE INJECTION (prefilled
syringe), 027482, VETQUINOL FRANCE, A.B.I. INT
FAISALABAD.
Remarks of the Evaluator • Master formulation with Complete Outline of
manufacturing method is required.
• Complete finished good testing specifications
mentioning assay of finished products.
• Form-5 cover letter dully signed by management.
• Section approval letter of prefilled syringes from CLB.
• Pack Size, container and closure is not provided.
• Pre-registration variation fee challan.
Decision: Deferred for following Shortcomings: -
1. Master formulation with Complete Outline of manufacturing method is required.
2. Complete finished good testing specifications mentioning assay of finished products.
3. Form-5 cover letter dully signed by management.
4. Section approval letter of prefilled syringes from CLB.
5. Pack Size, container and closure is not provided.
6. Pre-registration variation fee challan.
Applicant
Brand Name + Dosage Form + Strength TOCOSEL ORAL SOLUTION
Composition Each 1000 ml contains:
Vitamin E…………………….500 mg
Selenium……………………...120 G
Diary No. Date of R & I & fee Dy. No 123161 dated 06-03-2019; Rs.20,000/- dated 05-
03-2019.
Pharmacological Group Antibacterial

Pack size & Demanded Price 100ml,150ml,250ml,500ml,1L,2.5 L,25L
Me-too status Immunosel Oral Solution, 034539, ATTABAK
PHARMACEUTICALS, ISLAMABAD,
required. 30000/= along with revised
• Complete finished good form -5 with revised
testing specifications strength of label claim API
as under:
mentioning assay of Each ml contains:
finished products. Vitamin E….120000 mg
• Form-5 cover letter dully
Selenium as Sodium
signed by management. selenite…...2200 mg.
Firm has also submitted
revised
of product registered in Form- 5,
Pakistan. Manufacturing method,
• Pack Size, container and
master formulation, Pack
size, and finished product
specification.
Decision: Registration Board referred the case to Expert Working Group for review of
formulation.
Applicant
Brand Name + Dosage Form + Strength PENCINE W.W Powder
Composition Each Kg powder Contains:
Streptomycin………………………200 gm
Penicillin……………………………44 gm
2019.

Finished product Specification Innovator Specifications
Pack size & Demanded Price 250 gm,1000 gm
Me-too status PENCINE W.W. POWDER, 025733, MANHATTAN
PHARMA KARACHI.
Complete Outline of challan
manufacturing method is No.743165117561 dated
required. 16-06-2022 of 30000/=
• Complete finished good along with revised form -
testing specifications 5 with revised
mentioning assay of strength/salt of label
finished products. claim API as under:
• Form-5 cover letter dully Each Kg contains:
signed by management. Streptomycin as
sulphate…….200 gm
• Pack Size, container and Procaine
closure is not provided. Penicillin……44gm
revised Form- 5,
Manufacturing method,
master formulation, Pack
size, and finished product
specification.
Decision: Approved with innovator specification with following label claim;
“Each Kg contains:
Streptomycin as sulphate…….200 gm
Procaine Penicillin……………44gm”
Applicant
Brand Name + Dosage Form + Strength BACTICOM Injection
Composition Dimetridazole ……………………….100 mg
Tylosin Tartrate……………………….50 mg
Colistin Sulphate………………………10 mg
2019.
Pharmacological Group Board spectrum antibiotic
Finished product Specification Innovator
Pack size & Demanded Price 100 ml,Type II glass vial.
Me-too status Bacticom Injection, 043140, SELMORE
PHARMACEUTICALS, LAHORE, LAHORE,
• Complete finished good form -5 with revised per ml
testing specifications label claim as under:
finished products. Dimetridazole …...100 mg
• Form-5 cover letter dully Tylosin Tartrat….50 mg
signed by management. Colistin Sulphate…10 mg
revised Form- 5,
• Pack Size, container and Manufacturing method,
closure is not provided. master formulation, Pack
• Per ml composition is not size, and finished product
provided. specification.
formulation.
Applicant
Brand Name + Dosage Form + Strength CLIMISOL Drench
Composition Levamisol…………………….100 mg
Closental……………………...100 mg
2019.

Pack size & Demanded Price 100 ml,250 ml, 500 ml,1000 ml. plastic bottle.
Me-too status CLOMISOL DRENCH., 049626, SELMORE
Remarks of the Evaluator • Master Formulation with • Firm has submitted fee
Complete Outline of challan No.86060100 dated
manufacturing method is 16-06-2022 of 30000/=
required. along with revised form -5
• Complete finished good with revised per label claim
testing specifications as under:
mentioning assay of Clomisol Drench 100/100
finished products. Each ml contains:
• Fee Challan mentioned Levamisol as Hcl .100
dosage form as Injection mg
where as Form -5 Closental…………100
mentioned as Drench. mg
• Firm did not mention per • Firm has also submitted
ml composition. revised Form- 5,
• Pack Size, container and Manufacturing method,
closure is not provided. master formulation, Pack
• Evidence of me-too status size, and finished product
of product already specification.
registered in Pakistan. • However, the me-too
composition of Clomisol
Drench is
Levamisol Hcl…100mg
Decision: Approved with innovator specifications with following label claim.;
“Clomisol Drench 100/100
Each ml contains:
Levamisol Hcl …………………100 mg
Closental…………………….…100 mg”
Applicant
Brand Name + Dosage Form + Strength OXYFEN LA Injection
Composition Oxytetracycline……………100 mg
Ketoprofen…………………30 mg
2019.
Pack size & Demanded Price 100 ml , type II glass vial.
Me-too status Oxyfen LA injection, 071091, SELMORE
• Complete finished good form -5 with revised per
testing specifications label claim as under:
finished products. Oxytetracycline as
• Firm did not mention per Dihydrate………200 mg
ml composition. Ketoprofen…….30 mg
• Pack Size, container and • Firm has also submitted
closure is not provided. revised Form- 5,
Manufacturing method,
• Evidence of me-too status master formulation, Pack
of product already size, and finished product
registered in Pakistan. specification.
• However, Composition of
me -too is as under;
Oxytetracycline ….200MG
Ketoprofen……….30MG
formulation.
Applicant
Brand Name + Dosage Form + Strength COLIMOXIN FORTE Water-Soluble Powder
Composition Each 100 gm contains:
Amoxicillin Trihydrate…………………20 Gm
Colistin Sulphate……………………….80 MIU
2019.
Pack size & Demanded Price 100gm,250gm,500 gm,1000 gm.Plastic bottle.
Me-too status Colimoxin Forte Oral Dry Powder, 080961, Selmore
Pharmaceuticals (Pvt) Ltd., 36 Km Off. Multan Road
Lahore.
required. 7500/= along with signed
• Complete finished good form -5 along with
testing specifications Manufacturing method,
mentioning assay of master formulation, Pack
finished products. size, and finished product
• Pack Size, container and specification.
of product already
signed by management.
Decision : Approved with innovator’s specifications.
Applicant
Brand Name + Dosage Form + Strength NEFCOL ORAL SOLUTION
Florfenicol…………………………….23 Gm
Colistin Sulphate………………………50 MIU
2019.
Finished product Specification Innovator specification
Pack size & Demanded Price 50ml,100ml,250ml,500ml,1L,2.5L,5L, Plastic bottle.
Me-too status Fenicol Liquid, 079134, Univet Pharmaceuticals,
Rawalpindi.
required. along with signed form -5
• Complete finished good along with Manufacturing
testing specifications method, master
mentioning assay of formulation, Pack size, and
finished products. finished product
• Pack Size, container and specification.
Decision : Approved with innovator’s specifications.
Applicant
Brand Name + Dosage Form + Strength COMBIGENT Injection
Gentamycin as sulphate………………5 G
Tylosin Tartarated……………………10 G
Colistin Sulphate……………………20 MIU
2019.
Me-too status Not verifiable
Remarks of the Evaluator • Master Formulation with Complete Outline of
• Evidence of me-too status of product already registered
in Pakistan.
Decision: Deferred for following shortcomings:
1. Master Formulation with Complete Outline of manufacturing method is required.
4. Evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) alongwith registration number, brand name and name of firm.
5. Pre-registration variation fee challan.
Applicant
Brand Name + Dosage Form + Strength METABOLASE Injectable Solution
L-Carnitine Hcl(613.3 mg)Equivalent to Carnitine..50 mg
D.L Acetylmethionine …………………………...200 mg
Cyanocobalamin………………………………….0.2 m
A-Tocopherol Acetate(33.0mg) Equivalent to
A-Tocopherol…………………………………30 mg
2019.
Pharmacological Group Not provided
Me-too status METABOLASE INJECTABLE SOLUTION, 019904,
FATRO S.P.A ITALY, PRIX PHARMACEUTICAL
LAHORE
• Form-5 cover letter dully signed by management.
1. Master Formulation with Complete Outline of manufacturing method is required.
4. Form-5 cover letter dully signed by management.
5. Pre-registration variation fee challan
Applicant
Brand Name + Dosage Form + Strength LINCOMICINA 150 GANADEXIL oral powder
Composition Each Gram contains:
Lincomycin (as Hcl) ………………………...….150 mg
2019.
Pack size & Demanded Price 100gm,1 kg,25 kg, plastic jar
Me-too status lincomicina 150 ganadexil oral powder, 078290,
(manufactured by m/s. industrial veterinaria, s.a.-invesa,
spain)., m/s. forward solutions,lahore.
25-02-2021 and concluded as“ In view of above inspection
proceedings and facilities verified such as company
profile, building ,production, in process controls, quality
control testing , machinery/equipment , material
functional at time of inspection”
• Complete finished good form -5 mentioning Oral
testing specifications powder along with
mentioning assay of Manufacturing method,
finished products. master formulation, Pack
• Pack Size, container and size, and finished product
closure is not provided. specification.
• Brand name mentioned as
oral powder where as
route administration
mentioned in form -5 is
IM and IV.
Decision : Approved
Applicant
Brand Name + Dosage Form + Strength NEMASOL PLUS
Composition Oxyclozanide…………….60 mg
Levamisole……………….30 mg
Cobalt Sulphate………….3.34 mg
Sodium Selenite………….1 mg
2019.
Pharmacological Group Anthelmintic and minerals
Pack size & Demanded Price 100,250,500,1000 ml, plastic bottle.
Me-too status Helmex Gold Drench, 057005, SELMORE
PHARMACEUTICALS,LAHORE,
required. along with signed form -5
• Complete finished good mentioning per ml
testing specifications composition as under:
mentioning assay of Each ML Contain:
finished products. Oxyclozanide……60 mg
• Pack Size, container and Levamisole as Hcl..30 mg
closure is not provided. Cobalt Sulphate….3.34
• Per gram powder mg
composition is not Sodium Selenite…….1 mg
mentioned. Firm also provided
• Evidence of me-too status Manufacturing method,
of product already master formulation, Pack
registered in Pakistan. size, and finished product
specification.
Each ML Drench contain:
Oxyclozanide…………………………….…60 mg
Levamisole…………………………………30 mg
Cobalt Sulphate…………………………….3.34 mg
Sodium Selenite……………………………1 mg
Applicant
Brand Name + Dosage Form + Strength AMCOSIN powder
Amoxycillin…………………100 mg
Colistin Sulphate…………….50 MIU
Neomycin Sulphate………….200 mg
Diary No. Date of R & I & fee Dy. No 12321 A dated 06-03-2019; Rs.20,000/- dated 06-
03-2019.
Pharmacological Group Broad Spectrum Antibiotics
Finished product Specification Innovator Specification
Pack size & Demanded Price 100,250,500,1000 gm
Me-too status AMCOCIN ORAL DRY POWDER, 083243, M/S.
SELMORE PHARMACEUTICALS (PVT) LIMITED,
LAHORE.
• Complete finished good form -5 mentioning oral
testing specifications route and revised
mentioning assay of composition as under:
finished products. Each kg Contain:
• Pack Size, container and Amoxycillin Trihydrate eq.
closure is not provided. to Amoxicillin…...100 gm
• Per gram powder Colistin Sulphate...50 MIU
composition is not Neomycin Sulphate….200g
mentioned. Firm also provided
• Form-5 mentioned route Manufacturing method,
of administration as IM master formulation, Pack
and IV whereas reference size, and finished product
product is Oral powder. specification.
“Each kg Contain:
Amoxycillin Trihydrate eq. to Amoxicillin…………………...100 gm
Colistin Sulphate………………………………………...……..50 MIU
Neomycin Sulphate……………………………..……………...200g”
Applicant
Brand Name + Dosage Form + Strength FEBENSEL Suspension
Febentel…………………………………25mg
2019.
Finished product Specification innovator Specification
Pack size & Demanded Price 250 ml,500 ml,1000ml,5000ml.
Me-too status FEBANTEL ORAL LIQUID, 058715, SELMORE
PHARMACEUTICALS (PVT) LTD LAHORE
Remarks of the Evaluator • Master Formulation with Firm has submitted reply
Complete Outline of with fee challan No.
manufacturing method is 0119088516 dated 01-08-
required. 2022 of 7500/= along
• Complete finished good with signed form 5 with
testing specifications undertaking, master
mentioning assay of formulation, outline of
finished products. manufacturing method,
• container and closure are Finished good
not provided. specification as innovator
• Undertaking at ending of specs and details of
Form-5 container as plastic
bottles.
Decision : Approved with innovator’s specification.
Applicant
Brand Name + Dosage Form + Strength NOXYFLOR powder
Florfenicol…………………………….…100mg
Oxytetracycline……………………….….300mg
Neomycin………………………………..150mg
2019.
Pack size & Demanded Price Jar,100 mg , 250 mg , 500 mg , 1000 mg
Me-too status "NOXYFLOR WATER SOLUBLE POWDER, 087584,
M/S. DIVINE PHARMACEUTICALS, LAHORE.
manufacturing method is 26543666933 dated 01-
required. 08-2022 of 7500/= along
• Complete finished good with signed form 5 with
testing specifications undertaking, master
mentioning assay of formulation, outline of
finished products. manufacturing method,
• Pack size, container and Finished good
closure are not provided. specification as innovator
Form. container as plastic Jar.
Applicant
Brand Name + Dosage Form + Strength AVIVIT Oral Solution
Composition Each Litre Contains:
Betaine as Hcl…………………………….60Gm
Choline as Chloride………………………180Gm
Sorbitol……………………………………520Gm
Vitamin B6………………………………..12Gm
Vitamin B3………………………………..24Gm"
2019.
Pharmacological Group Vitamins and amino acids
Finished product Specification Innovators specification
Pack size & Demanded Price 1L,2L,5L,10L,25L,50 L,
Me-too status ANIVIT LIQUID., 041299, ARTIMON, FRANCE.,
GHAZI BROTHERS, KARACHi.
manufacturing method is 62539026211 dated 01-
with revised and signed
st th nd
• Complete finished good form 5 with undertaking,
testing specifications master formulation,
mentioning assay of outline of manufacturing
finished products. method, Finished good
• Pack size, container and specification as innovator
closure are not provided. specs and details of
• Undertaking at ending of container as plastic bottle.
Form-5
of already registered
product.
(Full fee required due to
salt forms of APIs)
Applicant
Brand Name + Dosage Form + Strength TETRA DELTA Suspension Injection (Sterile)
Neomycin……………………………….….105mg
Procaine Penicillin G……………………….1000000 IU
Novobiocin (As Sodium novobiocin) ……….100mg
Dihydrostreptomycin (As
Dihydrostreptomycin Sulphate) ………………100mg
2019.
Pack size & Demanded Price 24*10 ml
Me-too status TETRA-DELTA STERILE SUSPENSION, 015480,
UPJOHN LTD UK (manufacturer), UPJOHN
ISLAMABAD ( Importer)
Complete Outline of along with revised and
manufacturing method is signed form 5 with
required. undertaking, master
• Complete finished good formulation, outline of
testing manufacturing
specifications method,
mentioning assay of Finished good specification
finished products. as innovator specs and
• Pack size, container and details of container as
closure are not provided.plastic bottle.
• Undertaking at ending of Each ml Contains:
Form-5. 1-Neomycin as
(Challan fee Sulphate…………105mg
not
submitted, change of 2-Procaine Penicillin
formulation in label G……………….1000000
claim) IU
3-Novobiocin (As Sodium
novobiocin) ……….100mg
4-Dihydrostreptomycin (As
Dihydrostreptomycin
Sulphate)
…………..100mg
5.Prednisolone
Acetate…………….…10
mg
formulation.
Applicant
Brand Name + Dosage Form + Strength AVIPHOS Solution
Composition Each Litre Contains:
Calcium as Calcium Gluconate…………..……....15Gm
Phosphorus as Sodium Monobasic Phosphate…...110Gm
Magnesium as Magnesium Chloride……...…,,….22Gm
Sodium as sodium Chloride………………………15Gm
Iron as Iron II sulphate…………………………..1500mg
Zinc as Zinc Sulphate…………………………....2200mg
Manganese as manganese Sulphate……….….….2500mg
Copper as Copper Sulphate……………..……….110mg
2019.
Pharmacological Group Mineral Mix supplement
Pack size & Demanded Price 100ml,250 ml,500 ml,1 L,2 L,5L,10 L,25 L.
Me-too status 041298, Artiphos Liquid,Ghazi brothers ,Khi.
Remarks of the Evaluator • Master Formulation with • Firm has submitted
Complete Outline of replies with fee challan
manufacturing method is No. 289653847 dated 01-
required. 08-2022 of 7500/= and
• Complete finished good Challan No.8361231183
testing specifications dated 03-09-2022 of
mentioning assay of 30000/= along with
finished products. revised and signed form 5
• Pack size, container and with undertaking, master
closure are not provided. formulation, outline of
• Undertaking at ending of manufacturing method,
Form-5 Finished good
• Evidence of me-too status specification as innovator
of product already specs and details of
registered in Pakistan. container as plastic bottle.
(Full fee required due to
salt forms of APIs)

Applicant
Brand Name + Dosage Form + Strength UTAFIX Injection
Composition Each 20ml Contains
Oxytetracycline…………………………….500mg
Iodochlogroxy Quinolone…………………..500mg
Furazolidone………………………………...500mg
Vitamin E……………………………………200mg
Diary No. Date of R & I & fee Dy. No.12167 dated 06-03-2019; Rs.20,000/- dated 05-
03-2019.
Pharmacological Group Broad Spectrum Antibiotic with vitamin
Finished product Specification Innovator specifation.
Pack size & Demanded Price 20 ml
Me-too status Uterous Injector Floor ,Reg No. 017913 ,mfg by : Floris
Veterinary , Netherland , Import by : selmore Agencies
Lahore.
control testing,machinery/equipment,material
st
826
Remarks of the Evaluator • Master Formulation with • Firm has submitted reply
manufacturing method is 289653847 dated 01-08-
required. 2022 of 7500/= along
• Complete finished good with revised and signed
testing specifications form 5 with undertaking,
mentioning assay of master formulation,
finished products. outline of manufacturing
• Pack size, container and method, Finished good
closure are not provided. specification as innovator
Form-5 container as plastic bottle.
of product already
formulation.
Applicant
Brand Name + Dosage Form + Strength SIPICON Injection
Composition Each Dry Powder Vial Contains:
Benzathine Penicillin…………....................5000000 IU
Procaine Penicillin……………..……….. 15000000 IU
Streptomycin Sulphate………………………..….5Gm
Diary No. Date of R & I & fee Dy. No12306 dated 06-03-2019; Rs.20,000/- dated 06-03-
2019.
Pack size & Demanded Price 1’S
Me-too status SIPICON INJECTION, 020844, SHAHEEN AGENCIES
KARACHI (Importer)
testing specifications manufacturing method,
• Pack size, container and details of container as Glass
closure are not provided. vial. (Challan Fee Not
• Undertaking at ending of Submitted for
Form-5 preregistration variations)
• Undertaking to follow
innovator brand as per
249th meeting of DRB.
of already registered
product.
Decision: Approved with innovator specification. The firm shall submit preregistration variation
fee of 7500/= as per SRO.No. F.7-11/2012- B&A/DRAP dated 13-07-2021
Applicant
Brand Name + Dosage Form + Strength METABOLASE FORTE Injectable Solution
DL-Acetylmethionine 200mg Eq To
Cyanocobalamin………………………………...…0.2mg
Carnitine Hcl…61.3mg Eq To Carnitine…………. 50mg
A-Tocopherol Acetate……………………………. 30mg
2019.
Pharmacological Group Not provided
Pack size & Demanded Price Not provided
Me-too status METABOLASE FORTE INJECTABLE SOLUTION,
043109, PRIX PHARMACEUTICA, LAHORE
(Importer)
• Pack size, container and closure are not provided.
• Undertaking at ending of Form-5
• The applied composition does not resemble to mee to
provided, i-e Metabolase Forte Injection. Submit revised
label claim composition as per applied me to.
• Master Formulation with Complete Outline of manufacturing method is required.
• Complete finished good testing specifications mentioning assay of finished products.
• Pack size, container and closure are not provided.
• Undertaking at ending of Form-5
• The applied composition does not resemble to mee to provided, i-e Metabolase Forte Injection.
Submit revised label claim composition as per applied me to.
Applicant
Brand Name + Dosage Form + Strength BROCOTYD Water Soluble Powder
Composition Each 100Gm Contains:
Doxycycline Hyclate…………………………40Gm
Tylosin Tartrate………………………………20Gm
Colistin Sulphate…………………………….10Gm
Bromhexin Hcl……………………………….2Gm
2019.
Pharmacological Group Broad spectrum antibiotics
Pack size & Demanded Price 500 gm,1 kg
Me-too status BROCOTYD POWDER, 058962, UNIVET
PHARMACEUTICAL RAWALPINDI
Remarks of the Evaluator • Master Formulation with • Firm has submitted
Complete Outline of reply with fee challan
manufacturing method is No.4148868617 dated 01-
• Complete finished good with revised and signed
testing specifications form 5 with undertaking,
mentioning assay of master formulation, outline
finished products. of manufacturing method,
• Pack size, container and Finished good specification
closure are not provided. as innovator specs and
• Undertaking at ending of details of container as
Form-5 plastic jar.
• Undertaking to follow
innovator brand as per
249th meeting of DRB.
of registered product in
Pakistan.
Decision: Approved with innovator specification.
Applicant
Brand Name + Dosage Form + Strength SHATOPEN L.A Inj
Benzathine Penicillin G……..………100000 (IU)
Procaine Penicillin G……………… 100000 (IU)
Dihydrostreptomycin Sulphate……….200mg
2019.
Pharmacological Group Broad Spectrum Antibiotics
Pack size & Demanded Price 50 ml
Me-too status SHOTAPEN L.A. Injection, 022198, F.Y.Corporation
Karachi.
closure are not provided. vial. (Pre-registration
• Undertaking at ending of challan Fee 3000/
Form-5 submitted vide challan No.
• Evidence of me-too status 48230372 dated 29-08-
of registered product in 2022)
Pakistan.
Decision: Approved with innovator specification.
Applicant
Brand Name + Dosage Form + Strength MULTIJECT IMM Injection
Composition Each 5Gm Contains:
Procaine Penicillin……………………1000000IU
Streptomycin Sulphate…………………100mg
Neomycin Sulphate…………………….100mg
Prednisolone……………………………10mg
2019.
Pharmacological Group Antibiotics and steroid combination
Pack size & Demanded Price 24*5 gm
Me-too status MULTIJECT IMM INJECTION, 018871, NAWAN
TRADING CORP. KARACHI
closure are not provided. vial. (Challan Fee Not
• Undertaking at ending of Submitted for
Form-5 preregistration variations)
of registered product in
Pakistan.
formulation.
559. Name and address of manufacturer/ International Pharma Labs, Raiwind Road, Bhobtian
Applicant Chowk, Defence Road,1-Km, towards Kahna, Lahore.
Brand Name + Dosage Form + Strength I-Sterile Water of Injection (100 ml) (vet)
Sterile Water for Injection……….100 ml
Diary No. Date of R & I & fee Dy. No.218 (R&I) dated 27-08-2015; Rs.20,000/- dated
26-08-2015, DUPLICATE DOSSIER Dy.No.8504(R&I)
dated 31-03-2022.
Pharmacological Group Solvent / Diluent
Type of Form Form-5
Finished product Specification B.P Specifications.
Pack size & Demanded Price 100 ml glass vial, As per SRO
Me-too status
GMP status GMP Inspection Certificate Ref No.44/2022-DRAP (AD-
34697196-1037) issued on 13-04-2022 on the basis of
inspection on 13-01-2022.
Remarks of the Evaluator Undertaking to follow innovator brand as per 245th
meeting of DRB
Decision: Deferred for submission for following shortcomings:
• Evidence of already approved product /generic /me too with registration number in Pakistan.
• Indications and justifications for utilization of this product..
Brand Name + Dosage Form + Strength I-Sterile Water of Injection (50 ml) (Vet) (Diluent)
dated 31-03-2022.
Pharmacological Group Solvent / Diluent
Type of Form Form-5
Pack size & Demanded Price 50 ml Glass vial, As per SRO
Approval status of product in Reference N/A
Me-too status EACH VIAL CONTAINS: - WATER FOR INJECTION
50ML WATER FOR INJECTION, 020796, AMROS
PHARMACEUTICALS KARACHI.
meeting of DRB
Decision: Approved.
Brand Name + Dosage Form + Strength I-Sterile Water of Injection (500 ml) (vet)
dated 31-03-2022.
Pharmacological Group Solvent/Diluent
Type of Form Form-5
Pack size & Demanded Price 500 ml glass vial, As per SRO
Me-too status AQUA LITE DISTILLED WATER FOR
INJECTION,500ml, 044977, LEADS PHARMA (PVT)
LTD., ISLAMABAD
meeting of DRB
Decision: Deferred for submission for following shortcomings:
• Evidence of already approved product /generic /me too with registration number in Pakistan.
• Indications and justifications for utilization of this product..
562. Name and address of manufacturer/ Zakfas Pharmaceuticals (Pvt) Ltd. 12-Km, Lutafabad
Applicant Bosan Road,Multan.
Brand Name + Dosage Form + Strength LEVAZAK Granules (Sachet)
Levamisol Hcl…………………… 15 % w/w
Diary No. Date of R & I & fee Dy. No.43(R&I) dated 21-01-2015; Rs.20,000/- dated 20-
01-2015, DUPLICATE DOSSIER Dy.No.12070(R&I)
dated 18-05-2022.
Pharmacological Group Anthelminthic
Type of Form Form-5
Finished product Specification Inhouse method
Pack size & Demanded Price 10 g,50g,100g,200g,500g, 1000g.As per SRO
Me-too status NOBIMISOLE 15%.,062130, "NOBLE PHARMA,
B-1 OLD INDUSTRIAL AREA,
MIRPUR AZAD KASHMIR.
GMP status DML renewal inspection has been conducted on 15-06-
2021 and panel recommended approval of newly
upgrade(revised) Bolus section (Vet) and renewal of
DML.
Decision: Approved with innovator specification. Registration Board further decided to verify
fee challan as per decision of 285th meeting of Registration Board The firm shall submit
preregistration variation fee of 7500/= for revision of finished product specification as per
SRO.No. F.7-11/2012- B&A/DRAP dated 13-07-2021
Brand Name + Dosage Form + Strength ALBAZAK Bolus
Albendazole…………………….1gm
dated 18-05-2022.
Pharmacological Group Anthelminthic
Type of Form Form-5
Pack size & Demanded Price 5*100 sachet.As per SRO
Me-too status "UNI BABENZIN GRANULES,200 gm/Kg,(1 gm/5 gm),
094482, MANUFACTURER AND MARKETING
AUTHORIZATION HOLDER:- M/S. UNI BIOTECH
CO., LTD., 235-22, CHUSA-RO, SINAM-MYEON,
YESAN-GUN, CHUNGCHEONGNAM-DO, SOUTH
KOREA.
DML.
Decision: Approved with innovator specification. Registration Board further decided to verify
fee challan as per decision of 285th meeting of Registration Board The firm shall submit
564. Name and address of manufacturer/ Genix Pharma (Pvt) Ltd.44,45-B, Korangi Chowk Road,
Applicant Karachi.
Brand Name + Dosage Form + Strength BREX Tablet 2 mg
Brexpiprazole…………………………2 mg
2019.
Pharmacological Group Atypical Antipsychotic
Type of Form Form – 5D
Pack size & Demanded Price 10’s,20’s,30, s, As per SRO.
Approval status of product in Reference USFDA approved, Tablet REXULTI 2mg, OTSUKA
Me-too status Not provided.
findings of the inspection including the observation listed
above M/s Genix Pharma Private Limited Located at Plot
No.44-45-B Korangi, Creek Road Karachi, Pakistan was
considered to be operating at a good level of compliance
with cGMP guideline as of today.”
Remarks of the Evaluator • Evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) along with
registration number, brand name and name of firm.
• Stability study data as per guidelines provided in 293rd
meeting of Registration Board is required.
• Submission of Stability study data as per guidelines provided in 293rd meeting of Registration
Board.
Applicant Karachi.
Brand Name + Dosage Form + Strength ALLOP Tablet 100mg
Allopurinol…………………100 mg
2019.
Pharmacological Group Antigout
Type of Form Form – 5
Finished product Specification USP Specification
Pack size & Demanded Price 10’s,20’s,30’s,As per SRO.
Approval status of product in Reference Allopurinol (100mg & 300mg) Tablets by M/s Accord
Regulatory Authorities healthcare limited, MHRA approved.
Me-too status Zyuric-300 Tablet of M/s Rasco Pharma (Reg.#067966)
Remarks of the Evaluator Form-5 Annexure as per Firm has submitted revised
prescribed format of Drug Form -5 on prescribed format
(L, R&A) rules 1976. along with challan fee. No.
479530022 dated 22-06-2022
of 7500/=
Decision : Approved.
Applicant Karachi.
Brand Name + Dosage Form + Strength CLOBAZ Tablet 10mg
Clobazam…………………10 mg
2019.
Pharmacological Group Benzodiazepine, Psychotropic
Finished product Specification BP Specification
Pack size & Demanded Price 10’s,20’s,30’s, As per SRO.
Approval status of product in Reference Onfi tablet (10mg, 20mg) by M/s Lundbeck Pharms
Regulatory Authorities LLC, USFDA Approved
Me-too status Frisium tablet 10mg Reg No 002692
Remarks of the Evaluator • Form-5 Annexure as Firm has submitted revised
per prescribed format Form -5 on prescribed format
of Drug (L, R&A) rules along with challan fee.
1976. No96028051264 dated 22-
• Section approval letter 06-2022 of 7500/=.
of psychotropic section Firm inform that section
from CLB. approval from CLB is in
process.
Decision: Deferred for submission of evidence of approval of required manufacturing facility of
“Psychotropic tablet section” from CLB.
Applicant Karachi.
Brand Name + Dosage Form + Strength BREX Tablet 1 mg
Brexpiprazole…………………………1 mg
2019.
Pack size & Demanded Price 10’s,20’s,30, s, As per SRO.
Approval status of product in Reference USFDA approved, Tablet REXULTI 1mg, OTSUKA
Board.
Applicant Karachi.
Brand Name + Dosage Form + Strength VALPOR Tablet 250 mg
Composition Each Enteric Coated Tablet contains:
Divalproex Sodium Eq. to Valproic Acid……….250 mg
2019.
Pack size & Demanded Price 10’s,20’s,30’s,60’s, As per SRO.
Approval status of product in Reference Depakote (125mg, 250mg, 500mg) delayed-release
Regulatory Authorities tablets USFDA Approved
Me-too status EPL 250mg Tablet by M/s Rotex Pharma (Reg# 100815)
6464087798 dated 22-06-
2022 of 7500/=.
Applicant Karachi.
Brand Name + Dosage Form + Strength VALPOR Tablet 500 mg
Composition Each Enteric Coated Tablet contains:
Divalproex Sodium Eq. to Valproic Acid……….500 mg
2019.
Approval status of product in Reference Depakote (125mg, 250mg, 500mg) delayed-release
Regulatory Authorities tablets USFDA Approved
Me-too status Dapakan Tablet 500mg, Platinum Pharma Reg. No.
024465.
881327095652 dated 22-06-
2022 of 7500/=.
Applicant Karachi.
Brand Name + Dosage Form + Strength VONRAZ Tablet 10 mg
Composition Each Film Coated Tablet contains:
Vonoprazan Fumarate Eq.to Vonoprazan ………10 mg
2019.
Pharmacological Group Potassium-Completive acid blocker
Finished product Specification Innovator’s Specification
Approval status of product in Reference TAKECAB 10mg Tablet of M/s Takeda (PMDA
Regulatory Authorities Approved)
Me-too status Voniza 10mg Tablet of M/s Hilton Pharma
Remarks of the Evaluator • Form-5 Annexure as per Firm has submitted revised
prescribed format of Form -5 on prescribed format
Drug (L, R&A) rules along with challan fee. No.
1976.
• Stability study data as 32147046 dated 22-06-2022
per guidelines provided of 7500/=.
in 293rd meeting of Firm intimated that they have
Registration Board is submitted stability data on
required. 21-02-2022.
Decision: Deferred for evaluation of submitted stability studies data.

Applicant Karachi.
Brand Name + Dosage Form + Strength VONRAZ Tablet 20 mg
Composition Each Film Coated Tablet contains:
Vonoprazan Fumarate Eq.to Vonoprazan ………20 mg
2019.
Pharmacological Group Potassium-Completive acid blocker
Approval status of product in Reference TAKECAB 20mg Tablet of M/s Takeda (PMDA
Me-too status Voniza 20mg Tablet of M/s Hilton Pharma
of Drug (L, R&A) rules along with challan fee. No.
1976. 551178055051 dated 22-06-
• Stability study data as 2022 of 7500/=.
per guidelines Firm intimated that they have
provided in 293rd submitted stability data on
meeting of 21-02-2022.
Registration Board is
required.
Decision: Deferred for evaluation of submitted stability studies data.
Applicant Karachi.
Brand Name + Dosage Form + Strength FLUTIN Capsule 20 mg
Composition Each Capsule contains:
Fluvastatin Sodium Eq.to Fluvastatin…………….20 mg
2019.
Approval status of product in Reference Approved in MHRA
Me-too status Farmastin Capsules 20mg of Farmaceutics Int. Karachi.
per prescribed format Form -5 on prescribed
of Drug (L, R&A) format along with challan
rules 1976. fee. No. 02463888658 dated
22-06-2022 of 7500/=.
Decision : Approved
Applicant Karachi.
Brand Name + Dosage Form + Strength SILTAZ Tablet 50 mg
Cilostazole………………………50 mg
2019.
Pharmacological Group Antiplatelet agent
Finished product Specification Manufacturer specification
Pack size & Demanded Price 14’s, 28’s, As per SRO.
Approval status of product in Reference MHRA approved.
Me-too status Prigtal Tablets, 036228, Getz Pharma, Karachi.
of Drug (L, R&A) along with challan fee. No.
rules 1976. 86737321976 dated 22-06-
2022 of 7500/=.
Decision :Approved with innovator’s specifications.
Applicant Karachi.
Brand Name + Dosage Form + Strength BRIXAB Capsule 80 mg
Betrixaban Maleate eq. to Betrixaban………... 80 mg
2019.
Pharmacological Group Factor Xa Inhibitor
Finished product Specification Innovator’s specification
Pack size & Demanded Price 10’s.20’s,30’s, As per SRO.
Approval status of product in Reference Cap BEVYXXA 80mg, USFDA Marketing status
Regulatory Authorities discontinued,
Remarks of the Evaluator • Form-5 Annexure as per prescribed format of Drug (L,
R&A) rules 1976.
• Status of submitted reference product is discontinued
in reference regulatory authority. Evidence of
approval of applied formulation in reference
regulatory authorities/agencies which were adopted by
the Registration Board in its 275th meeting.
Board.
• Form-5 Annexure as per prescribed format of Drug (L, R&A) rules 1976.
• Status of submitted reference product is discontinued in reference regulatory authority.
Evidence of approval of applied formulation in reference regulatory authorities/agencies
Applicant Karachi.
Brand Name + Dosage Form + Strength ASINAP Tablet 5 mg
Composition Each Sublingual tablet Contains:
Asenapine Maleate eq. to Asenapine…….5 mg
2019.
Pack size & Demanded Price 20’s,60’s, As per SRO.
Approval status of product in Reference MHRA approved
Remarks of the Evaluator • Form-5 Annexure as Firm Informed that stability
per prescribed format is under process, will be
of Drug (L, R&A) submitted once completed.
rules 1976.
• Stability study data as
per guidelines
provided in 293rd
meeting of
required.
Decision: Deferred for submission of Stability study data as per guidelines provided in 293rd
Applicant Karachi.
Brand Name + Dosage Form + Strength REXANT Tablet 15 mg
Suvorexant…………………………15 mg
2019.
Pharmacological Group Hypnotic/Sedative
Pack size & Demanded Price 10’s, 20’s.30’s,As per SRO.
Approval status of product in Reference USFDA approved, Tablet BELSOMRA 15 mg film
Regulatory Authorities coated tablet.
rules 1976.
per guidelines
provided in 293rd
meeting of
required.
Applicant Karachi.
Brand Name + Dosage Form + Strength REXANT Tablet 20 mg
Suvorexant…………………………20 mg
2019.
Pharmacological Group Hypnotic/Sedative
Pack size & Demanded Price 10’s, 20’s.30’s, As per SRO.
Approval status of product in Reference USFDA approved, Tablet BELSOMRA 20 mg film
Regulatory Authorities coated tablet.
rules 1976.
per guidelines
provided in 293rd
meeting of
required.
Applicant Karachi.
Brand Name + Dosage Form + Strength RUDIN Oral Solution
Composition Each ml Contain:
Rupatadine as Fumarate…………………………1 mg
2019.
Pharmacological Group Antiallergic
Finished product Specification USP specification
Pack size & Demanded Price 10’s, 20’s.30’s, As per SRO.
Approval status of product in Reference MHRA approved, Aspire Pharma, UK
Me-too status Not provided
rules 1976.
per guidelines
provided in 293rd
meeting of
required.
Applicant Karachi.
Brand Name + Dosage Form + Strength RELOX 0.4mg/ml Injection
Composition Each ml Contain:
Naloxone Hydrochloride……………….0.4 mg
2019.
Pharmacological Group Opioid Antagonist
Pack size & Demanded Price 1’s,5’s,10’s ,25’s,30’s,50’s, As per SRO.
Approval status of product in Reference Naloxone of MHRA approved.
Me-too status Naloxone Injection 0.4mg of M/s Rehman Medicines Co.
(Reg.# 019587)
rules 1976. 1123289122 dated 22-06-
• Section approval letter 2022 of 7500/=.
from CLB. Firm inform that section
approval from CLB is in
process.
Decision: Approved.
Applicant Karachi.
Brand Name + Dosage Form + Strength APRANT Capsule 80 mg
Composition Each Capsule contain:
Aprepitant ……………...…………………….80 mg
2019.
Pharmacological Group Antiemetic
Pack size & Demanded Price 2’s, As per SRO.
Approval status of product in Reference TGA; Australia Approved
Me-too status Apreon 80mg Capsules of M/s Ferozesons Labs, 068202
rules 1976. 0663642988 dated 22-06-
2022 of 7500/=.
Decision: Approved.
Applicant Karachi.
Brand Name + Dosage Form + Strength HYPIN Tablet 20 mg
Composition Each Film coated Tablet Contains:
Lercanidipine Hydrochloride…………….…….20 mg
2019.
Approval status of product in Reference Lercadip 10mg of (MHRA approved)
Me-too status 095125, Canmap 10mg Tablet, Maple Pharmaceuticals
(Pvt) Ltd.,Karachi
rules 1976. 98840026 dated 22-06-2022
of 7500/=.

Applicant Karachi.
Brand Name + Dosage Form + Strength RANIGEN Effervescent Tablet 25 mg
Composition Each Effervescent Tablet Contains:
Ranitidine HCl Eq to Ranitidine…………….…….25 mg
2019.
Pharmacological Group H2 receptor Antagonist
Approval status of product in Reference USFDA marketing status as “Discontinued”.
Me-too status
rules 1976. 708812425 dated 22-06-
• RRA status of 2022 of 7500/=
Ranitidine
containing products
is suspended.
Decision: Deferred till the decision by reference regulatory authorities regarding ranitidine
containing medicinal products
583. Name and address of manufacturer/ Medipak Limited,554 sundar Industrial Estate, Lahore.
Applicant
Brand Name + Dosage Form + Strength Medisol Medilyte-M Intravenous Infusion 1000ml
Calcium Chloride Dihydrate……………0.22 gm
Potassium Chloride……………………...1.5 gm
Sodium Chloride…………………………2.16 gm
Sodium Acetate tri hydrate………………3.13 gm
Dextrose Anhydrous…………………….50 gm
2019.
Pharmacological Group Electrolytes
Finished product Specification Manufacturer specifications
Pack size & Demanded Price 1000 ml,Poly Propylene (P.P) bottle with Euro cap, As per
SRO.
Approval status of product in Reference Not Provided
Me-too status PLYABOLYTE-M INJ, 011225, OTSUKA, Karachi.
(Plabottle, not PP bottle)
GMP status GMP certificate issued on 29-07-2021 based on inspection
conducted on 21-05-2021 for Intravenous Infusion
Remarks of the Evaluator • Evidence of applied product in RRA in applied primary
packing of Polypropylene bottle or revise formulation
along fee challan.
• Revised master formulation as per revised label claim
Mee-too reference of applied product with applied primary
packaging (Poly Propylene) in Pakistan.
Decision: Deferred for following shortcomings
• Evidence of applied product in RRA in applied primary packing of Polypropylene bottle.
• Evidence of generic reference of applied product with applied primary packaging (Poly
Propylene) registered in Pakistan.
Applicant
Brand Name + Dosage Form + Strength Medisol Medilyte-M Intravenous Infusion 500 ml
Calcium Chloride Dihydrate……………0.22 gm
Potassium Chloride……………………...1.5 gm
Sodium Acetate tri hydrate………………3.13 gm
Dextrose Anhydrous…………………….50 gm
2019.
Pharmacological Group Electrolytes
Pack size & Demanded Price 500 ml, Poly Propylene (P.P) bottle with Euro cap, As per
SRO.
Me-too status PLYABOLYTE-M INJ, 011225, OTSUKA, Karachi.
(Plabottle, not PP bottle)
Remarks of the Evaluator • Revised composition as per 500 ml pack
• Evidence of applied product in RRA in applied primary
along fee challan.
• Mee-too reference of applied product with applied
primary packaging (Poly Propylene) in Pakistan.
• Revised composition as per 500 ml pack
• Evidence of applied product in RRA in applied primary packing of Polypropylene bottle
or revise formulation along fee challan.
• Generic reference of applied product with applied primary packaging (Poly Propylene)
in Pakistan
Applicant
Brand Name + Dosage Form + Strength Medisol 0.45 NS + Dextrose Intravenous Infusion 500 ml
Dextrose Anhydrous……………………...5 gm
2019.
Pharmacological Group Electrolytes & Carbohydrate
Finished product Specification USP Specs
Pack size & Demanded Price 500 ml, Poly Propylene (P.P) bottle with Euro Cap, As per
SRO.
Me-too status Sterifluid-DS 1/2 Infusion, 049285, Frontier Dextrose
Ltd.Hattar.
Remarks of the Evaluator • Evidence of applied product in RRA in applied primary
along fee challan.
• Me-too reference of applied product with applied primary
packaging (Poly Propylene) in Pakistan.
• Evidence of applied product in RRA in applied primary packing of Polypropylene bottle
• Generic reference of applied product with applied primary packaging (Poly
Propylene)registered in Pakistan
586. Name and address of manufacturer/ Schazoo Zaka (Pvt) Ltd.,20 km, Lahore jaranwala road,
Applicant Sheikhupura.
Brand Name + Dosage Form + Strength PREGAB Capsule 75 mg
Pregabalin………………………...75 mg
2019.
Finished product Specification Manufacturer Specifications
Pack size & Demanded Price 10’s. As per SRO.
Approval status of product in Reference Lyrica 75 mg capsule of Upjohn UK limited (MHRA)
Me-too status Bargan 75mg Capsule, 094931, CKD Pharmaceuticals
Pakistan (Pvt) Ltd.,Karachi
GMP status GMP Certificate issued on 24-07-2018 with following
sections:
1- Tablet (Gen, Anti TB)
2- Capsule (Gen)
3- Dry Powder suspension (Gen, Anti Tb)
4- Sachet (Gen, Anti Tb)
Firm has also submitted GMP inspection report conducted
on 31-03-2022 and recommended that firm had
maintained good level of GMP compliance as per schedule
B-II on Drug (Licensing, Registration & Advertising)
rules,1976 at the time of inspection.
Remarks of the Evaluator • Form-5 Annexure as per Firm has submitted reply
prescribed format of along with revised and
Drug (L, R&A) rules prescribed form-5. Firm has
1976 along with submitted their own testing
preregistration variation specification; however, the
fee. monograph is present in
• Product is in USP, submit USP. Firm did not submit
revised Finished product preregistration variation fee.
specification.
Decision: Approved with USP specification. The firm shall submit preregistration variation fee
of 7500/= for revision of finished product specification as per SRO.No. F.7-11/2012- B&A/DRAP
dated 13-07-2021
2019.
Me-too status Freglin Capsule 150 mg, 094034, FYNK Pharmaceuticals,
Lahore.
sections:
2- Capsule (Gen)
specification.
dated 13-07-2021
2019.
Me-too status Newgaba 300mg Capsules, 092105, Biolabs (Pvt) Ltd.,
Islamabad
sections:
2- Capsule (Gen)
specification.
of 7500/=as per SRO.No. F.7-11/2012- B&A/DRAP dated 13-07-2021
589. Name and address of manufacturer/ Reign Pharmaceuticals PCSIR-KLC (Pvt) Ltd.TBIC
Applicant building-1, PCSIR Laboratories complex, Karachi.
Brand Name + Dosage Form + Strength C-THROCIN Tablet 250 mg
Clarithromycin……………….250 mg
2019.
Pharmacological Group Quinolone Antibiotic
Finished product Specification B.P specification
Pack size & Demanded Price ,As per DPC
Approval status of product in Reference BIAXIN® (clarithromycin 250mg) film coated tablets,
Regulatory Authorities USFDA approved.
Me-too status Claramed 250mg Tablets, Global Pharma, R.No. 023993.
GMP status GMP certificate issued dated 31-12-2021 on the basis of

inspection conducted on 11-11-2021 for Tablet (
G),Capsule ( G) , Dry Powder Suspension (G) , Liquid ( G
) , and Sachet ( G) .
Remarks of the Evaluator • Master Formulation. Firm has submitted reply
• Form-5 not signed by along with Form-5 dully
firm management. signed by Firm management
• Complete with annexure including
manufacturing out line. master formulation, outline
• Complete finished of manufacturing method,
product testing. Section approval letter.
Decision: Approved with BP specification. The firm shall submit preregistration variation fee of
7500/= as per SRO.No. F.7-11/2012- B&A/DRAP dated 13-07-2021
Brand Name + Dosage Form + Strength C-THROCIN Suspension 250 mg
Clarithromycin (taste masked granules 27.5%) .....250 mg
2019.
Finished product Specification Not provided/USP
Pack size & Demanded Price 60 ml, As per DPC
Approval status of product in Reference Biaxin Suspension (USFDA approved)
Me-too status Maclacin of M/s Bosch
Remarks of the Evaluator • Master Formulation Firm has submitted reply
• Complete along with Form-5 dully
manufacturing out line. signed by Firm management
• Complete finished with annexure including
product testing master formulation, outline
specifications. (USP) of manufacturing method,
• Form-5 Signed by Section approval letter.
Firms management.
• Source of pellets with
COA, Stability and
GMP of source.
Decision: Approved with USP specification. Firm shall declare source of granules/pellets, GMP,
COA and stability study data before issuance of registration letter. The firm shall submit
applicable preregistration variation fee as per SRO.No. F.7-11/2012- B&A/DRAP dated 13-07-
2021
Brand Name + Dosage Form + Strength LAMIDE Tablet 200 mg
Lacosamide…………………………………200 mg
2019.
Pack size & Demanded Price Not provided, As per DPC
Approval status of product in Reference VIMPAT (50mg, 100mg, 150mg, 200mg) film coated
Regulatory Authorities tablet
USFDA approved
Me-too status Lacolit 200mg Tablet by M/s The Searle Company
Limited, (Reg#077125)
inspection conducted on 11-11-2021 for Tablet (G),
Capsule (G), Dry Powder Suspension (G) , Liquid ( G ) ,
and Sachet ( G) .
product testing master formulation, Section
specifications. approval letter.
• Form-5 Signed by
Firms management
• Pack size.
2019.
Finished product Specification Not provided / Innovator
Approval status of product in Reference MHRA Approved film coated 100 mg tablet, Torrent
Regulatory Authorities Pharma,UK.
Me-too status Lacogit-100 100mg Tablets, Reg # 083580, Glitz Pharma,
Islamabad
specifications. of manufacturing method,
• Form-5 Signed by Section approval letter.
Firms management
• Pack size.
2019.
Approval status of product in Reference Lacosamide Aspire 50 mg film-coated tablets by Aspire
Regulatory Authorities Pharma Limited. MHRA Approved
Me-too status Lalap 50mg tablet. Reg. No. 70470
specifications. of manufacturing method,
• Form-5 Signed by Section approval letter, and
Firms management pack size.
• Pack size.
Brand Name + Dosage Form + Strength ONDOR Tablet 4 mg
Ondansetron (as Hcl).…………………4 mg
2019.
Pharmacological Group Selective Serotonin 5HT3 Receptor Antagonist
Pack size & Demanded Price 10’s, As per DPC
Approval status of product in Reference MHRA Approved
Me-too status Onden 4mg tablet of M/s Macter (Reg. # 057754)
Remarks of the Evaluator • Revised label claim as Firm has submitted reply
USP with Master along with Form-5 dully
Formulation signed by Firm management
product testing Section approval letter, and
specifications. (USP) pack size.
Firms management
• Pack size.
of 7500/= as per SRO.No. F.7-11/2012- B&A/DRAP dated 13-07-2021
Brand Name + Dosage Form + Strength ONDOR Tablet 8 mg
Ondansetron (as Hcl).…………………8 mg
2019.
Pharmacological Group Selective Serotonin 5HT3 Receptor Antagonist
Me-too status Onfran Tablet 8mg of M/s Al-Habib Pharma (Reg.#
059257)
Capsule (G), Dry Powder Suspension (G), Liquid (G), and
Sachet (G).
Remarks of the Evaluator • Revised label claim as Firm has submitted reply
USP with Master along with Form-5 dully
Formulation signed by Firm management
product testing Section approval letter, and
specifications. (USP) pack size.
Firms management
• Pack size.
of 7500/= as per SRO.No. F.7-11/2012- B&A/DRAP dated 13-07-2021
Brand Name + Dosage Form + Strength DEXFEN Tablet 200 mg
Dexibuprofen.…………………200 mg
2019.
Pharmacological Group NSAID
Finished product Specification Not provided/innovator
Approval status of product in Reference Atriscal 200 mg - film-coated tablets of Gebro Pharma
Regulatory Authorities GmbH, Approved in Austria.
Me-too status Haltrin 200mg Tablet by M/s Brookes Pharmaceuticals,

Karachi. (Reg. # 061068).
Remarks of the Evaluator • Complete Firm has submitted reply
manufacturing out line. along with Form-5 dully
• Complete finished signed by Firm management
product testing with annexure including
specifications. master formulation, outline
(Innovator). of manufacturing method,
Firms management. pack size.
• Pack size
Decision: Approved with inovator’s specification. The firm shall submit preregistration variation
2019.
Approval status of product in Reference Dexibuprofen 300 mg film-coated tablets MHRA
Regulatory Authorities Approved
Me-too status Tercica 300mg Tablet. Reg. No. 58445
• Pack size.
Decision: Approved with innovator’s specification. The firm shall submit preregistration
variation fee of 7500/= as per SRO.No. F.7-11/2012- B&A/DRAP dated 13-07-2021
2019.
Finished product Specification Not provided/ Innovator
Approval status of product in Reference Dexibuprofen 400 mg film-coated tablets MHRA
Me-too status Tercica 400mg Tablet. Reg. No. 58446
• Pack size.
variation fee of 7500/= as per SRO. No. F.7-11/2012- B&A/DRAP dated 13-07-2021
Brand Name + Dosage Form + Strength HAEMREN Capsule 250 mg
Tranexamic Acid.…………………250 mg
2019.
Pharmacological Group Antifibrolytics
Finished product Specification Not provided / JP/BP
Approval status of product in Reference TRANEX 250 mg capsule, AIFA approved.
Me-too status Tranxet 250mg Capsules, 084338, Biolabs (Pvt) Ltd.,
Islamabad
Remarks of the Evaluator • GMP Firm has submitted reply
certificate/inspection along with Form-5 dully
conducted within last 3 signed by Firm management
years. with annexure including
• Complete master formulation, outline
manufacturing out line. of manufacturing method,
• Complete finished Section approval letter, and
product testing pack size.
specifications. (JP).
Firms management.
• Pack size.
Decision: Approved with JP specification. The firm shall submit preregistration variation fee of
7500/= as per SRO. No. F.7-11/2012- B&A/DRAP dated 13-07-2021
Brand Name + Dosage Form + Strength HAEMREN Capsule 500 mg
Tranexamic Acid.…………………500 mg
2019.
Pharmacological Group Hemostatics, (Amino acid antifibrinolytics) (B02AA02)
Finished product Specification Not provided/ JP/BP
Approval status of product in Reference TRANEX 500 mg capsule, AIFA approved.
Me-too status Ephamic Capsules 500mg, 096273, E-Pharm
Laboratories, Karachi
specifications. (JP). master formulation, outline
• Form-5 Signed by of manufacturing method,
Firms management. Section approval letter, and
• Pack size. pack size.
Brand Name + Dosage Form + Strength PENICIL Tablet 250 mg
Penicillamine…………………250 mg
2019.
Pharmacological Group Antirheumatic Agent
Finished product Specification Not provided/JP
Approval status of product in Reference Penicillamine 250 mg film-coated tablets of MHRA
Regulatory Authorities approved
Me-too status Penicillamine 250mg Tablet of M/s Medisure
Lab Reg no # 083907
specifications. (JP). master formulation, outline
Brand Name + Dosage Form + Strength APRANT Capsule 125 mg
Aprepitant…………………125 mg
2019.
Pack size & Demanded Price 3’s,As per DPC
Approval status of product in Reference EMEND Capsule of USFDA
Me-too status Apritus 125mg Capsule of M/s S.J&G
product testing pack size.
specifications. (USP).
Firms management.
• Pack size.
Brand Name + Dosage Form + Strength MINOLINE Tablet 100 mg
Minocycline as Hydrochloride…………………100 mg
2019.
Pharmacological Group Tetracycline antibiotics
Finished product Specification Not provided / USP
Me-too status Minokane 100mg tablet by M/s Kanel Pharma, Islamabad.
Registration No.099655
specifications. (USP). master formulation, outline
st th nd
of 7500/= as per SRO. No. F.7-11/2012- B&A/DRAP dated 13-07-2021
Brand Name + Dosage Form + Strength DELAS Capsule 60 mg
Dexlansoprazole (Enteric Coated pellets) ………60 mg
2019.
Pharmacological Group Proton Pump Inhibitor
Pack size & Demanded Price 30’s , As per DPC
Approval status of product in Reference Approved in US-FDA
Me-too status Razodex of Getz Pharma
product testing pack size. Firm has also
specification. submitted Source of Pellets as
• Stability study data as m/s Vision Pharmaceuticals
per guidelines provided (Pvt) Ltd along with stability
in 293rd meeting of study data, COA.
required.
GMP, COA and
stability study of
pellets
• Pack size.
Decision :Deferred for submission of Stability study data as per guidelines provided in 293rd
Brand Name + Dosage Form + Strength RIVBAN Tablet 20 mg
Rivaroxaban …………………………………20 mg
2019.
Pharmacological Group Antithrombotic Agent
Finished product Specification Not provided/BP
Approval status of product in Reference Rivaroxaban 20 mg film-coated tablets, MHRA
Me-too status Xarelto 20Mg Tablets, Bayer Pakistan, Reg. No. 072550.
specification. (BP) master formulation, outline
• Pack size. of manufacturing method,
Section approval letter, and
pack size.
Decision: Approved with B.P specification. The firm shall submit preregistration variation fee of
Brand Name + Dosage Form + Strength TERBIN Tablet 125 mg
Terbinafine as Hcl ………………………125 mg
2019.
Pharmacological Group Antifungal
Approval status of product in Reference Lamisil® Tablets 250mg by M/s Novartis
Regulatory Authorities Pharmaceuticals UK Limited,MHRA Approved.
Me-too status Logirid Tablet 250mg by M/s Lowitt Pharmaceutical (Pvt)
Ltd, Reg No. 80847
specification. master formulation, outline
(Innovator) of manufacturing method,
• Pack size. Section approval letter, and
pack size.
Brand Name + Dosage Form + Strength URDEOIC Suspension
Composition Each 5 ml Contains:
Ursodeoxycholic Acid………………………250 mg
2019.
Pharmacological Group Anti-Cholelithic Acid /Bile acid Preparation
Finished product Specification Not provided /BP
Approval status of product in Reference Ursofalk 250mg/5ml Suspension MHRA approved
Me-too status Urolic 250mg/5ml Oral Suspension by M/s Pharmasol
(Pvt) Ltd (Reg#099706)
Remarks of the Evaluator • Master formulation is Firm has submitted reply
required. along with Form-5 dully
specification. master formulation, outline
• Section Approval letter of manufacturing method,
from CLB Section approval letter, and
Decision: Approved with BP specification. The firm shall submit preregistration variation fee of
Brand Name + Dosage Form + Strength RICE ORS Sachet
Rice Powder (Pre cooked) ……….6 g
Sodium Citrate …………………...0.58 g
Sodium Chloride………………….0.35 g
Potassium Chloride……………….0.30 g
2019.
Pharmacological Group Electrolyte/Antidiarrheal
Finished product Specification Not provided/Innovator
Approval status of product in Reference Dioralyte Relief (MHRA Approved)
Me-too status HILYTE-R powders by M/s Hilton
pharma,(Reg#073733),
Remarks of the Evaluator • Master formulation. Firm has submitted reply
• Complete finished along with Form-5 dully
product testing signed by Firm management
specification with annexure including
(Innovator) master formulation, outline
form CLB. Section approval letter, and
Brand Name + Dosage Form + Strength BIOFEN Sachet 600 mg
IBUPROFEN………………………600 mg
(Effervescent Granules)
2019.
Pack size & Demanded Price As per DPC
Approval status of product in Reference Brufen Granules (MHRA approved)
Me-too status Brufen 600mg Sachet, Abbott Laboratories, Reg. No.
044414.
form CLB. Section approval letter.
• Pack size.
Brand Name + Dosage Form + Strength GASTRO Sachet
Composition Each Sachet Contain:
Dioctahedral smectite…………….3.00 g
2019.
Pharmacological Group Intestinal Adsorbents
Approval status of product in Reference ANSM; France Approved
Me-too status Semetamed 3g Sachet of M/s Mediate Pharmaceutical
(Pvt.) Ltd, Karachi,061925
form CLB. Section approval letter and
Brand Name + Dosage Form + Strength MEBINE Sachet
Mebeverine Hcl…………….135 mg
Ispaghula Husk……………..3.5 g
2019.
Pharmacological Group Antispasmodic
Pack size & Demanded Price 6.335 * 10’s, As per DPC
Approval status of product in Reference Fybogel Mebeverine effervescent granules by M/s
Regulatory Authorities Reckitt Benckiser Healthcare (UK) Ltd. (MHRA
approved)
Me-too status Colospas Fibro 135mg/3.5g powder by M/s Nabiqasim.
(Reg# 058672)
(Innovator). master formulation, Section
• Section Approval letter approval letter, and pack size.
form CLB.
• Pack size.
Brand Name + Dosage Form + Strength ACETIN Sachet
Acetylcysteine ……………………….200 mg
2019.
Pharmacological Group Expectorant
Approval status of product in Reference Acetylcysteine 200 mg Powder for Oral Solution by M/s
Regulatory Authorities NTC S.r.l. (MHRA approved
Me-too status Mucolator 200mg powders by M/s Abbott Laboratories.
(Reg# 017693)
(Innovator) master formulation, Section
• Section Approval letter approval letter, and pack size.
form CLB.
• Pack size.
613. Name and address of manufacturer/ Goodman Labortories(Pvt) Ltd,Plot No. 5 , St No. S-
Applicant 5,National Industrial Zon,Rawat,Islamabad.
Brand Name + Dosage Form + Strength BET Tablet 75 mg
Irbesartan……………………….75 mg
2019.
Pharmacological Group Angiotension II receptor antagonist
Finished product Specification BP
Pack size & Demanded Price 10’s’20’s30’s,60’s, As per DPC
Approval status of product in Reference Aprovel (75mg, 150mg, 300mg) film coated tablet by
Regulatory Authorities M/s Sanofi Aventis, MHRA Approved.
Me-too status Gooday-H Tablets 300mg, by M/s Wilson, Reg No. 75366
GMP statu Not provided within last 3 years
Remarks of the Evaluator • GMP certificate/inspection conducted within last 3
years.
• Manufacturing method /outline of tubes of
cream/ointment is provided instead of Tablet.
• DML renewal status from CLB.
• Section Approval letter form CLB.
• Pack size.
• Submission of Manufacturing method /outline of applied product.
Brand Name + Dosage Form + Strength T-SART Tablet 40 mg
Telmisartan………….40 mg
2019.
Pack size & Demanded Price 10’s’20’s30’s, As per DPC
Approval status of product in Reference Telmisartan Mylan 40 mg uncoated tablets, MHRA
Regulatory Authorities Approved.
Me-too status Misar 40mg Tablet, Highnoon Laboratories, Reg. No.
065687.
GMP status Not provided within last 3 years
years.
• Pack size.
Brand Name + Dosage Form + Strength FIBREN Capsule 67 mg
Fenofibrate……………….67 mg
2019.
Pharmacological Group Lipid Reducing Agent
Pack size & Demanded Price 10’s’20’s30’s, As per DPC
Approval status of product in Reference Fenofibrate 67mg capsules
Regulatory Authorities Actavis Barnstaple UK (MHRA approved)
Me-too status Fenoget 67mg micronized capsules of M/s Getz
Pharmaceuticals,Karachi.(047197)
years.
cream/ointment is provided instead of Capsule.
• Pack size.
Brand Name + Dosage Form + Strength ROXET CR Tablet 12.5 mg
Composition Each Controlled Release Tablet Contains:
Paroxetine as HCl……….12.5 mg
2019.
Pharmacological Group SSRI /Anti-Depressant
Pack size & Demanded Price 10’s,14’s,20’s30’s, As per DPC
Approval status of product in Reference PAXIL CR (paroxetine 25 mg) film coated tablets,
Regulatory Authorities USFDA approved.
Me-too status Parxet 25mg Tablets/s Biolabs Islamabad, 084343
years.
• Pack size.
Brand Name + Dosage Form + Strength VILMET Tablet 50/500 mg
Vildagliptin ………….50 mg
Metformin Hcl……….500 mg
2019.
Pharmacological Group Antidiabetic
Pack size & Demanded Price 10’s,14’s,20’s,28’s,30’s, As per DPC
Approval status of product in Reference Eucreas 50/500mg film coated tablet, Novartis Pharma,
Regulatory Authorities Germany (MHRA)
Me-too status Galvus Met (50mg/500mg) tablet by Novartis Pharma,
Reg. No.078106.
years.
• Pack size.
Brand Name + Dosage Form + Strength ZOMID Capsule 50 mg
Zonisamide ………………50 mg
2019.
Pack size & Demanded Price 10’s,14’s,20’s,30’s, As per DPC
Approval status of product in Reference Zonisamide Warren 50mg capsule MHRA Approved
Me-too status Seizof 50mg Capsule of OBS Pakistan Reg#73643)
years.
• Master formulation mentioned API Fenofibrate instead
of Zonisamide.
cream/ointment is provided instead of Capsule
• Pack size.
619. Name and address of manufacturer/ Quaper Pvt.Ltd.,26-A small Industrial Estate, Lahore road,
Applicant Sargodha.
Brand Name + Dosage Form + Strength DICTIL Tablet
Misoprostol………………….200 Mcg
Diclofenac Sodium…………..75 mg
2019.
Pharmacological Group Prostaglandin E1 Analogue, NSAID
Type of Form Form-5
Pack size & Demanded Price 2*10’s, As per SRO
Approval status of product in Reference Arthrotec of USFDA Approved
Me-too status Cytopan-75 Tablets by Getz Pharma (Reg#024014)
GMP status Firm was granted GMP certificate dated 19-06-2019 on
the basis of GMP inspection conducted on 28-01-2019
for Tablet (General).
Panel inspection of firm for grant of additional sections
was also conducted on 16-06-2020 & 18-06-2020 and
firm was recommended for grant of following additional
sections as per approved layout plan:
1. Tablet (General) section
2. Capsule (general) section
3. R&D laboratory
4. Sachet (general)
Remarks of the Evaluator • Firm does not mention • Firm has submitted reply
as “enteric Coated with fee challan
inner tablet of No.09189046503 dated
Diclofenac Sodium” 03-08-2022 of
in form-5. 30000/=along with
revised form-5 with USP
• Form-5 and Master specification of finished
formulation does not drug product mentioning
mentioned • Each Bilayer Tablet
Misoprostol in 1 % Contains:
HPMC dispersion. “Enteric coated inner tablet of
• Evidence of facility of Diclofenac Sodium ….75
manufacturing of mg.
Tablet within tablet Misoprostol ameliorated with
formulation (Bilayer 1 % HPMC eq. to
Tablet Machine). Misoprostol …...200 mcg”
• USP monograph is Firm has submitted revised
available master formulation for
bilayer tablet with
manufacturing method
through Bilayer Tablet
machine. Firm has submitted
copy of Invoice of bilayer
Tablet machine dated 25-06-
2022.
Decision: Approved with innovator’s specifications,the firm shall submit Installation
Qualification ( IQ) , Operational qualification ( OQ) before issuance of registration letter.
Applicant Sargodha.
Brand Name + Dosage Form + Strength HYOSCINE PLUS Tablet
Paracetamol …………………….….500 mg
Hyoscine Butyl bromide …………...10 mg
2019.
Pharmacological Group Spasmodic,Analgesic
Type of Form Form-5
Pack size & Demanded Price 100’s, As per SRO
Approval status of product in Reference Buscopan Plus film-coated tablet. DMDI Germany
Me-too status Hyo-Plus Tablets. Reg. No. 064452 (film-coated) of M/s.
Roryan Pharmaceuticals.
3. R&D laboratory
4. Sachet (general)
Remarks of the Evaluator Already registered.
Decision: Registration Board disposed of application with no further action as applied
formulation has already been registered in the name of M/s Quaper Pvt.Ltd.,26-A small
Industrial Estate, Lahore road, Sargodha.
Applicant Sargodha.
Brand Name + Dosage Form + Strength ABESTATIN Tablet 20 mg
Composition Each Film Coated tablet contains:
Atorvastatin Calcium Eq. to Atorvastatin……….…20mg
2019.
Pharmacological Group Antilipidemic
Type of Form Form-5
Approval status of product in Reference MHRA approved, 20 mg Film coating Tablets.
Me-too status LIPIGET TABLETS 20mg (Reg. No.: 029957)
manufactured by M/s Getz Pharma (Pvt.) Limited Plot No.
29 -30, Sector 27, Korangi Industrial Area, Karachi
3. R&D laboratory
4. Sachet (general)
Remarks of the Evaluator • Firm does not mention •Firm has submitted reply
as “Film Coated with fee challan
tablet” in form-5. No.036783126358 dated 03-
• Revised label claim 08-2022 of 7500/=along with
and composition as revised form-5 and master
“Each Film Coated formulation mentioning label
tablet contains: claim as;
Atorvastatin calcium Each film Coated tablet
trihydrate eq to Contains:
Atorvastatin 20 mg Atorvastatin calcium
trihydrate eq to Atorvastatin
Calcium………….20 mg
Decision: Approved.
Applicant Sargodha.
Brand Name + Dosage Form + Strength THYROXINE Tablet
Thyroxin Sodium……………………….50 Mcg
2019.
Pharmacological Group Thyroid Hormone
Type of Form Form-5
Finished product Specification Innovator Specifications (USP)
Approval status of product in Reference USFDA approved, Uncoated tablet Levothyroxine
Regulatory Authorities Sodium 50 mcg.
Me-too status M/s GlaxoSmithKlin Pakistan Limited, 000374
3. R&D laboratory
4. Sachet (general)
Remarks of the Evaluator • The reference product contains Levothyroxine Sodium
50 mcg per tablet where as applied product contains
thyroxine Sodium 50 mcg, submit revised form-5 with
label claim as per reference product.
• Section approval letter of hormone section from CLB.
• Pharmacological Group is not mentioned in form -5.
• Finished product monograph as per USP.
• The reference product contains Levothyroxine Sodium 50 mcg per tablet where as applied
product contains thyroxine Sodium 50 mcg, submit revised form-5 with label claim as per
reference product.
• Section approval letter of hormone section from CLB is required.
• Pharmacological Group is not mentioned in form -5.
• Finished product monograph as per USP
Applicant Sargodha.
Brand Name + Dosage Form + Strength LETRO Tablet 2.5 mg
Composition Each Film Coated tablet contains:
Letrozole……………………….……….2.5 mg
2019.
Pharmacological Group Aromatase inhibitor
Type of Form Form-5
Approval status of product in Reference FEMARA 2.5mg film coated tablet USFDA Approved
Me-too status Letzole 2.5mg Tablet by M/s Opal Labs (Reg#075805)
3. R&D laboratory
4. Sachet (general)
tablet” in form-5. No.1590869186 dated 03-08-
Submit revised Form- 2022 of 7500/=along with
5 with label claim as revised form-5 and master
per reference product. formulation mentioning label
claim as;
Each film Coated Tablet
Contains:
Letrozole………..2.5 mg
Decision: Registration Board approved registration of product in general manufacturing areas
with condition that manufacturer shall provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of these drugs.
Applicant Sargodha.
Brand Name + Dosage Form + Strength IBUNAC FORTE TABLET
Ibuprofen………….………..400 mg
Pseudoephedrine……………..60 mg
2019.
Pharmacological Group Analgesic, Antipyretic, Nasal Decongestant
Type of Form Form-5
Approval status of product in Reference Lasynac Max Strength 400mg/60mg film coated tablets
Regulatory Authorities (MHRA Approved)
Me-too status Alvry Forte Tablet by M/s The Schazoo Pharmaceutical
Laboratories (Reg#087563)
3. R&D laboratory
4. Sachet (general)
tablet” in form-5. No.9672048438 dated 03-08-
• Reference product 2022 of 7500/=along with
label claim is revised form-5 and master
Pseudoephedrine HCl, formulation mentioning label
Revised label claim claim as;
on form-5 as Each film Coated Tablet
pseudoephedrine HCl Contains:
60 mg is required. Ibuprofen………400 mg
Pseudoephedrine Hcl..60 mg
Decision: Approved.
Applicant Sargodha.
Brand Name + Dosage Form + Strength Q-SPAM Tablet
Composition Each Sugar-Coated Tablet Contains:
Phloroglucinol…………………………80 mg
Trimethyl Phloroglucinol……………...80 mg
2019.
Type of Form Form-5
Approval status of product in Reference Spasfon, coated tablet by M/s Teva Sante, ANSM France
Regulatory Authorities Approved.
Me-too status Gluwix Tablet 80/80mg by M/s Wnsfield, Reg. No.
097067
3. R&D laboratory
4. Sachet (general)
as “Sugar Coated tablet” with fee challan
in form-5. No.3899378886 dated 03-08-
• Reference product 2022 of 7500/=along with
contains revised form-5 and master
“Phloroglucinol formulation mentioning label
Hydrate”. Revised claim as;
Formulation of form -5 Each Sugar-Coated Tablet
mentioning hydrated Contains:
Phloroglucinol 80 mg. Phloroglucinol Hydrate
……………………80 mg
Trimethyl
Phloroglucinol….....80 mg
Decision:Approved with innovators specifications.
Applicant Sargodha.
Brand Name + Dosage Form + Strength Q-SPA Tablet
Drotaverine……………………………….40 mg
2019.
Type of Form Form-5
Approval status of product in Reference Approved in three EMA states as un-coated tablets in
Regulatory Authorities Hungary, Romania & Solvakia
Me-too status Paspa Tablets of M/s Pliva Pharma 026881
3. R&D laboratory
4. Sachet (general)
Remarks of the Evaluator • Firm 5 mentions •Firm has submitted reply
“Each Tablet with revised form -5
contains: Drotaverine mentioning label claim as:
40 mg”, whereas Each Tablet Contains:
master formulation Drotaverine Hcl……40 mg
mentions drotaverine
Hcl 40 mg. which
needs correction.
627. Name and address of manufacturer/ Goodman Laboratories (Pvt) Ltd., Plot No. 5, St No. S-5,
Applicant National Industrial Zone, Rawat, Islamabad.
Brand Name + Dosage Form + Strength PINE XR Tablet 150 mg
Quetiapine as Fumarate…... ………………150 mg
2019.
Pack size & Demanded Price 10’s,14’s,20’s,30’s,50’s, As per DPC
Approval status of product in Reference Seroquel XR of USFDA approved.
Me-too status Qusel XR 150mg Tablet of M/s Hilton Pharma
years.
cream/ointment is provided instead of Tablets.
Vidagliptin…... ………………50 mg
Metformin HCl……………….850 mg
2019.
Approval status of product in Reference Galvumet 50mg/850mg tablets by M/s. Novartis
Regulatory Authorities Pharmaceuticals Australia (TGA approved)
Me-too status Galvus Met 50mg/850mg tablets of M/s Novartis Pharma,
Karachi
years.
Vildagliptin…... ………………50 mg
Metformin HCl……………….1000 mg
2019.
Approval status of product in Reference MHRA approved, TEVA UK Limited, PL 00289/2175
Me-too status Vilda Plus 50/1000mg Tablet, Reg # 090282, Rotex
Pharma
(Pvt) Ltd., Islamabad,
years.
630. aName and address of manufacturer/ Goodman Laboratories (Pvt) Ltd., Plot No. 5, St No. S-5,
Brand Name + Dosage Form + Strength DULEX Capsule 20 mg.
Duloxetine as Hcl (as Enteric Coated Pellets) ……20 mg
2019.
Pharmacological Group SUI (Stress Urinary Incontinence)
Pack size & Demanded Price 10’s,20’s,30’s, As per DPC
Approval status of product in Reference Cymbalta 30mg capsules by Lilly USA, LLC,
Regulatory Authorities (USFDA Approved)
Me-too status Dulact 30mg Capsule by Genome Pharmaceutical
years.
• Manufacturing method /outline of Tubes of
cream/ointment is provided instead of Capsules.
• Source of Pellets, COA, GMP of Source and Stability
study data of 3 batches of Pellets (In case of foreign
source of pellets, fee for source approval).
631. aName and address of manufacturer/ Goodman Laboratories (Pvt) Ltd., Plot No. 5, St No. S-5,
Brand Name + Dosage Form + Strength APRENT Capsule 40 mg.
Aprepitant…………………………….40 mg
2019.
Pharmacological Group Neurokinin 1 (NKI) receptors antagonist, antiemetic agent
Approval status of product in Reference TGA; Australia Approved
Me-too status Apreon 40mg Capsules of M/s Ferozesons Labs, 068201
years.
• Master formulation mentioned API Fenofibrate instead
of Aprepitant.
cream/ointment is provided instead of Capsule
632. aName and address of manufacturer/ Baxter Pharmaceuticals (Pvt.) Ltd., A-1/A Scheme 33,
Applicant Phase 1, S.I.T.E, Super Highway, Karachi.
Brand Name + Dosage Form + Strength NIPINE Capsule 5 mg
Nifedipine………………………….5 mg
2019.
Pharmacological Group Calcium Channel Blocker
Pack size & Demanded Price Not Provided
Approval status of product in Reference -
Me-too status -
years.
• In Covering letters, Form-5 Cover letter and Fee
Challan, Capsule dosage form is mentioned. Where as
in Form-5 annexure and master formulation, Tablet
dosage form is mentioned which needs
clarification/correction along with revised documents.
• Evidence of approval of applied formulation in
reference regulatory authorities/agencies which were
adopted by the Registration Board in its 275th meeting.
• Finished Product testing specification not provided.
• Evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm
• Pack size not provided.

• GMP certificate/inspection conducted within last 3 years is
• In Covering letters, Form-5 Cover letter and Fee Challan, Capsule dosage form is mentioned.
Where as in Form-5 annexure and master formulation, Tablet dosage form is mentioned
which needs clarification/correction along with revised documents.
along with registration number, brand name and name of firm
• DML renewal status from CLB is required.
• Section Approval letter form CLB is required.
Brand Name + Dosage Form + Strength NIPINE Capsule 20 mg
Nifedipine………………………….20 mg
2019.
Pharmacological Group Calcium Channel Blocker
Approval status of product in Reference -
Me-too status -
years.
• In Covering letters, Form-5 Cover letter and Fee
Challan, Capsule dosage form is mentioned. Where as
in Form-5 annexure and master formulation, Tablet
dosage form is mentioned which needs
clarification/correction along with revised documents.
registration number, brand name and name of firm
• GMP certificate/inspection conducted within last 3 years is
• In Covering letters, Form-5 Cover letter and Fee Challan, Capsule dosage form is mentioned.
Where as in Form-5 annexure and master formulation, Tablet dosage form is mentioned
which needs clarification/correction along with revised documents.
along with registration number, brand name and name of firm
• DML renewal status from CLB is required.
• Section Approval letter form CLB is required.
Brand Name + Dosage Form + Strength AMSARTAN Tablet 20/10 mg
Olmesartan Medoxomil……………...…….20 mg
Amlodipine………………………………...10 mg
2019.
Pharmacological Group Calcium Ion influx inhibitor, Antihypertensive.
Finished product Specification Not provided (USP)
Approval status of product in Reference Azor 20mg/10mg film coated tablet, Daiichi-Sankyo UK
Regulatory Authorities ltd. UK(USFDA)
Me-too status Olmedip 10mg/20mg tablet by Shrooq Pharmaceuticals,
Lahore.Reg. No. 068082.
years.
• Master formulation mentions film coating material,
whereas Form-5 label claim doses not mention film
coating dosage form. Which needs correction.
• Form-5 label claim mentioned Amlodipine 10 mg
where as master formulation mentioned Amlodipine
besylate 10 mg, which need correction.
• GMP certificate/inspection conducted within last 3 years.
• Master formulation mentions film coating material, whereas Form-5 label claim doses not
mention film coating dosage form. Which needs correction.
• Form-5 label claim mentioned Amlodipine 10 mg where as master formulation mentioned
Amlodipine besylate 10 mg, which need correction.
Brand Name + Dosage Form + Strength PINEX-V Tablet 10/160 mg
Amlodipine………………………………...10 mg
Valsartan……………………………………160 mg
2019.
Pharmacological Group Calcium Ion influx inhibitor, Angiotensin II receptor
blocker.
Approval status of product in Reference Exforge film-coated tablet 10/160. USFDA approved
Me-too status VALTAN -M 170 PLUS TABLET. Reg. No. 77207
years.
• Master formulation mentions film coating material,
whereas Form-5 label claim doses not mention film
coating dosage form. Which needs correction.
• Form-5 label claim mentioned Amlodipine 10 mg
where as master formulation mentioned Amlodipine
besylate 10 mg, which need correction.
• Master formulation mentions film coating material, whereas Form-5 label claim doses not
mention film coating dosage form. Which needs correction.
• Form-5 label claim mentioned Amlodipine 10 mg where as master formulation mentioned
Amlodipine besylate 10 mg, which need correction.
Brand Name + Dosage Form + Strength VASORIL Tablet 20 mg
Nicorandil……………………………….20 mg
2019.
Pharmacological Group Potassium Channel Activator
Finished product Specification Not provided (BP)
Approval status of product in Reference Ikorel MHRA Approved.
Me-too status 058054Ikodil 20mg Tablet of M/s OBS Pakistan (Pvt) Ltd,
years.
• Latest GMP inspection report conducted within last three years.
637. aName and address of manufacturer/ Getz Pharma (Pvt.) Ltd., 29-30, Sector-27, Korangi
Applicant Industrial Area, Karachi.
Brand Name + Dosage Form + Strength VORTIGET Tablet 5 mg
Composition Each Film Coated Tablet Contains;
Vortioxetine Hydrobromide eq. to Vortioxetine……5 mg
2019.
Finished product Specification Manufacturer Specification’s
Pack size & Demanded Price 14’s Rs: 1125 & 28s Rs:2250.
Approval status of product in Reference USFDA Approved
Me-too status
GMP status Last GMP certificate is issued on 24-02-2019 based on
inspection conducted on 07-01-2019 valid for 3 years.
Remarks of the Evaluator • Stability study data as per the guidelines approved in
293rd meeting of Registration Board.
• GMP certificate/inspection conducted within last 3
years.
Decision: Deferred for submission and evaluation of Stability study data as per the guidelines
approved in 293rd meeting of Registration Board on their turn .
Vortioxetine Hydrobromide eq. to Vortioxetine…10 mg
2019.
Me-too status
years.
2019.
Me-too status
years.
2019.
Pack size & Demanded Price 14’s Rs: 1500 & 28s Rs:3000
Me-too status
years.
641. aName and address of manufacturer/ PharmEVO (Pvt.) Ltd. A-29,North Industrial Zone,Port
Applicant Qasim,Karachi.
Brand Name + Dosage Form + Strength LESIRINOL Tablet 200/300 mg
Lesinurad……………...200 mg
Allopurinol……………300 mg
Diary No. Date of R & I & fee Dy. No. 12303 dated 06-03-2019; Rs.50,000/- dated 06-
03-2019.
Pharmacological Group Uric Acid reabsorption Inhibitor, Xanthine oxidase
Inhibitor.
Pack size & Demanded Price 7’s,10’s,14’s,20’s,28’s,30’s, As per DPC
Approval status of product in Reference USFDA discontinued.
Me-too status
GMP status Last GMP inspection was conducted on 23-02-2018
concluding acceptable level of GMP compliance.
years.
• The product status in USFDA is discontinued, provide
valid RRA reference for international availability.
Decision: deferred for following shortcomings:
• Submission of Stability study data as per the guidelines approved in 293rd meeting of
Registration Board.
• The product status in USFDA is discontinued, provide valid RRA reference .
642. aName and address of manufacturer/ PharmEVO (Pvt.) Ltd. A-29, North Industrial Zone, Port
Brand Name + Dosage Form + Strength LESIRINOL Tablet 200/200 mg
Lesinurad……………...200 mg
Allopurinol……………200 mg
03-2019.
Pharmacological Group Uric Acid reabsorption Inhibitor, Xanthine oxidase
Inhibitor.
Approval status of product in Reference USFDA discontinued
Me-too status
years.
• The product status in USFDA is discontinued, provide
valid RRA reference for international availability.
Registration Board.
• The product status in USFDA is discontinued, provide valid RRA reference .
Brand Name + Dosage Form + Strength DAPAMET XR 5/1000 mg
st
876
Dapagliflozin propanediol Monohydrate eq to
Dapagliflozin ………………………….….....5mg
Metformin HCl………………………………1000 mg
03-2019.
Pharmacological Group Reversible Competitive SGLT2 Inhibitor, Anti
Hyperglycemic
Approval status of product in Reference USFDA approved, XIGDUO XR , Extended release
Regulatory Authorities Tablet.
Me-too status -
years.
• Label Claim does not mention extended release dosage
form which needs clarification.
Registration Board.
• Label Claim does not mention extended release dosage form which needs clarification.
Brand Name + Dosage Form + Strength DAPAMET XR 10/1000 mg
Dapagliflozin propanediol Monohydrate eq to
Dapagliflozin ………………………….….....10mg
Metformin HCl………………………………1000 mg
03-2019.
Pharmacological Group Reversible Competitive SGLT2 Inhibitor, Anti
Hyperglycemic
Approval status of product in Reference USFDA approved, XIGDUO XR , Extended release
Regulatory Authorities Tablet.
Me-too status
years.
• Label Claim does not mention extended release dosage
form which needs clarification.
Registration Board.
• Label Claim does not mention extended release dosage form which needs clarification.
645. aName and address of manufacturer/ Reign Pharmaceuticals PCSIR-KLC (Pvt) Ltd.TBIC
Brand Name + Dosage Form + Strength DELAS Capsule 30 mg
Dexlansoprazole (Enteric Coated pellets) ………30 mg
2019.
Approval status of product in Reference Approved in US-FDA, Dexilant Capsule
manufacturing out line. along with master
• Complete finished formulation, outline of
product testing manufacturing Method and
specification. GMP certificate.
per guidelines provided
in 293rd meeting of
required.
GMP, COA and
stability study of
pellets
• Pack size.
meeting of Registration Board is required along with source of pellets (Source approval Fee in
case of foreign source of pellets )
Brand Name + Dosage Form + Strength C-THROCIN Tablet 500 mg
Clarithromycin……………….500 mg
2019.
Me-too status Clarital 500mg tablet of M/s Arsons Pharma, Lahore
085500
• Form-5 not signed by along with, master
firm management. formulation, outline of
• Complete manufacturing Method and
manufacturing out line. GMP certificate.
• Complete finished
product testing
specifications.
Decision:Approved with USP specifications. The firm shall submit preregistration variation fee
Brand Name + Dosage Form + Strength APRANT Capsule (Combo Pack)
Composition Each Combo Pack Contains:
2 Capsule of Aprepitant
Aprepitant ……………80mg
1 Capsule of Aprepitant
Aprepitant……………125mg
2019.
Pack size & Demanded Price Combo Pack ( Aprepitant 80 mg ,2 Cap & Aprepitant 125
mg ,1 Cap), As per DPC
Approval status of product in Reference USFDA Approved.
Regulatory Authorities EMEND® 125 mg hard capsules, EMEND® 80 mg hard
capsules. Aluminium blister containing one 125mg
capsule and two 80mg capsules
Me-too status Apreon Combo Pack Capsules of M/S Ferozesons Labs,.
Reg. No. 068204
manufacturing out line GMP certificate.
mentioning combo
pack manufacturing
and packaging method.
product testing
specifications.
Decision:Deferred for confirmation of required manufacturing facility/equipment for Combo
Packaging.
Brand Name + Dosage Form + Strength LINZO Suspension (Dry Powder)
Composition Each 5 ml Contain: (After reconstitution)
Linezolid……………………………….100 mg
2019.
Approval status of product in Reference ZYVOX (100mg/5ml) for oral suspension USFDA
Me-too status Nezo 100mg/5ml Dry Suspension by M/s Rotex Pharma
(Reg#097440)
• Manufacturing method manufacturing Method and
of liquid syrup GMP certificate.
provided where as label
claim is granular
powder for suspension.
Provide revised
manufacturing out line.
product testing
specifications.
Brand Name + Dosage Form + Strength ORLIT Capsule
Orlistat IR Pellets 50% Eq .to Orlistat……………120 mg
(Source of pellets: M/s Vision Pharmaceuticals,
Islamabad.)
2019.
Pharmacological Group Not mentioned.
Approval status of product in Reference Approved by MHRA of UK
Me-too status Orlovit capsules by M/s CCL Pharma (Reg.#046324)
• Form-5 not signed by along with master
• Manufacturing method manufacturing Method and
of powder Capsule is GMP certificate.
provided where as label
claim is capsule
containing pellets.
• Provide revised
manufacturing out line.
product testing
specifications. (usp)
• COA of pellets,
Stability Study of
pellets, GMP of Source
of pellets.
Brand Name + Dosage Form + Strength CLOMI Tablet 50 mg
Clomiphene Citrate ………………….50 mg
2019.
Pharmacological Group Anti-Oestrogen
Approval status of product in Reference Clomid 50mg Tablets MHRA Approved as uncoated
Regulatory Authorities tablet.
Me-too status Clomidex Tablets 50mg by CSH Pharmaceuticals-North
(Reg#078433)
Manufacturing outline. GMP certificate.
product testing
specifications. (USP)
Decision: Registration Board approved registration of product with USP specification ,in
general manufacturing areas with condition that manufacturer shall provide safety and
protective measures for workers and personnel which remain in direct contact or are involved
in close handling of these drugs.
The firm shall submit preregistration variation fee of 7500/= as per SRO. No. F.7-11/2012-
Brand Name + Dosage Form + Strength FEBSTAT Tablet 80 mg
Febuxostat ………………….80 mg
2019.
Pharmacological Group Antigout preparation
Approval status of product in Reference ULORIC (40mg, 80mg) film coated tablets USFDA
Me-too status Febuxin 80mg tablet by AGP Ltd (Reg. 081105)
product testing
specifications.
(Innovator)
Decision: Approved with innovator specifications. The firm shall submit preregistration
Brand Name + Dosage Form + Strength ACTIN Capsule 10 mg
Acitretin ………………….10 mg
2019.
Pharmacological Group Antipsoriatics
Finished product Specification Not provided/USP
Approval status of product in Reference NEOTIGASON acitretin 10mg capsule by M/s Teva
Regulatory Authorities Pharma Australia Pty Ltd (TGA Approved)
Me-too status Acetin Capsules 10mg by M/s Genome Pharmaceuticals
(Reg#064012)
product testing
specifications. (USP)
Decision: Approved with USP specifications. The firm shall submit preregistration variation fee
Brand Name + Dosage Form + Strength ONDRON Syrup
Ondansetron (as Hcl) ……………………….4mg
2019.
Pharmacological Group Selective 5-HT3 Receptor Antagonist (Antiemetic)
Approval status of product in Reference Zofran solution 4mg/5ml, USFDA Approved,
Me-too status Dantron Syrup of M/s Sharooq Pharma Reg No. 077076
• Complete finished manufacturing Method and
product testing GMP certificate.
specifications.
(Innovator)
Brand Name + Dosage Form + Strength MOXAFOS Capsule 500 mg
Fosfomycin Calcium eq to Fosfomycin…………500 mg
2019.
Pharmacological Group Anti-Bacterial
Approval status of product in Reference Calcium Fosfomycin Solufos 500 mg hard capsules.
Regulatory Authorities CIMA approved
Me-too status Cynfo 500mg Capsule. Reg. No. 73702
Sachet (G).
product testing
specifications.
Brand Name + Dosage Form + Strength MOXAFOS Sachet
Fosfomycin Trometamol eq to Fosfomycin………...3 gm
2019.
Pharmacological Group Anti-Bacterial
Approval status of product in Reference Berny 3g granules for oral solution MHRA approved
Me-too status Monufos 3g Oral Sachet by M/s Rotex Pharma
(Reg#097453)
Sachet (G).
product testing
specifications.
(innovator)
Brand Name + Dosage Form + Strength VOMGYNE Tablet
Composition Each Enteric Coated Delayed Release Tablet Contains:
Doxylamine Succinate………………10 mg
Pyridoxine HCl…………………………...10 mg
2019.
Pharmacological Group Antihistamine, Vitamin B6
Approval status of product in Reference Doxylamine Succinate And Pyridoxine Hydrochloride
Regulatory Authorities (10/10) | ANDA #205811 | Tablet, Delayed Release;Oral
| Prescription | Actavis Labs Fl Inc. Approved in USFDA
Me-too status Femiroz Tablet by M/s Efroze (Reg#061026)
Manufacturing outline GMP certificate.
for dual release enteric
coated tablet.
product testing
specifications.
(innovator)
Brand Name + Dosage Form + Strength ERDINE Sachet 225 mg
Erdosteine……………………………………225 mg
2019.
Pharmacological Group AntiFungal
Finished product Specification Not provided/Innovator
Approval status of product in Reference AIFA Italy, ESTECLIN Sachet,
Me-too status Mucolec 225 mg Sachet of M/s Wnsfeild Pharmaceutical,
Industrial Estate, Hattar 078593
Capsule (G), Dry Powder Suspension (G), Liquid ( G ) ,
and Sachet ( G) .
manufacturing Method and
GMP certificate.
product testing
specifications.
• Pack size
Brand Name + Dosage Form + Strength LEXATIVE Sachet
Macrogol 3350……………………….………..13.125 g
Sodium Chloride…………………………….…0.3507 g
Sodium Bicarbonate……………………………0.1785 g
Potassium Chloride………………………….…0.0466 g
2019.
Pharmacological Group Antacid
Approval status of product in Reference Movicol 13.8g sachet, powder for oral solution.
Regulatory Authorities Approved by MHRA
Me-too status Forlax Sachet. Reg. No. 82099
product testing
specifications.
(innovator)
• Pack/sachet contents
net weight is not
mentioned in label
claim.
Brand Name + Dosage Form + Strength RENISCON PLUS Syrup
Sodium Alginate…………………………..…1000 mg
Potassium Hydrogen Carbonate………………200 mg
2019.
Pharmacological Group Antacid
Approval status of product in Reference Gaviscon Advance Oral suspension 1000mg/200mg per
Regulatory Authorities 10ml by M/s Reckitt Benckiser Healthcare (UK) Ltd,
MHRA Approved
Me-too status Gesecon Advance 1000/200 syrup by M/s Winthrox
Karachi, Reg. No. 74951
st
885
product testing
specifications.
(Innovator Spec)
660. Name and address of manufacturer/ Pulse Pharmaceuticals (Pvt) Ltd, Mozay Baddoki Raiwind
Applicant Road (Sua Aasil Road) Lahore.
Brand Name + Dosage Form + Strength BACKALEN Capsule 100 mg
Pregabalin……………………………….100 mg
2019.
Pharmacological Group Anticonvulsant /GABA analogue
Type of Form Form-5
Approval status of product in Reference Lyrica capsule 100mg by M/s Pfizer, USFDA Approved.
Me-too status Zeegap Capsule 100mg by M/s Hilton Pharma,047360
GMP status Firm was granted GMP certificate dated 14-12-2021on the
basis of GMP inspection conducted on 11-06-2021 for
Tablet (General) & (Psychotropic), Capsule (General)
&(Cephalosporin), Oral Dry Powder Suspension (Ceph),
Dry Powder Injection (Ceph), Liquid Injection Ampoule
(General) & Liquid Ampoule (General)
2019.
Type of Form Form-5
Approval status of product in Reference LYRICA (25mg, 50mg, 75mg, 100mg, 150mg, 200mg,
Regulatory Authorities 225mg,300mg) Capsules, USFDA Approved
Me-too status Gabica 300mg Capsules, Getz Pharma, Reg. No. 047368.
2019.
Type of Form Form-5
Me-too status Gabica 150mg Capsules by M/s Getz Pharma
(Reg#48724)
2019.
Type of Form Form-5
Me-too status Zeegap Capsule 75mg by M/s Hilton Pharma, Reg. No.
047359
Brand Name + Dosage Form + Strength PECOLEP Tablet 100 mg
Lacosamide …………………………………100 mg
2019.
Pharmacological Group Antiepileptic/ Sodium Channel Inactivator
Type of Form Form-5
Approval status of product in Reference MHRA Approved film coated 100 mg tablet, Torrent
Regulatory Authorities Pharma,UK.
Me-too status Lacogit-100 100mg Tablets, Reg # 083580, Glitz Pharma,
Islamabad.
2019.
Type of Form Form-5
Regulatory Authorities tablet USFDA approved.
Me-too status Atcomid 150mg Tablet M/s Atco Lab
2019.
Type of Form Form-5
Approval status of product in Reference Lacosamide Aspire 50 mg film-coated tablets by Aspire
Regulatory Authorities Pharma Limited. MHRA Approved.
Me-too status Lalap 50mg tablet. Reg. No. 70470
2019.
Type of Form Form-5
Regulatory Authorities tablet USFDA approved.
Me-too status Lacolit 200mg Tablet by M/s The Searle Company
Limited,(Reg#077125)
668. Name and address of manufacturer/ Pharmasol (Pvt) Ltd. Plot No.549, Sundar Industrial
Brand Name + Dosage Form + Strength DABROXOL Capsule 50 mg
Dabrafenib……………………………….50 mg
2019.
Pharmacological Group Inhibitor of BRAF Kinases
Type of Form Form-5
Finished product Specification innovator Specifications
Pack size & Demanded Price 28’s,120’s
Approval status of product in Reference Tafinlar capsule (50mg & 75mg) by M/s Novartis,
Regulatory Authorities USFDA Approved.
Me-too status Not Confirmed.
GMP status The Last GMP inspection was conducted on 08-07-
2019 & 25-07-2019 with following recommendations:
“The firm M/s Pharmasol Pvt Ltd was evaluated for
facilities like building, flow, HVAC, Water treatment,
personnel, and Quality Control/QA and production
operations.
Keeping in view the observations made on the day of
inspection and after going through the documentation and
overall assessment, the panel is of the opinion that the firm
M/s Pharmasol Lahore was operating at satisfactory level
of GMP compliance”.
Remarks of the Evaluator • The reference product Firm has submitted reply
contains Dabrafenib with fee challan No
(as mesylate) ……… 18869751112 dated 21-07-
50mg. 2022 of 7500/= along with
• Evidence of applied revised Form -5 mention
formulation/drug revised label claim as under:
already approved by Each capsule Contains:
DRAP (generic / me-
too status) along with Dabrafenib as
registration number, mesylate………50 mg
brand name and name (Pharmasol Spec.)
of firm.
Decision: Deferred for
• Submission of evidence of applied formulation/drug already approved by DRAP (generic / me-
too status) along with registration number, brand name and name of firm.
• Deferred for submission of stability study data as per the guidelines approved in 293rd meeting
of Registration Board
Brand Name + Dosage Form + Strength DABROXOL Capsule 75 mg
Dabrafenib………………….75 mg
2019.
Pharmacological Group Inhibitor of BRAF Kinases
Type of Form Form-5
Pack size & Demanded Price 28’s,120’s
Approval status of product in Reference Tafinlar capsule (50mg & 75mg) by M/s Novartis,
Regulatory Authorities USFDA Approved.
Me-too status Not Confirmed.
GMP status The Last GMP inspection was conducted on 08-07-2019
& 25-07-2019 with following recommendations:
operations.
Remarks of the Evaluator • The reference product Firm has submitted reply
contains Dabrafenib (as with fee challan No
mesylate) ……… 75 mg. .90660622 dated 21-07-2022
• Evidence of applied along with revised Form -5
formulation/drug already mention revised label claim
approved by DRAP as under:
(generic / me-too status) Each capsule Contains:
along with registration Dabrafenib as
number, brand name and mesylate………75 mg
name of firm (Pharmasol Specs.).
Decision: Deferred for

• Submission of evidence of applied formulation/drug already approved by DRAP (generic / me-
too status) along with registration number, brand name and name of firm.
• Deferred for submission of stability study data as per the guidelines approved in 293rd meeting
of Registration Board.
Brand Name + Dosage Form + Strength ZIPSOL Capsule 20 mg
Ziprasidone (As Hydrochloride Monohydrate) …….20mg
2019.
Pharmacological Group Dopamine D2 and Serotonin 5HT2 antagonist
Type of Form Form-5
Pack size & Demanded Price 10’s,14’s,20’s,28’s,30’s
Approval status of product in Reference Geodon capsule (20mg, 40mg, 60mg, 80mg) by M/s
Regulatory Authorities Pfizer, USFDA Approved.
Me-too status Xavidone 20mg Capsule, 103335, Genetics
Pharmaceuticals (Pvt) Ltd,Lahore
operations.
Remarks of the Evaluator Firm has submitted copy of GMP certificate upon
Decision: Approved.
Brand Name + Dosage Form + Strength ZIPSOL Capsule 40 mg
Ziprasidone (As Hydrochloride Monohydrate) …….40mg
2019.
Pharmacological Group Dopamine D2 and Serotanin 5HT2 antagonist
Type of Form Form-5
Approval status of product in Reference Geodon capsule (20mg, 40mg, 60mg, 80mg) by M/s
Regulatory Authorities Pfizer, USFDA Approved.
Me-too status Xavidone 40mg Capsule, 103336, Genetics
Pharmaceuticals (Pvt) Ltd,Pakistan
operations.
Decision: Approved.
Brand Name + Dosage Form + Strength BISCORD-H Tablet 5 /6.25 mg
Bisoprolol Fumarate …………………………….5 mg
Hydrochlorothiazide……………………………6.25 mg
2019.
Type of Form Form-5
Approval status of product in Reference Ziac Tablets by Teva Pharms
Me-too status Actim-H by Sami
operations.
Decision: Approved.
Brand Name + Dosage Form + Strength BISCORD-H Tablet 2.5 /6.25 mg
Bisoprolol Fumarate …………………………….2.5 mg
2019.
Type of Form Form-5
Me-too status Lodoz Tablets Each Film Coated Tablet Contains: -
Bisoprolol Fumarate………2.5mg
Hydrochlorothiazide…….6.25mg
Reg # 025583, Merck Pvt Ltd., 7, Jail Road, Quetta.
operations.
Decision: Approved.
Brand Name + Dosage Form + Strength BISCORD-H Tablet 10 /12.5 mg
Bisoprolol Fumarate …………………………...10 mg
2019.
Type of Form Form-5
Pack size & Demanded Price 10’s,14,20’s,28’s,30’s
Me-too status Actim-H by Sami
operations.
Decision: Approved.
Brand Name + Dosage Form + Strength ROXONIB Tablet 15 mg
Ruxolitinib as Phosphate………………15 mg
2019.
Pharmacological Group Selective Inhibitor of the Janus Associated Kinases
(JAKs)
Type of Form Form-5
Finished product Specification Innovator specifcations
Pack size & Demanded Price 10’s,20’s,56’s,60’s.
Approval status of product in Reference Jakavi® 15 mg tablets, MHRA approved.
Me-too status Ruxonib 15mg Tablet, 101690, Rotex Pharma (Pvt)
Ltd.,Pakistan
operations.
Decision: Approved
Brand Name + Dosage Form + Strength ROXONIB Tablet 5 mg
Ruxolitinib as Phosphate………………5 mg
2019.
Pharmacological Group Selective Inhibitor of the Janus Associated Kinases
(JAKs)
Type of Form Form-5
Finished product Specification innovator specification
Pack size & Demanded Price 10’s,20’s,56’s,60’s.
Approval status of product in Reference Jakavi® 5 mg tablets, MHRA approved
Me-too status Ruxonib 5mg Tablet, 101689, Rotex Pharma (Pvt)
Ltd.Islamabad.
operations.
Decision: Approved
Brand Name + Dosage Form + Strength ELTROM Tablet 50 mg
Eltrombopag as Olamine………………50mg
2019.
Pharmacological Group TPO-receptor Agonist
Type of Form Form-5
Pack size & Demanded Price 25’s
Approval status of product in Reference Revolade® 50 mg film-coated tablets, MHRA approved
Me-too status Revolade Tablet 50mg, 084159, Novartis Pharma (Pak)
Ltd.,Karachi
operations.
Decision: Approved
Brand Name + Dosage Form + Strength ELTROM Tablet 25 mg
Eltrombopag as Olamine………………25mg
2019.
Pharmacological Group TPO-receptor Agonist
Type of Form Form-5
Approval status of product in Reference Revolade® 25 mg film-coated tablets, MHRA approved
Me-too status Revolade Tablet 25mg, 084158, Novartis Pharma (Pak)
Ltd., Karachi.
operations.
Decision: Approved
Brand Name + Dosage Form + Strength CYTOCARB Injection 500mg/5ml
Composition Each 5 ml Vial Contains:
Cytarabine……………………….500 mg
2019.
Pharmacological Group Antineoplastic
Type of Form Form-5
Finished product Specification BP specification
Approval status of product in Reference ANSM approved.
Me-too status Cytu 500mg/5ml Solution for injection, 099018, Punjab
Medical Services, Lahore (Importer)
operations.
Remarks of the Evaluator Undertaking /commitment as approved in 245th meeting of
DRB.
Decision: Approved.
Brand Name + Dosage Form + Strength CYTOCARB Injection 1gm/10ml
Cytarabine……………………….1000 mg
2019.
Pharmacological Group Antineoplastic
Type of Form Form-5
Approval status of product in Reference CYTARABINE ACCORD 100 mg / ml, solution for
Regulatory Authorities injection or infusion of HEALTHCARE FRANCE SAS
AGREEMENT,45 RUE DU FAUBOURG DE
ROUBAIX 59000 LILLE(ANSM approved)
Me-too status Cytabine Injection., 072596, Each 10ml vial contains
Cytarabine: 1000mg, AJM Pharma (Pvt) Ltd., Plot No. 44
Sector 27 Korangi Industrial Area Karachi., Karachi

operations.
Decision: Approved.
Brand Name + Dosage Form + Strength LEUKORIN Injection 15mg/2ml
Composition Each 2ml ampoule Contains:
Folinic Acid as Calcium Folinate…………………15 mg
2019.
Pharmacological Group Detoxifying agent for Antineoplastic Treatment
Type of Form Form-5
Finished product Specification USP specification (B.P)
Pack size & Demanded Price 1’s,10’s, As per SRO
Approval status of product in Reference MHRA approved (15mg/2ml Injection)
Me-too status Calco 15mg/2ml Injection, 097796, Rotex Pharma (Pvt)
Ltd., Islamabad
operations.
Remarks of the Evaluator • Copy of claimed • Firm has submitted copy
official finished of USP monograph for
product specification, Leucovorin Calcium
i-e USP. Injection.
Brand Name + Dosage Form + Strength LEUKORIN Injection 50mg/5ml
Composition Each 5ml ampoule Contains:
Folinic Acid as Calcium Folinate…………………50 mg
2019.
Pharmacological Group Detoxifying agent for Antineoplastic Treatment, Vitamin
Type of Form Form-5
Finished product Specification USP specification (B.P)
Approval status of product in Reference MHRA approved, 50 mg/5 ml (10 mg/ml) Injection.
Me-too status Calco 50mg/5ml Injection, 097797, Rotex Pharma (Pvt)
Ltd., Islamabad.
operations.
Remarks of the Evaluator Copy of claimed official Firm has submitted copy of
finished product USP monograph for
specification, i-e USP. Leucovorin Calcium
Injection.
Decision: Approved
Brand Name + Dosage Form + Strength OXALISOL Injection 100mg/20ml
Composition Each 20 ml Vials Contains:
Oxaliplatin…………………….…100 mg
2019.
Pharmacological Group Selective inhibitor of DNA synthesis
Type of Form Form-5
Approval status of product in Reference MHRA approved as concentrate for solution for Infusion.
Regulatory Authorities 50 mg/10 ml (5mg/ml) and 100 mg/20 ml
Me-too status Oxaliplatin “Ebewe” 100mg /20ml – Concentrate For
Solution For Infusion. 081776, Novartis Pharma (Pak)
Ltd. Karachi
operations.
Remarks of the Evaluator • Master Formulation • Firm has submitted reply
mentioned “Lactose with challan fee
Mono hydrate as No.60945157521 dated
Lyophilization Aid. 21-07-2022 of 7500/=
“whereas per label along with revised master
claim the product is formulation as liquid
Liquid Injection which Injection .
needs clarification and
revision of
formulation.
Decision: Approved
Brand Name + Dosage Form + Strength OXALISOL Injection 50mg/10ml
Composition Each 10 ml Vials Contains:
Oxaliplatin…………………….…50 mg
2019.
Pharmacological Group Selective inhibitor of DNA synthesis
Type of Form Form-5
Approval status of product in Reference MHRA approved as concentrate for solution for Infusion.
Regulatory Authorities 50 mg/10 ml ( 5mg/ml) and 100 mg/20 ml
Me-too status ELOXATIN 50mg per vial injection by M/S SANOFI
AVENTIS PAKISTAN LIMITED
operations.
Remarks of the Evaluator • Master Formulation • Firm has submitted reply
mentioned “Lactose with challan fee
Mono hydrate as No.399578222 dated 21-
Lyophilization Aid”. 07-2022 of 7500/= along
Whereas per label with revised master
claim the product is formulation as liquid
Liquid Injection which Injection .
needs clarification and
revision of
formulation.
Decision: Approved.
Brand Name + Dosage Form + Strength GLYNIB Tablet 400 mg
Imatinib as Mesylate…………………….400 mg
2019.
Pharmacological Group Tyrosine Kinase Inhibitor
Type of Form Form-5
Pack size & Demanded Price 30’,90’s, As per SRO
Approval status of product in Reference MHRA. Glivec 100mg & 400mf f/c tablet by M/s
Regulatory Authorities Novartis.
Me-too status 087793, IM-Tab Tablet 400mg ,M/s Werrick
Pharmaceuticals, Islamabad.
operations.
Decision: Approved
Brand Name + Dosage Form + Strength TRAMAX-SR Tablet 100 mg
zafirlukast…………………….10 mg
2019.
Pharmacological Group Selective and competitive receptor antagonist of
Leukotriene D4 and E4.
Type of Form Form-5
Pack size & Demanded Price 10’s,14’s,20’s,28’s,30’ As per SRO
Approval status of product in Reference ACCOLATE of (USFDA approved)
Me-too status Zilesta 10mg Tablet of M/s Genix Pharma
operations.
Decision: Approved
Brand Name + Dosage Form + Strength CERTIVIN Capsule 150mg
Ceritinib………………………….150 mg
2019.
Pharmacological Group Selective Inhibitor of anaplastic lymphoma kinase
Type of Form Form-5
Finished product Specification innovator specification
Approval status of product in Reference Cap ZYKADIA 150 mg USFDA discontinued.
Me-too status Zykadia 150Mg Hard Gelatin Capsules, 088399, Novartis
Pharma (Pak) Ltd.,Karachi
operations.
Remarks of the Evaluator • Provided RRA • Firm has submitted reply
reference of USFDA of and RRA reference of TGA
Cap ZYKADIA is approved product, Capsule
discontinued. Provide Zykadia 150 mg
valid RRA registration ,Sponsor:Novartis
status. Pharmaceuticals Australia
Pty Limited, Australia.
Decision: Approved
Brand Name + Dosage Form + Strength SOLAP Injection 200 mg/20 ml
2019.
Type of Form Form-5
Approval status of product in Reference Approved in USFDA
Me-too status Lacolep 10mg/ml Injection (20ml) of Hilton Pharma
operations.
Remarks of the Evaluator Innovator Specs
Decision: Approved with innovator specifications.
Brand Name + Dosage Form + Strength GRANISOL Injection 3mg/3 ml
Composition Each 3ml ampoule contains:
Granisetron Hydrochloride eq, to Granisetron…….3 mg
2019.
Type of Form Form-5
Approval status of product in Reference Granisetron 1 mg/ml concentrate for solution for
Regulatory Authorities injection or
infusion (3ML AMPOULE) by M/s Hameln Pharma
gmbh, MHRA Approved.
Me-too status Granicip injection (3mg/3ml) by M/s AJ Mirza pharma
(pvt) ltd., Reg. No. 52261
operations.
Decision: Approved.
Brand Name + Dosage Form + Strength IROTICAN Injection 100mg/5 ml
Irinotecan Hydrochloride as Trihydrate ……100 mg
2019.
Pharmacological Group Topoisomerase I inhibitor
Type of Form Form-5
Approval status of product in Reference Campto Injection 100mg/5ml of M/s Pfizer (Reg #
Regulatory Authorities 021128)
Irinotecan Injection 100mg/5ml of M/s Novartis (Reg#
066187)
Me-too status Pipetecan 100mg/5ml Injection, 092306, Rotex Pharma
(Pvt) Ltd.,Islamabad
operations.
Decision: Approved.
Brand Name + Dosage Form + Strength VINOBIN Injection 50mg/5 ml
Vinorelbine as tartrate………...……50 mg
2019.
Pharmacological Group Semi synthetic Vinca-Alkaloid/ antitumor activity
Type of Form Form-5
Pack size & Demanded Price 1’s,As per SRO
Approval status of product in Reference MHRA approved, Vinorelbine (as Tartrate) 50mgl5ml
Regulatory Authorities sterile concentrate.
Me-too status Vinorelbine Karma 10mg/ml (50mg/5ml)concentrate for
Solution for Injection, 101954, Lab Diagnostic System
(Pvt) Ltd,Rawalpindi.
operations.
Decision: Approved.
Brand Name + Dosage Form + Strength SOQUIN Cream 2% w/w
Composition Each gram of cream contains:
Hydroquinone……………………20 mg
2019.
Pharmacological Group Depigmentation agent
Type of Form Form-5
Pack size & Demanded Price 5 gm,10gm,15gm, 20 gm, As per SRO
Approval status of product in Reference Symba Skin Toner Cream by M Sarner (1969) Limited.
Regulatory Authorities MHRA approved
Me-too status Dermoquin 2% Cream by Wilson Pharma (Reg No.
007581)
operations.
Decision: Approved.
Brand Name + Dosage Form + Strength TAZOMIL GEL 0.05% w/w
Composition Each gram of gel contains:
Tazarotene……………………0.5 mg
2019.
Pharmacological Group Anti-psoriasis
Type of Form Form-5
Pack size & Demanded Price 5 gm,10gm,15gm, As per SRO
Approval status of product in Reference ZORAC 0.05%, gel by M/s Allergan Pharmaceuticals
Regulatory Authorities Ireland (MHRA Approved)
Me-too status Trazene 0.05% Gel by M/s PharmEvo (Pvt.) Ltd.
(Reg#057748)
operations.
Decision: Approved
694. Name and address of manufacturer/ Sharex Laboratories (Pvt)Ltd., K.L.P Road, Sadiqabad.
Applicant
Brand Name + Dosage Form + Strength Sterile Water of Injection (IM/IV)
Water for Injection……………2 ml/3ml/5ml/10ml
Diary No. Date of R & I & fee Dy. No 3333 (R&I) dated 21-12-2016; Rs.20,000/- dated
dated 05-04-2022.
Pharmacological Group Solvent
Type of Form Form-5
Finished product Specification Manufacturer Specifications.
Pack size & Demanded Price 2 ml.3.50/,3ml.4.50/,5ml.5.10/,10ml.10.70/.
Approval status of product in Reference Sterile water for injection, USFDA approved.
Me-too status Sterile water for injection: 5ml, Aquason Injection,
083140, Hudson Pharma (Pvt) Ltd., D-93 Port Qasim
Authority Karachi, Karachi.
GMP status As per available record, last GMP inspection was
conducted on 29-03-2017 which concluded as, “the
operations of manufacturing and QC were found
satisfactory to GMP compliance on the day of inspection.”
Remarks of the Evaluator • GMP • Firm has submitted reply
certificate/inspection and choose 5 ml ampoule of
conducted with last 3 sterile water for injection
years is required. along with revised finished
• Firm has applied 4 fill product specification as
volumes of ampoules of USP specs. Firm has also
2ml,3ml,5ml & 10 ml in submitted DML renewal
same application. Only inspection conducted on 13-
one application can be 04-2021 &14-04-2021, in
applied per application. which panel had
• The official monograph recommended DML
is present in B.P and renewal.
USP. • Firm has submitted fee
• The duplicate application preregistration variation fee
(form 5) is forwarded by challan No. 38696578627 of
Reg II vide letter No.F.1- 7500/=
11/2019-Reg-II dated 29-
06-2022 with Dairy No.
1513 (R-V) & dated 22-
12-2016 of Registration
Section II, where they
have mentioned that
above application is
verified from Dairy
record of R-II section for
further processing.
(photocopy of section
dairy page of the register
is also enclosed.)
Decision: Approved with USP specification (5 ml ampoule.)
695. Name and address of manufacturer/ Sharex Laboratories (Pvt)Ltd., K.L.P Road, Sadiqabad.
Applicant
Brand Name + Dosage Form + Strength Lignocaine Injection 1 %
Composition Each ml of Ampoule Contains:
Lignocaine Hydrochloride……………….10 mg
Diary No. Date of R & I & fee Dy. No 3334 (R&I) dated 21-12-2016; Rs.20,000/- dated
dated 05-04-2022.
Pharmacological Group Solvent
Type of Form Form-5
Finished product Specification Manufacturer Specifications.
Pack size & Demanded Price 2 ml. Rs 5/, 5 ml. Rs 12.50/=
Approval status of product in Reference MHRA approved, Injection Lidocaine Hcl 1 % w/v.
Me-too status Lignocaine 1% Injection, 074295, Wilshire Laboratories
(Pvt) Ltd., Lahore.
GMP status As per available record, last GMP inspection was
conducted on 29-03-2017 which concluded as, “the
operations of manufacturing and QC were found
satisfactory to GMP compliance on the day of inspection.”
Remarks of the Evaluator • GMP • Firm has submitted reply
certificate/inspection and choose 2 ml ampoule of
conducted with last 3 Lignocaine injection 1%
years is required. along with revised finished
• Firm has applied 2 fill product specification as
volumes of ampoules of USP specs. Firm has also
2ml & ,5ml in same submitted DML renewal
application.one fill inspection conducted on 13-
volume can be applied 04-2021 &14-04-2021, in
per application. which panel had
• The official monograph recommended DML
is present in B.P s renewal.
•
• The duplicate application Firm has submitted fee
(form 5) is forwarded by preregistration variation fee
Reg II vide letter No.F.1- challan No. 33730632 of
11/2019-Reg-II dated 29- 7500/=
06-2022 with Dairy No.
1514 (R-V) & dated 22-
12-2016 of Registration
Section II, where they
have mentioned that
above application is
verified from Dairy
record of R-II section for
further processing.
(photocopy of section
dairy page of the register
is also enclosed.)
Decision: Approved with USP specification ( 2 ml ampoule)
Applicant Karachi.
Brand Name + Dosage Form + Strength TEGLIP Tablet 20 mg
Teneligliptin Hydrobromide Hydrate eq. to
Teneligliptin………………………………………20 mg
2019.
Pack size & Demanded Price 7’s,14’s,28’s,10’s,20’s &30’s, As per SRO.
Approval status of product in Reference Tablet Tenelia, Mitsubishi Tanabe Pharma, PMDA
Regulatory Authorities Japan.
Remarks of the Evaluator • Evidence of applied • Form submitted reply and
formulation/drug submitted me-too reference
already approved by as tablet Tenliptin,Reg #
DRAP (generic / me-too 105239,Indus Pharma , the
status) along with same is not verifiable from
registration number, available record.
brand name and name of • Firm has submitted scan
firm. copy of Form-5 annexure
• Stability study data as on prescribed format.
per guidelines provided
in 293rd meeting of
required.
• Form-5 Annexure as per
prescribed format of
Drug (L, R&A) rules
1976.
Decision: Deferred for following

• Stability study data as per guidelines provided in 293rd meeting of Registration Board is
required.
Applicant Karachi.
Brand Name + Dosage Form + Strength LORCAS Tablet 10 mg
Lorcaserin Hcl Hemihydrate eq.to Lorcaserin……10 mg
2019.
Pharmacological Group AntiObesity
Pack size & Demanded Price 10’s,20’s,30’s,50, s,100’s As per SRO.
Approval status of product in Reference USFDA Tentative approved.
• Form-5 Annexure as per prescribed format of Drug (L,
R&A) rules 1976.

required.
• Form-5 Annexure as per prescribed format of Drug (L, R&A) rules 1976
Applicant Karachi.
Brand Name + Dosage Form + Strength ASINAP Tablet 10 mg
Composition Each Sublingual Tablet Contains:
Asenapine Maleate eq.to Asenapine……….……10 mg
2019.
Approval status of product in Reference MHRA approved, Tablet Sycrest 10 mg,
R&A) rules 1976.

required.
Applicant Karachi.
Brand Name + Dosage Form + Strength PRULOP Tablet 1mg
Prucalopride succinate eq to Prucalopride…………..1mg
2019.
Pharmacological Group 5-HT4 receptor agonist, Gut motility enhancer.
Pack size & Demanded Price 10’s,20’s,30’s. As per SRO.
Approval status of product in Reference MHRA approved, Tablet Resolor 1 mg
R&A) rules 1976.

required.
Applicant Karachi.
Brand Name + Dosage Form + Strength BRIXAB Capsule 40 mg
Betrixaban Maleate eq.to Betrixaban……………...40 mg
2019.
Pharmacological Group Factor Xa Inhibitor
Approval status of product in Reference USFDA marketing status discontinued. Cap BEVYXXA
Regulatory Authorities 40 mg.
R&A) rules 1976.
required.
Applicant Karachi.
Brand Name + Dosage Form + Strength PENTOSAL Capsule 100 mg
Pentosan Polysulfate Sodium……………...100 mg
2019.
Pharmacological Group Vasoprotective
Approval status of product in Reference Cap ELMIRON 100 mg, USFDA approved.
R&A) rules 1976.
required.
Applicant Karachi.
Brand Name + Dosage Form + Strength LEVUNIC Gel
Composition Each One Gram Gel Contains:
5-Aminolaevulinic Acid (as Hydrochloride) ……...78 mg
2019.
Pharmacological Group Antineoplastic agent, L01XD04
Pack size & Demanded Price 2 gm, As per SRO.
Approval status of product in Reference Not traceable
• Anticancer gel section approval from CLB.
• Finished product specification
R&A) rules 1976.
required.
• Anticancer gel section approval from CLB.
• Finished product specification
• Evidence of approval of applied formulation in reference regulatory authorities/agencies which
Applicant Karachi.
Brand Name + Dosage Form + Strength NOCHOL Sachet 4 gm (orange flavor)
Cholestyramine…………………………...4 gm
2019.
Pharmacological Group Bile acid sequestrants, ATC code: C10AC01
Pack size & Demanded Price 30’s,50’s’60’s, As per DPC
Approval status of product in Reference Cholestyramine 4GM Powder for oral suspension of
Regulatory Authorities Bristol Myers (Discontinued in USFDA)
**Federal Register determination that product was not
discontinued or withdrawn for safety or efficacy reasons
R&A) rules 1976.
•Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
•Stability study data as per guidelines provided in 293rd meeting of Registration Board is
required.
•Form-5 Annexure as per prescribed format of Drug (L, R&A) rules 1976.
Applicant Karachi.
Brand Name + Dosage Form + Strength NETCIN Ophthalmic Suspension
Composition Each ml of Ophthalmic Suspension Contains:
Natamycin…………………….…………50 mg (5 %)
2019.
Approval status of product in Reference NATACYN 5 % ophthalmic suspension, USFDA
Me-too status Zolvin Eye Drops., 040117, Zinta Pharmaceuticals
Industry, Peshawar
Remarks of the Evaluator Form-5 Annexure as per Firm has submitted scan copy
prescribed format of Drug of Form-5 annexure on
(L, R&A) rules 1976. prescribed format.
Decision: Approved The firm shall submit preregistration variation fee of 7500/= as per SRO.No.
F.7-11/2012- B&A/DRAP dated 13-07-2021
Applicant Karachi.
Brand Name + Dosage Form + Strength FLUTIM NEBULES, Inhalation Suspension for
Nebulization,0.5 mg/2ml
Composition Each 2 ml plastic ampoule contains:
Fluticasone Propionate………………………….0.5 mg
03-2019.
Pack size & Demanded Price 10’s.20’s, As per DPC
R&A) rules 1976.
• Section approval letter for plastic Ampoule section
(Steroid) from CLB.
by DRAP (generic / me-too status) along with registration
number, brand name and name of firm.
• Section approval letter for plastic Ampoule section (Steroid) from CLB.
required.
Applicant Karachi.
Brand Name + Dosage Form + Strength FLUTIM NEBULES, Inhalation Suspension for
Nebulization,2mg/2ml
Composition Each 2 ml plastic ampoule contains:
Fluticasone Propionate………………………….2 mg
03-2019.
Pack size & Demanded Price 10’s.20’s, As per DPC
R&A) rules 1976.
• Section approval letter for plastic Ampoule section
(Steroid) from CLB.
by DRAP (generic / me-too status) along with registration
number, brand name and name of firm.
• Section approval letter for plastic Ampoule section (Steroid) from CLB.
required.
707. Name and address of manufacturer/ Remington Pharmaceutical Industries (Pvt.) Ltd. ,18 Km
Applicant Multan Road, Lahore.
Brand Name + Dosage Form + Strength DEXLANSO Capsule 30 mg
Dexlansoprazole (22.5 % EC pellets) …………30 mg
03-2019.
Pharmacological Group Anti-Ulcerant
Type of Form Form-5
Finished product Specification Inhouse
Pack size & Demanded Price 30’s, As per DPC.
Approval status of product in Reference Approved in US-FDA Dexilant Capsule
GMP status GMP inspection report dated 30th Sep 2021 and panel
recommends considering the firm for grant of cGMP
certificate in respect of all manufacturing sections.
Remarks of the Evaluator • Stability study data as per Firm has submitted reply
guidelines provided in with fee challan No.
293rd meeting of 105776623168 along with
Registration Board is revised Form-5 mentioning,
required. Each delayed Release
• Firm has not provided Capsule contains;
source of pellets along Dexlansoprazole Enteric
with stability studies Coated Pellets…….30 mg.
data, GMP certificate of Firm also submitted COA
supplier and differential and stability data of Pellets
fee in case of import of of Vision Pharmaceuticals
pellets. (Pvt) Ltd Islamabad.
• Form-5 label claim does Firm also submitted
not does not mentioned undertaking that they will
pellets, however master conduct stability study for
formulation does real time and accelerated.
mentioned pellets,
provide revised form 5
label claim
Decision: Deferred for submission of stability study data as per guidelines provided in 293rd
708. cName and address of manufacturer/ Remington Pharmaceutical Industries (Pvt.) Ltd. ,18 Km
Brand Name + Dosage Form + Strength DEXLANSO Capsule 60 mg
Dexlansoprazole (22.5 % EC pellets) …………60 mg
03-2019.
Pharmacological Group Anti-Ulcerant
Type of Form Form-5
Approval status of product in Reference Approved in US-FDA Dexilant Capsule
Remarks of the Evaluator • Stability study data as per Firm has submitted reply
guidelines provided in with revised Form-5
293rd meeting of mentioning,
Registration Board is Each delayed Release
required. Capsule contains;
• Firm has not provided Dexlansoprazole Enteric
source of pellets along coated Pellets…….60 mg.
with stability studies Firm also submitted COA
data, GMP certificate of and stability data of Pellets
supplier and differential of Vision Pharmaceuticals
fee in case of import of (Pvt) Ltd Islamabad.
pellets. Firm also submitted
undertaking that they will
conduct stability study for
real time and accelerated.
Decision: Deferred for submission of stability study data as per guidelines provided in 293 rd
Brand Name + Dosage Form + Strength E-Glif Tablet 10 mg
Empagliflozin……………………………………10mg
03-2019.
Type of Form Form-5
Approval status of product in Reference Jardiance Tablets 10mg of M/s BOEHRINGER
Regulatory Authorities INGELHEIM (USFDA Approved).
Me-too status Diampa Tablets 10mg by M/s Getz Pharma Reg. No.
093073
Remarks of the Evaluator • Stability study data as per • Firm also submitted
guidelines provided in undertaking that they will
293rd meeting of conduct stability study for
Registration Board is real time and accelerated
required.
Brand Name + Dosage Form + Strength E-Glif Tablet 20 mg
Empagliflozin……………………………………20mg
03-2019.
Type of Form Form-5
Approval status of product in Reference Jardiance Tablets 25mg, USFDA Approved.
Me-too status Diampa Tablets 25mg by M/s Getz Pharma Reg. No.
093074
required.
Brand Name + Dosage Form + Strength MERIGON Tablet 25 mg
Composition Each prolonged release Tablet Contains:
Mirabegron……………………………………25mg
03-2019.
Pharmacological Group Urinary Antispasmodic
Type of Form Form-5
Approval status of product in Reference BETMIGA mirabegron 25 mg film-coated prolonged
Regulatory Authorities release tablet, TGA approved.
Me-too status Mibega Tablets 25mg, Getz Pharma, Reg. No. 089375
required.
Brand Name + Dosage Form + Strength TAMSIFLO Capsule
Tamsulosin Hcl (Modified release pellets) ……...0.4mg
03-2019.
Pharmacological Group Alpha 1 A Antagonist
Type of Form Form-5
Approval status of product in Reference FLOMAX capsule by Boehringer Ingelheim
Me-too status Tamflo 0.4mg Capsule by Genome Pharmaceutical
Remarks of the Evaluator Firm has not provided Firm also submitted COA
source of pellets along and stability data of Pellets of
with stability studies data, Vision Pharmaceuticals (Pvt)
GMP certificate of Ltd Islamabad, however the
supplier and differential submitted GMP certificate of
fee in case of import of Vision Pharmaceuticals (Pvt)
pellets. Ltd is expired.
Decision: Approved , Firm shall submit valid copy of GMP certificate of source of their pellets.
Brand Name + Dosage Form + Strength RELCOMB Ear Drops
Composition Each ML contains:
Gramicidin…………………0.225 mg
Neomycin Sulphate…………2.25 mg
Nystatin…………………….90000 IU
Triamcinolone acetonide……0.9 mg
03-2019.
Pharmacological Group Antifungal/Corticosteroid
Type of Form Form-5
Finished product Specification Manufacturer Spec.
Pack size & Demanded Price 10 ml, As per DPC.
Approval status of product in Reference TGA approved ,Kenacomb Otic ear drops.
Me-too status Xecomb Ear Drops, 048526, Triamcinolone
Acetonide……1mgNeomycin Base (as
Sulphate)………...2.5mgGramicidin……………0.25mg
Nystatin…………..100,000 units ,
Elko Org , Karachi,
Remarks of the Evaluator Provided Me to reference does not comply with same
strength of active ingredients.
(generic / me-too status) along with registration number, brand name and name of firm
Brand Name + Dosage Form + Strength FUSIREM-H Cream
Fusidic Acid……………………………….20 mg
Hydrocortisone acetate…………………….10 mg
03-2019.
Pharmacological Group Antibiotic/Corticosteroid
Type of Form Form-5
Finished product Specification Inhouse Spec.
Pack size & Demanded Price 5 gm, As per DPC.
Approval status of product in Reference Fucidin – H Cream (MHRA approved).
Me-too status Fucort – H Cream by Saffron (Reg. # 089436).
Decision: Approved with innovator specifications.
Brand Name + Dosage Form + Strength RETAVAL Ointment 0.1 % w/w
Betamethasone as valerate ………….1 mg
03-2019.
Pharmacological Group Topical Corticosteroid
Type of Form Form-5
Finished product Specification USP Spec.
Approval status of product in Reference MHRA Approved.
Me-too status Betnovate ointment by GSK
Decision: Approved.
Brand Name + Dosage Form + Strength AVIRONE Ointment 0.1 %
Methylprednisolone aceponate………….1 mg
03-2019.
Pharmacological Group Topical Corticosteroid
Type of Form Form-5
Pack size & Demanded Price 5 gm & 10 gm, As per DPC.
Approval status of product in Reference ADVANTAN Methylprednisolone Aceponate 1mg/g
Regulatory Authorities ointment tube. TGA approved.
Me-too status Depomax Ointment 1mg/g of M/s. Shaigan
Pharmaceuticals, Rawalpindi Reg. No. 083598
fee of 7500/= for revision of finished product specification as per SRO.No. F.7-11/2012-
Brand Name + Dosage Form + Strength REMPIR Ointment 2 %
Mupirocin……………………………20 mg
03-2019.
Type of Form Form-5
Approval status of product in Reference Bactroban 2% Ointment MHRA approved
Me-too status Muricin 2% Ointment by M/s Crystolite Pharma
(Reg#077628)
Decision:Approved.
Brand Name + Dosage Form + Strength TACILUS Ointment 0.03 %
Tacrolimus Monohydrate eq.to Tacrolimus…….0.3 mg
03-2019.
Type of Form Form-5
st
916
Pack size & Demanded Price 10 gm,30 gm, As per DPC.
Approval status of product in Reference Protopic (0.03%, 0.1%) ointment USFDA approved
Me-too status Graftil 0.1% Ointment by M/s Biolabs (Pvt) Ltd
(Reg#096755)
719. Name and address of manufacturer/ Friends Pharma (Pvt) Ltd.31-Km Ferozepur Road, Lahore.
Applicant
Brand Name + Dosage Form + Strength FEMIZOLE Tablet 2.5 mg
Letrozole………………………….2.5 mg
Diary No. Date of R & I & fee Dy. No.448 dated 31-03-2015; Rs.20,000/- dated 31-03-
2015. Duplicate Dossier Dy. No1007 dated 11-01-2022.
Pharmacological Group Non-steroidal aromatase inhibitor
Type of Form Form-5
Pack size & Demanded Price As per DPC.
Approval status of product in Reference FEMARA (Novartis) US FDA approved
Me-too status Oreta 2.5mg tablet of M/s Aries pharma, Peshawar.
Registration No. 085909
GMP status DML renewal inspection was conducted on 08-03-2019
and recommends the renewal of DML.
Remarks of the Evaluator • Applied product is film enteric coated product,
however no coating material is mentioned in master
formulation. moreover, in manufacturing method firm
mentioned Methylene chloride, Revised Master
formulation and correct manufacturing method
without methylene chloride is required.
• GMP inspection /certificate within last 3 years is
required.
Decision: Approved with innovator’s specification Registration Board further decided to verify
fee challan as per decision of 285th meeting of Registration Board. Firm shall submit revised
master formulation mentioning coating material and Valid copy of GMP certificate /inspection
report before issuance of Registration letter. The firm shall submit preregistration variation fee
dated 13-07-2021
720. Name and address of manufacturer/ Friends Pharma (Pvt) Ltd.31-Km Ferozepur Road, Lahore.
Applicant
Brand Name + Dosage Form + Strength FROXICAM Tablet 8 mg
Lornoxicam…………………….8 mg
2015. Duplicate Dossier Dy. No.1005 dated 11-01-2022.
Pharmacological Group Anti-inflammatory
Type of Form Form-5
Approval status of product in Reference Xefo 8 mg tablet (EMA approved)
Me-too status Recam Tablet 8 mg by M/s Regal Pharmaceuticals
(Reg.#081952)
Remarks of the Evaluator • Applied product is enteric coated product, however
reference product is film coated product more no
coating material is mentioned in master formulation.
Revised label claim and Master formulation is
required.
• GMP inspection /certificate within last 3 years is
required.
Decision: Approved with innovators specification as Film coated tablet. Registration Board
further decided to verify fee challan as per decision of 285th meeting of Registration Board. Firm
shall submit revised master formulation mentioning filmcoating material and valid copy of GMP
certificate /inspection report before issuance of Registration letter. The firm shall submit
721. t Name and address of manufacturer/ Friends Pharma (Pvt) Ltd.31-Km Ferozepur Road, Lahore.
Applicant
Brand Name + Dosage Form + Strength FROXIN-CR Tablet
Composition Each Controlled Release Tablet Contains:
Paroxetine (as Hcl) …………………….25 mg
2015. Duplicate Dossier Dy. No.1006 dated 11-01-2022.
Pharmacological Group Antidepressant/SSRI
Type of Form Form-5
Approval status of product in Reference Paxil CR tablets (USFDA),
Me-too status Seroxat CR by GSK
Remarks of the Evaluator • GMP inspection /certificate within last 3 years is
required.
• Reference product is enteric coated, Controlled
release; however, the enteric coating is not mentioning
in master formulation and manufacturing method.
Decision: Approved. Rgsitration letter wil be issued upon submission of revised composition
and label claim as per innovator product along with fee of Rs. 30,000/- for change/correction
in composition as per notification no. as per notifications 7-11/2012-B&A/DRAP dated 07-
05-2021 & 13-07-2021.
722. Name and address of manufacturer/ Bio-Mark Pharmaceuticals, plot No.527, Sunder industrial
Applicant Estate Lahore
Brand Name + Dosage Form + Strength MALIQUIN Sachet
Dihydroartemisinic…………………….15 mg
Piperaquine Phosphate…………………120 mg
Pharmacological Group Anti-Malarial
Type of Form Form-5
Me-too status TIMEQUIN SACHET 15/120 by M/s SAMI
PHARMACEUTICALS (PVT) LTD, Reg No. 70787
GMP status GMP certificate was issued on 19-05-2020 on the basis of
inspection conducted on 13-02-2020
Remarks of the Evaluator Evidence of approval of applied formulation in reference
which were adopted by the Registration Board in its 275th
meeting.
Brand Name + Dosage Form + Strength ERDOSTENE Sachet
Erdosteine………………………………225 mg
Pharmacological Group Expectorant
Type of Form Form-5
Finished product Specification Biomark specification
Me-too status Erdozet Sachet 225 mg by M/s Wenovo Pharmaceuticals
(Reg# 078072)
meeting.
Brand Name + Dosage Form + Strength BIDOPA Tablet
Levodopa………………………………250 mg
Carbidopa………………………………25 mg
06-2017. Duplicate Dossier Dy. No 33915 dated 28-12-
2021.
Pharmacological Group Anti-Parkinsonism
Type of Form Form-5
Pack size & Demanded Price 30’s,100’s,As per DPC.
Approval status of product in Reference Co-Careldopa 25 mg/250 mg tablets. MHRA approved
Me-too status Validopa Tablets. Reg. No. 31109
Decision: Approved. Registration Board further decided to verify fee challan as per decision of
285th meeting of Registration Board
Brand Name + Dosage Form + Strength OTILIUM Tablet
Otilonium Bromide ……………………………40 mg
2017. Duplicate Dossier Dy. No 10013 dated 20-04-2022.
Pharmacological Group anticholinergic, quaternary ammonium compounds
Type of Form Form-5
Approval status of product in Reference Spasmomen of Italy, Otilonio Stada 40 mg by Laboratorio
Regulatory Authorities Stada, Sl (Spain Approved)
Me-too status Spasmomen tablet 40mg of Pharmatech.
Decision: Approved with innovator’s specification. Registration Board further decided to verify
fee challan as per decision of 285th meeting of Registration Board
Brand Name + Dosage Form + Strength LACOS Tablet
Lacosamide……………………………………200 mg
2022.
Type of Form Form-5
Approval status of product in Reference Vimpat 200mg tablet of M/s UCB Pharma Limited, UK
Regulatory Authorities (MHRA Approved)
Me-too status Otomin Tablet by Genome Pharma (Reg # 059407)
Decision: Approved with innovator’s specification. Registration Board further decided to verify
Brand Name + Dosage Form + Strength SEDAP Tablet
Serratiopeptidase……………………………10 mg
2021
Pharmacological Group Anti-Inflammatory Enzyme
Type of Form Form-5
Pack size & Demanded Price 10’s,20’s,100’s, As per DPC.
Me-too status Danzen DS Tab, Helix pharma, Reg. No. 028173.
regulatory authorities/agencies which were
declared/approved
by the Registration Board in its 275th meeting.
Brand Name + Dosage Form + Strength MENTINE Oral syrup
st
920
Memantine Hydrochloride………………….10mg
2017. Duplicate Dossier Dy. No 10014 dated 20-04-2022
Pharmacological Group Glutamate NDMA receptor Antagonist
Type of Form Form-5
Pack size & Demanded Price 1*120ml, As per DPC.
Approval status of product in Reference Not provided
Me-too status Mantin Syrup by M/s Pharmasol (Pvt) Ltd (Reg# 089890)
Remarks of the Evaluator evidence of approval of applied formulation in reference
regulatory authorities/agencies which were adopted by the
729. Name and address of manufacturer/ Applicant /Contract giver: Bio-Mark Pharmaceuticals,
Applicant plot No.527, Sunder industrial Estate Lahore.
Manufacturer / Contract acceptor: Bio Lab, (Pvt) Ltd, plot
No.145, Industrial Triangle,Kahuta Road,Islamabad.
Brand Name + Dosage Form + Strength UCON Infusion 100 ml (200mg/vial)
Composition Each ml Infusion Contain:
Fluconazole ……………………….2mg
2022
Type of Form Form-5
Pack size & Demanded Price 1*100ml, Amber type II glass vial. As per DPC.
Approval status of product in Reference Fluconazole 200 mg/100 ml (2mg/ml) Fresenius Kabi
Regulatory Authorities USA
(USFDA Approved-076145) & Diflucan (Fluconazole)
200
mg/100 ml injection vial by Pfizer Australia Pty Ltd (TGA
Approved).
It is also approved by EMA (European Medicine Agency),
UK MHRA & PMDA (Japan).
Me-too status Fluzone Infusion of M/s Pharmedic (Pvt.) Ltd, (Reg. #
025995)
Remarks of the Evaluator • Original Contract • Firm has submitted reply
manufacturing vide diary No.2016 PEC
agreement DRAP dated 30/08/2022
mentioning quality along with form-5
policy and mandate to covering letter dully
procure API raw singed by applicant, i-e
materials, excipients M/s Biomark
ad packaging Pharmaceutical, Lahore,
material. • Firm has also submitted
• Form-5 covering copy of GMP certificate of
letter dully signed by contract acceptor ,M/s Bio
applicant. Labs (Pvt) Ltd, Islamabad,
• GMP inspection mentioning Liquid
/Certificate of Infusion section (100 ml)
contract manufacturer
within last 3 years.
•Section approval
letter from CLB.
Brand Name + Dosage Form + Strength LIVPAR Oral Syrup
Betaine Glucuronate…………………………3.750 gm
Diethanolamine Glucuronate………………….1.0 gm
Nicotinamine…………………………………0.200 gm
2021
Pharmacological Group Amino acid/vitamins
Type of Form Form-5
Pack size & Demanded Price 1*120ml, As per DPC.
Approval status of product in Reference Not provided.,
Me-too status 002188, Jetepar Syrup,
731. Name and address of manufacturer/ Shrooq Pharmaceutical (Pvt) Ltd,21-KM, Feroze Pur
Applicant Road, Lahore
Brand Name + Dosage Form + Strength PANCRO Injection I.V (4 mg/2ml)
Pancuronium Bromide……………….2 mg
2014. Duplicate Dossier Dy. No13049 dated 28-05-2022
Pharmacological Group Muscle relaxant
Type of Form Form-5
Finished product Specification BP specification.
Pack size & Demanded Price Ampoule of 2 ml, As per DPC
Approval status of product in Reference Pancuronium Injection 4mg/2ml of Mercury Pharma,
Regulatory Authorities Ireland.(MHRA approved)
Me-too status Pancron injection of Brookes Pharma (Reg#020299)
GMP status DML renewal inspection conducted on 26-10-2021 & 29-
10-2021 and panel recommended renewal of DML for
following sections, Tablet (general ) , Tablet (quinolone),
Oral Liquid , Capsule ( general ) , Sachet , Capsule ( ceph)
,Dry Powder Suspension (ceph),Topical ( cream/ointment,
lotion and gel) , Dry Powder Injection(ceph) , Injection
ampoule ( general ) , Vial Infusion , Eye/Ear/Nose Drops
(New),Capsule ( steroid) ( new, revised).
732. Name and address of manufacturer/ Shrooq Pharmaceutical (Pvt) Ltd,21-KM, Feroze Pur
Applicant Road, Lahore
Brand Name + Dosage Form + Strength FANTAL Injection (I/M, I/V)
Fentanyl Citrate…………………0.5 mg
Diary No. Date of R & I & fee Dy. No.687dated 11-04-2014; Rs. 20,000/- dated 11-04-
Pharmacological Group Narcotic Analgesic
Type of Form Form-5
Finished product Specification USP specification.
Pack size & Demanded Price Ampoule of 5 ml, As per DPC
Approval status of product in Reference Fentanyl 50 microgram/ml Injection by M/s Hameln
Regulatory Authorities Pharmaceuticals Ltd, MHRA approved
Me-too status Fentra Injection by M/s Brookes (Reg#061402)
10-2021 and panel recommended renewal of DML for
following sections, Tablet (general ) , Tablet (quinolone),
Oral Liquid , Capsule ( general ) , Sachet , Capsule ( ceph)
,Dry Powder Suspension (ceph),Topical ( cream/ointment,
lotion and gel) , Dry Powder Injection(ceph) , Injection
ampoule ( general ) , Vial Infusion , Eye/Ear/Nose Drops
(New),Capsule ( steroid) ( new, revised).
Remarks of the Evaluator Firm has submitted letter vide R&I dairy No 22871 dated
12-08-2022 along with revised master formulation and
Form -5 along with fee challan of 30000/= vide challan no
55412351423 with following revised composition:
Each 5 ml Contains
Fentanyl Citrate as Fentanyl……………...0.05 mg/ml
(USP specifications)
Decision: Deferred for evidence of approval of required manufacturing facility of “Tablet
Psychotropic section” from Cnetral Licensing Board.
733. Name and address of manufacturer/ Star Laboratories (Pvt) Ltd, 23 Km Multan Road Lahore.
Applicant
Brand Name + Dosage Form + Strength MOXISTAR Tablet 400 mg
Moxifloxacin as Hcl……………………400 mg
Diary No. Date of R & I & fee Dy. No.162dated 07-08-2016; Rs.20,000/- dated 08-08-
Pharmacological Group quinolones
Type of Form Form-5
Pack size & Demanded Price 1*5’s
Approval status of product in Reference AVELOX (moxifloxacin as hydrochloride) 400mg
Regulatory Authorities tablets, film coated. USFDA approved
Me-too status Moxizyan 400mg Tablets, film-coated. Reg. No. 77252
GMP status GMP certificate issued on 20-07-2020 on the basis on
Remarks of the Evaluator Monograph is present in USP.
Decision: Approved with USP specifications. Registration Board further decided to verify fee
challan as per decision of 285th meeting of Registration BoardDecision.The firm shall submit
734. Name and address of manufacturer/ Lahore Chemical and Pharmaceuticals Works (Pvt)
Applicant Ltd.137 Shahrah Moulana Jalaludin Roomi Road.
Brand Name + Dosage Form + Strength RETANE Eye Drops
Composition Cantinas:
Polyethylene glycol (400) …….0.4%
Propylene glycol……………….0.3 %
Pharmacological Group Lubricant
Type of Form Form-5
Finished product Specification LCPW Specs.
Pack size & Demanded Price 375/15 ml, LDPE bottle.
Approval status of product in Reference Systane of Alcon, UK, OTC product (Daily Med)
Me-too status Corniwet Eye Solution,076375, Medicaids (Pvt) Ltd., Plot
No 10 Sector 37 Korangi Industrial Area Karachi.
GMP status GMP certificate issued on 18-10-2019 based on GMP
Remarks of the Evaluator • Per ml Composition is Firm has submitted reply
not provided in form-5 with fee challan of 7500/=
• Pack size and container vide challan No.7015760239
details not provided in dated 05-08-2022 along with
form-5 revised master formulation
• Master Formulation and form-5 mentioning
along with quantities of composition as under,
each ingredient is not Each ml contains:
provided. Polyethylene glycol (400)
………………...…….4 mg
Propylene glycol…….3 mg
Decision: Approved with innovators specification. Registration Board further decided to verify
735. Name and address of manufacturer/ Shaigan Pharmaceuticals (Pvt) Ltd. 14 km Adyala Road,
Applicant Rawalpindi.
Brand Name + Dosage Form + Strength THISTLE Tablet 200 mg
Silymarin………………….200 mg
Pharmacological Group Supportive therapy for liver diseases
Type of Form Form-5
Pack size & Demanded Price 20’sAs per SRO
Me-too status Silliver 200 mg Tablets, 023930, Abbott Laboratories
(Pakistan) Ltd.
GMP status Not provided
Remarks of the Evaluator • Form -5 does not mention as film coated tablet,
however master formulation and manufacturing
method outline do mention film coating. Revise Form
5 with label claim as fil coat
• GMP inspection /certificate within last 3 years not
provided.
• Section approval letter form CLB not provided.
authorities/agencies which were adopted by the Registration Board in its 275th meeting
736. Name and address of manufacturer/ Sigma Pharma International (Pvt) Ltd. Plot No.E-50
Applicant ,North Westren Industrial Zone , Port Qasim, Karachi
Brand Name + Dosage Form + Strength SIXIL Vaginal Cream 2 %
Clindamycin as Phosphate …………….20 mg (2%w/w)
Type of Form Form-5
Pack size & Demanded Price 20g,40g, As per DPC
Approval status of product in Reference Dalacin Cream 2% MHRA approved
Me-too status Clindacef-V Vaginal Cream 2% w/w by M/s Roryan
Pharmaceutical (Reg#096939)
GMP status DML renewal inspection conducted on 12-08-2020
Remarks of the Evaluator • Master formulation is Firm has submitted reply
not provided. along with revised Form-5
• Form -5 Annexures dully signed along with
should be dully signed master formulation.Firm has
/stamped. submitted fee challan of
30000/= vide slip
No.3627357150 dated 30-08-
2022
737. Name and address of manufacturer/ Al-Fazal Pharma (Pvt), Plot 20,21,22 Defense Industrial
Applicant zone, moman Pura ,16-Km Sheikhupura, Lahore.
Brand Name + Dosage Form + Strength CLINDACIN T Lotion 1 %
Clindamycin as Phosphate ……………….10 mg
Type of Form Form-5
Finished product Specification Manufacturer
Approval status of product in Reference CLEOCIN T Topical Lotion USFDA approved
Me-too status CDX-T T 1% Lotion by M/s Fresh Pharmaceutical
(Reg#099902)
Remarks of the Evaluator • Form -5 Annexures • Firm has submitted vide
should be dully signed dairy No. 24073 dated 25-
/stamped. 08-2022 along with form-
• Finished product 5 dully singed (
specification as per Undertaking at end is
USP. missing ) with Finished
• Lotion section approval product as USP
from CLB. specification and Copy of
• GMP DML renewal inspection
inspection/certificate conducted on 29-01-2022
within last 3 years. and recommended
renewal of DML for
following section (a) Oral
Liquid general (b)
Capsule General (c)
Cream/ointment/Gel
General
• Decision: Approved with BP specifications The firm shall submit fee of Rs. 7500/- for
Brand Name + Dosage Form + Strength NUTRIZAK Bolus
Composition Each Bolus Contains:
Vitamin A…………………………...5000IU
Vitamin D3………………………….12500IU
Vitamin E…………………..………..25 mg
Vitamin C………………..………..…62.5 mg
Vitamin B1…………………………..5 mg
Vitamin B2…………………………..11.5 mg
Vitamin b6………………..……..…...6.25 mg
Biotin…………………………...…....27.5
Nicotinamide…………………...…….62.5 mg
Calcium D Pantothenate………..……..18.75 mg
Folic Acid………………….………..1.25 mg
Vitamin K3………………………….7.1 mg
DL-Methionine……………………….25 mg
L-Lysin……………………………….12.25 mg
Potassium Chloride……………………75 mg
Manganese Sulphate ………………….37.5 mg
Zinc Sulphate………………………….37.5 mg
Sodium Sulphate……………..……….12.5 mg
Copper Sulphate……………..………..5 mg
Ferrous Sulphate……………..………..37.5 mg
dated 18-05-2022.
Pharmacological Group Vitamins & Minerals.
Type of Form Form-5
Pack size & Demanded Price 50 bolus,100 bolus.
Me-too status Farvisol Bolus, 075639, Prix Pharmaceutica (Pvt) Ltd.,
Plot No. 5 Pharmacity 30-Km Multan Road Lahore.,
Lahore, Pakistan, Pakistan
DML.
Decision:Approved with innovator specification. The firm shall submit preregistration variation
B&A/DRAP dated 13-07-2021. Registration Board further decided to verify fee challan as per
decision of 285th meeting of Registration BoardDecision
739. Name and address of manufacturer/ Ephram Labortories ,A-40,Road No 01, S.I.T.E,Super
Applicant Highway Industrial Area , North Karachi .
Brand Name + Dosage Form + Strength MONFUSI Cream 2 %
Fusidic Acid………….20 mg
2021
Type of Form Form-5
Finished product Specification B.P specification
Pack size & Demanded Price 5 gm, 15 gm , 20 gm , As per SRO
Approval status of product in Reference Fucidin (fusidic acid) 20mg/g cream MHRA Approved
Me-too status Fusinax-A Cream 2%w/w by M/s Winbrain Research
Laboratories (Reg# 082537)
GMP status GMP within last 3 years not provided
Remarks of the Evaluator GMP inspection/certificate within last 3 years is required.
Section approval letter from CLB.
285th meeting of Registration Board. The firm shall submit latest GMP inspection report
conducted within last three years.
740. Name and address of manufacturer/ Ephram Labortories ,A-40,Road No 01, S.I.T.E,Super
Applicant Highway Industrial Area , North Karachi .
Brand Name + Dosage Form + Strength NAPHATE Ophthalmic Solution
Naphazoline Hydrochloride……………….0.25 mg
Pheniramine Maleate……………………….3.0 mg
2021
Pharmacological Group Decongestant and Antihistamine
Type of Form Form-5
Pack size & Demanded Price 10 ml, 15 ml, AS per SRO
Approval status of product in Reference Naphcon-A by Alkon (USFDA)
Me-too status Ocucon-A Eye Drops Farmigea (Reg # 026351)
Remarks of the Evaluator GMP inspection/certificate within last 3 years is required.
Section approval letter from CLB.
285th meeting of Registration Board. The firm shall submit latest GMP inspection report
conducted within last three years.
741. Name and address of manufacturer/ High Q Pharmaceuticals, B64, KDA, Karsaz Road,
Applicant Karachi
Brand Name + Dosage Form + Strength EPRION Tablet 50 mg
Eprisone Hydrochloride………….50 mg
2021
Pharmacological Group Muscle relaxanat
Type of Form Form-5
Finished product Specification Japanese Pharmacopoeia
Pack size & Demanded Price 10’s,20’s,30’s,100’s
Approval status of product in Reference Expose 50mg film coated tablet, AIFA approved.
Me-too status Perispa 50mg tablets, Platinum pharma, Reg. No. 039302.
Remarks of the Evaluator • GMP inspection/certificate within last 3 years is required
• Firm has claimed “Eprisone” instead on “Eperisone”
moreover the reference product is film coated, where as
applied product is not film coated nor coating is
mentioned in master formulation and manufacturing
method.
Decision: Approved as per following label claim:
Eprisone Hydrochloride………….50 mg
Registration Board further decided that registration letter will be issued upon submission of
following:
• Verification fee challan as per decision of 285th meeting of Registration Board.
• The firm shall submit latest GMP inspection report conducted within last three years.
• The firm shall submit preregistration variation fee challan of 7500/- along with revised
master formulation and manufacturing method for uncoated tablet.
Applicant Karachi
Brand Name + Dosage Form + Strength EZOLIN Tablet 600 mg
Linezolid……………………………………600 mg
Diary No. Date of R & I & fee Dy. No.279 dated 18-09-2014; Rs. 20,000/- dated 18-09-
2014. Duplicate Dossier Dy. No 21633-D dated 09-10-
2021
Pharmacological Group Synthetic, Antibacterial, Oxazolidinones
Type of Form Form-5
Finished product Specification High-Q specification
Pack size & Demanded Price 10’s,12’s,
Approval status of product in Reference Zyvox 600 mg tablet by Pharmacia and Upjohn Pharma
Regulatory Authorities (USFDA)
Me-too status Ecasil by M/s Sami Pharma ,Khi
Remarks of the Evaluator • Copy of last inspection report conducted on 10-08-2022
recommends good level of compliance.
• Innovator Specification.
Decision: Approved with innovator specifications. Registration Board further decided that
registration letter will be issued upon verification of fee challan as per decision of 285th meeting
of Registration Board and submission of fee of Rs. 7500/- for correction/pre-approval change in
Applicant Karachi
Brand Name + Dosage Form + Strength TOPRAX Tablet 100 mg
Topiramate…………………….100 mg
2014. Duplicate Dossier Dy. No 21633-H dated 09-10-
2021
Pharmacological Group Sulphamate
Type of Form Form-5
Pack size & Demanded Price 30’s.60’s
Approval status of product in Reference MHRA Approved (Topiramate 100,25,50,200) as film
Regulatory Authorities coated tablet
Me-too status Tic-g 100mg Tablet of M/s. Genix Pharma
(Reg.no.055677)
Remarks of the Evaluator • Copy of last inspection report conducted on 10-08-2022
recommends good level of compliance.
• Submitted labeling samples mentioned Manufacturer
specifications.
challan as per decision of 285th meeting of Registration Board.The firm shall submit pre-
registration variation fee challan of 7500/=.as per SRO.No. F.7-11/2012- B&A/DRAP dated 13-
07-2021.
Applicant Karachi
Brand Name + Dosage Form + Strength AMIDOX Tablet
Composition Each SR(Sustain Release) Tablet Contains:
Doxylamine Succinate………………………10 mg
Pyridoxamine………………………………..10 mg
09-2017. Duplicate Dossier Dy. No 21633-J dated 09-10-
2021
Pharmacological Group Antihistamine and Vitamin B (Antiemetic)
Type of Form Form-5
Finished product Specification High-Q specification
Approval status of product in Reference Doxylamine Succinate And Pyridoxine Hydrochloride
Regulatory Authorities (10/10) | ANDA #205811 | Tablet, Delayed Release;Oral
| Prescription | Actavis Labs Fl Inc. Approved in USFDA
Me-too status Femiroz Tablet by M/s Efroze (Reg#061026)
Remarks of the Evaluator • GMP inspection/certificate within last 3 years is required.
• Submitted labeling samples mentioned Manufacturer
specifications.
Decision: Approved with innovator specifications. Registration Board further decided to verify
fee challan as per decision of 285th meeting of Registration Board. The firm shall submit pre-
registration variation fee challan of 7500/=as per SRO.No. F.7-11/2012- B&A/DRAP dated 13-
07-2021.
Applicant Karachi
Brand Name + Dosage Form + Strength SILDOMET Tablet 50/850 mg
Sitagliptin as Sitagliptin Phosphate monohydrate…50 mg
Metformin Hcl…………………………………..850 mg
Diary No. Date of R & I & fee Dy. No.41 dated 03-11-2016, Rs.20,000/- dated 31-10-
2016. Duplicate Dossier Dy. No 21633-I dated 09-10-
2021
Pharmacological Group DPP-4 Inhibitor and Biguanide, Antidiabetic
Type of Form Form-5
Finished product Specification Manufacturer Specification.
Pack size & Demanded Price 14’s.28’s,30’s, As per SRO
Approval status of product in Reference Velmetia 50/850mg film coated tablet, Australia.
Me-too status S-gliptin plus. Reg # 081619
Remarks of the Evaluator • GMP inspection/certificate within last 3 years is required.
• Firm has submitted Master formulation mentioning
methylene chloride in coating material, revised master
formulation and manufacturing method without
methylene chloride.
Decision: Approved with innovators specifications. Registration Board further decided to verify
fee challan as per decision of 285th meeting of Registration Board. The firm shall submit pre-
registration variation fee challan of 7500/=as per SRO.No. F.7-11/2012- B&A/DRAP dated 13-
07-2021.
746. Name and address of manufacturer/ Welwrd Pharmaceuticals Plot no.3, Block A, Phase III,
Applicant Industrial Estate Hattar, Pakistan.
Brand Name + Dosage Form + Strength THIOWALT Injection 4mg/2ml
Composition Each Ampoule of 2 ml Contains:
Thiocolchicoside…………………….4 mg
2021
Pharmacological Group Muscle Relaxant
Type of Form Form-5
Finished product Specification Innovators Specification
Approval status of product in Reference COLTRAMYL 4mg/2ml, solution for injection IM in
Regulatory Authorities ampoule.ANSM approved
Me-too status Takeze 4mg/2ml Injection by M/s Shaigan Pharmaceutical
(Reg#084355)
GMP status 12-11-2018. Overall the firm is GMP compliant.
285th meeting of Registration Board.
747. Name and address of manufacturer/ Brookes Pharma (Private) Limited, 58 & 59, Sector 15,
Applicant Korangi Industrial Area, Karachi
Brand Name + Dosage Form + Strength LAMADOL SR Tablet 100 mg
Composition Each Sustain Release Tablet Contains:
Tramadol Hydrochloride……………………… 100 mg
2021
Pharmacological Group Opioid Analgesic
Type of Form Form-5
Approval status of product in Reference USFDA approved as extended release tablet.
Me-too status Neromal ER Tablet 100mg,092941, Nabiqasim Industries
(Pvt) Ltd.,Karachi
GMP status GMP inspection dated 11-10-2017 and 16-10-2017
concluded that the firm is considered to be operating at
satisfactory level of compliance.
748. Name and address of manufacturer/ Epla Laboratories, D-12, Estate Avenue, S.I.T.E.,
Applicant Karachi.
Brand Name + Dosage Form + Strength OSNO-D Tablet
Ossein Mineral Complex……………………830 mg
Vitamin D……………………………………400 IU
2021
Pharmacological Group Calcium Supplement
Type of Form Form-5
Finished product Specification Inhouse Specification
Pack size & Demanded Price 6*5’s, As per DPC
Approval status of product in Reference Wellese Calcium and Vitamin D3 Tablet by Botanical
Regulatory Authorities Laboratories, USA.
Me-too status Bonmin Tablet by M/s. S J & G Fazal Elahi, Karachi.
GMP status Last GMP inspection was conducted on 11-05-2018 and
the report concludes good level of GMP compliance.
Remarks of the Evaluator Methylene chaloride in coating,
Form-5 Undertaking
Facility of Atomic absorption and complete composition
of ossein Mineral Complex is required.
• Submissin of detailed compositionof ossein mineral complex.
• Revised formulation of coating free from methylene chaloride.
• Form-5 Undertaking is required.
• Evidence of availability of Atomic absorption spectrophotometer..
749. Name and address of manufacturer/ Rakaposhi Pharmaceuticals Pvt Ltd. 97-K, Industrial
Applicant Estate, Hayatabad, Peshawar, Pakistan
Brand Name + Dosage Form + Strength RAZOLID Dry Suspension
Linezolid…………………………100 mg
2021
Pharmacological Group Oxazolidinones Antibiotic
Type of Form Form-5
Finished product Specification R.Poshi Specification
Pack size & Demanded Price 60ml , as per sro
Approval status of product in Reference ZYVOX (100mg/5ml) for oral suspension USFDA
Me-too status Nezo 100mg/5ml Dry Suspension by M/s Rotex Pharma
(Reg#097440)
GMP status Inspection date 19/09/2018, The panel recommended
issuance of GMP certificate.
Decision: Approved with innovator specifications. Registration Board further decided to verify
fee challan as per decision of 285th meeting of Registration Board. The firm shall submit valid
GMP certificate/inspection report before issuance of registration letter. The firm shall submit
pre-registration variation fee challan of 7500/= as per SRO.No. F.7-11/2012- B&A/DRAP dated
13-07-2021.
B. Registration applications Human (New): -
(C) M/s Rotex Pharma (Pvt.) Ltd. Plot No.206-207, Industrial Triangle,Kahuta Road,Islamabad.
CLB in its 179th meeting held on 18th February 2021 has considered and approved the grant the following
additional/amended sections of M/s Rotex Pharma (Pvt.) Ltd. Plot No.206-207, Industrial Triangle,Kahuta
Road, Islamabad under DML No.000651 (Formulation):-
1- Gel (Preparation & filling) New Additional/Amended Section
In 317th meeting of DRP following cases were presented, however one product file was not traceable in PEC,
Firm has submitted duplicate dossier, which is evaluated as below:
Section No. Of No. of No. of No. of
Previously remaining Molecule remaining
Product product previously molecule
applied applied. applied applied.
considered in considered on
317th meeting 317th meeting
Gel (Preparation & Filling) 08 01 08 01
(Amended section)
Name and address of manufacturer/ Rotex Pharma (Pvt.) Ltd. Plot No.206-207, Industrial
Applicant Triangle,Kahuta Road,Islamabad.
Brand Name + Dosage Form + Strength VOLDEN Gel 1 %
Diclofenac Diethylamine eq to Diclofenac Sodium….10 mg
Diary No. Date of R & I & fee Dy. No 16790 dated 07-03-2019; Rs.20,000/- dated 07-03-2019.
(Duplicate Dossier)
Pharmacological Group Phenylacetic Acid
Type of Form Form-5
Finished product Specification B. P
Pack size & Demanded Price 5gm,10gm,20gm, 50gm.As per SRO
Approval status of product in Reference Voltaren 1%w/w Gel (MHRA approved)
Me-too status Voltral by GSK (Reg. # 083991)
GMP status New section
Remarks of Evaluator
Decision: Approved. Registration Board further decided to verify fee challan as per decision of 285th
D- New Cases Human (Import): -
750. Name and address of Applicant Name: Revive Healthcare

Address: 503, 5th floor, Eden Hieghts,6 Main Gulberg, Jail
road, Lahore
Detail of Drug Sale License Name: Revive Healthcare
Address: 503, 5th floor, Eden Hieghts,6 Main Gulberg,
Jail road, Lahore
Go-down address: N/A
License No: 05-352-0065-031159D
Validity: 21st May 2020
Status: Distributor license in Form No. 11
Name and address of manufacturer United Biotech (p) Limited, Bagbania, Baddi-Nalagarh
Road, District Solan(HP)-174 101,India
Name and address of marketing authorization United Biotech (p) Limited, Bagbania, Baddi-Nalagarh
holder Road, District Solan(HP)-India
Name of exporting country India
Type of Form Form-5A
Diary No. & Date of R& I Dy. No. 13066 dated 06-03-2019
Fee including differential fee Rs.100000/- dated 06-03-2019 Challan No.1902056
dated: 06.03.2019
Brand Name +Dosage Form + Strength UNIFOLIN 100 Injection
Composition Each Vail Contains;
Leucovorin Calcium ………………….100 mg/10 ml
Finished Product Specification USP
Pharmacological Group Detoxifying agent for antineoplastic treatment
Shelf life 24 Month ( 2-8 C)
Demanded Price As per DPC
Pack size 1’s
International availability Not traceable
Me-too status Not varified
Stability studies Firm has submitted real-time stability data sheets
conducted at 50C ± 3ºC three industrial batches for 24
months (Shelf life 24 months) and accelerated stability data
sheets conducted at 250C ± 2 ºC and 65%RH ± 5%RH of
three industrial batches for six months.
Mfg. Date: 06-2013
Detail of certificates attached legalized GMP certificate:
Certificate No: HFW-H(Drugs)427/05
Certifying Authority: State Drugs Controller, Controlling
Cum Licensing Authority Nagar panchayat Bhawan, Sai
road baddl dist,Solan.
Scan copy of legalized DML.

Serial: Not Provided
Original legalized CoPP (Embassy attested).

Certificate No: HFW-H9(DRUGS) 461/05/241 18-09-
2019
Certificate date:22-01-2018
Certifying Authority: Office of State Drugs Controller,
Licensing Authority Cum Controlling Authority Health &
family welfare Department, Himachal Pradesh, India
legalized Free sale Certificate.
Certificate No: HFW-H(DRUGS)/427/09
Certifying Authority: State Drugs Controller, Licensing
Authority Cum Controlling Authority, Baddi, District -
Solan (HP)
Issuing Date: 21-11-2017
Agency Agreement (Copy)
Between Revive Healthcare, 503, 5th floor, Eden Hieghts,6
Main Gulberg, Jail road, Lahore. (Distributor) and United
BioTech (P) Limited, E-142, aket, New Dehli 110017.
India.
Date of Agreement: 01-03-2012
Validity: Complete agreement mentioning validity is not
provided.
Remark of the Evaluator XVI 1. DML (copy) is not provided.
2. Firm has conducted Accelerated stability study for 3
batch at 65 % RH, where as recommended Relative
Humidity is 60 % for accelerated stability study.
3. Original legalized (Embassy attested) CoPP is missing.
Copy is provided which is also expired.
4. Legalized copy of GMP certificate is missing,
Photocopy is provided valid up to 18-09-2019.
5. Complete Agency /Exclusive distribution agreement
mentioning validity is not provided.
6. DSL expired.
7. Evidence of approval of applied formulation in
8. Form 5-A mentioning “UNIFOLIN(Leucovorin)
Injection 50 mg, where in attached annexures the
composition as label claim is Each Vial Contains
Leucovorin calcium Injection 100 mg/10 ml.
9. evidence of applied formulation/drug already approved
10. Product label does not have” URDU “Inscription as
required under drug labeling and packaging rule 1978.
1. DSL (copy) is not provided.
2. Firm has conducted Accelerated stability study for 3 batch at 65 % RH, where as recommended
Relative Humidity is 60 % for accelerated stability study.
3. Original legalized (Embassy attested) CoPP is missing. Copy is provided which is also expired.
4. Legalized copy of GMP certificate is missing, Photocopy is provided valid up to 18-09-2019.
5. Complete Agency /Exclusive distribution agreement mentioning validity is not provided.
6. DSL expired.
7. Evidence of approval of applied formulation in reference regulatory authorities/agencies which
8. Form 5-A mentioning “UNIFOLIN(Leucovorin) Injection 50 mg, where in attached annexures the
composition as label claim is Each Vial Contains Leucovorin calcium Injection 100 mg/10 ml.
9. evidence of applied formulation/drug already approved by DRAP (generic / me-too status) along
with registration number, brand name and name of firm.
10.Product label does not have” URDU “Inscription as required under drug labeling and packaging
rule 1978.
751. Name and address of Applicant Name: Revive Healthcare
Address: 503, 5th floor, Eden Hieghts,6 Main Gulberg, Jail
road, Lahore
Detail of Drug Sale License Name: Revive Healthcare
Address: 503, 5th floor, Eden Hieghts,6 Main Gulberg,
Jail road, Lahore
Go-down address: N/A
License No: 05-352-0065-031159D
Validity: 21st May 2020
Status: Distributor license in Form No. 11
Name and address of manufacturer United Biotech (p) Limited, Bagbania, Baddi-Nalagarh
Road, District Solan(HP)-174 101,India
Name and address of marketing authorization United Biotech (p) Limited , Bagbania, Baddi-Nalagarh
holder Road, District Solan(HP)-India
Name of exporting country India
Type of Form Form-5A
Diary No. & Date of R& I Dy. No. 13065 dated 06-03-2019
Fee including differential fee Rs.100000/- dated 06-03-2019 Challan No.1902057
dated: 06.03.2019
Brand Name +Dosage Form + Strength UNIPLATIN Injection 50 mg
Composition Each Vail Contains;
Cisplatin …………………….50 mg/50ml
Finished Product Specification BP
Pharmacological Group Other antineoplastic agents (Platinum compounds)
Shelf life 24 Month
Demanded Price As per DPC
Pack size 1’s * 50 ml
International availability Cisplatin 1 mg/ml Concentrate for solution for infusion
(50ml vial) by M/s EBEWE Pharma (MHRA approved)
Me-too status UNISTIN 50mg vial by M/s Al- Habib Pharma
(Reg#020661)
Stability studies Firm has submitted long term stability data sheets
conducted at 25 ºC ± 2ºC and 60% RH for three industrial
batches for 24 months (Shelf life 24 months) and
accelerated stability data sheets conducted at 400C ± 2 ºC
and 75%RH ± 5%RH of three industrial batches for six
months.
Mfg. Date: 07-2015
Detail of certificates attached legalized GMP certificate:
Certificate No: HFW-H(Drugs)427/05
Certifying Authority: State Drugs Controller, Controlling
Cum Licensing Authority Nagar panchayat Bhawan, Sai
road baddl dist, Solan.
Scan copy of legalized DML.

Serial: Not Provided
Original legalized CoPP (Embassy attested).

Certificate No: HFW-H(DRUGS) 461/05/231
Certificate date:22-01-2018
Certifying Authority: Office of State Drugs Controller,
Licensing Authority Cum Controlling Authority Health &
family welfare Department, Himachal Pradesh, India.
legalized Free sale Certificate.
Certificate No: HFW-H(DRUGS)/427/09
Certifying Authority: State Drugs Controller, Licensing
Authority Cum Controlling Authority, Baddi, District -
Solan (HP)
Issuing Date: 21-11-2017
Agency Agreement (Copy)
Between Revive Healthcare, 503, 5th floor, Eden Hieghts,6
Main Gulberg, Jail road, Lahore. (Distributor) and United
BioTech (P) Limited, E-142, aket, New Dehli 110017.
India.
Date of Agreement: 01-03-2012
Validity: Complete agreement mentioning validity is not
provided.
Remark of the Evaluator XVI 1. DML (copy) is not provided.
2. The temperature and humidity conditions (25 ºC ±
2ºC and 60% RH) of the submitted stability study
data for long term stability of 3 batches is not
according to zone IV a, which needs clarification.
3. Original legalized (Embassy attested) CoPP is
missing. Copy is provided which is also expired.
4. Legalized copy of GMP certificate is missing,
Photocopy is provided valid up to 18-09-2019.
5. Complete Agency /Exclusive distribution
agreement mentioning validity is not provided.
6. DSL expired.
7. Label claim in firm 5A mentions 50 mg/5ml, where
in attached annexure master formulation is
mentioned as 50 mg/20 ml, which needs
clarification.
Decision: Deffered for following shortcomings:
1. DSL (copy) is not provided.
2. The temperature and humidity conditions (25 ºC ± 2ºC and 60% RH) of the submitted stability
study data for long term stability of 3 batches is not according to zone IV a, which needs
clarification.
3. Original legalized (Embassy attested) CoPP is missing. Copy is provided which is also expired.
4. Legalized copy of GMP certificate is missing, Photocopy is provided valid up to 18-09-2019.
5. Complete Agency /Exclusive distribution agreement mentioning validity is not provided.
6. DSL expired.
7. Label claim in firm 5A mentions 50 mg/5ml, where in attached annexure master formulation is
mentioned as 50 mg/20 ml, which needs clarification.
E- Deferred Cases Human:

752. Name and address of manufacturer/ Relizon Pharmaceuticals, plot No. 118, Sundar Industrial
Brand Name + Dosage Form + Strength RELBROF TABLET 400 mg
Ibuprofen……………….400 mg
2019.
Type of Form Form-5
Pack size & Demanded Price 10’s,250’s As per SRO.
Approval status of product in Reference Ibuprofen 400mg Tablets by M/s AUROBINDO
Regulatory Authorities PHARMA Ltd , USFDA Approved
Me-too status Fenbro tablet of M/s Stanley Pharmaceuticals
GMP status GMP status/report within last 3 years not provided
Remarks of the Evaluator Deficiency letter was issued to firm and asked to provide:
• Firm has mentioned film coated tablet in some
documents as well as gelatin coated tablet which needs
clarification.
• Firm has mentioned a material “tab-coat” in their
manufacturing out line however tab-coat is not
mentioned in master formulation.
• Evidence of applied product in RRA and me
too/generic in Pakistan as gelatin coated tablets or
revise formulation along fee challan.
• GMP inspection report conducted within last 3 years is
not provided.
Previous Decision 317th meeting: Deferred for following shortcomings;
1. Firm has mentioned film coated tablet in some documents as well as gelatin coated tablet which
needs clarification.
2. Firm has mentioned a material “tab-coat” in their manufacturing out line however tab-coat is
not mentioned in master formulation.
3. Evidence of applied product in RRA and me too/generic in Pakistan as gelatin coated tablets or
revise formulation along fee challan.
4. GMP inspection report conducted within last 3 years is not provided.
5. Preregistration variation fee challan.
Reply of the Firm:
• This is Film Coated Tablet and Gelatin was written mistakenly.
• Fee Challan No.356326580 dated 16-06-2022 of 7500/= is submitted.
• Firm has submitted revised Master formulation mentioning “Tab Coat” as part of coating
materials.
• Firm has submitted copy of GMP inspection report Conducted on 07-06-2022 which concluded
as “Keeping in the View of the Observations made on the day of inspection and after going
through the documentations and overall operations, the panel was of the opinion that the firm
M/s Relizone Pharmaceuticals,plot No.118,sunder Industrial estate Lahore was GMP compliant
on the day of inspection.
Decision: Approved as film coated tablet with USP specifications.
Brand Name + Dosage Form + Strength RELBROF TABLET 200 mg
Ibuprofen……………….200 mg
2019.
Type of Form Form-5
Pack size & Demanded Price 10’s,250’s, as per SRO.
Approval status of product in Reference Brufen 200mg film coated tablets (MHRA Approved)
Me-too status Ibumed 200mg tablets, 074799, Medley Pharmaceuticals,
41/A Punjab Small Industries Estate Jhang Bahtar Road
Wah Cantt., Wah Cantonment, Pakistan
GMP status GMP status/report within last 3 years not provided
• Composition of coating material “TabCoat” is not
provide for film coating.
not provided.
Preregistration variation fee challan.
1. Composition of coating material “TabCoat” is not provide in master formulation for film
coating.
3. Preregistration variation fee challan.
Reply of the Firm:
• This is Film Coated Tablet and Gelatin was written mistakenly.
• Firm has submitted revised Master formulation mentioning “Tab Coat” as part of coating
materials.
as “Keeping in the View of the Observations and after going through the documentations and
overall operations, the panel was of the opinion that the firm M/s Relizone Pharmaceuticals,plot
No.118,sunder Industrial estate Lahore was GMP compliant on the day of inspection.
Decision: Approved as film coated tablet with USP specifications.
Brand Name + Dosage Form + Strength RELFEN Tablet 500 mg
Mefenamic Acid………………500 mg
2019.
Pharmacological Group Anti-inflammatory, Analgesic
Type of Form Form-5
Finished product Specification B.P specifications
Approval status of product in Reference Ponston SF 500 by chemidex (MHRA)
Me-too status Amic by Libra
GMP status GMP status/report within last 3 years not provided.
• Firm has mentioned as Film coted tablet however master
formulation and manufacturing method does not depict
film coating, submit revised master formulation and
manufacturing method with preregistration variation fee.
not provided.
Previous Decision 317th meeting: Deferred for following followings;

1. Firm has mentioned as Film coted tablet however master formulation and manufacturing
method does not depict film coating, submit revised master formulation and manufacturing
method with preregistration variation fee.
Reply of the Firm:
• Firm has submitted revised Master formulation mentioning label claim of tablet without coating.
Decision: Approved.
Brand Name + Dosage Form + Strength LEZIR Tablet 10 mg
Cetirizine Hydrochloride………………….…10 mg
2019.
Type of Form Form-5
Finished product Specification B.P specifications
Approval status of product in Reference MHRA. Zirtek 10mg film coated tablet
Me-too status Serzine 10mg Tablets, Qintar Pharma, Reg. No. 030644.
• Firm-5 Cover letter is not signed. Submit revised signed
Form-5 cover letter with pre-registration variation fee.
GMP inspection report conducted within last 3 years is not
provided.
th
Previous Decision 317 meeting: Deferred for following followings;
1. Firm-5 Cover letter is not signed. Submit revised signed Form-5 cover letter with pre-
registration variation fee.
Reply of the Firm:
• Firm has submitted signed form-5 along with annexure.
Decision: Approved.
Brand Name + Dosage Form + Strength TRAMCET Tablet 325/37.5 mg
Paracetamol……………………………………325 mg
Tramadol Hydrochloride………………………37.5 mg
2019.
Pharmacological Group Opioid Analgesic/Antipyretic
Type of Form Form-5
Approval status of product in Reference Ultracet Tablet by M/s Janssen Ortho, (USFDA
Regulatory Authorities approved)
Me-too status Forgesil Tablet by M/s Genome Pharmaceutical
(Reg No:080874
• Firm has mentioned as Film coted tablet however master
formulation and manufacturing method does not depict
film coating, submit revised master formulation and
manufacturing method with preregistration variation fee.
not provided.

1. Firm has mentioned as Film coted tablet however master formulation and manufacturing
method does not depict film coating, submit revised master formulation and manufacturing
method with preregistration variation fee.
Reply of the Firm:
• Firm has submitted revised master formulation and method of manufacturing mentioning
Coating material and method.
Decision:Approved.
Applicant
Brand Name + Dosage Form + Strength PANAFIN I.V Infusion (100ml)
Paracetamol……………...10 mg
2019
Pharmacological Group Antipyretic
Pack size & Demanded Price 100 ml, Polypropylene Bottle with Euro Cap, As per SRO
Approval status of product in Reference MHRA approved with Type I colourless glass vial with
Regulatory Authorities bromobutyl stopper and an aluminum /plastic flip-off cap
GMP status GMP report within 3 years is required
st
938
Remarks of the Evaluator • GMP inspection report conducted within last 3 years is
required.
• Evidence of applied product in RRA in applied primary
along with evidence of manufacturing facility and
preregistration variation fee challan.
• Revised master formulation as per revised label claim.
• Mee-too reference of applied product with applied
primary packaging in Pakistan.
Previous Decision 317th meeting: Deferred for Following shortcomings:
1. GMP inspection report conducted within last 3 years is required.
2. Evidence of applied product in RRA in applied primary packing of Polypropylene bottle or
revise formulation along with evidence of manufacturing facility and preregistration variation fee
challan.
3. Revised master formulation as per revised label claim.
4. Mee-too reference of applied product with applied primary packaging in Pakistan.
Reply of the Firm:
• Firm has submitted copy of GMP certificate issued on 29-07-2021 based on inspection
conducted on 21-05-2021 for Intravenous Infusion.
• Firm has submitted MHRA reference of Paracetamol 10mg/ml (1000mg/100 ml) Solution for
infusion mentioning nature and contents of container as,”100 ml solution contained in 100 ml
polyethylene/polyamide/polypropylene (Viaflo) plastic bags, provided with one polyethylene
dummy non-accessible port and one polyethylene administration port with clear/foil over
pouch.”
Remarks of the Evaluator • Reference /evidence of Me-Too of applied product
already registered in Pakistan with Polypropylene
Bottle with Euro Cap is not provided. Nor Firm has
applied as new Formulation.
• Application on Form 5-D with differential fee for
registration of new molecule along with stability study
data/comparative study with RRA product container
closure system, is also not provided.
• The firm shall submit fee of Rs. 7500/- for correction/pre-approval change in product
Applicant
Brand Name + Dosage Form + Strength MEDISOL MANITOL I.V Infusion (500ml)
Mannitol ………………………….175 g
Sorbitol…………. ……………….25 g
Water for Injection……………….1000 ml
2019
Pharmacological Group Osmotic Diuretic
Remarks of the Evaluator 1. GMP inspection report conducted within last 3 years is
required.
2. Label claim and master formulation mentioned water
for injection 1000 ml instead of whereas applied pack
size is 500 ml, clarification is needed
3. Evidence of applied product in RRA in applied primary
along fee challan.
5. Mee-too reference of applied product with applied
th
Previous Decision 317 meeting: Deferred for Following shortcomings:
2. Label claim and master formulation mentioned water for injection 1000 ml instead of whereas
applied pack size is 500 ml, clarification is needed
3. Evidence of applied product containing Glucose anhydrous in RRA in applied primary packing of
Polypropylene bottle or revise formulation along fee challan.
Reply of the Firm:
• Firm has submitted revised Form-5 along with fee challan No.20306238907 dated 06-06-2022
with revised label claim composition and formulation as “Each 100 ml Contains:
Mannitol……………………20 gm
Water for Injection ……….100 ml
(500 ml in Polypropylene Bottle)
• Firm has also provided RRA refence of USFDA, Mannitol 20 % in Plastic Container (20
gm/100ml). pack size 500 ml.
• Firm has provided me too reference of Steriflutol-20, Reg # 076884, FDL Limited.
Remarks of Evaluator • The me too provided has sorbitol in composition, which
is not mentioned in revised form-5, more over the mee
too product, Steriflutol-20 has container closure with
LDPE where as applied product container closure
system is Polypropylene.
• The me too provided has sorbitol in composition, which is not mentioned in revised form-5,
more over the me too product, Steriflutol-20 has container closure with LDPE where as applied
product container closure system is Polypropylene.
• Application on Form 5-D with differential fee for registration of new molecule along with
stability study data/comparative study with RRA product container closure system, is required.
Applicant
Brand Name + Dosage Form + Strength MEDISOL I.V Infusion 10 % (1000ml)
Dextrose Anhydrous ………………………….10 g
Water for Injection ………………………...…100 ml
2019
Pharmacological Group Carbohydrates
Pack size & Demanded Price 1000 ml, Polypropylene Bottle with Euro Cap, As per
SRO
Remarks of the Evaluator 1. GMP inspection report conducted within last 3 years is
required.
2. Evidence of applied product containing Glucose
anhydrous in RRA in applied primary packing of
Polypropylene bottle or revise formulation along fee
challan.
th
Previous Decision 317 meeting: Deferred for Followings:
2. Evidence of applied product containing Glucose anhydrous in RRA in applied primary
packing of Polypropylene bottle or revise formulation along fee challan.
Reply of the Firm:
• Firm has also provided RRA refence of USFDA, Dextrose 10 % in Plastic Container
(100gm/100ml). Pack Size not mentioned.
• Firm has provided me too reference of Steriflutol, Reg # 049819, FDL Limited.
Remarks of Evaluator • The me- too product, Steriflutol-20 has container
closure with LDPE where as applied product container
closure system is Polypropylene.
• USFDA in label has described that the plastic container
is made from a multilayered film specifically developed
for parenteral drugs. The solution contact layer is a
rubberized copolymer of ethylene and propylene. The
container is nontoxic and biologically inert. The
container-solution unit is a closed system and is not
dependent upon entry of external air during use. The
container is overwrapped to provide protection from the
physical environment and to provide an additional
moisture barrier when necessary.
Decision: Deferred for further deliberation regarding container closure system of applied
product, already approved generic and RRA approved products.
Applicant
Brand Name + Dosage Form + Strength MEDISOL I.V Infusion 10 % (500ml)
Dextrose Anhydrous ………………………….10 g
Water for Injection ………………………...…100 ml
2019
Pharmacological Group Carbohydrates
Remarks of the Evaluator 1. GMP inspection report conducted within last 3 years
is required.
2. Evidence of applied product containing Glucose
anhydrous in RRA in applied primary packing of
Polypropylene bottle or revise formulation along fee
challan.
3. Revised mate formulation as per revised label claim.
Previous Decision 317th meeting: Deferred for Followings:
2. Evidence of applied product containing Glucose anhydrous in RRA in applied primary packing
of Polypropylene bottle or revise formulation along fee challan.
Reply of the Firm:
• Firm has also provided RRA refence of USFDA, Dextrose 10 % in Plastic Container
(100gm/100ml). Pack Size not mentioned.
• Firm has provided me too reference of Steriflutol, Reg # 049819, FDL Limited.
Remarks of Evaluator • The me- too product, Dextrose 10 % has container
closure with LDPE where as applied product container
closure system is Polypropylene.
• USFDA in label has described that the plastic container
is made from a multilayered film specifically developed
for parenteral drugs. The solution contact layer is a
rubberized copolymer of ethylene and propylene. The
container is nontoxic and biologically inert. The
container-solution unit is a closed system and is not
dependent upon entry of external air during use. The
container is overwrapped to provide protection from the
physical environment and to provide an additional
moisture barrier when necessary.
Decision: Deferred for further deliberation regarding container closure system of applied
product, already approved generic and RRA approved products.
761. Name and address of manufacturer/ Cibex (Pvt) Ltd. F-405 S.I.T.E, Karachi.
Applicant
Brand Name + Dosage Form + Strength RHIZIN-X NASAL SPRAY 15 ml
Composition Each ml of spray contains:
Sodium Cromoglycate…………………4 %
Xylometazoline…………………………0.025 %
2019
Finished product Specification Innovator’s Specification.
Approval status of product in Reference Not verified
Me-too status Oxycrom-P Nasal Spray, Sante (Pvt)Ltd. (Not verified)
GMP status GMP inspection conducted on 11/6/2021 on the basis of
GMP inspection conducted 02/06/2021
Remarks of the Evaluator 1. Form-5 on prescribed Firm has submitted revised
format including the form -5 on prescribed
composition /label claim. format with label claim as:
2. Manufacturing Flow Each ml of spray contains:
chart/outline. Sodium
3. Section approval letter. Cromoglycate……4 %
4. Evidence of approval of Xylometazoline…0.025 %
applied formulation in along with annexures
reference regulatory (master formulation and
authorities/agencies which manufacturing method),
were adopted by the along with Fee challan No.
Registration Board in its 41766043424 dated 08-03-
275th meeting. 2022 of 7500/=.
5. In some documents firm
has mentioned
Xylometazoline 0.025
mg/ml and in some
documents, they mentioned
it as xylometazoline 0.25
mg / ml, clarify the label
claim with full
differentiation
preregistration variation fee
challan of 20000/=.
Previous Decision 316th meeting: Deferred for following;
• The firm shall submit full differential fee of 22500/= for submission of revised Form-5 on prescribed
format as per SRO No. F.7-11/2012-B&A/DRAP dated 13-07-2021.
Reply of the Firm: Firm has submitted differential fee challan No.918407119119 dated 28-06-
2022 of 22500/= and claimed manufacturing facility of Nasal spray in topical section. (copy of
approval of Topical section from CLB is attached)
Remarks of Evaluator • Evidence of approval of applied formulation in
• Me-too/Generic product registered in Pakistan.
• Nasal spray manufacturing facility/Section from CLB
• Me-too/Generic product registered in Pakistan.
762. Name and address of manufacturer/ Cibex (Pvt) Ltd. F-405 S.I.T.E, Karachi.
Applicant
Brand Name + Dosage Form + Strength RHIZIN NASAL SPRAY 15 ml
Composition Each ml of spray solution contains:
Sodium Cromoglycate………………4 %
2019
Finished product Specification USP Specification.
Approval status of product in Reference Not Verified
Me-too status Oxycrom-P nasal spray 15ml of M/s Sante Pakistan Ltd.
(Reg.#025164)
GMP status GMP inspection conducted on 11/6/2021 on the basis of
GMP inspection conducted 02/06/2021
Remarks of the Evaluator 1. Form-5 on prescribed Firm has submitted revised
format including the form -5 on prescribed
composition /label claim. format along with
2. Manufacturing Flow annexures (master
chart/outline. formulation and
3. Section approval letter. manufacturing method),
along with Fee challan No.
4.Evidence of approval of 41766043424 dated 08-03-
applied formulation in 2022 of 7500/=
reference regulatory
authorities/agencies which
were adopted by the
Registration Board in its
275th meeting.
Previous Decision 316th meeting: Deferred for following;
• The firm shall submit full differential fee of 22500/= for submission of revised
Reply of the Firm: Firm has submitted differential fee challan No.3848400538 dated 28-06-2022
of 22500/= and claimed manufacturing facility of Nasal spray in topical section. (copy of
approval of Topical section from CLB is attached)
Remarks of Evaluator • Evidence of approval of applied formulation in
763. Name and address of manufacturer/ M/s. Shrooq Pharmacetuicals (Pvt) Ltd., 21-Km Ferozepur
Applicant Road, Lahore.
Brand Name + Dosage Form + Strength Occunet I.V Infusion
Composition Each 250ml Contains: -
Moxifloxacin (as Hydrochloride) ………….….400mg
Diary No. Date of R & I & fee Dy. No 563 dated 27-3-2014, Rs.20,000/
Pharmacological Group (Quinolone)
Finished product Specification Manufacturer Specification.
Pack size & Demanded Price 1×250ml, As per SRO
Approval status of product in Reference BNF: Avelox (Bayer)
Regulatory Authorities Moxifloxacin 400mg/250mL Solution for infusion
MHRA Approved.
Me-too status Molox (CCL).
M-Floxsel Infusion 400mg/250ml by M/s Pharmasol (Pvt)
Ltd (Reg#100857)
10-2021, the panel recommends the renewal of DML.
Previous remarks of the Evaluator 1. Firm has RW-500 vial filling Machine which has filling
range of 2-100ml, However Firm claims that its range can
be increase to 250ml.
2. TOC analyzer and liquid particle counter are under the
process of procurement.
Previous Decision 245th meeting:
Deferred for TOC & Liquid Particle counter. The confirmation of manufacturing facility requirement
for large volume parenteral shall be sought out from directorate of Drug Licensing.
Reply of the Firm:
Firm has submitted their reply along with last inspection report dated 26-10-2021 & 29-10-2021 for
Renewal of DML, where in the panel of inspectors has mentioned on page 5 under the heading h) Vial
Infusion Section: The washing and solution area for ampoules and vials were same. Separate
filling room for vial infusion was provided which was equipment with vial filling and sealing
machine under laminar flow hood, HEPA filter. the area was maintained.
On page 6 of report under the heading 5. Laboratory Control: The quality control laboratory was
divided in to chemical laboratory, instrument room and microbiology laboratory. Requisite
equipment such as three HPLC, UV spectrophotometer, FTIR, TOC apparatus, Dissolution
apparatus, Liquid Particle Counter e.t.c were installed.
Firm has also attached approval of Vial Infusion section vide letter No. F. 6-2/2013-Lic (M-233) dated
7-4-2014 issued by CLB.
Agenda of Evaluator PEC-XVII.

Case No. 1: Registration applications for local manufacturing of (Human) drugs.
a; New cases:
764. Name and address of manufacture / M/s Epla Laboratories (Pvt) Ltd., D-12, Estate
Applicant Avenue, S.I.T.E, Karachi.
Brand Name + Dosage Form and CLARBACT suspension (125mg/5ml)
Strength
Composition Each 5ml of reconstituted suspension contains:
Clarithromycin…...125mg
(as taste-mask granules)
Dairy No. date of R &I fee Dy. No. 13054 dated 06-03-2019 Rs.20,000/- dated
05-03-2019 Challan No. 0817936 dated: 26.02.2019
Type of form Form 5
Finished product specifications USP specifications
Pack size and Demand Price 60ml, as per DRAP policy/ Brand leader
Approval status of product in MHRA approved (Granules for oral suspension)
Me-too-status Texklar 125mg/5ml Dry Suspension of Rotex pharma
Islamabad. Registration No. 097435
GMP Status Routine GMP inspection conducted on 21-06-2022
with conclusion as:
Based on the areas inspected, the people met and the
documents reviewed, M/s Epla Laboratories (Pvt)
Limited is considered to be operating at good level of
GMP compliance as per DRAP Act, 2012 and rules
framed thereunder.
Remark of the Evaluator (PEC-XVII) • Firm has changed taste-mask granules source from
Guobang Pharmachem Group Co., Ltd. China to
M/s Surge Laboratories Pvt. Ltd. Sheikhupura and
submitted fee of Rs: 30,000/- vide online deposit
slip No.3966850056 for source change.
• Firm has provided CoA of Clarithromycin taste
mask coated granules 27.5% w/w (suspension
grade).
• Firm has provided GMP certificate of granules
manufacturer/supplier (Surge laboratories,
Sheikhupura) dated 04-07-2019.
• Firm has submitted real-time stability data sheets
conducted at 30 0C ± 2ºC and 65%RH ± 5%RH of
three batches for 36 months and accelerated stability
data sheets conducted at 40 0C ± 2 ºC and 75%RH ±
5%RH of three batches for six months with testing
points as 0, 3, 6, 9, 12, 18, 24 & 36 months (for Long
term stability studies) and 0, 1, 2, 3 & 6 months (for
Accelerated Stability Conditions).
• The Dry Powder Suspension (General) Section
mentioned/available vide Licensing Division,
DRAP Islamabad letter No.F.2-4/2000-Lic (Vol-II)
dated 20-09-2021, titles as “Renewal of Drug
Manufacturing Licensing Under the Drugs Act,
1976.
Decision: Approved.
765. Name and address of manufacture / M/s Epla Laboratories (Pvt) Ltd., D-12, Estate
Applicant Avenue, S.I.T.E, Karachi.
Brand Name + Dosage Form and CLARBACT DS suspension (250mg/5ml)
Strength
Composition Each 5ml reconstituted suspension contains:
Clarithromycin…...250mg
(as taste-mask granules)
Dairy No. date of R &I fee Dy. No. 13053 dated 06-03-2019 Rs.20,000/- dated
05-03-2019 Challan No. 0817937 dated: 26.02.2019
Type of form Form 5
Pack size and Demand Price 60ml, as per DRAP policy/ Brand leader
Approval status of product in MHRA approved (Granules for oral suspension)
Me-too-status Karit 250mg/5ml Dry Suspension of Saffron
Pharmaceuticals, Faisalabad. Registration No.
097781
GMP Status Routine GMP inspection conducted on 21-06-2022
with conclusion as:
documents reviewed, M/s Epla Laboratories (Pvt)
Limited is considered to be operating at good level of
GMP compliance as per DRAP Act, 2012 and rules
framed thereunder.
Remark of the Evaluator (PEC-XVII) • Firm has changed taste-mask granules source from
Guobang Pharmachem Group Co., Ltd. China to
M/s Surge Laboratories Pvt. Ltd. Sheikhupura and
submitted fee of Rs: 30,000/- vide online deposit
slip No.69855717275 for source change.
• Firm has provided CoA of Clarithromycin taste
mask coated granules 27.5% w/w (suspension
grade).
• Firm has provided GMP certificate of granules
manufacturer/supplier (Surge laboratories,
Sheikhupura) dated 04-07-2019.
conducted at 30 0C ± 2ºC and 65%RH ± 5%RH of
three batches for 36 months and accelerated stability
data sheets conducted at 40 0C ± 2 ºC and 75%RH ±
5%RH of three batches for six months with testing
points as 0, 3, 6, 9, 12, 18, 24 & 36 months (for Long
term stability studies) and 0, 1, 2, 3 & 6 months (for
• The Dry Powder Suspension (General) Section
mentioned/available vide Licensing Division,
DRAP Islamabad letter No.F.2-4/2000-Lic (Vol-II)
dated 20-09-2021, titles as “Renewal of Drug
Manufacturing Licensing Under the Drugs Act,
1976.
Decision: Approved.
766. Name and address of manufacturer/ Applicant: Gillman Pharmaceuticals, Plot No.41/2-A,
Applicant Phase I & II, Industrial Estate Hattar.
Manufactured by:
Brand Name + Dosage Form + Strength TRANSAGIL 500mg/5ml injection
Tranexamic acid…………. 500mg
Diary No. Date of R & I & fee Dy.No 11486 dated 05-03-2019 Rs.50,000/- dated 04-
03-2019
Pharmacological Group Anti-fibrinolytic agent
Type of Form Form 5
Finished product Specification BP specifications
Me-too status Hixamic 500mg injection, Himont Pharmaceuticals
Lahore. Registration No. 047937
GMP status Panel inspection for renewal of DML conducted on 13-
02-2019 and concluded as “Based on the area inspected,
the people met, documents reviewed and considering
the findings especially the efforts in removal of
observations noticed during the last inspection of the
premises, the panel unanimously recommended the
renewal of Drug Manufacturing License No.000752 (by
way of formulation) to M/s EG Pharmaceuticals, Plot
No.13A, Industrial Triangle, Kahuta Road, Islamabad.
Remarks of the Evaluator (PEC-XVII) • GMP inspection report of the contract acceptor that is
M/s EG Pharmaceuticals, Kahuta road, Islamabad is
required.
• GMP inspection report of the contract giver that is M/s
Gillman Pharmaceuticals, Plot No.41/2-A, Phase I & II,
Industrial Estate Hattar is required.
•Method of sterilization has not been mentioned in
• Registration Board in its 288th meeting upon
detailed deliberation of capacity assessment
report and considering the measures taken by
the firm for upgradation of QC lab decided to
allow contract manufacturing by M/s EG
Pharmaceuticals, Industrial Triangle Kahuta
• Road, Islamabad
•For above revision, submit applicable fee as per
notifications 7-11/2012-B&A/DRAP dated 07-05-2021
& 13-07-2021.
Decision: Approved.
Registration letter will be issued upon submission of following:
• Revised manufacturing outlines with details of sterilization method employed alongwith fee
of Rs. 7,500/- as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021 for
manufacturing outlines revision
• Latest GMP inspection report of both applicant and manufacturer conducted within last
three years.
767. Name and address of manufacturer/ Applicant: Gillman Pharmaceuticals, Plot No.41/2-A,
Applicant Phase I & II, Industrial Estate Hattar.
Manufactured by:
Brand Name + Dosage Form + Strength SETRON 8mg/4ml injection (IM/IV)
Ondansetron (as Hydrochloride dihydrate) …...8mg
Diary No. Date of R & I & fee Dy.No 11485 dated 05-03-2019 Rs.50,000/- dated 04-
03-2019
Pharmacological Group 5HT3 antagonist
Type of Form Form 5
Me-too status Anomed 8mg injection by Evergreen pharmaceuticals,
Lahore. Registration No.069099
Vemtix 8mg/4ml Injection by M/s Biolabs Islamabad.
Reg# 093252)
02-2019 and concluded as “Based on the area inspected,
the people met, documents reviewed and considering
the findings especially the efforts in removal of
observations noticed during the last inspection of the
premises, the panel unanimously recommended the
renewal of Drug Manufacturing License No.000752 (by
way of formulation) to M/s EG Pharmaceuticals, Plot
No.13A, Industrial Triangle, Kahuta Road, Islamabad.
Remarks of the Evaluator (PEC-XVII) • GMP inspection report of the contract acceptor that is
M/s EG Pharmaceuticals, Kahuta road, Islamabad is
required.
• GMP inspection report of the contract giver that is M/s
Gillman Pharmaceuticals, Plot No.41/2-A, Phase I & II,
Industrial Estate Hattar is required.
• Weight of API is not adjusted in the master formulation
considering the salt and hydrated form of the drug.
• Method of sterilization has not been mentioned in
& 13-07-2021.
Decision: Approved.
• Revised manufacturing outlines with details of sterilization method employed alongwith fee
of Rs. 7,500/- as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021 for
manufacturing outlines revision
• Latest GMP inspection report of both applicant and manufacturer conducted within last
three years.
768. Name and address of manufacture / M/s Bio Mark Pharmaceuticals. Plot No. 527, Sundar
Applicant Industrial Estate, Lahore (Tablet I & II General)
Brand Name + Dosage Form and BIOMP 40mg Tablet
Strength
Composition Each gastro resistant tablet contains:
Omeprazole ……. 40mg
Dairy No. date of R &I fee Form-5 Dy. No. 10339 dated 05-03-2019 Rs.20,000
dated 04-03-2019
Type of form Form 5
Finished product specifications Innovator’s specifications
Pack size and Demand Price 14’s, As per SRO
Approval status of product in Losec MUPS (multiple unit pellet system) 40mg
Reference Regulatory Authorities AstraZeneca UK (MHRA approved)
Omeprazole 40 mg gastro-resistant tablets
Each gastro-resistant tablet contains 40 mg Omeprazole
(MHRA approved
Me-too-status BENZIM 40mg Tablet (M/S Wilshire) Reg. # 044599
GMP Status GMP certificate valid till 12-02-2022, issued on the basis
of inspection conducted on 13-02-2020.
Remark of the Evaluator (PEC-XVII) • Revision is not required since the label claim provided
is in line with reference product. Submit master
formulation of the product.
• Revision of manufacturing outlines not required as the
applied formulation is available as gastro-resistant tablet
(enteric coated). For above revision, submit applicable
fee as per notifications 7-11/2012-B&A/DRAP dated 07-
05-2021 & 13-07-2021.
• DML granted vide letter No. F.1-29/2011-Lic dated 12-
06-2017 w.e.f 12.06.2017 for following sections:
Tablet I (General)
Tablet II (General)
Capsule (General)
Sachet (General)
Oral syrup (General)
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product
Brand Name + Dosage Form and NEBVAL 5/80mg tablet
Strength
Composition Each film-coated tablet contains:
Nebivolol …. 5mg
Valsartan …... 80mg
Dairy No. date of R &I fee Form-5 Dy.No 10331 dated 05-03-2019 Rs.20,000 dated
04-03-2019
Pharmacological Group Nebivolol: Beta adrenergic blocker /Anti-hypertensive
Valsartan: Angiotensin Receptor Antagonists/Anti-
hypertensive
Type of form Form 5
Finished product specifications Innovator specifications
Pack size and Demand Price 14’s, 30’s, 60’s, As per SRO
Approval status of product in BYVALSON 5mg/80mg Allergen USA
Reference RegulatoryAuthorities (USFDA status is discontinued)
Me-too-status Could not be confirmed
GMP Status GMP certificate valid till 12-02-2022, issued on the basis
of inspection conducted on 13-02-2020.
Remark of the Evaluator (PEC-XVII) • Provide evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along with
registration number, brand name and name of firm as the
“Me too” provided by the firm could not be confirmed.
• Provide evidence of approval of applied formulation in
reference regulatory authorities / agencies which were
adopted by the Registration Board in its 275th meeting as
BYVALSON 5mg/80mg Allergen USA (USFDA) status
is discontinued.
• DML granted vide letter No. F.1-29/2011-Lic dated 12-06-
2017 w.e.f 12.06.2017 for following sections:
Tablet I (General)
Tablet II (General)
Capsule (General)
Sachet (General)

•Evidence of approval of applied formulation in reference regulatory authorities/agencies which
were declared/approved by the Registration Board in its 275th meeting.
Brand Name + Dosage Form and Deflu 10mg Tablet
Strength
Loratadine…10mg
Dairy No. date of R &I fee Form-5 Dy. No 10851 dated 05-03-2019 Rs.20,000/- dated
04-03-2019
Pharmacological Group Histamine H1 Antagonists
Type of form Form 5
Pack size and Demand Price 10’s, As per SRO
CLARITIN 10mg tablet (Bayer) MHRA approved
Me-too-status ANTIAL 10mg tablet by Sami pharmaceuticals, Karachi
(Registration No. 019675)
GMP Status GMP certificate valid till 12-02-2022, issued on the basis of
Remark of the Evaluator (PEC-XVII) • Revise label claim as per reference product as:
Each tablet contains:
Loratadine…...10mg
notifications 7-11/2012-B&A/DRAP dated 07-05-2021 &
13-07-2021.
Tablet I (General)
Tablet II (General)
Capsule (General)
Sachet (General)
Decision: Approved with revised label claim as;
Each tablet contains:
Loratadine…...10mg
•Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change in composition
(correction/change of formulation from film-coated tablet to un-coated tablet), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and INVGA 3mg tablet
Strength
Composition Each sustained release tablet contains:
Paliperidone…3mg
04-03-2019
Pharmacological Group Anti-Psychotic
Type of form Form 5
Pack size and Demand Price 14’s, 28’s, As per SRO
Approval status of product in Trilayer capsule-shaped white tablets of 11 mm in length
Reference Regulatory Authorities and 5 mm in diameter printed with “PAL 3”
INVEGA 3mg Janssen Inc. UK Approved MHRA
(BNF p# 374-375)
Me-too-status VEGADON SR 3mg Danas Pharmaceuticals Reg. #
080372
Remark of the Evaluator (PEC-XVII) • The reference product Invega, approved by USFDA is
Extended release tablet manufactured by OROS Push-Pull
Technology and the public assessment report describes
that osmotic pressure delivers paliperidone from the
dosage form at a controlled rate. Provide evidence of
required manufacturing technology as per reference
product.
• The firm has claimed USP specifications while the product
is non-pharmacopoeial.
• Master formulation for the applied product is required.
13-07-2021.
Tablet I (General)
Tablet II (General)
Capsule (General)
Sachet (General)
• Evidence of availability of requisite manufacturing technology (OROS Push-Pull technology as per
innovator/reference product (INVEGA 3mg).
• Revision of finished drug product specifications as firm has claimed USP specifications, while
official monograph of the product not available.
• Submission of master formulation as per reference product.
Applicant Industrial Estate, Lahore (Oral Syrup General)
Brand Name + Dosage Form and I folk 40mg/5mg
Strength
Iron Protein Succinylate 800mg Eq. to Elemental Iron
……50mg
Folic Acid…5mg
Dairy No. date of R &I fee Form-5 Dy. No 10870 dated 05-03-2019 Rs.20,000/- dated
04-03-2019
Pharmacological Group Iron preparation
Type of form Form 5
Finished product specifications Innovator
Approval status of product in Reference Couldn’t be confirmed
Me-too-status Sucrofer F (800mg, 5mg/15ml) syrup by M/s CCL
Pharmaceuticals, Lahore.
Varience HB (800mg, 5mg/15ml syrup by Unison
Chemicals, Lahore.
Batema-F syrup (800mg, 5mg/15ml) Cibex Pvt. Ltd.
Karachi Reg # 076713
Remark of the Evaluator (PEC-XVII)
• The strength mentioned in the cover letter as “Iron protein
succinylate 200mg + Folid acid 2.5mg/5ml” while in
Form-5, the composition mentioned as “Each 15 ml
contains Iron Protein Succinylate 800mg equivalent to
elemental iron 40mg and folid acid 5mg. Furthermore,
there is variation in composition in different sections of
the dossier.
Tablet I (General)
Tablet II (General)
Capsule (General)
Sachet (General)
Decision: Deferred for further deliberation regarding composition of applied product and already
approved generic products.
773. Name and address of manufacture / M/s Bio-Labs (Pvt) ltd., Plot No.145, Industrial Triangle,
Applicant Kahuta Road, Islamabad.
Capsule Section (General)
Brand Name + Dosage Form and CHOLITOLRATE capsules 4mg
Strength
Composition Each prolonged-release capsule contains:
Tolterodine tartrate………….4mg
Dairy No. date of R &I fee Dy. No 12434 dated 06-03-2019 Rs.20,000/- dated 05-03-
2019
Pharmacological Group Anti-cholinergic agent
Type of form Form 5
Finished product specifications BP specifications
Pack size and Demand Price 30’s as per DRAP’s pricing policy
Approval status of product in Reference Detrusitol XL 4 mg, prolonged-release capsules, hard
Regulatory Authorities (MHRA approved)
Me-too-status Urot 4mg capsules by Ciba pharmaceuticals, Karachi.
GMP Status GMP certificate issued to firm on 21st May, 2019, on the
basis of panel GMP inspection conducted on 23.04.2019
and valid upto 22.04.2022.
• GMP inspection report conducted within last 03years is
required.
• The firm has mentioned tolterodine tartrate sustained
release pellets 2%. Please provide source of pellets,
stability studies data of 3 batches, GMP certificate of
supplier, COA of pellets and submit differential fee in case
of imported pellets source.
• Revise label claim as;
Each prolonged-release capsule contains:
Tolterodine tartrate Sustained Release Pellets Eq. to
Tolterodine tartrate……...4mg” since the firm has
mentioned Tolterodine tartrate sustained release pellets
2% in master formulation.
• Capsule section (General) approved vide Licensing
Division letter No.F.1-12/98-Lic (Vol-II) dated
24.03.2007.
13-07-2021.
• Submission of pellets source, stability study data of 03 batches, GMP certificate of pellets
manufacturer and in case of imported source of pellets, applicable fee shall be submitted.
• Revision of label claim as;
Each prolonged-release capsule contains:
Tolterodine tartrate sustained release pellets equivalent to Tolterodine tartrate……4mg.
• Submission of GMP audit report from QA & LT Division, valid within last 03 years.
• Submission of applicable fee as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-
2021.
774. Name and address of manufacture / M/s Baxter Pharmaceuticals, A-1/A, Scheme No.33, Phase-
Applicant 1, S.I.T.E., Super Highway, Karachi.
Brand Name + Dosage Form and PINEX-V (5/80mg) tablet
Strength
Amlodipine….5mg
Valsartan…….80mg
2019
Pharmacological Group Angiotensin-II receptor blocker and Ca channel blocker
Type of form Form 5
Pack size and Demand Price As per PRC
Approval status of product in Reference Exforge® 5 mg/80 mg film-coated tablets (Novartis,
Regulatory Authorities MHRA approved)
Me-too-status Amlowell 5mg/80mg tablet of M/s Aspin pharma Karachi.
GMP Status Updated GMP compliance status required
Each film-coated tablet contains:
Amlodipine (as besylate) ……...5mg
Valsartan……………………. 80mg
• The firm to revise master formulation and manufacturing
outlines accordingly.
• Provide evidence of relevant section approval by
Licensing division, DRAP Islamabad.
• GMP inspection report conducted within last 03 years
required.
13-07-2021.
Decision: Approved as per following label claim;
“Each film-coated tablet contains:
Amlodipine (as besylate) …….5mg
Valsartan…………………….80mg
Firm shall submit following before issuance of registration letter:

• Fee of Rs. 30,000 for correction/pre-approval change in composition (correction/change of salt form
of the drug substance), as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and PINEX-V (5/160mg) tablet
Strength
Amlodipine….5mg
2019
Pharmacological Group Angiotensin-II receptor blocker and Ca channel blocker
Type of form Form 5
Approval status of product in Reference Exforge® 5 mg/160 mg film-coated tablets (Novartis,
Regulatory Authorities MHRA approved)
Me-too-status Amlowell 5mg/160mg tablet of M/s Aspin pharma
Karachi. Registration No. 100106
Amlodipine (as besylate) ……...5mg
Valsartan……………………. 160mg
required.
13-07-2021.
• Each film-coated tablet contains:
Amlodipine (as besylate) …….5mg
Valsartan…………………….160mg

Brand Name + Dosage Form and Valart 160mg tablet
Strength
2019
Pharmacological Group Angiotensin-II receptor blocker
Type of form Form 5
Approval status of product in Reference Valsartan 40mg, 80mg, 160mg and 320 mg film-coated
Regulatory Authorities tablets (MHRA approved)
Me-too-status Converge 160mg tablet, Scotmann pharmaceuticals,
Valsartan…………160mg, along with revision of
st
954
• Finished product testing methods provided for Vimet
50/500mg tablet that is Vildagliptin and metformin HCl
tablet.
required.
13-07-2021.
Valsartan …………. 160mg

Brand Name + Dosage Form and Sitaformin 50mg/500mg tablet
Strength
Sitagliptin Phosphate Monohydrate….50mg
Metformin hydrochloride………...500mg
2019
Pharmacological Group Dipeptidyl Peptidase-4/DPP-4 Inhibitors and Biguanide
Antidiabetic combinations
Type of form Form 5
Approval status of product in Reference Janumet® 50 mg/500 mg film coated tablets (MHRA
Me-too-status Sitanext 50/500mg film coated tablet of M/s Next
Pharmaceutical products Lahore Regist. No.084472
Sitagliptin (as phosphate monohydrate) ……...50mg
Metformin hydrochloride……………. 500mg
required.
13-07-2021.
Decision: Approved with revised label claim;
Sitagliptin (as phosphate monohydrate) ….50mg

Brand Name + Dosage Form and Sitaformin 50mg/1000mg tablet
Strength
Sitagliptin Phosphate Monohydrate….50mg
2019
Pharmacological Group Dipeptidyl Peptidase-4/DPP-4 Inhibitors and Biguanide
Antidiabetic combinations
Type of form Form 5
Approval status of product in Reference Janumet® 50 mg/1,000 mg film coated tablets (MHRA
Me-too-status Sitanext 50/1000mg film coated tablet of M/s Next
Pharmaceutical products Lahore Regist. No.084473
Sitagliptin (as Phosphate monohydrate) ……...50mg
Metformin hydrochloride……………. 1000mg
• Mater formula given is for “Lornoxicam”
• In the manufacturing outlines, the drug Tizanidine has
been mentioned.
required.
13-07-2021.
Decision: Approved with following revised label claim;
Sitagliptin (as phosphate monohydrate) ….50mg

Brand Name + Dosage Form and Vimet 50mg/500mg tablet
Strength
Vildagliptin………50mg
Metformin hydrochloride……….500mg
2019
Type of form Form 5
Approval status of product in Reference Galvumet 50 mg/500 mg film coated tablets, Novartis
Regulatory Authorities Pharmaceuticals (TGA Australia)
Me-too-status Viglip M 50/500mg tablet of Atco laboratories, Karachi.
required.
13-07-2021.
Decision: Approved with following revised label claim;

• Fee of Rs. 7,500 for correction/pre-approval change in composition (correction/change of
formulation from un-coated tablet to film coated tablet), as per notification No.F.7-11/2012-
Brand Name + Dosage Form and Vimet 50mg/1000mg tablet
Strength
Vildagliptin…...50mg
Metformin hydrochloride………1000mg
2019
Type of form Form 5
Approval status of product in Reference Galvumet 50 mg/1000 mg film coated tablets, Novartis
Regulatory Authorities Pharmaceuticals (TGA Australia)
Me-too-status Velon M 50/1000mg tablet of Genix pharma, karachi.
• Applied product specifications mentioned as per USP but
the product monograph does not exist in USP.
required.
13-07-2021.
st
957
Decision: Approved with innovators specifications and following revised label claim;

• Fee of Rs. 7,500 for correction/pre-approval change in composition (correction/change of
formulation from un-coated tablet to film coated tablet), as per notification No.F.7-11/2012-
Brand Name + Dosage Form and Amsartan 20mg/5mg tablet
Strength
Olmesartan medoxomil…...20mg
Amlodipine………5mg
2019
Pharmacological Group Ca+ ion influx inhibitor of the dihydropyridine group
Type of form Form 5
Finished product specifications Manufacturer specifications
Approval status of product in Reference (MHRA approved)
Me-too-status Olmedip 5mg/20mg tablet by Shrooq Pharmaceuticals,
Lahore. Reg. No. 068083
Amlodipine (as besyate) ………5mg
required.
13-07-2021.

Strength
Olmesartan medoxomil…. 40mg
2019
Type of form Form 5
Me-too-status Onato-OM 5/40mg Tablet by Sami Pharmaceuticals
required.
13-07-2021.

Strength
Olmesartan medoxomil…. 40mg
2019
Type of form Form 5
Me-too-status Onato-OM 10/20mg Tablet by Sami Pharmaceuticals
required.
13-07-2021.

Latest GMP inspection report conducted within last three years.
Brand Name + Dosage Form and Furox 20mg tablet
Strength
Furosemide….20mg
2019
Pharmacological Group Diuretics
Type of form Form 5
Approval status of product in Reference (US FDA approved)
Me-too-status Asumide 20mg tablet by Maple Pharmaceuticals Karachi.
Reg. No. 089030
GMP Status GMP inspection conducted within last 03 years required
Remark of the Evaluator (PEC-XVII) • The applied formulation is uncoated tablet while the firm
has mentioned coating materials in master formulation.
required.
13-07-2021.
Decision: Approved. Firm shall submit fee of Rs.7,500 for correction/pre-approval change in master
formulation as per label claim by excluding coating materials, as per notification No.F.7-11/2012-
Registration letter will be issued upon submission of latest GMP inspection report conducted
Brand Name + Dosage Form and Furox 40mg tablet
Strength
Furosemide….40mg
2019
Type of form Form 5
Approval status of product in Reference (US FDA approved)
Me-too-status Asumide 40mg tablet by Maple Pharmaceuticals Karachi.
Reg. No. 089031
Remark of the Evaluator (PEC-XVII) • The applied formulation is uncoated tablet while the firm
has mentioned coating materials in master formulation.
required.
13-07-2021.
Decision: Approved. Firm shall submit fee of Rs.7,500 for correction/pre-approval change in
master formulation as per label claim by excluding coating materials, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Furox 5mg/5ml
Strength
Composition Each suspension contains:
Furosemide….5mg/ml
2019
Type of form Form 5
Approval status of product in Reference (US FDA approved strengths are 10mg/ml & 40mg/5ml
Me-too-status Could not be confirmed

Remark of the Evaluator (PEC-XVII) • Provide evidence of availability of applied
formulation/strength that is 5mg/5ml in reference
regulatory authorities as approved by the Drug
• Provide evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along with
registration number, proprietary name and manufacturer.
• Master formulation and manufacturing outlines of the
product is not provided.
• The approved strengths (10mg/ml & 40mg/5ml) in US
FDA are in the form of clear solution, while the firm has
applied for suspension.
• Analytical testing method and specifications of the
finished drug product not provided.
• In MHRA shelf life for oral solution given is 18months
(unopened) and 3months (when opened).
required.
• For revision, if any to be made, submit applicable fee as
per notifications 7-11/2012-B&A/DRAP dated 07-05-
st
961
2021 & 13-07-2021.
alongwith registration number, brand name and name of firm.
were declared/approved by the Registration Board in its 275th meeting.
• Submission of master formulation and manufacturing outlines for the applied product.
• Finished product specification not provided.
• Submission of GMP audit report from QA & LT Division, valid within 03 years.
• Submission of evidence of required manufacturing facility / section from Licensing Division.
Brand Name + Dosage Form and Fenorate 67mg capsules
Strength
Finofibrate…….67mg
2019
Pharmacological Group Antilipemics and fibric acid
Type of form Form 5
Approval status of product in Reference Fenofibrate 67mg capsules. Each capsule contains 67 mg of
Regulatory Authorities micronized fenofibrate (Teva, UK) MHRA approved
Me-too-status Fenoget 67mg capsules (fenofibrate micronized) of Getz
Pharma, Karachi. Registration No.047197
Remark of the Evaluator (PEC-XVII) • The firm has claimed manufacturer specifications and
official monograph not available.
required.
• Submit fee of Rs. 7,500 for correction/pre-approval change in product specifications, as per
• Registration letter will be issued upon submission of latest GMP inspection report conducted
788. Name and address of manufacture / M/s Baxter Pharmaceuticals, A-1/A, Scheme No. 33, Phase-
Brand Name + Dosage Form and Fenorate 200mg capsules
Strength
Finofibrate…….200mg
2019
Pharmacological Group Antilipemics and fibric acid
Type of form Form 5
Approval status of product in Reference Fenofibrate 200mg capsules. Each capsule contains 200 mg
Regulatory Authorities of micronized fenofibrate (Teva, UK) MHRA approved
Me-too-status Fenoget 200mg capsules (fenofibrate micronized) of Getz
Pharma, Karachi. Registration No.047198
Remark of the Evaluator (PEC-XVII) • The firm has claimed manufacturer specifications and
official monograph not available.
required.
However, before issuance of registration letter, the firm shall;
• Submit fee of Rs. 7,500 for correction/pre-approval change in product specifications, as per
Brand Name + Dosage Form and Atenox 50mg tablet
Strength
Atenolol…….50mg
2019
Pharmacological Group Beta blocker, Antihypertensive
Type of form Form 5
Approval status of product in Reference TENORMIN®, AstraZeneca pharmaceuticals (US FDA
Me-too-status Lotonol 50mg tablet of M/s Lotus Pharmaceuticals
Remark of the Evaluator (PEC-XVII) • The product is available as both uncoated and film-coated
tablet.
required.
Decision: Approved.
Brand Name + Dosage Form and Lecetine 5mg tablet
Strength
Levocetirizine…….5mg
2019
Pharmacological Group Non-sedating antihistamine
Type of form Form 5
Me-too-status Merlozine 5mg tablet of Medicraft pharmaceuticals,
Peshawar. Registration No. 101383
Levocetirizine dihydrochloride………5mg
• The reference product is film coated while in master
formulation and manufacturing outlines, the film coating
materials and process not mentioned.
required.
13-07-2021.
Levocetirizine dihydrochloride………5mg
• Submit fee of Rs. 30,000 for correction/pre-approval change in composition (correction/change of
salt form of the drug substance), as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form and Nipine 10mg capsules
Strength
Nifedipine…….10mg
2019
Pharmacological Group Dihydropyridine calcium channel blocker
Type of form Form 5
Me-too-status ADALAT 10mg capsules of M/s Bayer. Reg.No.004162
Remark of the Evaluator (PEC-XVII) • Clarification is required regarding the applied dosage
form, as the firm label claim is for tablet while in different
sections of the dossiers, the capsule dosage form is also
mentioned.
• Provide evidence of availability of applied formulation in
reference regulatory authorities as approved by the Drug
• The product is available as SR hard capsules, soft gelatin
capsule and modified/sustained release tablets in various
Reference regulatory authorities.
• Confirmation of relevant manufacturing facility/section,
Me-too status and requisite fee will be determined after
clarification from the firm regarding applied formulation
is received.
• GMP inspection conducted within last 03 years required.
• Clarification regarding the applied dosage form, as the firm label claim is for tablet while in
different sections of the dossiers, the capsule dosage form is also mentioned.
• Submission of evidence of availability of applied formulation in reference regulatory authorities as
approved by the Drug Registration Board in its 275th meeting.
• Confirmation of relevant manufacturing facility/section, Me-too status and requisite fee will be
determined after clarification from the firm regarding applied formulation is received.
• Submission of GMP audit report from QA & LT Division, valid within 03 years.
Brand Name + Dosage Form and Diazide 30mg tablet
Strength
Gliclazide…….30mg
2019
Pharmacological Group Anti-diabetic
Type of form Form 5
Finished product specifications Innovators specifications
Approval status of product in Reference 30mg strength are in the form of modified release tablet.
Regulatory Authorities Diamicron 30mg MR Tablets (Les laboratories Servier,
France) (MHRA approved)
Me-too-status Diabetron CR 30mg tablet of M/s Ferozsons laboratories,
Nowshera. Registration No.070314
Remark of the Evaluator (PEC-XVII) • Provide evidence of availability of applied formulation in
reference regulatory authorities as adopted by the Drug
Registration Board in its 275th meeting or else revise label
claim/formulation as per reference product as:
Each modified-release tablet contains:
Gliclazide……30mg, since the applied strength is
available in modified release form.
• The master formulation submitted is for conventional
tablets, while the applied strength is available as modified
release tablet in reference regulatory authorities.
• In the master formulation firm has mentioned coating
materials, while the applied composition is uncoated.
• The testing method provided for conventional tablet as per
BP monograph. While the firm has mentioned USP
specifications for finished drug product. Official
monograph for modified release tablet dosage form is not
available.
required.
13-07-2021.
• Submission of evidence of availability of applied formulation in reference regulatory authorities as
adopted by the Drug Registration Board in its 275th meeting or else revise label claim/formulation
as per reference product as:
Each modified-release tablet contains:
Gliclazide……30mg, along with revision of master formulation, manufacturing outlines and
finished product specifications.
• Submission of GMP audit report from QA & LT Division, valid within last 03 years.
• The firm shall submit applicable fee as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021
& 13-07-2021.
Brand Name + Dosage Form and Vasoril 10mg tablet
Strength
Nicorandil…….10mg
2019
Pharmacological Group Potassium channel activator
Type of form Form 5
Approval status of product in Reference Nicorandil 10mg & 20mg tablet (Dexel Pharma laboratories
Regulatory Authorities UK) MHRA approved
Me-too-status Nikobar 10mg tablet of Barrett Hodgson, Karachi.
Remark of the Evaluator (PEC-XVII) • Shelf life of 18 months and 15 months mentioned in
reference product.
• GMP inspection conducted within last 03 years required.
Decision: Approved. Firm shall submit latets GMP inspection report conduted within last three
years before issuance of registration letter.
794. Name and address of manufacture / M/s Alina combine pharmaceuticals (Pvt.) Ltd.
Applicant A/27, S.I.T.E, Super Highway, Karachi.
Brand Name + Dosage Form and Artex 80mg IM injection
Strength
Artemether….80mg
2019 Challan No.0835046 dated: 02.03.2019
Pharmacological Group Anti-malarial
Type of form Form 5
Pack size and Demand Price As per PRC policy
Approval status of product in Reference Artemether solution for injection 80mg/ml
Regulatory Authorities WHO Approved formulation
Me-too-status Falcinil injection of M/s Bosch Pharmaceuticals Pvt ltd.
GMP Status Routine GMP inspection conducted on 08-01-2018 with
conclusion:
Based on the above observations their overall GMP
compliance level is rated as satisfactory.
• 1st page of Form 5 not signed by the firm/
applicant.
• Proposed route of administration mentioned as “Oral”
instead of Intra muscular injection.
Licensing Division, DRAP Islamabad.
• Panel inspection conducted on 03-10-2019
recommends renewal of DML No. 000441Frim has
mentioned manufacturer specifications, while the
product official monograph is given in
International pharmacopoeia. Revision of finished
product specifications as per IP is required.
13-07-2021.
Decision: Approved with International pharmacopoeia specifications.
Registration Board further decide that registration letter will be issued upon submission of Signed
& stamped Form 5 including relevant annexure for route of administration as “Intramuscular
injection”, as per innovator product along with fee of Rs. 7,500 for correction/pre-approval change/
in product specifications and route of administration as per notification No.F.7-11/2012-
Brand Name + Dosage Form and Domin 50mg injection (50mg/ml, 5ml)
Strength
Dobutamine (as Hydrochloride) ….50mg
2019 Challan No.0843227 dated: 02.03.2019
Pharmacological Group Cardiovascular
Type of form Form 5
Pack size and Demand Price 5ml ×1’s, 5ml × 5’s, Price not provided
Approval status of product in Reference Dobutamine 12.5 mg/ml concentrate for solution for
Regulatory Authorities infusion (5ml, 10ml or 20ml) &
Dobutamine 5 mg/ml (250 mg in 50 ml) ampoules/vials
(MHRA approved)
250 mg/20 mL or 12.5mg/ml Dobutamine (as hydrochloride)
concentrated injection. (TGA approved)
Me-too-status Dobamine 250mg vial of Biolabs (Pvt) Ltd. Islamabad.
Tobuject inj 250mg (20ml) of M/s MTI Medical (Pvt.) ltd.
Dobutine 12.5mg/ml injection of M/s Bajwa
Pharmaceuticals, Sheikhupura. Registration No. 093769
conclusion:
Remark of the Evaluator (PEC-XVII) • 1st page of Form 5 not signed by the applicant.
• Provide evidence of approval of applied formulation
(50mg/ml) in reference regulatory authorities/agencies
meeting or else revise label claim/formulation as per
reference product.
• Finished product specifications not provided. Official
monograph is available.
• For revision, if any to be made, submit applicable fee as
per notifications 7-11/2012-B&A/DRAP dated 07-05-
2021 & 13-07-2021.
• Submission of evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the Registration Board in its 275th meeting
or else revision of label claim as per reference product.
• Submission of signed/stamped copy of 1st page of Form-5 along with relevant annexure of drug
product specifications.
• Submission of applicable fee as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021 for
pre-approval change/correction in drug product specifications.
Brand Name + Dosage Form and Linadine 1gm injection
Strength
Composition Each vial contains:
Cephradine USP………1gm
2019 Challan No.0843231 dated: 02.03.2019
Pharmacological Group Antibiotic (Cephalosporin)
Type of form Form 5
Finished product specifications Not provided
Pack size and Demand Price 1’s vial, price not mentioned
Approval status of product in Reference Velosef 1gm vial approved in US FDA but the status is
Regulatory Authorities discontinued.
Me-too-status Valued dry powder 1gm injection of Trigon pharmaceuticals
conclusion:
Remark of the Evaluator (PEC-XVII) • 1st page of Form 5 not signed
• Provide evidence of approval of applied
formulation in reference regulatory authorities /
agencies which were adopted by the Registration
Board in its 275th meeting as the reference product
is discontinued in USFDA.
• Finished drug product specifications and analytical
testing methods not provided. However, product
official monograph available (USP).
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product specifications
Brand Name + Dosage Form and Albac 2gm injection
Strength
Cefoperazone U.S.P as equivalent to Cefoperazone
Sodium………1gm
Sulbactum U.S.P as equivalent to Sulbactum
Sodium….1gm
2019 Challan No.0835048 dated: 02.03.2019
Type of form Form 5
Approval status of product in Reference Sulperazon Injection by Pfizer Co. PMDA Japan Approved
Me-too-status Ceone 1gm injection Zesion Pharmaceuticals, Islamabad.
conclusion:
• 1st page of Form 5 is not signed by the firm/applicant.
• The strength in fee challan mentioned is 1gm and product
applied is 1gm. However, the label claim/composition
given is for 2gm strength, as both Cefoperazone and
Sulbactam are mentioned 1gm each. Clarification is
required from the firm in this regard. The label claim for
the applied product should then be revised as per reference
product as: (for 1gm strength)
Each vial contains:
Cefoperazone (as sodium) ….500mg
Sulbactum (as sodium) …….500mg
required.
• Finished product specifications not mentioned, however
official monograph available as per JP.
13-07-2021.
Decision: Approved with JP specifications as per following label claim:
Each vial contains:
Cefoperazone (as sodium) ….1gm
Sulbactum (as sodium) …….1gm.
• Firm shall submit the fee of Rs. 30,000 for correction/pre-approval change in composition
(correction/change of salt form of the drug substance), as per notification No.F.7-11/2012-
Brand Name + Dosage Form and Axime 750mg injection
Strength
Cefuroxime (as Cefuroxime sodium) ………750mg
2019 Challan No.0835050 dated: 02.03.2019
Type of form Form 5
Approval status of product in Reference Zinacef 750 mg powder for solution for injection or infusion
Regulatory Authorities Sandoz Pharmaceuticals (MHRA approved)
Me-too-status Astalexim 750mg IV injection of Astellas Pharmaceuticals,
Peshawar. Registration No.079751
conclusion:
Remark of the Evaluator (PEC-XVII) • Form 5 is not signed by the firm/applicant.
required.
official monograph for the drug product is available (USP).
Decision: Approved with USP specifications. Firm shall submit the fee of Rs. 7,500 for
correction/pre-approval change/ in product specifications as per notification No.F.7-11/2012-
Brand Name + Dosage Form and Axime 1.5 gm injection
Strength
Cefuroxime (as Cefuroxime sodium) ………1.5 gm
2019 Challan No.0835036 dated: 02.03.2019
Type of form Form 5
Approval status of product in Reference Zinacef 1.5 gm powder for solution for injection or infusion
Regulatory Authorities Sandoz Pharmaceuticals (MHRA approved)
Me-too-status Astalexim 1.5gm IV injection of Astellas Pharmaceuticals,
Peshawar. Registration No.079750
conclusion:
Remark of the Evaluator (PEC-XVII) • Form 5 is not signed by the firm/applicant.
required.
official monograph for the drug product is available (USP).
• In master formulation, the quantity of Cefuroxime (as
cefuroxime Na) mentioned is 1gm.
13-07-2021.
800. Name and address of manufacture / M/s Ambrosia Pharmaceuticals. Plot No. 18, Street No. 09,
Applicant National Industrial Zone, Rawat-Islamabad.
Brand Name + Dosage Form and Levtam 250mg tablet
Strength
Levetiracetam ...…250mg
2019 Challan No.0841511 dated: 06.03.2019
Pharmacological Group Anti-seizure (antiepileptic) drug
Type of form Form 5
Pack size and Demand Price 1 × 10, As per SRO
Me-too-status Levepil 250mg tablet of M/s Evolution Pharmaceuticals,
GMP Status Date: 08-10-2018
Recommendations:
During the follow up inspection of M/s Ambrosia
Pharmaceuticals Rawat, it is observed, that majority of the
observations noted in the previous inspection i.e. conducted
on 16-07-2018 have been rectified and the firm was found
working in compliance to GMP as of the date of inspection.
Remark of the Evaluator (PEC-XVII) • Provide evidence of relevant section approval by
• GMP inspection report dated 28-12-2021 recommends
renewal of DML.
• Primary packaging material for applied formulation is not
mentioned.
• Revise finished drug product specifications as per official
monograph (USP).
13-07-2021.
Strength
2019 Challan No.0841512 dated: 06.03.2019
Type of form Form 5
Recommendations:
mentioned.
monograph (USP).
13-07-2021.
Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product specifications
Registration letter will be issued upon submission of latest GMP inspection report conducted within
last three years.
Strength
2019 Challan No.0841513 dated: 06.03.2019
Type of form Form 5
Recommendations:
mentioned.
monograph (USP).
13-07-2021.
Strength
2019 Challan No.0841514 dated: 06.03.2019
Type of form Form 5
Recommendations:
mentioned.
• In the master formula, the quantity per tablet comes out to
be 100mg/tablet while the applied strength is
1000mg/tablet.
13-07-2021.
Brand Name + Dosage Form and Ambrig 40 mg tablet
Strength
Febuxostat ...…40mg
2019 Challan No.0841517 dated: 06.03.2019
Pharmacological Group Xanthine oxidase inhibitor used for treatment of gout
Type of form Form 5
Approval status of product in Reference Uloric 40 mg and 80 mg tablet (Takeda),
Regulatory Authorities US FDA approved with following boxed warning in revised
label (02-2019)
WARNING: CARDIOVASCULAR DEATH
Gout patients with established cardiovascular (CV) disease
treated with ULORIC had a higher rate of CV death
compared to those treated with allopurinol in a CV
outcomes study.
Consider the risks and benefits of ULORIC when deciding
to prescribe or continue patients on ULORIC. ULORIC
should only be used in patients who have an inadequate
response to a maximally titrated dose of allopurinol, who are
intolerant to allopurinol, or for whom treatment with
allopurinol is not advisable
Me-too-status Uristat 40mg tablet of M/s Medizan laboratories, Islamabad.
Recommendations:
• The firm has claimed manufacturer specifications, while
product official monograph is not available.
13-07-2021.
Decision: Approved with innovators specifications. Firm shall submit the fee of Rs. 7,500 for
Brand Name + Dosage Form and Ambrig 80 mg tablet
Strength
Febuxostat ...…80mg
2019 Challan No.0841518 dated: 06.03.2019
Pharmacological Group Xanthine oxidase inhibitor used for treatment of gout
Type of form Form 5
Approval status of product in Reference Uloric 40 mg and 80 mg tablet (Takeda),
Regulatory Authorities US FDA approved with following boxed warning in revised
label (02-2019)
WARNING: CARDIOVASCULAR DEATH
Gout patients with established cardiovascular (CV) disease
treated with ULORIC had a higher rate of CV death
compared to those treated with allopurinol in a CV
outcomes study.
Consider the risks and benefits of ULORIC when deciding
to prescribe or continue patients on ULORIC. ULORIC
should only be used in patients who have an inadequate
response to a maximally titrated dose of allopurinol, who are
intolerant to allopurinol, or for whom treatment with
allopurinol is not advisable
Me-too-status Uristat 80mg tablet of M/s Medizan laboratories, Islamabad.
Recommendations:
product official monograph is not available.
13-07-2021.
Decision: Approved with innovators specifications. Firm shall submit the fee of Rs. 7,500 for
Brand Name + Dosage Form and Dexflam 200 mg tablet
Strength
Dexibuprofen...…200mg
2019 Challan No.0841515 dated: 06.03.2019
Type of form Form 5
Me-too-status Vanit 200mg tablet of M/s Getz pharma, Karachi.
Recommendations:
• The raw material testing method is provided for
azithromycin instead of Dexibuprofen.
official monograph of the drug product is not available.
13-07-2021.
Decision: Approved with innovators specifications. Firm shall submit the fee of Rs. 7,500/- for
Brand Name + Dosage Form and Dexflam 300 mg tablet
Strength
Dexibuprofen...…300 mg
2019 Challan No.0841516 dated: 06.03.2019
Type of form Form 5
Me-too-status Vanit 300mg tablet of M/s Getz pharma, Karachi.
Recommendations:
required.
official monograph of the drug product is not available.
• Raw material testing method is provided for azithromycin
instead of Dexibuprofen,
• In the master formula, Dexflam 600mg tablet is mentioned,
instead of Dexflam 300mg tablet.
13-07-2021.
Decision: Approved with innovators specifications. Firm shall submit the fee of Rs. 7,500/- for
Brand Name + Dosage Form and G-Taz 1mg tablet
Strength
Glimepiride...…1mg
2019 Challan No.0841508 dated: 06.03.2019
Pharmacological Group Sulfonylureas
Type of form Form 5
Me-too-status Ajglip 1mg tablet of M/s AJM pharma, Karachi.
Recommendations:
• pThe firm has claimed manufacturer specifications.
However, official monograph available (BP, USP).
13-07-2021.
Decision: Approved with USP specifications. Firm shall submit the fee of Rs. 7,500/- for
Strength
2019 Challan No.0841509 dated: 06.03.2019
Type of form Form 5
Me-too-status Zoryl 3mg tablet of M/s Innvotek pharmaceuticals,
Recommendations:
• The firm has claimed manufacturer specifications.
13-07-2021.
Strength
2019 Challan No.0841510 dated: 06.03.2019
Type of form Form 5
Me-too-status Zoryl 4mg tablet of M/s Innvotek pharmaceuticals,
Recommendations:
13-07-2021.
Brand Name + Dosage Form and Mukast 5mg tablet
Strength
Composition Each chewable tablet contains:
Montelukast as sodium...…5mg
2019 Challan No.0841522 dated: 06.03.2019
Pharmacological Group Leukotriene receptor blocker
Type of form Form 5
Pack size and Demand Price 1 × 14’s, As per SRO
Approval status of product in Reference Singulair (4mg, 5 mg) Chewable Tablet
Regulatory Authorities (US FDA Approved)
Me-too-status Blumont 5mg tablet of M/s Bloom pharmaceuticals, Hattar.
Recommendations:
However, official monograph available (BP, USP, JP).
13-07-2021.
Brand Name + Dosage Form and Suva (Rosuvastatin) 20mg tablet
Strength
Atorvastatin as calcium trihydrate...…40mg
2019 Challan No.0841523 dated: 06.03.2019
Pharmacological Group Statins, HMG-CoA reductase inhibitor
Type of form Form 5
Me-too-status Rovista 20mg tablet of M/s Getz pharma, Karachi
Recommendations:
Remark of the Evaluator (PEC-XVII) • Composition/label claim of the product is mentioned as
“Each film coated tablet contains:
Atorvastatin as calcium trihydrate….40mg”, while the
dossier submitted is for Rosuvastatin 20mg tablet.
• Master formulation and manufacturing outlines of the
product not provided.
13-07-2021.
• Clarification regarding applied formulation/drug product is required since the application
submitted is of Suva (Rosuvastatin) 20mg tablet, while the label claim provided as:
Each film-coated tablet contains;
Atorvastatin (as calcium trihydrate) …….40mg.
• Submission of master formulation and manufacturing outlines for the applied product.
• Submission of GMP audit report by QA & LT Division, valid within last 03 years.
• Firm shall submit the applicable fee for correction/pre-approval change in composition, as per
Brand Name + Dosage Form and Lipam 40mg tablet
Strength
Atorvastatin as calcium trihydrate...…40mg
2019 Challan No.0841519 dated: 06.03.2019
Pharmacological Group Lipid lowering agent, HMG-CoA reductase inhibitor
Type of form Form 5
Me-too-status Truva 40mg tablet of M/s Sami pharmaceuticals, Karachi
Recommendations:
Decision: Approved.
Brand Name + Dosage Form and Ambozial D 5mg tablet
Strength
Desloratadine.…5mg
2019 Challan No.0841521 dated: 06.03.2019
Pharmacological Group antihistamine
Type of form Form 5
Regulatory Authorities (both as film coated and uncoated tablet)
Me-too-status Rodelo 5mg tablet of M/s Sigma pharma, Karachi

Recommendations:
Decision: Approved.
Brand Name + Dosage Form and Dinaar 40mg capsule
Strength
Enteric coated pellets of omeprazole equivalent to
omeprazole…...40 mg
2019 Challan No.0841525 dated: 06.03.2019
Type of form Form 5
Me-too-status Saimep 40mg capsules of M/s Saibins pharmaceuticals
Recommendations:
• Provide source of pellets, COA, real time and accelerated
stability study data of 03 batches and GMP certificate of
pellets source/supplier.
• Differential fee, in case of imported pellets source.
• Submission of source of pellets, CoA of pellets, real time and accelerated stability study data of 03
batches of pellets and GMP certificate of pellets source/Manufacturer. In case of imported pellets
source applicable fee shall also be submitted.
• Submission of GMP audit report by QA & LT Division, valid within last 03 years.
Brand Name + Dosage Form and Albizole H cream
Strength
Clotrimazole….10mg
Hydrocortisone acetate….11.2mg
2019 Challan No.0841520 dated: 06.03.2019
Pharmacological Group Clotrimazole (imidazoles, antifungal, antibacterial) and
Hydrocortisone acetate (mild steroid, anti-inflammatory)
Type of form Form 5
Pack size and Demand Price 15gm, 20gm, As per SRO
Approval status of product in Reference Canesten HC cream (MHRA approved)
Me-too-status Conic-H cream 1% of M/s Rotex pharma Islamabad.
Recommendations:
• Evidence of section approval is required.
• Revise the label claim as per reference product as:
st
980
Each gram of cream contains:
Clotrimazole……...10mg
Hydrocortisone (as acetate) ……...10mg
• Provide evidence of separate dispensing facility for
steroids materials.
• The finished product specifications are mentioned as
manufacturer, while the analytical testing methods
provided for clotrimazole cream and Hydrocortisone
cream from USP. Please clarify and revise the finished
product test specifications as per pharmacopoeia as the
product is mentioned in BP.
• Primary packaging container not mentioned.
13-07-2021.
Decision: Approved with BP specifications as per following label claim:
Each gram of cream contains:
Clotrimazole……...10mg
Hydrocortisone (as acetate) ……...10mg
• Registration letter will be issued upon submission of evidence of availability of separate dispensing
facility for steroidal materials.
Case No. 2: Registration applications for local manufacturing of (Veterinary) drugs.

a; New cases:
Brand Name + Dosage Form and DOXIN-EF Soluble powder (Veterinary)
Strength
Composition Each 100gram contains:
Doxycycline HCl….10 gm
Tylosin Tartrate……5 gm
Furaltradone HCl….15 gm
Erthromycin thiocyanate…6 gm
2019 Challan No.0835040 dated: 02.03.2019
Pharmacological Group Antibacterial and anti-infective
Type of form Form 5
Pack size and Demand Price 100 gm, 500 gm, 1 kg & 2.5 kg, De-controlled
Approval status of product in Reference ………………….
Me-too-status Bio-Multibiotic powder of M/s Biolabs Pvt ltd.
Islamabad. Registration No.043182
conclusion:
Remark of the Evaluator (PEC-XVII) • Cover letter and Form 5 not signed by the
firm/applicant.
• Firm has claimed manufacturer specifications, while the
product is non-pharmacopoeial.
Decision: Deferred for review of formulation by Expert Working group.
Case No. 3: Registration applications for local manufacturing of (Human) drugs (Differential
Fee cases)
a. New cases:
817. Name and address of manufacturer/ M/s Epharm Laboratories, A-40, Road No. 1, S.I.T.E.
Applicant Super Highway Industrial Area, North Karachi.
Brand Name + Dosage Form + Strength EPHANAC 50mg capsule
Diclofenac sodium enteric coated pellets eq. to
Diclofenac Sodium……50mg
Diary No. Date of R & I & fee Dy. No.46 dated 05-01-2011 Rs. 8,000/- dated 04-01-
2011 (Photocopy),
Differential fee, dated 21-07-2014, Rs. 12,000/- vide
Challan No.0053249.
Differential fee Rs: 80,000/- dated 02-07-2018 vide
Challan No. 0756688 dated 21-06-2018 (statistical
officer verified)
“Duplicate dossier, R & I verified”
Pharmacological Group Anti-rheumatics
Type of Form Form-5
Pack size & Demanded Price 20’s, 30’s, 100’s, as per SRO
Approval status of product in Reference DIFENE 50mg Capsule (Gastro-resistant) of M/s
Regulatory Authorities Glenwood GmbH (HPRA, Ireland approved)
Me-too status Mobikare 50mg Capsule of M/s Barrett Hodgson
(Reg # 024699)
12-2021, wherein grant of renewal of DML of the firm
recommended.
Remarks of the Evaluator (PEC-XVII) • Firm initially provided specifications as per BP
monograph for prolonged release capsules. A fee of Rs:
7500/- submitted vide deposit slip No. 6442077437 for
revision of specifications.
• Firm has provided GMP certificate of pellets
source/supplier (M/s Zen Biotech Pvt. Ltd. India) that is
• Firm has provided CoA of Diclofenac Sodium enteric
coated pellets 30% w/w.
conducted at 30 0C ± 2ºC and 65%RH ± 5%RH of three
batches for 36 months and accelerated stability data
sheets conducted at 40 0C ± 2 ºC and 75%RH ± 5%RH
of three batches for 12 months with testing points as 0,
3, 6, 9, 12, 18, 24 & 36 months (for Long term stability
studies) and 0, 1, 2, 3, 6 and 12 months (for Accelerated
Stability Conditions).
• Capsule (General) Section available as per DML
renewal inspection report dated 30-12-2021.
• Official monograph for Diclofenac prolonged release
capsule, gastric resistant and extended release tablets
available, however, gastric resistant capsule not
available.
Decision: Approved with innovator’s specifications. Registration Board further decided to verify
fee challan as per decision of 285th meeting of Registration Board.
818. Name and address of manufacturer/ M/s Epharm Laboratories, A-40, Road No. 1, S.I.T.E.
Applicant Super Highway Industrial Area, North Karachi.
Brand Name + Dosage Form + Strength EPHANAC-SR 100mg capsule
Diclofenac Sodium SR pellets eq. to Diclofenac
Sodium……100mg
2011 (Photocopy),
Differential fee dated 21-07-2014 Rs. 12,000/- vide
Challan No.0053250.
“Duplicate dossier, R & I verified”.
Type of Form Form-5
Pack size & Demanded Price 2 × 10’s, as per SRO
Approval status of product in Reference Diclomax Retard Capsule 100mg (MHRA Approved)
Me-too status Dicloyan-S 100mg capsule Roryan Pharma, Peshawar
(Reg. No. 68337)
12-2021, wherein grant of renewal of DML of the firm
recommended
Remarks of the Evaluator (PEC-XVII) • Firm revised finished drug product specifications as per
official monograph for Diclofenac prolonged release
capsules, also further revised the assay limits as per
official monograph and submitted fee Rs: 7500/- vide
slip No. 57023644305 and Rs: 7500/- vide slip
No.661600972, separately.
source/supplier (M/s Vision Pharmaceuticals,
Islamabad) that is valid till 09-05-2022.
• Firm has provided CoA of Diclofenac Sodium SR pellets
33%.
3, 6, 9, 12, 18, 24, 36 & 48 months (for Long term
stability studies) and 0, 1, 2, 3 & 6 months (for
• Capsule (General) Section available as per DML
renewal inspection report dated 30-12-2021.
819. Name and address of manufacturer/ Kanel Pharma, Plot No.6, Road SS-3, National Industrial
Applicant Zone, Rawat, Rawalpindi.
Brand Name + Dosage Form + Strength KORTEL DS tablet
Artemether………… 40mg
Lumefantrine ……….240 mg
Diary No. Date of R & I & fee Dy. No.7053 dated 13/07/2012 Rs. 8,000/- dated 02-07-
2012 (Chall No.47, Photocopy).
Dy.No.574, Differential fee Rs. 12,000/- dated
26/01/2016
“Original dossier and original challans of differential
fee”
Pharmacological Group Systemic anti-malarial agent
Type of Form Form-5
Pack size & Demanded Price 1 × 8’s, As fixed by the MoH competent authority
Approval status of product in Reference WHO prequalified drug
Me-too status Winterm 40mg/240mg tablet of M/s Winthrox
laboratories, Karachi. Registration No. 100493
GMP status GMP certificate issued on 04-06-2020, based on
evaluation conducted on 03-06-2020.
Remarks of the Evaluator (PEC-XVII) • Lumefantrine….240mg. Firm was asked to clarify and
couldn’t provide any clarification. The product Kortel-D
DS tablet of the firm already considered in 312 Firm
provided initial fee challan copy of Rs: 8000 (Challan
No.47 dated 28-06-2012) for product Kortel DS tablet
(Artemether…40mg & Lumefantrine….240mg), having
statistical officer stampe dated 02-07-2012.Firm revised
master formulation and manufacturing outlines as per
label claim which is of un-coated tablet.
• Firm revised finished drug product specifications as per
official monograph that is International pharmacopoeia.
• Tablet Section (General) mentioned in GMP certificate
No. F.3-52/2020-Addl.Dir. (QA & LT-I)/93 dated 04-
06-2020.
& 13-07-2021.
Decision: Approved with International Pharmacopoeia specifications. Registration Board
further decided to verify fee challan as per decision of 285th meeting of Registration Board.
820. Name and address of manufacturer/ Roryan Pharmaceutical Industries (Pvt) Ltd. 85/B,
Applicant Hayatabad Industrial Estate, Peshawar
Brand Name + Dosage Form + Strength Clomicit 50mg tablet
Clomiphene Citrate ………50mg
Diary No. Date of R & I & fee Dy.No. 378 dated 08-06-2012, Fee Rs: 8,000/-, Date.08-
06-2012 (Photo copy)
Dy.No. 578 dated 27-10-2016, Differential fee: Rs.
12,000 Dated 27-10-2016, Challan No.0284427
(Photocopy)
Pharmacological Group Antiestrogen
Type of Form Form-5
Pack size & Demanded Price 1× 10’s, As per SRO
Approval status of product in Reference CLOMID® 50mg tablet (Sanofi) US FDA approved
Me-too status Fensipro 50mg tablet of M/s Evolution pharmaceuticals
GMP status GMP certificate No.F.11-52/2022-DRAP-71 dated 17-
06-2022 issued based on evaluation conducted 13-01-
2022.
BP monograph for Clomifene tablets and submitted fee
of Rs: 7500/- vide online deposit slip No.623150462
dated 20-07-2022.
• VR & I record verified. Details incorporated in relevant
column above.
• Tablet Section (General) mentioned in panel inspection
for renewal of DML conducted on 13-01-2022.
Decision: Approved with BP specifications. Registration Board further decided to verify fee
challan as per decision of 285th meeting of Registration Board.
Brand Name + Dosage Form + Strength Montelu 10mg chewable tablet
Composition Each chewable tablet contains:
Montelukast (as Montelukast Sodium) ………10mg
Dy.No.575 dated 27-10-2016, Differential fee: Rs.
12,000 Dated 27-10-2016, Challan No.0284433
(Photocopy)……
Pharmacological Group Leukotriene receptor antagonist (antiasthmatic)
Type of Form Form-5
Finished product Specification Manufacture specification
Pack size & Demanded Price 2× 10’s, PKR 480.00/- per pack
Approval status of product in Reference SINGULAIR® 10mg film coated tablets (US FDA
Regulatory Authorities approved with boxed warning:
SERIOUS NEUROPSYCHIATRIC EVENTS
See full prescribing information for complete boxed
warning. Serious neuropsychiatric events have been
reported in patients taking SINGULAIR.
Discuss benefits and risks of SINGULAIR with patients
and Caregivers. Monitor for neuropsychiatric symptoms
in patients taking SINGULAIR. Discontinue
SINGULAIR immediately if neuropsychiatric symptoms
occur. Because the benefits of SINGULAIR may not
outweigh the potential risk of neuropsychiatric
symptoms in patients with allergic rhinitis, reserve use
for patients who have an inadequate response or
intolerance to alternative therapies.
Me-too status Aonukast 10mg Tablet of M/s Relizon Pharma, Lahore.
2022.
Remarks of the Evaluator (PEC-XVII) • Firm revised label claim as:
Montelukast (as Montelukast Sodium) ………10mg and
submitted fee of Rs: 30,000/- vide online deposit slip No.
7755782079 dated 20-07-2022 and also revised master
formulation and manufacturing outlines accordingly.
• Firm revised the finished drug product specifications as
per USP.
• Tablet Section (General) mentioned in panel inspection
report for renewal of DML conducted on 13-01-2022.
• V R & I record verified. Details incorporated in relevant
column above.
Decision: Approved with USP specifications & revised label claim as;
Montelukast (as Montelukast sodium) …….10mg
Registration Board further decided to verify fee challan as per decision of 285th meeting of
Registration Board.
Brand Name + Dosage Form + Strength Azocin 250mg capsule
Azithromycin (as dihydrate) ………250mg
Dy.No. 576 dated 27-10-2016, Differential fee: Rs.
12,000 Dated 27-10-2016, Challan No.0284424
(Photocopy)……
Pharmacological Group Macrolide
Type of Form Form-5
Pack size & Demanded Price 2× 6’s, As per SRO
Me-too status Mascin 250mg capsule of M/s Regal pharmaceuticals,
2022.
Remarks of the Evaluator (PEC-XVII) • The firm initially claimed USP specifications for their
drug product. Firm was asked to provide evidence of
availability of requisite testing facilities as per USP
monograph, as the product testing requires
Amperometric electrochemical detector. However, the
firm revised the finished drug product specifications as
per BP monograph and submitted fee of Rs: 7500/- vide
online deposit slip No.638206400764 dated 20-07-2022.
• Capsule Section (General) mentioned in panel
inspection report for renewal of DML conducted on 13-
01-2022.
column above.
823. Name and address of manufacturer/ Standpharm Pakistan (Pvt) Ltd. 20Km,
Applicant Ferozepur Road, Lahore.
Brand Name + Dosage Form + Strength VEXNIL-P TABLET
Paracetamol……325mg
Tramadol Hydrochloride….37.5mg
Diary No. Date of R & I & fee Form-5,
Dy.No. dated 23-02-2015, Differential fee: Rs. 12,000
Dated 19-02-2015 vide deposit slip No.0308737 dated
19-02-2015.
“Duplicate dossier”
Pharmacological Group Analgesic
Type of Form Form-5
Pack size & Demanded Price 10’s, MRP Rs: 10.0 per tablet
Approval status of product in Reference Ultracet coated tablet (Janssen Pharma) US FDA
Regulatory Authorities approved. In MHRA both coated and uncoated available.
Me-too status Tramal plus film coated tablet of M/s The Searle
Company, Lahore. Registration No. 077129
GMP status cGMP compliance certificate No. 101/2020-DRAP
(AD-322072-1295) dated 29-06-2020 issued based on
Remarks of the Evaluator (PEC-XVII) • Firm was asked to submit covering letter, bearing
statistical officer and DRAP R & I stamp along with fee
challan copy of initial submission but did not provide
the same.
• Firm has revised finished drug product specifications as
per USP and submitted fee Rs:7500/- vide deposit slip
No.60091350.
• Tablet Section (General) section available as per
Licensing Division letter No.F.1-51/84-Lic (Vol-II)
dated 30-06-2020 for renewal of Drug Manufacturing
License.
Decision: Deferred for verification of R & I record of initial submission of registration
application and differential fee submission.
824. Name and address of manufacturer/ Standpharm Pakistan (Pvt) Ltd. 20Km,
Applicant Ferozepur Road, Lahore.
Brand Name + Dosage Form + Strength DEXIDOL SUSPENSION 100mg/5ml
Dexibuprofen…….100mg
Diary No. Date of R & I & fee Form-5,
Dy.No. dated 23-02-2015, Differential fee: Rs. 12,000
Dated 19-02-2015 vide deposit slip No.0308748 dated
19-02-2015.
Type of Form Form-5
Pack size & Demanded Price Rs: 60/- per 60ml, Rs: 90/- per 90ml, Rs: 101.00/- per
120ml
Approval status of product in Reference International availability of applied formulation in the
Regulatory Authorities approved RRA could not be confirmed.
Me-too status Detefen liquid suspension of M/s FYNK
Pharmaceuticals, Lahore. Registration No. 074443
GMP status cGMP compliance certificate No. 101/2020-DRAP
(AD-322072-1295) dated 29-06-2020 issued based on
Remarks of the Evaluator (PEC-XVII) • Firm was asked to submit covering letter, bearing
statistical officer and DRAP R & I stamp along with fee
challan copy of initial submission but did not provide
the same.
• Firm was asked to provide evidence of approval of
applied formulation in reference regulatory
authorities/agencies which were adopted by
Registration Board in its 275th meeting. However, the
firm provided excerpt from PharmaGuide having
various generic drug products of same formulation.
• Firm provided the finished drug product specifications
(Manufacture specifications). However, the firm also
submitted fee Rs:7500/- vide deposit slip
No.6467846931
• Liquid syrup (General) section available as per
Licensing Division letter No.F.1-51/84-Lic (Vol-II)
dated 30-06-2020 for renewal of Drug Manufacturing
License.
• Verification of R & I record of initial submission of registration application and
differential fee submission.
825. Name and address of manufacturer/ M/s. Epoch Pharmaceuticals Plot no.83-85, Sector
Applicant No.15, Korangi Industrial Area, Karachi.
Brand Name + Dosage Form + Strength EPOXCIL Dry Syrup 250mg
Composition Each reconstituted 5ml contains:
Amoxicillin trihydrate eq. to Amoxicillin ……250mg
Diary No. Date of R & I & fee Dy. No. 1226 dated 19-07-2012, Rs. 8,000/-
(Photocopy),
Dy. No. 991 dated 13-05-2016 Differential fee Rs.
12,000/- vide Challan No.0138621 dated 29-04-2016
(Original),
(Duplicate dossier, R & I verified)
Type of Form Form 5
Me-too status Amoxicillin 250mg Dry Suspension of Medimarker,
GMP status Routine GMP inspection conducted on 26-07-2019 with
conclusion as:
documents reviewed, and considering the findings of the
inspection, M/s Epoch Pharmaceuticals is considered to
be operating at SATISFACTORY level of compliance
with GMP guidelines as per Drugs Act, 1976 and Drap
Act 2012 and rules framed there under.
Remarks of the Evaluator (PEC-XVII) • Application not submitted in prescribed format. Only
annexures/enclosures are provided as per check list.
Firm was advised to re-submit application form as per
prescribed format, but again enclosures/annexures
were submitted.
• Firm was advised to resubmit manufacturing outlines
in elaborate manner. However, same manufacturing
outlines were re-submitted.
• Penicillin dry syrup section mentioned in Panel
inspection for renewal of DML conducted on 10-09-
2018.
• Firm revised finished drug product specifications as
per BP monograph for amoxicillin oral suspension.
notifications 7-11/2012-B&A/DRAP dated 07-05-
2021 & 13-07-2021.
• Submission of application in prescribed Form 5, as only annexures/enclosures are
provided.
• Submission of manufacturing outlines in elaborate manner.
• Submission of applicable fee as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021
& 13-07-2021 for product specifications revision.
826. Name and address of manufacturer/ M/s Xenon Pharmaceuticals (Pvt.) Ltd. 9.5-Km,
Applicant Sheikhupura road, Lahore.
Brand Name + Dosage Form + Strength CLOPAM 0.5mg tablet
Clonazepam…........0.5mg
Diary No. Date of R & I & fee Dy. No. 171 dated 11-01-2012, Rs. 8,000/- challan dated
06-01-2012 (Photocopy),
12,000/- vide challan No.0313818 dated 27-11-2015
(Photocopy),
Pharmacological Group Benzodiazepines
Type of Form Form 5
Pack size & Demanded Price 30’s, 50’s, As per SRO
Approval status of product in Reference KLONOPIN tablet 0.5mg (USFDA approved)
Me-too status Catier 0.5mg tablet of M/s Medizan laboratories,
GMP status Panel inspection for renewal of DML and regularization
of sections conducted on 11-02-2022 and recommended
renewal of DML.
Remarks of the Evaluator (PEC-XVII)
• Tablet (Psychotropic) Section available as per Panel
inspection for renewal of DML and regularization of
sections conducted on 11-02-2022.
• Firm has provided undertaken that the product (Clopam
0.5mg tablet) has never been discussed or deferred in
any meeting and that given information are true.
Brand Name + Dosage Form + Strength CLOPAM 2mg tablet
Clonazepam…........2mg
06-01-2012 (Photocopy),
(Photocopy),
Type of Form Form 5
Approval status of product in Reference KLONOPIN tablet 2mg (USFDA approved)
Me-too status Catier 2mg Tablet of M/s Medizan laboratories,
renewal of DML.
Remarks of the Evaluator (PEC-XVII) • Tablet (Psychotropic) Section available as per Panel
• R & I record verified. Details incorporated in relevant
column above.Firm has provided undertaken that the
product (Clopam 2mg tablet) has never been discussed
or deferred in any meeting and that given information
are true.
Brand Name + Dosage Form + Strength CLONAP Drops 0.25% (w/v)
Clonazepam…........2.5mg
06-01-2012 (Photocopy),
(Photocopy),
Type of Form Form 5
Pack size & Demanded Price 10ml, As per SRO
Approval status of product in Reference Rivotril 2.5 mg/ml oral drops, solution
Regulatory Authorities (Approved by AEMPS of Spain),
(AIFA Italy Approved)
Me-too status Clonopin Oral Solution (Drops) 2.5mg/ml of M/s Aries
Pharma, Peshawar. Reg. No. 102837
renewal of DML.
Remarks of the Evaluator (PEC-XVII) • Oral liquid (Psychotropic) Section available as per
Panel inspection for renewal of DML and regularization
of sections conducted on 11-02-2022.
column above.Firm has provided undertaken that the
product (Clopam drops 10ml) has never been discussed
or deferred in any meeting and that given information
are true.
•Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product
Brand Name + Dosage Form + Strength TANEXA 250mg Capsule
Tranexamic acid…........250mg
20-12-2011 (Photocopy),
Differential fee Rs. 12,000/- dated 27-01-2016 vide
challan No.0313819 dated 12-11-2015 (Photocopy),
Pharmacological Group Antifibrinolytic agent
Type of Form Form 5
Approval status of product in Reference Tranex 250mg capsule, AIFA Italy approved
Me-too status Normic 250 mg Capsules of M/s Nortech
Pharmaceuticals, Islamabad. Registration No. 077973
renewal of DML.
• Capsule (General) Section available as per Panel
column above.Initially in the manufacturing outlines,
pellets were mentioned, which are revised to powder.
• Firm revised finished drug specifications as per JP
monograph.
• Firm has provided undertaken that the product (Tanexa
250mg capsule) has never been discussed or deferred in
• For above revision, firm submitted applicable fee Rs:
7500/- vide slip No. 54907592 as per notifications 7-
11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021.
Decision: Approved with JP specifications. Registration Board further decided to verify fee
Brand Name + Dosage Form + Strength TANEXA 500mg Capsule
Tranexamic acid…........500mg
20-12-2011 (Photocopy),
challan No.0313820 dated 27-11-2015 (Photocopy),
Pharmacological Group Antifibrinolytic agent
Type of Form Form 5
Approval status of product in Reference Tranex 500mg capsule, AIFA Italy approved
Me-too status Trenfold Capsule 500mg of M/s Weatherfold, Hattar.
renewal of DML.
Remarks of the Evaluator (PEC-XVII) • Capsule (General) Section available as per Panel
column above. Initially in the manufacturing outlines,
• Firm revised finished drug specifications as per JP
monograph.
• Firm has provided undertaken that the product (Tanexa
500mg capsule) has never been discussed or deferred in
7500/- vide slip No. 56887352 as per notifications 7-
11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021.
Decision: Approved with JP specifications. Registration Board further decided to verify fee
Brand Name + Dosage Form + Strength XEFLUCAN 150mg Capsule
Fluconazole…........150mg
Diary No. Date of R & I & fee Dy. No.605 dated 30-01-2012, Rs. 8,000/- challan dated
28-01-2012 (Photocopy),
(Photocopy)
Type of Form Form 5
Finished product Specification BP Specifications
Approval status of product in Reference Fluconazole 150mg capsule, MHRA approved
Me-too status Flucoaid Capsule 150mg of M/s Aspin Pharma, Karachi.
renewal of DML.
Remarks of the Evaluator (PEC-XVII) • Capsule (General) Section available as per Panel
column above. Initially in the manufacturing outlines,
• Firm has provided undertaken that the product
(Xeflucan 150mg capsule) has never been discussed or
deferred in any meeting and that given information are
true.
7500/- vide slip No. 68384717169 as per notifications
7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-
2021.
Brand Name + Dosage Form + Strength XEFLUCAN Dry Suspension
Composition Each 1ml of reconstituted suspension contains:
Fluconazole……...10mg
28-01-2012 (Photocopy),
Dy.No. 424 dated 27-01-2016 Differential fee Rs.
(Photocopy),
Type of Form Form 5
Pack size & Demanded Price 35ml (After reconstitution), As per SRO
Approval status of product in Reference Diflucan 10 mg/ml powder for oral suspension, MHRA
Me-too status Orclu Powder for Oral Suspension 10mg/ml of M/s
Aulton pharma, Hattar. Registration No. 101211
renewal of DML.
Remarks of the Evaluator (PEC-XVII) • Dry Powder Suspension (General) Section available as
per Panel inspection for renewal of DML and
regularization of sections conducted on 11-02-2022.
column above. Firm has provided undertaken that the
product (Xeflucan dry powder suspension, 50mg/5ml)
has never been discussed or deferred in any meeting and
that given information are true.
Brand Name + Dosage Form + Strength XELOSE Syrup
Lactulose…........3.35gm
Diary No. Date of R & I & fee Dy. No.601 dated 30-01-2012, Rs. 8,000/- challan dated
28-01-2012 (Photocopy),
(Photocopy)
Pharmacological Group Laxative
Type of Form Form 5
Pack size & Demanded Price 120ml (After reconstitution), As per SRO
Me-too status CK-Lac Syrup 3.35g/5ml of M/s CKD pharmaceuticals,
renewal of DML.
Remarks of the Evaluator (PEC-XVII) • Oral liquid (General) Section available as per Panel
column. Submit differential fee as Lactulose
concentrate will be imported from Fresenius Kabi
Austria GmbH Estermannstraβe 17, 4020 Linz, Austria.
• Provide valid cGMP certificate of Lactulose
concentrate manufacturer (Imported source).
batches for 36 months, accelerated stability data sheets
conducted at 40 0C ± 2 ºC and 75%RH ± 5%RH of three
batches for six months and stability data sheets
batches for 36 months.
• Clarification is required whether the Lactulose
concentrate will be diluted before filling or to be filled
without dilution. The manufacturing outlines and
master formulation need to be revised accordingly.
• Firm has provided undertaken that the product (Xelose
syrup 120ml) has never been discussed or deferred in
& 13-07-2021.
Decision: Approved. Registration board further decided to verify fee challan as per decision of
285th meeting of Registration Board. However, before issuance of registration letter, the firm
shall:
• Submit valid GMP certificate of pellets manufactuer.
• Submit applicable fee for pellets source approval that is Fresenius Kabi Austria GmbH
Estermannstraβe 17, 4020 Linz, Austria.
834. Name and address of manufacturer/ M/s Life Pharmaceutical Company, 24-III, Industrial
Applicant Estate, Multan.
Brand Name + Dosage Form + Strength MYOLIF 20mg tablet
Famotidine…........20mg
Diary No. Date of R & I & fee Dy. No. 5913 dated 23-05-2011, Rs. 8,000/- challan
dated 21-05-2011 (Photocopy),
Dy. No.21667 dated 20-11-2017 Differential fee Rs.
(Photocopy)
Pharmacological Group H2-receptor antagonists.
Type of Form Form 5
Approval status of product in Reference Pepcid Tablet (USFDA approved)
Me-too status Pepcidine Tablet 20mg of M/s OBS Pakistan, Karachi.
GMP status GMP certificate dated 23-08-2021 issued based on
evaluation (DML renewal) conducted on 16-06-2021.
Remarks of the Evaluator (PEC-XVII) • Tablet (General) Section approval granted vide letter
No. F. 1-30/84-Lic (Vol.I) (M-227) dated 24-06-2011.
column. Firm revised pharmacological group as H2-
receptor antagonists.
• Firm provided the requisite list of manufacturing
equipment/machinery.
• Firm revise the label claim as:
Famotidine…........20mg, along with revision of master
formulation and manufacturing outlines.
• For above revisions, the firm submitted fee of Rs:7500/-
vide slip number 31071598578 as per notifications 7-
11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021.
Brand Name + Dosage Form + Strength MYOLIF 40mg tablet
Famotidine…........40mg
Diary No. Date of R & I & fee Dy.No.5888 dated 23-05-2011, Rs. 8,000/- challan dated
21-05-2011 (Photocopy),
Dy.No.21668 dated 20-11-2017 Differential fee Rs.
(Photocopy)
Pharmacological Group Antipeptic ulcerants
Type of Form Form 5
Approval status of product in Reference Pepcid Tablet (USFDA approved)
Me-too status Famoxo 40mg Tablet of M/s Horizon Health Care,
column. Firm revised pharmacological group as H2-
receptor antagonists.
• Firm provided the requisite list of manufacturing
equipment/machinery.
• Firm revise the label claim as:
Famotidine…........40mg, along with revision of master
formulation and manufacturing outlines.
• For above revisions, the firm submitted fee of Rs:7500/-
vide slip number 7945752111 as per notifications 7-
11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021.
Brand Name + Dosage Form + Strength AVELOX 400mg tablet
Moxifloxacin (as Hydrochloride) …........400mg
Diary No. Date of R & I & fee Dy. No.5927 dated 23-05-2011, Rs. 8,000/- challan
(Photocopy)
Pharmacological Group Quinolones
Type of Form Form 5
Me-too status Oxef 400mg Tablet of M/s Parmedic laboratories,
column. Firm revised the label claim as per reference
product:
Moxifloxacin (as hydrochloride) …….400mg and
amended the master formulation and manufacturing
• Firm revised the finished drug product specifications, as
per USP.
• For above revision, firm submitted applicable fee of Rs:
30,000/- vide slip No. 97840961190 as per notifications
7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-
2021.
Brand Name + Dosage Form + Strength XENID 50mg tablet
Diclofenac Potassium…........50mg
(Photocopy)
Type of Form Form 5
Approval status of product in Reference 12.5mg, 25mg & 50mg film-coated tablets
Me-too status Dicloflex-P 50mg tablet of M/s MKB pharma, Peshawar.
column above.Initially application submitted for
Diclofenac potassium….100mg tablet. Now the firm
has revised the label claim as:
Diclofenac potassium……50mg but without
submission of fee.
& 13-07-2021.
•Firm shall submit the fee of Rs. 30,000/- for correction/pre-approval change in composition
(correction/change of strength from Diclofenac potassium 100mg tablet to Diclofenac potassium
50mg ), as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength DICLORD 100mg SR Capsule
Composition Each sustained release capsule contains:
Diclofenac Sodium
(as Diclofenac Sodium SR Pellets) …........100mg
(Photocopy)
Pharmacological Group Anti-inflammatory and Antirheumatic
Type of Form Form 5
Approval status of product in Reference Rhumalgan® XL 100 mg Modified Release Capsules &
Regulatory Authorities Difene 25mg & 50mg gastro-resistant capsules (HPRA
approved)
Me-too status Volden Forte SR 100mg Capsule (Diclofenac sodium
sustained release pellets 32% Eq to Diclofenac sodium:
100mg) of M/s Rotex Pharma, Islamabad. Registration
No. 100882
Remarks of the Evaluator (PEC-XVII) • Capsule (General) Section approval granted vide letter
column above. Initially firm has not specified the pellets
nature whether enteric, dual release or sustained release
etc), while as per master formulation, Diclofenac
sodium as enteric coated pellets are to be utilized. The
firm then specified that sustained release diclofenac
sodium pellets (32%) to be purchased form Vision
Pharmaceuticals, Islamabad and will be re-filled.
• The firm revised the label claim as:
Each sustained release capsule contains:
Diclofenac Sodium
(as Diclofenac Sodium SR Pellets) …........100mg
of three batches for six months.
• CoA of Diclofenac Sodium SR pellets (32%) from
Vision Pharmaceuticals, Islamabad also provided.
• Official monograph available in BP.
• For above revision, the firm submitted fee Rs: 30,000/-
vide slip No.607703979 as per notifications 7-11/2012-
B&A/DRAP dated 07-05-2021 & 13-07-2021.
Brand Name + Dosage Form + Strength FERRY-CIN 100mg tablet
Iron Polymaltose complex equivalent to elemental
Iron…........100mg
Dy.No. 21665 dated 20-11-2017 Differential fee Rs.
(Photocopy)
Pharmacological Group Anti-anaemic preparations
Type of Form Form 5
Me-too status Redroze Tablets of M/s Himont Pharma, Lahore.
Iriver 100mg Chewable Tablet of M/s Sigma Pharma
International,Karachi. Registration No. 090941
column above.Firm clarified that the applied
formulation is in the form of chewable tablet and
revised label claim as:
Each Chewable tablet contains:
Iron (III) Hydroxide Polymaltose complex eq. to
elemental Iron…………...100mg.
• With regard to approval of applied formulation in
adopted by the Registration Board in its 275th meeting,
firm informed that since Iron preparations are not
considered as drug by various reference regulatory
authorities, therefore such approval is not applicable.
& 13-07-2021.
Decision: Approved with revised label claim as:
Each Chewable tablet contains:
Iron (III) Hydroxide Polymaltose complex eq. to elemental Iron…………...100mg.
• Registration Board further decided to verify fee challan as per decision of 285th meeting
of Registration Board.
(correction/change of formulation from plain tablet to chewable tablet), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength LYCLEAR Lotion 5% w/v
Permethrin….50mg (5% w/v)
Diary No. Date of R & I & fee Dy. No.5988 dated 23-05-2011, Rs. 8,000/- challan
(Photocopy)
Pharmacological Group Scabicide
Type of Form Form 5
Approval status of product in Reference MHRA approved as Permethrin Lotion 5% w/w
Regulatory Authorities TGA Australia approval as (QUELLADA SCABIES
TREATMENT LOTION permethrin 50mg/mL bottle)
Me-too status Dynarix (Permethrin) 5% Lotion (Each gm contains
permethrin 50mg) of M/s Dynatis Pakistan Ltd. Lahore.
Remarks of the Evaluator (PEC-XVII) • External liquid preparation section (General) Section
approval granted vide letter No. F. 1-30/84-Lic (Vol.I)
dated 27-04-2017.
column above.
Decision: Deferred for submission of following docuements:
• Submission of applicable fee as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021
& 13-07-2021 for correction/pre-approval change/ in product specifications.
841. Name and address of manufacturer/ M/s Lisko Pakistan (Pvt.) Ltd. L-10/D, Block-21,
Applicant Shaheed Rashid Minhas Road, Federal B Industrial
Area, Karachi.
Brand Name + Dosage Form + Strength MOXIFLOX 400mg tablet
Moxifloxacin (as hydrochloride) …...400mg
Diary No. Date of R & I & fee Dy. No.997 dated 11-06-2012, Rs.8000/- Challan dated
08-06-2012, (Photocopy),
Dy.No. 539 dated 13-04-2016, Differential fee
Rs.12000/- dated 13-04-2016 vide Challan No.0519774
(Photocopy).
“Duplicate Dossier, R & I verified”
Type of Form Form 5
Remarks of the Evaluator (PEC-XVII) • Tablet Section (General) mentioned in the GMP
certificate dated 17-08-2021.
column above.
Area, Karachi.
Brand Name + Dosage Form + Strength DESALEX 5mg tablet
Desloratadine ………….5mg
Diary No. Date of R & I & fee Dy. No. 999 dated 11-06-2012, Rs.8000/- Challan dated
08-06-2012, (Photocopy),
(Photocopy).
Type of Form Form 5
Me-too status Deslomed Tablet 5mgof M/s Medicraft pharmaceuticals,
Remarks of the Evaluator (PEC-XVII) • Tablet Section (General) mentioned in the GMP
column above.
Area, Karachi.
Brand Name + Dosage Form + Strength DESALEX Syrup (2.5mg/5ml)
Desloratadine …………2.5mg
Diary No. Date of R & I & fee Dy. No.998 dated 11-06-2012, Rs.8000/- Challan dated
08-06-2012, (Photocopy),
Dy.No.540 dated 13-04-2016, Differential fee
(Photocopy).
Type of Form Form 5
Pack size & Demanded Price 30ml, 60ml, 120ml, As per SRO
Approval status of product in Reference Desloratadine 0.5 mg/ml Oral solution
Me-too status Macdin 0.5mg/ml Syrup of M/s Searle IV Solutions
(Pvt) Ltd. Lahore. Registration No. 101671
Remarks of the Evaluator (PEC-XVII) • Oral liquid Section (General) mentioned in the GMP
• Firm has claimed manufacturer specifications; product
is non-pharmacopoeial.
column above.
844. Name and address of manufacturer/ M/s Atco Laboratories limited, B-18, S.I.T.E., Karachi.
Applicant
Brand Name + Dosage Form + Strength ATCORT Ointment (0.1% w/w)
Triamcinolone Acetonide.……1mg or
Triamcinolone Acetonide….0.1% w/w
Diary No. Date of R & I & fee Dy. No. 10 dated 17-05-2011, Rs.8000/- dated 17-05-
2011, Challan (Photocopy),
(Photocopy).
(Duplicate Dossier, R & I verified)
Pharmacological Group Anti-acne/ Dermatosis
Type of Form Form 5
Pack size & Demanded Price 5gm,15gm, As per SRO
Approval status of product in Reference Triamcinolone acetonide 0.1% topical ointment
Regulatory Authorities (US FDA approved)
Me-too status Oralone Ointment (Each gram contains Triamcinolone
acetonide…1mg) of M/s Hiranis pharmaceutical,
3-2022 & 05-04-2022, wherein panel recommended the
grant of renewal of DML
Remarks of the Evaluator (PEC-XVII) • The firm has provided copy of approved layout plan of
cream/ointment manufacturing facility, mentioning
three dispensing booths as:
1. Solid dispensing 1.
3. Liquid dispensing
Amongst these, firm has submitted notarized stamp
paper, stating that they have dedicated solid Dispensing-
1 facility for topical steroids.
• Firm was advised to revise pharmacological group as
“Corticosteroids, dermatological preparations”. In
response firm stated that there is no need of revision of
pharmacological group and hence submission of any fee
is not applicable.
& 13-07-2021.
• Cream/ointment (General) Section available as per
Licensing Division letter No.F.2-5/85-Lic (Vol-VI)
dated 18-03-2021.
•Firm shall submit the fee of Rs. 7,500 for variation in registration application i.e.,
correction/change of pharmacological group, as per notification No.F.7-11/2012-B&A/DRAP
dated 13-07-2021.
Applicant
Brand Name + Dosage Form + Strength ATCORT Cream (0.1% w/w)
Triamcinolone Acetonide.……1mg or
Triamcinolone acetonide….0.1% w/w
(Photocopy).
Pharmacological Group Anti-acne/ Dermatosis
Type of Form Form 5
Approval status of product in Reference Triamcinolone acetonide 0.1% topical cream
Regulatory Authorities (US FDA approved)
Me-too status K-Kort Cream (Each gram contains Triamcinolone
acetonide…1mg) of Ophth-Pharma Karachi.
grant of renewal of DML
Remarks of the Evaluator (PEC-XVII) • The firm has provided copy of approved layout plan of
cream/ointment manufacturing facility, mentioning
three dispensing booths as:
6. Liquid dispensing
Amongst these, firm has submitted notarized stamp
paper, stating that they have dedicated solid Dispensing-
1 facility for topical steroids.
• Firm was advised to revise pharmacological group as
“Corticosteroids, dermatological preparations”. In
response firm stated that there is no need of revision of
pharmacological group and hence submission of any fee
is not applicable.
& 13-07-2021.
• Cream/ointment (General) Section available as per
Licensing Division letter No.F.2-5/85-Lic (Vol-VI)
dated 18-03-2021.
•Firm shall submit the fee of Rs. 7,500 for variation in registration application i.e.,
correction/change of pharmacological group, as per notification No.F.7-11/2012-B&A/DRAP
dated 13-07-2021.
Applicant
Brand Name + Dosage Form + Strength BETADERM-N Lotion
Composition Betamethasone Valerate eq. to Betamethasone… 0.1%
w/v
Neomycin Sulphate eq. to Neomycin …….0.35% w/v
(Photocopy).
Pharmacological Group Corticosteroid combination / dermatological
Type of Form Form 5
Regulatory Authorities However, Betnovate-N cream is available in MHRA.
Each 1g of cream contains 1mg (0.1% w/w)
betamethasone (as valerate)
and 5mg (0.5% w/w) neomycin sulfate.
Me-too status Betnovate-N Lotion of M/s GSK. Registration
No.000252
grant of renewal of DML.
• Firm was asked to provide evidence of approval of
applied formulation in reference regulatory authorities /
agencies which were adopted by the Registration Board
in its 275th meeting. In response firm stated that the
applied formulation is not approved in any of reference
regulatory authority.
• Lotion (General) Section available as per Licensing
Division letter No.F.2-5/85-Lic (Vol-VI) dated 18-03-
2021.
Applicant
Brand Name + Dosage Form + Strength BETACAL GEL
Composition Calcipotriol Monohydrate BP eq to
Calcipotriol…0.005% w/w
Betamethasone Dipropionate BP eq to
Betamethasone….0.05% w/w
(Photocopy). Total fee: 50,000/-
Pharmacological Group Topical anti-psoriasis
Approval status of product in Reference (MHRA approved) One gram of gel contains 50
Regulatory Authorities micrograms Calcipotriol (as monohydrate) and 0.5 mg
Betamethasone (as dipropionate).
grant of renewal of DML.
Remarks of the Evaluator (PEC-XVII) • Provide evidence of availability of separate dispensing
facility for steroids.
• Provide stability data as per decision of the DRB in 293rd
meeting.
• Provide the updated master formulation, method of
manufacturing and drug product specifications along
with stability data.
• Provide the available me-too/generic drug already
approved by DRAP, along with brand name, registration
number and manufacturer.
• Gel (General) Section available as per Licensing
Division, DRAP Islamabad letter No.F.2-5/85-Lic (Vol-
VI) dated 18-03-2021.
• In response firm has stated that stability studies are in-
process and will be submitted once completed.
• Submission of stability study data as per guidelines of 293rd meeting of Drug Registration
Board, along with updated/revised master formulation, method of manufacturing and
drug product specifications.
• Submission of differential fee of Rs. 25,000/- for new drug or molecule/drug not
manufactured locally, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
848. Name and address of manufacturer/ Bryon pharmaceuticals (Pvt.) Ltd. 48-Hayatabad
Applicant Industrial Estate, Peshawar.
Brand Name + Dosage Form + Strength VALSAR 160 tablet
Composition Each film coated tablet contains: -
Valsartan …………...……160mg
Diary No. Date of R & I & fee Dy. No.86/R&I dated 03-04-2012 Rs. 8,000/- dated 03-
04-2012 (Challan photocopy),
Dy. No. 238/R&I dated 12-07-2016, Differential fee Rs.
12,000/- dated 12-07-2016 submitted vide deposit slip
No.0556432.
Pharmacological Group Anti-hypertensive drug
Type of Form Form-5
Pack size & Demanded Price 2×7’s, As per SRO
Approval status of product in Reference (USFDA approved) DIOVAN ®
Regulatory Authorities (Valsartan 160mg tablets)
Me-too status Diovan 160mg Tablet of M/s Novartis Pharma, Karachi.
of layout plan conducted on 07-09-2021 & 22-10-2021.
Recommendation for renewal of DML granted and
regularization of layout plan verified.
Remarks of the Evaluator (PEC-XVII) • Firm has revised finished drug product specifications as
per official monograph (USP) without submission of fee.
& 13-07-2021.
• Tablet Section (General) available as per DML renewal
inspection conducted on 07-09-2021 & 22-10-2021.
849. Name and address of manufacturer/ Bryon pharmaceuticals (Pvt.) Ltd. 48-Hayatabad
Applicant Industrial Estate, Peshawar.
Brand Name + Dosage Form + Strength VALSAR-H 160/12.5 tablet
Composition Each film coated tablet contains: -
Valsartan …………...……160mg
Hydrochlorothiazide..........12.5mg
Diary No. Date of R & I & fee Dy. No.139/R&I dated 26-04-2012 Rs. 8,000/- dated 25-
04-2012 (Challan photocopy),
Dy. No. 241/R&I dated 12-07-2016, Differential fee Rs.
No.0565468.
Pharmacological Group Anti-hypertensive drug
Type of Form Form-5
Pack size & Demanded Price 2×7’s, As per SRO
Approval status of product in Reference (USFDA approved) DIOVAN HCT®
Regulatory Authorities (valsartan and hydrochlorothiazide USP) tablets
Me-too status HC-Valdil Tablet 160/12.5 AJM pharma, Karachi.
of layout plan conducted on 07-09-2021 & 22-10-2019.
Recommendation for renewal of DML granted and
regularization of layout plan verified.
Remarks of the Evaluator (PEC-XVII) • Firm has revised finished drug product specifications as
per official monograph (USP) without submission of fee.
& 13-07-2021.
• Tablet Section (General) available as per DML renewal
inspection conducted on 07-09-2021 & 22-10-2021.
850. Name and address of manufacturer/ M/s CCL Pharmaceuticals (Pvt.) Ltd. 62-Industrial
Applicant Estate, Kot Lakhpat, Lahore.
Brand Name + Dosage Form + Strength SPRING Tablet
Doxylamine Succinate……10mg
Pyridoxine HCl…….10mg
Diary No. Date of R & I & fee Dy. No. dated 08-10-2011, Rs. 8,000/- dated 08-10-2011
Challan (Photocopy),
Dy. No.75-R&I dated 30-11-2015, Differential fee Rs.
12,000/- vide challan No. 0296713 dated 27-11-2015
(Photocopy),
Pharmacological Group Antihistamine and vitamin
Type of Form Form 5
Approval status of product in Reference Diclegis film-coated, delayed release tablet (USFDA
Regulatory Authorities approved), Gastro-resistant film-coated tablet (MHRA
approved)
Me-too status Vomifit Tablet 10/10mg of M/s Hilton Pharma, Karachi.
09-2020, 15-09-2020 & 21-10-2020, wherein panel
recommends renewal of DML of the firm.
Remarks of the Evaluator (PEC-XVII) • Firm revised label claim as per reference product as:
Each delayed-release, film-coated tablet contains:
Pyridoxine HCl…….10mg and also revised the master
formulation and manufacturing outlines. The requisite
fee Rs: 30,000/- submitted vide deposit slip
No.224459835117.
• Tablet Section (General) available as per DML
inspection report dated 14-09-2020, 15-09-2020 & 21-
10-2020.
application.
Brand Name + Dosage Form + Strength SPRING-S Tablet
Pyridoxine HCl…….10mg
Silymarin……………10mg
Diary No. Date of R & I & fee Dy. No. dated 08-10-2011, Rs. 8,000/- dated 08-10-2011
Challan (Photocopy),
Dy. No. dated 30-11-2015, Differential fee Rs. 12,000/-
vide challan No. 0296714 dated 27-11-2015
(Photocopy),
(Duplicate dossier)
Pharmacological Group Antihistamine and vitamin
Type of Form Form 5
09-2020, 15-09-2020 & 21-10-2020, wherein panel
Remarks of the Evaluator (PEC-XVII) • Provide evidence of approval of applied formulation in
• Provide evidence of Me-too/generic drug product
already approved by DRAP, mentioning its name,
registration number and manufacturer.
• Tablet Section (General) available as per DML
inspection report dated 14-09-2020, 15-09-2020 & 21-
10-2020.
were declared/approved by the Registration Board.
• Verification of R & I record of initial submission of registration application.
Brand Name + Dosage Form + Strength VAXOL 375/20 DR tablet
Composition Each delayed released tablet contains:
Naproxen……...375mg
Esomeprazole magnesium eq. to esomeprazole……...
20mg
Diary No. Date of R & I & fee Dy. No.2370 dated 08-02-2011, Rs. 15,000/- dated 08-
02-2011 Challan (Photocopy),
challan No. 0296709 dated 27-11-2015 (Photocopy),
Pharmacological Group NSAID and Proton pump inhibitor
Type of Form Form 5
Approval status of product in Reference USFDA approved (Vimovo delayed release tablets) 375
Regulatory Authorities mg enteric-coated naproxen /20 mg immediate-release
esomeprazole
09-2020, 15-09-2020 & 21-10-2020, wherein panel
Remarks of the Evaluator (PEC-XVII) • Revise label claim as per reference product as:
Each enteric film coated tablet contains:
Naproxen (as enteric coated inner core) ……… 375 mg
Esomeprazole (As Magnesium trihydrate as film coated
outer core) ……….20mg
meeting.
& 13-07-2021.
• Revision of label claim as per reference product as:
Esomeprazole (As Magnesium trihydrate as film coated outer core) ……….20mg
• Submission of stability study data as per guidelines of 293rd meeting of Drug Registration Board.
• Submission of revised/updated master formulation, method of manufacturing and drug product
specifications.
• Submission of applicable fee as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-
07-2021.
Brand Name + Dosage Form + Strength VAXOL 500/20 DR tablet
Composition Each delayed released tablet contains:
Naproxen……...500mg
Esomeprazole magnesium eq. to esomeprazole……...
20mg
Diary No. Date of R & I & fee Dy. No. 2371 dated 08-02-2011, Rs. 15,000/- dated 08-
02-2011 Challan (Photocopy),
challan No. 0296710 dated 27-11-2015 (Photocopy),
Pharmacological Group NSAID and Proton pump inhibitor
Type of Form Form 5
Approval status of product in Reference USFDA approved (Vimovo delayed release tablets) 500
Regulatory Authorities mg enteric-coated naproxen /20 mg immediate-release
esomeprazole
Me-too status Couldn’t be confirmed
09-2020, 15-09-2020 & 21-10-2020, wherein panel
• Revise label claim as per reference product as:
Esomeprazole (As Magnesium trihydrate as film coated
outer core) ……….20mg
meeting.
& 13-07-2021.
Esomeprazole (As Magnesium trihydrate as film coated outer core) ……….20mg
• Submission of stability study data as per guidelines of 293rd meeting of Drug Registration Board.
• Submission of revised/updated master formulation, method of manufacturing and drug product
specifications.
07-2021.
854. Name and address of manufacturer/ Vega pharmaceuticals (Pvt) Ltd. Pharma city, Plot No.4,
Applicant 30-Km, Multan Road, Lahore.
Brand Name + Dosage Form + Strength LUMETHER tablet
Artemether……… 80mg
Lumefantrine……...480mg
2010 (Photocopy),
Dy. No. dated 01-06-2016 Differential fee Rs. 12,000/-
dated 31-05-2016 vide Challan No.0517705 (Photocopy)
(Duplicate dossier, R & verified)
Type of Form Form-5
Pack size & Demanded Price 1 × 4’s, M.R.P Rs: 320/- per pack
Approval status of product in Reference WHO prequalified drug (Artemether/Lumefantrine
Regulatory Authorities 80mg/480mg) Tablets (Novartis Pharma AG), MA108
Me-too status Trimed 80/480mg Tablet of M/s Trigon Pharmaceuticals
(Pvt) Ltd. Lahore. Registration No. 102694
09-2020, 15-10-2020 & 10-11-2020, wherein panel
recommends grant of renewal of DML.
• Firm revised equipment/machinery list as coating
equipment were mentioned whereas the applied
formulation is in un-coated form.
International pharmacopoeia.
• Tablet Section (General) mentioned in DML renewal
inspection conducted on 28-09-2020, 15-10-2020 & 10-
11-2020.
• Firm submitted fee of Rs: 7500/- vide on-line deposit
slip No.34283933975 for above revision/amendments.
Decision: Approved with International Pharmacopoeia specifications. Registration Board
further decided to verify fee challan as per decision of 285th meeting of Registration Board.
Brand Name + Dosage Form + Strength DANSTRO 8mg tablet
Ondansetron Hydrochloride eq. to
Ondansetron……8mg
2011 (Photocopy),
(Duplicate dossier, R & I verified)
Pharmacological Group 5-HT3-receptor antagonist with anti-emetic activity.
Type of Form Form-5
Pack size & Demanded Price 1 × 10’s, M.R.P Rs: 2000/- per pack
Approval status of product in Reference ZOFRAN® (ondansetron hydrochloride) 4mg & 8mg
Regulatory Authorities tablets Novartis pharma (US FDA approved)
Me-too status Ondesmed Tablet 8mg Medicraft Pharmaceuticals (Pvt)
Ltd. Peshawar. Registration No. 101379
09-2020, 15-10-2020 & 10-11-2020, wherein panel
Remarks of the Evaluator (PEC-XVII) • Firm revised label claim as per reference product
Ondansetron (as hydrochloride dihydrate) ……8mg
• Firm provided complete testing methods as per official
monograph (BP).
slip No.258898379.
• Firm has to submit differential fee of Rs: 22,500/- as full
fee required for above revision of label
claim/composition.
•Firm shall submit the differential fee of Rs. 22,500/- for correction/pre-approval change in
composition (correction/change of salt form of the drug substance), as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength TRAVOTIM eye drops
Composition Each ml of ophthalmic solution contains:
Travoprost……….40mcg
Timolol (as timolol maleate) ……5mg
2010 (Photocopy),
(Duplicate dossier, R & I verified).
Pharmacological Group Anti-glaucoma + Beta blocker
Type of Form Form-5
Pack size & Demanded Price 1 × 2.5ml, M.R.P Rs: 1000/- per vial of 2.5ml
Approval status of product in Reference DuoTrav eye drops, solution (Novartis UK, MHRA
Me-too status Co-Travost Eye Drops (Travoprost: 0.004%; Timolol
maleate: 0.5%) of M/s Sante (Pvt) Ltd. Karachi.
09-2020, 15-10-2020 & 10-11-2020, wherein panel
innovators product.
slip No.4452987443.
• Eye/Ear Drops & Nasal Spray Sections (both General &
Steroid) available as per Licensing Division letter
• Official monograph for individual drugs available.
Brand Name + Dosage Form + Strength FLONASE nasal spray
Composition Each 100mg spray delivered contains:
Fluticasone propionate……….50 mcg
2010 (Photocopy), Dy. No. dated 01-06-2016
Challan No.0517704 (Photocopy)
(Duplicate dossier R & I verified)
Pharmacological Group Corticosteroid
Type of Form Form-5
Pack size & Demanded Price Rs: 300/- per vial of 120 spray doses.
Me-too status Kartico Nasal SprayRotex Pharma (Pvt) Ltd., Islamabad.
Remarks of the Evaluator (PEC-XVII) • The various label claim mentioned for reference product
as:
Each 100-microliter metered spray contains 50
microgram (mcg) of fluticasone propionate”
Each spray delivers 100 mg suspension containing 50
micrograms of fluticasone propionate as a delivered
dose.
Aqueous suspension of 0.5 mg (500 micrograms)/ml
fluticasone propionate.
Each actuation delivers 100 mg suspension containing
50 micrograms of fluticasone propionate as a delivered
dose.
• Eye/Ear Drops & Nasal Spray Sections (both General &
Steroid) available as per Licensing Division letter
Decision: Deferred for clarification of label claim, since reference product has declared label
claim in terms of “microliter of delivered dose contains” whereas firm has applied in terms of
“mg of delivered dose contains”.
858. Name and address of manufacturer/ M/s Oval Pharmaceuticals, 112/11, Industrial Estate,
Applicant Township, Lahore.
Brand Name + Dosage Form + Strength REOPOL Suspension (120mg/5ml)
Composition Each 5ml of syrup contains:
Paracetamol……120mg
Diary No. Date of R & I & fee Dy. No.4485 dated 08-08-2009, Rs. 8,000/- dated 08-08-
2009 (Photocopy),
Dy. No. dated Differential fee Rs. 12,000/- vide
Challan No.0001229 dated 18-09-2013 (Photocopy)
Pharmacological Group Antipyretic, analgesic
Type of Form Form 5
Pack size & Demanded Price 60ml,120ml,450mlRs:45.50/-, Rs:84.20/-, Rs: 298.62/-
Approval status of product in Reference Paracetamol 120 mg/5 ml Oral Suspension by M/s
Regulatory Authorities Pinewood Laboratories Limited (MHRA approved)
Me-too status Fempol 120mg/5ml suspension by M/s Atlantic
Pharmaceuticals Pvt. Limited. (Reg# 062314)
GMP status Panel inspection to check the rectifications of
deficiencies, conducted on 07-01-2020 and concluded
that “In view of above findings of inspection, areas
checked, documents reviewed, the panel is of the opinion
that the firm had rectified most of the previous
observations. Hence the firm may be allowed to resume
the production activities. The management assured that
they would strictly follow the Drugs Act 1976 for GMP
compliance”.
Remarks of the Evaluator (PEC-XVII) • R & I cover letter of differential fee submission in the
year 2013 is required.
• Firm revised paracetamol quantity in master formula
from 40mg/ml to 120mg/5ml.
• In the label claim the word “Syrup” revised as
“Suspension”.
• At annexure-VI, in the product specifications table, the
assay mentioned is for Promethazine HCl with limits of
90-110%. Firm rectified and provided correct assay of
paracetamol.
• The finished drug product specifications given as per B.P
monograph for paracetamol oral suspension. In B.P the
different monographs given are:
Pediatric paracetamol oral suspension 5% w/v
(250mg/5ml), Paracetamol Oral Suspension and
Pediatric Paracetamol Oral Solution 2.4% w/v
(120ml/5ml).
• Oral liquid Section mentioned in panel inspection
conducted on 07-01-2020, to check the rectifications of
deficiencies.
• Firm has provided letter No.F.1-24/93-Lic (Vol-II) dated
03-11-2021 titled as “approval of revised layout plan
under DML No.000156 (Formulation)”, evidence of oral
liquid section availability.
& 13-07-2021.
Each 5ml suspension contains:
Paracetamol….120mg
• Registration Board further decided to verify fee challan as per decision of 285 th meeting of
Registration Board.
(correction/change of formulation from syrup to suspension), as per notification No.F.7-11/2012-
Brand Name + Dosage Form + Strength PROMIZINE Elixir (5mg/5ml)
Promethazine HCl……5mg
2009 (Photocopy), Dy. No. dated
Differential fee Rs. 12,000/- vide Challan No.0044192
dated 18-09-2013 (Photocopy)
Pharmacological Group First generation antihistamine, antiemetic
Type of Form Form 5
Pack size & Demanded Price 120ml,450ml Rs:45.50/-
Approval status of product in Reference Phenergan Elixir 5mg/5ml (MHRA approved)
Me-too status DEMATIC Oral Solution 5mg/5ml of M/s Oakdale
pharmaceuticals, Peshawar. Registration No. 087037
deficiencies conducted on 07-01-2020 and concluded
compliance”.
• The dosage form mentioned in application form was oral
suspension, while the formulation applied is
Elixer/solution. Firm revised/rectify it and also replaced
the word “syrup” in label claim as “elixir”.
deficiencies.
& 13-07-2021.
Each 5ml elixir contains:
Paracetamol….120mg
Registration Board further decided to verify fee challan as per decision of 285th meeting of
Registration Board.
Firm shall submit the fee of Rs. 30,000 for correction/pre-approval change in composition
(correction/change of formulation from suspension to elixir), as per notification No.F.7-11/2012-
Brand Name + Dosage Form + Strength RIOZINE syrup (5mg/5ml)
Composition Each 5ml syrup contains:
Cetirizine Dihydrochloride……5mg
08-2009 (Photocopy), Dy. No. dated Differential fee
Rs.12,000/- vide Challan No.0001236 dated 18-09-2013
(Photocopy),
Pharmacological Group H1 receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 60ml, Rs:36.50/-
Approval status of product in Reference CHILDREN'S ZYRTEC ALLERGY (US FDA
Me-too status Tririz 1mg Oral Solution of Trillium Pharmaceuticals
Faisalabad. Registration No. 096416
compliance”.
• Firm revised label claim as:
Each 5ml syrup contains:
Cetirizine hydrochloride……5mg
• In official monograph, the structural formula given is
cetirizine dihydrochloride, but the content mentioned is
cetirizine hydrochloride.
deficiencies.
& 13-07-2021.
Each 5ml syrup contains:
Cetirizine hydrochloride……5mg
Registration Board.
Brand Name + Dosage Form + Strength REOTRAN pediatric suspension
Trimethoprim……...40mg
Sulphamethoxazole……...200mg
2009 (Photocopy), Dy. No. dated Differential fee Rs.
(Photocopy)
Pharmacological Group Antibacterial-sulfonamide
Type of Form Form 5
Pack size & Demanded Price 50ml, Rs:45/-
Approval status of product in Reference USFDA approved
Me-too status Methotrix Suspension of M/s Dr. Raza pharma,
compliance”.
• Firm replace the word “syrup” in label claim by
“suspension”, as the applied formulation is in suspension
form.
deficiencies.
& 13-07-2021.
Trimethoprim……...40mg
Sulphamethoxazole……...200mg
Registration Board.
Brand Name + Dosage Form + Strength XANTAL suspension
Albendazole……...200mg
(Photocopy)
Type of Form Form 5
Pack size & Demanded Price 10ml, Rs:28.30/-
Approval status of product in Reference ZENTEL 0.4 g/10 mL, oral suspension GSK (ANSM
Regulatory Authorities France)
Me-too status Intestinil Oral Suspension of M/s Sapient Pharma,
compliance”.
Remarks of the Evaluator (PEC-XVII) • Provide DRAP R & I stamped cover letter copy for
differential fee submission in the year 2013.
• Firm replace the form “syrup” in label claim by
“suspension”, as the applied formulation is in suspension
form.
deficiencies.
notifications 7-11/2012-B&A/DRAP dated 07-05-
2021 & 13-07-2021.
• Albendazole……...200mg
• Registration Board further decided to verify fee challan as per decision of 285th meeting of
Registration Board.
Brand Name + Dosage Form + Strength RIOFAX topical ointment
Composition Each 1gm of ointment contains:
Polymyxin B Sulphate……...1000 IU
Bacitracin Zinc……………...500 IU
Rs. 12,000/- vide Challan No.0001233 dated 18-09-2013
(Photocopy)
Type of Form Form 5
Pack size & Demanded Price 20gm, Rs:66.00/-
Approval status of product in Reference Health Canada approved with schedule as OTC and
Regulatory Authorities electronic product monograph not available.
In DailyMed data base, the product is available as OTC
drug (Polysporin first aid antibiotic, Double antibiotic
ointment)
US FDA approved but status is discontinued.
Me-too status Polycort Ointment of Aspin pharma, Karachi.
compliance”.
• Firm revised the quantity of Bacitracin Zinc in master
formulation as per label claim from 0.39kg to 0.204kg
for a 30kg batch size.
• Ointment Section mentioned in panel inspection
deficiencies.
under DML No.000156 (Formulation)”, evidence of
Semi solid (cream, ointment, gel lotion) (General)
Section availability.
• Previous approval given as per US FDA, HPRA and
MHRA.
Brand Name + Dosage Form + Strength RIOMYCIN ointment (0.5% w/w)
Neomycin Sulphate………1mg (0.5% w/w)
(Photocopy)
Pharmacological Group Aminoglycoside Antibiotic
Type of Form Form 5
Me-too status Neomycin Skin Ointment Neomycin Sulphate….0.5%
w/w (Antibacterial) Adamjee Pharmaceuticals, Karachi.
Neomycin Skin Ointment (Neomycin Sulphate 5mg)
Eros Pharmaceuticals, Karachi., Karachi. Registration
No. 031261
compliance”.
Each 1gm of ointment contains:
Neomycin Sulphate………5mg (0.5% w/w)
• The finished drug product specifications are given as per
USP monograph, while firm have referred to BP in their
SOP for finished drug product specifications. Firm
revised finished drug product specifications from USP to
BP.
deficiencies.
& 13-07-2021.
• Submission of fee Rs. 30,000/- for correction/pre-approval change in composition
(correction/change of formulation from 1mg per gm to 5mg per gram), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength RIODEX N Cream
Dexamethasone Sodium Phosphate.…0.1% w/w
Neomycin Sulfate………0.5% w/w
(Photocopy)
Pharmacological Group Combination corticosteroid + antibiotic
Type of Form Form 5
Me-too status Dexa-N Cream Switss Pharmaceuticals, Karachi.
Dexazone-N Cream Adamjee Pharmaceuticals, Karachi.
Kanadex-N Cream, DEXAMETHASONE SODIUM
PHOSPHATE 1mg NEOMYCIN SULPHATE 3500IU
KRKA Karachi. Registration No.012475
compliance”.
• R & I cover letter of differential fee submission in the
• As per master formulation, the quantity of
dexamethasone sodium phosphate for 30kg batch size
given as 0.3kg, which does not corresponds/match with
the label claim. The firm revised the master formulation
with correct quantity of dexamethasone sodium
phosphate that is 0.03kg.
• Provide evidence of separate dispensing facilities for
steroidal materials.
deficiencies.
& 13-07-2021.
• Evidence of availability of separate dispensing facilities for steroidal materials.
Brand Name + Dosage Form + Strength RIOVATE N cream
Betamethasone Valerate.…0.1% w/w
Neomycin Sulfate…………0.5% w/w
(Photocopy)
Pharmacological Group Combination corticosteroid + antibiotic
Type of Form Form 5
Approval status of product in Reference Betnovate N cream (MHRA approved)
Me-too status Betnovate – N Cream by GSK (Reg. # 000254).
compliance”.
• R & I cover letter of differential fee submission in the
• Firm revise label claim as per reference product as:
Each 1gm of cream contains:
Betamethasone valerate eq. to Betamethasone…...
……1mg (0.1% w/w)
Neomycin sulphate……….5mg (0.5% w/w) and also
revised the master formulation accordingly.
• Firm has claimed manufacturer specifications. Official
monograph not available.
deficiencies.
& 13-07-2021.
Decision: Approved as per following label claim:
“Each 1gm of cream contains:
Betamethasone valerate eq. to Betamethasone …. …… 1mg (0.1% w/w)
Neomycin sulphate ………. 5mg (0.5% w/w)”

• Submission of fee Rs: 30,000/- for correction/pre-approval change in composition
B&A/DRAP dated 13-07-2021 as label claim revised.
Brand Name + Dosage Form + Strength RIOVATE ointment
Betamethasone (as Valerate).…1mg (0.1% w/w)
(Photocopy)
Pharmacological Group Topical corticosteroid
Type of Form Form 5
Me-too status Betnovate ointment of M/s GSK, Karachi. Registration
No. 000257
compliance”.
• The initial and differential challan submitted bearing the
product name as “Riovate-N Ointment”. Firm re-submit
the initial challan with the word “N” cross-marked.
Moreover, as per R & I record, the product applied with
Dy.No.4481 dated 08-08-2009 is “Riovate-N ointment
5gm”.
• The firm revised master formulation by adjusting the salt
factor of Betamethasone valerate.
deficiencies.
& 13-07-2021.
Decision: Approved. Registration letter will be issued upon submission of following:
• Clarification is required since the initial and differential fee challans copies provided bearing
product name as “Riovate-N Ointment”, while the product applied/mentioned in duplicate
application (Form-5) is Riovate ointment.
• Submission of fee Rs: 30,000/- for correction/pre-approval change in composition
B&A/DRAP dated 13-07-2021 as label claim revised.
Brand Name + Dosage Form + Strength VOLTREX gel
Composition Each 100gm of gel contains:
Diclofenac Diethyl Ammonium Salt 1.16gm equivalent
to Diclofenac Sodium….1gm
(Photocopy)
Pharmacological Group Other dermatological/ topical NSAID
Type of Form Form 5
Approval status of product in Reference Voltarol 1.16% Emulgel, gel, 1g of Voltarol Emulgel
Regulatory Authorities contains 11.6mg of the active substance diclofenac
diethylammonium, which corresponds to 10mg
diclofenac sodium. (MHRA approved)
Me-too status Dicmaf 1% gel of M/s Mafins Pharma, Karachi.
compliance”.
869. Name and address of manufacturer/ M/s Lowitt Pharma (Pvt.) Ltd. Plot No.24-Industrial
Applicant Estate, Hayatabad, Peshawar
Brand Name + Dosage Form + Strength NURZOL 40mg capsule
Omeprazole……40mg
31-01-2011 (Photocopy, no statistical officer stamp
mentioned),
Rs: 7000/- dated 04-01-2013 (Challan No. 82 dated 26-
12-2012, Photocopy),
Dy. No. dated 08-08-2017 Rs: 5000/- 01-08-2017 vide
challan No. 0588736 (Photocopy)
Pharmacological Group Antipeptic ulcerants
Type of Form Form 5
Approval status of product in Reference US FDA approved
Me-too status Parkoprazole Capsule 40mg of M/s Parkar Pharma,
Kotri. Registration No. 102818
GMP status Panel inspection report dated 01-08-2019 for grant of
cGMP certificate provided, wherein panel recommended
for award of cGMP certificate to the firm.
Remarks of the Evaluator (PEC-XVII) • Cover letter bearing only statistical officer stamp for Rs:
7000/- dated 04-01-2013 (initial submission) provided.
While two fee challan of Rs: 8000/- dated 31-01-2011
and fee challan Rs: 7000/- bearing statistical officer
stamp dated 04-01-2013 are also provided. Differential
fee Rs: 5000/- submitted on 08-08-2017.
• Signed Form 5 re-submitted by the firm.
Each delayed-release capsule contains:
Omeprazole ………40mg
(As enteric coated pellets) and submitted fee Rs:
30,000/- vide online deposit slip No.30575305912.
• Firm has changed pellets source/supplier from Pharma
Gen Limited, Lahore (specified in differential fee
submission cover letter submitted in 2017) to Vision
Pharmaceuticals, Islamabad.
• Firm has submitted CoA of omeprazole pellets 8.5%,
DML of pellets supplier and GMP certificate with
validity till 09-05-2022.
• Firm has also submitted real-time stability data sheets
conducted at 30 oC ± 2ºC and 65%RH ± 5%RH of three
sheets conducted at 40
o
C ± 2 ºC and 75%RH ± 5%RH of three batches for six
months.
• Firm has revised master formulation by excluding 5%
overage.
• Verification of initial and differential fee submission
required.
• Confirmation of fee for pellets source change required.
• Capsule Section (General) approved/available as per
Licensing Division letter No.F.3-3/2002-Lic (Vol-I)
dated 11-05-2022.
Each delayed-release capsule contains:
Omeprazole ………40mg
(As enteric coated pellets)
• Registration board further decided to verify fee challans as per decision of 285th meeting of
Registration Board.
870. Name and address of manufacturer/ M/s Karachi Chemical Industries (Pvt.) Ltd. Plot No.
Applicant F/25, Estate Avenue, S.I.T.E., Karachi.
Brand Name + Dosage Form + Strength KLARACIN 250mg tablet
Clarithromycin………….250mg
Diary No. Date of R & I & fee Dy. No. 172 dated 28-02-2011, Rs. 8,000/- dated 28-02-
2011 Challan (Photocopy)
(Photocopy),
(Duplicate dossier, R & I verified”
Type of Form Form 5
Me-too status Clareta 250mg tablet of M/s Arreta pharmaceuticals,
Rawalpindi. Registration No.100669
of approved layout plan conducted on 12-10-2021,
wherein the panel recommends the grant of renewal of
DML and regularization of approved layout plan of the
firm.
Remarks of the Evaluator (PEC-XVII) • Tablet (General) Section available as per Licensing
Division letter No.F.2-25/84-Lic (Vol-I) dated 22-11-
2021.
official monograph (USP).
• Firm has submitted fee of Rs: 7500/-vide online deposit
slip No.61549370 for above revision.
Brand Name + Dosage Form + Strength KLARACIN 500mg tablet
Clarithromycin………….500mg
(Photocopy),
Type of Form Form 5
Me-too status Clareta 500mg tablet of M/s Arreta pharmaceuticals,
Rawalpindi. Registration No.100659
firm.
2021.
Brand Name + Dosage Form + Strength MOXICIN 400mg tablet
Moxifloxacin (as hydrochloride) ………….400mg
(Photocopy),
Pharmacological Group Fluoroquinolone antibiotic
Type of Form Form 5
firm.
2021.
• Firm revised label claim as per reference product as Each
film-coated tablet contains:
Moxifloxacin (as hydrochloride) …….400mg.
The firm had given label claim as “Moxifloxacin”.
• The firm has revised finished drug product
specifications as per official monograph (USP).
• The firm has to submit differential fee of Rs: 22,500/-
for revision of label claim.
•Firm shall submit the differential fee of Rs. 22,500 for correction/pre-approval change in
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength PEP-EEZ 40mg tablet
Composition Esomeprazole…….40mg
(Photocopy),
Type of Form Form 5
st
1022
Approval status of product in Reference MHRA approved (Esomeprazole 40mg Gastro-resistant
Regulatory Authorities Tablets)
Me-too status Esbril 40mg tablet (Esomeprazole as magnesium tri-
hydrate 40mg) of M/s Briell Pharmaceuticals (Pvt) Ltd.
Lahore, Lahore Registration No. 103263
firm.
2021.
• Firm provided/revised label claim as per reference
product as
Each gastro-resistant tablet contains:
Esomeprazole (as Magnesium trihydrate) …….40mg
and revised master formula and manufacturing outlines
accordingly.
• Official monograph not available and firm has claimed
manufacture specifications.
• The firm has to submit differential fee of Rs: 22500/- for
revision of label claim.
Decision: Approved with innovator’s specifications and revised label claim as:
Each gastro-resistant tablet contains:
Esomeprazole (as Magnesium trihydrate) …….40mg
Registration Board.
• Firm shall submit the differential fee of Rs. 22,500 for correction/pre-approval change in
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength ZINC SULPHATE 20mg tablet
Composition Zinc sulphate….
(Photocopy),
Pharmacological Group Zinc supplement
Type of Form Form 5
Approval status of product in Reference WHO prequalified Zincfant dispersible tablet 20 mg
Regulatory Authorities manufactured by Laboratories Pharmaceutique s Rodael
–France
Me-too status Zixol 20mg dispersible tablet of M/s Vision
pharmaceuticals, Islamabad. Registration No. 099565
firm.
2021.
• Firm provided/revised label claim as per reference
product as:
Each dispersible tablet contains:
Zinc sulphate monohydrate eq to elemental zinc…….
20mg and revised manufacturing outlines accordingly.
• Official monograph available in International
Pharmacopoeia as Paediatric Zinc Sulphate tablet
(dispersible) and in USP, BP as Zinc Sulphate tablet.
Decision: Approved with USP specifications and revised label claim as:
Each dispersible tablet contains:
Zinc sulphate monohydrate eq to elemental zinc……. 20mg
Registration Board.
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength ZINC SULPHATE Syrup
Composition Zinc sulphate….
(Photocopy),
Pharmacological Group Zinc supplement
Type of Form Form 5
Approval status of product in Reference Applied formulation has been verified from International
Regulatory Authorities Pharmacopoeia of WHO
Available in IP as solution (Available strengths: 10 mg
or 20 mg of zinc per 5 mL)
Me-too status Zevro Syrup 10mg/5ml Reg. No. 77058
Zincasa DS 20mg/5ml Syrup of M/s Macter Int
(R#076710)
firm.
Remarks of the Evaluator (PEC-XVII) • Liquid (General) Section available as per Licensing
2021.
• Initially, the product strength, composition/master
formulation and label claim had not been mentioned but
firm provided the strength and label claim as per
reference product as:
Each 5ml Contains:
Elemental Zinc (as Zinc Sulphate Monohydrate)
……20mg
• Official monograph available in International
Pharmacopoeia as Paediatric Zinc Sulphate oral solution
and in USP as Zinc Sulphate oral solution.
Each 5ml Contains:
Elemental Zinc (as Zinc Sulphate Monohydrate) ……20mg
Registration Board.
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength EXIDOL DROPS (80mg/0.8ml)
Paracetamol……...100mg
(Photocopy),
Pharmacological Group Analgesic & antipyretic, Anilide
Type of Form Form 5
Pack size & Demanded Price 15ml, 30ml, As per SRO
Approval status of product in Reference ZAPAIN 500MG/5ML ORAL SOLUTION
Regulatory Authorities (MHRA approved) (the product is qualitatively and
quantitatively the same as Paracetamol Infant Drops 100
mg/ml, Infadrops (PL 12762/0135), differing only in
pack size
Me-too status Children’s Panadol Drops of M/s GSK OTC (Pvt)
Ltd.Jamshoro. Registration No. 101140
firm.
• Liquid (General) Section available as per Licensing
2021.
• Firm revised manufacturing outlines according to the
• Firm provided/specified label claim as per reference
product as
Each ml Contains:
Paracetamol…...100mg
• Official monograph for the strength 100mg/ml is not
available.
Registration Board.
Brand Name + Dosage Form + Strength EXIDOL PLUS SYRUP (250mg/5ml)
Composition Paracetamol….
(Photocopy),
Pharmacological Group Analgesic & antipyretic, Anilide
Type of Form Form 5
Approval status of product in Reference Paracetamol 250mg/5ml Oral Suspension
Me-too status Bemol 6 Plus Suspension of M/s BJ Pharmaceuticals,
firm.
Remarks of the Evaluator (PEC-XVII) • Liquid (General) Section available as per Licensing
2021.
• Firm revised manufacturing outlines according to the
• Firm provided master formulation of the applied
product.
• The reference product is in suspension form while the
firm has applied for syrup form.
• Firm provided/specified label claim as:
Each 5 ml suspension contains:
Paracetamol…...250mg
Paracetamol ……250mg
Registration Board.
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength KLARACIN SYRUP (125mg/5ml)
Composition Clarithromycin……
(Photocopy),
Type of Form Form 5
Approval status of product in Reference MHRA approved (Granules for oral suspension)
Me-too status Texklar 125mg/5ml Dry Suspension of Rotex pharma
firm.
Remarks of the Evaluator (PEC-XVII) • Provide evidence of approval of relevant section by
• As per master formulation, the formulation is in syrup
form. Provide evidence of approval of applied
formulation in reference regulatory authorities/agencies
which were adopted by the Registration Board in its
275th meeting or else provide label claim/composition as
per reference product as:
Each 5ml of the reconstituted suspension contains:
Clarithromycin…….125mg and revise master
formulation and manufacturing outlines accordingly.
• The formulation provided is not as per reference
product, which is in the form taste-masked granules.
Please clarify as to how the applied formulation is in line
with reference product or else specify source of taste
masked pellets, provide CoA of pellets along with
stability data of 03 batches of such pellets. In case of
imported pellets, submit the differential fee as well.
• Provide finished drug product specifications.
slip No.8080748342 for finished drug product
specifications.
Clarithromycin…….125mg
(as taste mask granules)
• Submission of pellets source, CoA of pellets, stability study data of 03 batches of pellet and GMP
certificate of pellets manufacturer. In case of imported pellets source, applicable fee should also
be submitted.
879. Name and address of manufacturer/ M/s Jawa Pharmaceuticals Pvt. Ltd. 112/10, Quaid-e-
Applicant Azam Industrial Area, Kot Lakhpat, Lahore.
Brand Name + Dosage Form + Strength MIKACIN 500MG INJECTION (250mg/ml)
Amikacin Sulphate…...250mg
(Photocopy),
(Duplicate dossier, R & I record of initial submission
verified vide letter No.F.1-11/2019-Reg-II dated 07-05-
2020. Verification of initial and differential fee challans
required)
Pharmacological Group Aminoglycoside antibiotic
Type of Form Form 5
Pack size & Demanded Price 1× 2ml ampoule, As per SRO
Approval status of product in Reference MHRA approved (Amikacin 250mg/ml Injection)
Regulatory Authorities 1ml of solution for injection contains 250mg of amikacin
(as sulphate).
1 vial of 2ml of solution for injection contains 500mg of
amikacin (as sulphate).
Me-too status AMC 500mg/2ml Injection of M/s Rotex pharma,
GMP status Inspection for ground check/inspection of NOC for
quota allocation of controlled substances conducted on
17-02-2022 submitted as evidence of GMP status of the
firm.
• Liquid Injectable (General ampoules only) section
approved vide Licensing Division letter No.F.1-38/91-
Lic (Vol-I) dated 10-08-2015.
• Firm revised label claim as per reference product as:
Amikacin (as sulphate) …...500mg
• Firm revised the manufacturing process/flow chart as
initially the manufacturing process/flow chart submitted
depicts sterile powder filing in vials, while the
formulation applied is solution for injection.
• Firm resubmit the HVAC and air handling system
parameters for injection section as initially these were
provided for tablet and capsule sections.
• No fee submitted for above mentioned
revision/amendments. Firm stated that the applied
product is a generic product having same formulation as
innovator/reference product, so no need to pay further
fee.
Amikacin (as sulphate) …...500mg.
Registration Board.
11/2012-B&A/DRAP dated 13-07-2021.
• Registration letter will be issued after submission of GMP audit report from QA&LT Division,
valid within last three years.
Brand Name + Dosage Form + Strength CECAM INJECTION (Piroxicam 20mg/ml)
Piroxicam…...20mg
06-2011 Challan (Photocopy)
(Photocopy),
required)
Pharmacological Group Anti-rheumatics, NSAID
Type of Form Form 5
Pack size & Demanded Price 1ml × 5 ampoules, As per SRO
Approval status of product in Reference (ANSM France) PIROXICAM PFIZER 20 mg/1 ml,
Regulatory Authorities solution for injection in ampoule (IM)
Me-too status Salden 20mg Injection of M/s Danas Pharma
(Reg.#080373)
firm.
• Liquid Injectable (General ampoules only) section
Lic (Vol-I) dated 10-08-2015.
• Initially the Form-5 submitted by the firm was not in
prescribed format. Moreover, the applicant name
mentioned as Lawrance pharma (Pvt) Ltd. 10.5 Km
Sheikhupura road, Lahore, while the brand (proprietary)
name mentioned is Lawrcam Injection.
• Firm resubmit Form 5 in prescribed format and rectify
the applicant name and brand (proprietary name) as well.
• The firm specified the route of administration as
parenteral. The reference product is for IM use.
• Firm provided complete manufacturing outlines for the
• Firm submitted fee of Rs: 7500/- vide online deposit slip
No.31965800.
Decision: Approved with innovator’s specifications. • Registration Board further decided to
verify fee challan as per decision of 285th meeting of Registration Board.
•Firm shall submit the differential fee of Rs. 22,500 for correction/pre-approval change in Form
5 (correction/change of applicant name), as per notification No.F.7-11/2012-B&A/DRAP dated
13-07-2021.
•Registration letter will be issued after submission of GMP audit report from QA&LT Division,
Brand Name + Dosage Form + Strength JASTINE SYRUP (Ebastine 5mg/5ml)
Ebastine…...5mg
Diary No. Date of R & I & fee Dy. No. 274 dated 24-03-2009, Rs. 8,000/- dated Challan
(not provided)
(Photocopy),
(Duplicate dossier, R & I cover letter copy of initial
submission not provided Verification of initial and
differential fee submissions along with challans
required)
Pharmacological Group Other antihistamines for systemic use
Type of Form Form 5
Approval status of product in Reference Ebastel oral solution 1mg/ml of Almirall, (AEMPS –
Regulatory Authorities CIMA Spain Approved)
Me-too status Fystine Liquid Syrup of M/s Fynk Pharmaceuticals,
Lahore. (Reg. # 077173)
firm.
Remarks of the Evaluator (PEC-XVII) • Provide evidence of approval of relevant section by
• Provide DRAP R & I stamped cover letter of initial
submission of application form along with fee challan.
• Product is non-pharmacopoeia and firm has claimed
manufacturer specifications.
& 13-07-2021.
• Verification of DRAP R & I record of initial submission of registration application along with
fee.
Brand Name + Dosage Form + Strength JAWAFLOX DRY SUSPENSION (125mg/5ml)
Ciproflxocin (as hydrochloride) …...125mg
(Photocopy),
required)
Type of Form Form 5
Regulatory Authorities Ciproxin 250mg/5ml granules and solvent for oral
suspension
5 ml suspension after reconstitution (1 measuring spoon)
contains 250 mg ciprofloxacin.
2.5 mL suspension after reconstitution (1/2 measuring
spoon) contains 125 mg ciprofloxacin.
Me-too status Ciplozin Dry Powder Suspension 125mg/5ml of M/s
KBR Pharmaceuticals, Hattar (Reg.No. 103023)
firm.
Remarks of the Evaluator (PEC-XVII) • Dry Powder Suspension (General antibiotic) Section
Lic (Vol-II) (M-212) dated 18-06-2008.
• Registration Board in its 269th meeting decided as
follows: Keeping in view the following statement
written in Qualitative and quantitative composition “2.5
ml suspension after reconstitution (1/2 measuring spoon)
contains 125 mg ciprofloxacin” and domestic conditions
for difficulties in dispensing 250mg/5ml suspension for
children under 2 years of age, Registration Board
decided to approve the formulation of ciprofloxacin
125mg/5ml granules and solvent for oral suspension as
per reference product approved by USFDA and MHRA.
Ciprofloxacin (as hydrochloride) (taste mask granules)
….…125mg
• Firm revised master formulation and manufacturing
outlines, in line with reference product which is in the
form of taste mask granules.
• Firm specified the source/vendor of taste-mask granules
as M/s Vision Pharmaceuticals, Islamabad.
studies) and 0, 1, 2, 3 & 6 months (for Accelerated
Stability Conditions).
No.98219470485.
• The firm has to submit differential fee Rs: 22,500/- as
the applicable fee as per notifications 7-11/2012-
B&A/DRAP dated 07-05-2021 & 13-07-2021 is 30,000.
Since firm has revised the formulation/composition from
powder form to taste mask granules (ready to fill).
Ciprofloxacin (as hydrochloride) ….…125mg
(As taste mask granules)
Registration Board.
• The firm shall ensure the supply of Ciprofloxacin granules for oral suspension along with the
solvent/diluent as per innovator’s product in compliance with decision of 290th meeting of Drug
Registration Board.
composition (correction/change of formulation from powder to taste-mask granules), as per
• Registration letter will be issued after submission of GMP audit report within last three years.
Brand Name + Dosage Form + Strength BETSAL CREAM
Betamethasone dipropionate………… 0.5mg
Salicylic acid…………... 30mg
(Photocopy),
required)
Type of Form Form 5
Pack size & Demanded Price 5gm, 15gm, As per SRO
Approval status of product in Reference MHRA approved products are cutaneous solution and
Regulatory Authorities ointment:
Diprosalic Scalp Application 0.05% w/w / 2% w/w,
cutaneous solution, Betamethasone Dipropionate
0.064% w/w* (* equivalent to 0.05% Betamethasone)
Salicylic Acid 2.00% w/w.
Diprosalic 0.05% w/w / 3% w/w Ointment,

Betamethasone Dipropionate 0.064% w/w*
(* equivalent to 0.05% Betamethasone)
Salicylic Acid 3.00% w/w.
Me-too status Novasalic Ointment Contains: - Betamethasone (as
Dipropionate) ...0.05% w/w Salicylic Acid….3.0% w/w
of M/s Mass Pharma, Lahore. Reg.No. 024370
GMP status GMP certificate granted on 06/07/2020
Remarks of the Evaluator (PEC-XVII) • Cream/ointment (General) section approved vide
Licensing Division letter No.F.1-38/91-Lic (Vol-I) (M-
227) dated 17-06-2011.
• Initially firm applied product was “Betsal cream”. The
firm was asked to provide evidence of approval of
authorities/agencies which were approved by
Registration Board in its 275th meeting or else revise
label claim/formulation as per reference product and
revise master formulation, label claim and
manufacturing outlines accordingly. The firm clarified
that the applied formulation is ointment but mistakenly
mentioned as cream in application form.
No.986857453.
• The firm has to submit differential fee Rs: 22,500/- as
the applicable fee as per notifications 7-11/2012-
B&A/DRAP dated 07-05-2021 & 13-07-2021 is 30,000.
Since firm has revised the formulation/composition from
cream to ointment as per reference product.
• Evidence of availability of separate dispensing facility
for steroidal materials required.
Each gm ointment contains:
Betamethasone (as Dipropionate) ........ 0.5mg (0.05% w/w)
Salicylic Acid……………. 30mg (3.0% w/w)
following:
• Verification of fee challan as per decision of 285th meeting of Registration Board.
• Submission of differential fee of Rs. 22,500 for correction/pre-approval change in composition
• Evidence of availability of separate dispensing facility for steroidal materials.
Brand Name + Dosage Form + Strength ACAID CREAM (0.1% w/w)
Adapalene………… 1mg
(Photocopy),
Pharmacological Group Anti-ance
Type of Form Form 5
Pack size & Demanded Price 15gm, As per SRO
Approval status of product in Reference MHRA approved, Differin 0.1% w/w Cream (1g cream
Regulatory Authorities contains 1mg adapalene)
Me-too status Redap 0.1% Cream of M/s Evolution pharmaceuticals,
Islamabad. (Reg. No. 101639)
GMP status GMP certificate granted on 06/07/2020
• Cream/ointment (General) section approved vide
227) dated 17-06-2011.
• Initially the brand (proprietary) name mentioned in
application form as “JDPENE”, while in fee challans,
cover letters and enclosure, the name mentioned is
ACAID CREAM. Firm clarified that the correct name is
“Acaid cream” and JDPENE mentioned by mistake. The
firm revised Form 5 with correct brand (proprietary)
name.
• Firm has claimed manufacturer specifications, however,
official monograph available in BP.
• The firm has submitted fee of Rs:7500/- vide online
deposit slip No.12090631814 for revision of finished
drug product specifications.
Registration Board.
Brand Name + Dosage Form + Strength ISORID GEL (0.05% w/w)
Isotretinoin………… 0.5mg
(Photocopy),
required)
Pharmacological Group Retinoids for topical use in acne
Type of Form Form 5
Approval status of product in Reference Isotrex Gel, (MHRA approved) The active substance is
Regulatory Authorities isotretinoin 0.05% w/w (0.05 g per 100 g gel).
Me-too status Maso Gel of M/s Masfa Industries, Lahore.
(Reg. No. 101589)
firm.
Remarks of the Evaluator (PEC-XVII) • The firm has provided Cream/ointment (General)
section approved vide Licensing Division letter No.F.1-
38/91-Lic (Vol-I) (M-227) dated 17-06-2011 as
evidence of availability of required manufacturing
facility for gel.
application form as “T-IOSKIN GEL”, while in fee
challans, cover letters and enclosure, the name
mentioned is ISORID GEL. Firm clarified that the
correct name is “ISORID GEL” and T-IOSKIN GEL
mentioned by mistake. The firm revised Form 5 with
correct brand (proprietary) name.
• Clarification regarding fee submission as per
& 13-07-2021 is required.
Decision: Approved.
Registration Board.
• Firm shall submit fee of Rs. 7,500/- for correction/pre-approval change in Form 5, as per
Brand Name + Dosage Form + Strength POLYWAX PLUS OINTMENT
Polymyxine B Sulphate……… 10000 units
Bacitracin Zinc…………… 500 units
Lignocaine…………… 40mg
(Photocopy),
Type of Form Form 5
Me-too status Polyfax plus ointment of M/s GSK. Registration
No.023511 Needs confirmation.
firm.
Remarks of the Evaluator (PEC-XVII) • Cream/ointment (General) section approved vide
227) dated 17-06-2011.
application form as “JAWABACT CREAM”, while in
fee challans, cover letters and enclosure, the name
mentioned is POLYWAX PLUS OINTMENT. Firm
clarified that the correct name is “POLYWAX PLUS
OINTMENT” and JAWABACT CREAM mentioned by
mistake. The firm revised Form 5 with correct brand
(proprietary) name.
• The firm was asked to provide evidence of approval of
authorities/agencies which were adopted by the
label claim/composition as per reference product. The
firm revised the label claim as:
Each gm contains:
Polymyxine B Sulphate……… 5000 units
Bacitracin Zinc…………… 500 units
Neomycin (as Sulphate) ……3.5mg
Lidocaine…………… 40mg
• The firm has submitted fee of Rs:7500/- vide online
deposit slip No.66819852739 for above revision.
were declared/approved by the Registration Board.
• Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) along
with registration number, brand name and name of firm.
• Submission of GMP audit report from QA&LT Division, valid within last three years.
887. Name and address of manufacturer/ M/s Medera Pharmaceuticals (Pvt.) Ltd. Plot No.2,
Applicant Street No. N-4, National Industrial Zone, Rawat.
Brand Name + Dosage Form + Strength MEDVERINE 135mg tablet
Composition Each film-coated tablet contains: -
Mebeverine Hydrochloride ………135mg
04-2011 (Challan photocopy)
Dy. No.34 dated 18-03-2016, Differential fee Rs.
12,000/- dated 18-03-2016 vide challan No.0527626
dated 15-03-2016.
(Duplicate dossier, R & I verified”
Pharmacological Group Anticholinergics / anti-spasmodic
Type of Form Form 5
Approval status of product in Reference MHRA approved (Mebeverine hydrochloride 135mg
Regulatory Authorities Film-coated Tablets)
Me-too status Mebfolds Tablet 135mg of M/s WeatherFolds, Hattar.
Reg. No. 10281
GMP status Inspection report/CAPA report dated 19-07-2021 in lieu
of inspection conducted on 03-11-2020, submitted by the
firm. Remarks made by the FID as:
“The firm was inspected on 19-07-2021 and following
improvements has been found made the firm and is
satisfactory further improvement is a continuous process
and firm is willing to improve further”.
Remarks of the Evaluator (PEC-XVII) • Initially the type of container/packaging materials was
not mentioned. Firm specified the packaging materials
as Alu-Alu blister in Unit Carton with leaflet.
• Tablet (General) section available as per Licensing
Division letter No.F.1-16/2005-Lic dated 15-06-2011
for issuance of Drug Manufacturing License.
Decision: Approved.
Registration Board.
Brand Name + Dosage Form + Strength MONTIMED 10mg tablet
Montelukast (as sodium) ………10mg
dated 15-03-2016.
Type of Form Form 5
Approval status of product in Reference Montelukast 10mg (as Montelukast Sodium) Film-
Regulatory Authorities coated tablets, MHRA approved.
Me-too status Dowkast 10mg tablet of M/s Seatle (Pvt) Ltd. Lahore
The firm was inspected on 19-07-2021 and following
and firm is willing to improve further.
official monograph (USP) as in cover letter of initial
submission, manufacturer specifications mentioned,
while in duplicate dossier submitted, USP specifications
are claimed.
• Firm has submitted fee of Rs: 7500/- vide online deposit
Registration Board.
Brand Name + Dosage Form + Strength ENTIVIRE 0.5mg tablet
Entecavir ………0.5mg
2011 (Challan photocopy)
dated 15-03-2016.
Pharmacological Group Anti-viral
Type of Form Form 5
Regulatory Authorities (Entecavir 0.5 mg film-coated tablets)
Me-too status Cavirent Tablet 0.5mg by M/s CKD Pharmaceuticals
Reg#092969)
Each film-coated tablet contains: -
Entecavir monohydrate eq. to Entecavir ………0.5mg
and also revised master formulation/composition and
manufacturing outlines accordingly.
• Firm has submitted fee of Rs: 30000/- vide online
Each film-coated tablet contains: -
Entecavir monohydrate eq. to Entecavir ………0.5mg
Registration Board.
Brand Name + Dosage Form + Strength IRO tablet
Composition Each tablet contains: -
Iron (III) Polymaltose Complex ………100mg
dated 15-03-2016.
Pharmacological Group Anti-anaemic
Type of Form Form 5
Approval status of product in Reference (TGA Australia approved) Maltofer film-coated tablet
Regulatory Authorities (Iron polymaltose 370 mg Equivalent: Iron 100 mg) of
Vifor Pharma, Australia
• In cover letters of initial and differential submission drug
name mentioned as IRO Chewable tablets (Iron (III)
Hydroxide Polymaltose complex….100mg, while label
claim/composition in Form-5 mentioned as:
Each tablet contains: -
Iron (III) Polymaltose Complex ………100mg.
The firm then revised label claim as:
Each chewable tablet contains: -
Iron (III) hydroxide Polymaltose Complex equivalent to
elemental Iron ………100mg. The master formulation
and manufacturing outlines were also revised
accordingly.
• Each chewable tablet contains: -
Iron (III) hydroxide Polymaltose Complex equivalent to elemental Iron ………100mg
Registration Board.
Brand Name + Dosage Form + Strength IROFOL Chewable tablet
Iron (III) Polymaltose Complex eq. to Elemental Iron
………100mg
Folic Acid…….0.35mg
dated 15-03-2016.
Pharmacological Group Anti-anaemic
Type of Form Form 5
Me-too status Fogyma 100mg/0.35mg chewable tablet of M/s
Theramed Pharma, Lahore. Reg.No. 101702
• In cover letters of initial and differential submission drug
name mentioned as IROFOL Chewable tablets while
label claim/composition in Form-5 mentioned as:
Iron (III) Polymaltose Complex eq. to Elemental Iron
………100mg
Folic Acid…….0.35mg.
The firm then revised label claim as:
Each chewable tablet contains: -
Iron (III) hydroxide Polymaltose Complex eq. to
Elemental Iron ………100mg.
The master formulation and manufacturing outlines
were also revised accordingly.
• Ferrum Fol 100 mg / 350 micrograms, Chewable Tablets
(Iron as Iron (III)-hydroxide polymaltose complex / folic
acid) Vifor France (PIL available on google)
Division letter No.F.1-16/2005-Lic dated 15-06-2011 for
issuance of Drug Manufacturing License.
• Each chewable tablet contains: -
Iron (III) hydroxide Polymaltose Complex eq. to Elemental Iron ………100mg.
Registration Board.
Brand Name + Dosage Form + Strength SPASNIL 4mg tablet
Tizanidine as HCl …….4mg
dated 15-03-2016.
Pharmacological Group Alpha-2-Adrenergic agonist, muscle relaxant
Type of Form Form 5
Approval status of product in Reference Zanaflex® Tablets uncoated (USFDA approved)
Me-too status Ternine Tablet 4mg of M/s Hiranis pharmaceuticals,
Karachi. Reg.No. 103161
Remarks of the Evaluator (PEC-XVII) • Firm revised pharmacological group as “muscle
relaxants, centrally acting agents, other centrally acting
agents”.
• Firm has submitted fee of Rs: 7500/- vide online deposit
Decision: Approved.
Registration Board.
Brand Name + Dosage Form + Strength ALEMAX 70mg tablet
Alendronate Sodium as Sesquihydrate ………. 70mg
dated 15-03-2016.
Pharmacological Group Inhibitor of osteoclastmediated bone resorption
Type of Form Form 5
Approval status of product in Reference (MHRA approved), Each tablet contains 70 mg
Regulatory Authorities alendronic acid (as sodium trihydrate), uncoated
Me-too status Entrate 70mg Tablet of M/s Genetics pharmaceuticals,
Lahore. Reg.No. 098263
• Firm revised master formula and manufacturing outlines
as per label claim for uncoated tablet.
Alendronic acid (As sodium trihydrate) ………. 70mg
Alendronic acid (As sodium trihydrate) ………. 70mg
Registration Board.
Brand Name + Dosage Form + Strength ARTEMED DS DRY SUSPENSION
Composition Each 5ml of the reconstituted suspension contains: -
Artemether………30mg
Lumefantrine…….180mg
2011 (Challan photocopy), Dy.No.1637 dated 10-06-
2011 (Section diary),
dated 15-03-2016.
Pharmacological Group Anti-malarial
Type of Form Form 5
Approval status of product in Reference Mentioned strength in International Pharmacopoeia is 15
Regulatory Authorities mg Artemether and 90 mg of Lumefantine per 5 ml.
Me-too status Artem Plus 30/180 Dry Suspension of Hilton Pharma,
Remarks of the Evaluator (PEC-XVII) • Type of container/packaging materials not mentioned by
the firm.
• Revise finished drug product specifications as per
official monograph (International Pharmacopoeia).
• Dry powder suspension (General) section available as
per Licensing Division letter No.F.1-16/2005-Lic dated
15-06-2011 for issuance of Drug Manufacturing
License. For above revision, submit applicable fee as per
& 13-07-2021.
were declared/approved by the Registration Board in its 275th.
Brand Name + Dosage Form + Strength ARTEPIP DRY SUSPENSION
Composition Each 5ml of the reconstitution suspension contains: -
Dihydroartemisinin …...15mg
Piperaquine …………120mg
dated 15-03-2016.
Pharmacological Group Anti-diarrheal
Type of Form Form 5
Pack size & Demanded Price 60ml, 30ml, As per SRO
Me-too status Euaria 15mg/120mg/5ml Powder for Oral Suspension of
M/s Martin Dow, Karachi. Reg.No. 076463
• Revise pharmacological group as “Anti-malarial.
• Provide evidence of availability of applied formulation
in reference regulatory authorities adopted by the
• Product is non-pharmacopoeial.
License. For above revision, submit applicable fee as per
& 13-07-2021.
were declared/approved by the Registration Board in its 275th.
• Revision of pharmacological group as “Anti-malarial”.
• Submission of applicable fee, as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-
07-2021.
Brand Name + Dosage Form + Strength CONAZOLE DRY SUSPENSION (40mg/ml)
Composition Each ml of the reconstitution suspension contains: -
Voriconazole ………... 40mg
dated 15-03-2016.
Pharmacological Group Anti-fungal
Type of Form Form 5
Approval status of product in Reference Voriconazole Pfizer 40 mg/ml powder for oral
Regulatory Authorities suspension (MHRA approved)
Me-too status Voricon Suspension of M/s S.J & G. Fazul Ellahie,
Remarks of the Evaluator (PEC-XVII) • Firm revised pharmacological group as “Antimycotics
for Systemic Use, triazole and tetrazole derivatives”.
• Firm claimed manufacture specifications, while the
applied product is non-pharmacopoeial.
License.
Registration Board.
897. Name and address of manufacturer/ M/s Medera Pharmaceuticals Plot No.249/A, Industrial
Applicant triangle, Kahuta road, Islamabad.
Brand Name + Dosage Form + Strength ESOZOLE 20mg Capsule
Composition Each capsule contains: -
Magnesium Trihydrate (enteric coated pellets)
…...…20mg
Dy. No. 383 dated 18-03-2016, Differential fee Rs.
dated 15-03-2016.
Type of Form Form 5
Me-too status Parko-Eprazole Capsule 20mg of M/s Parkar Pharma,
Remarks of the Evaluator (PEC-XVII) • Firm revised label claim as:
Each capsule contains:
Esomeprazole (as Magnesium trihydrate enteric coated
pellets) ………20mg
• Firm specified the source/vendor of Esomeprazole
enteric coated pellets as M/s Vision Pharmaceuticals,
Islamabad.
• Firm provided CoA of Esomeprazole magnesium enteric
coated pellets 8.5%.
studies) and 0, 3 & 6 months (for Accelerated Stability
Conditions).
• Firm has submitted fee of Rs: 7500/- vide on-line deposit
slip No.01508481016 for label claim revision.
• Capsule (General) section available as per Licensing
• Composition as per master formulation provided is:
Esomeprazole (as Magnesium trihydrate enteric coated
pellets 8.5%) ………20mg
Esomeprazole (as Magnesium trihydrate enteric coated pellets) ………20mg
Registration Board.
Brand Name + Dosage Form + Strength OMED 40mg Capsule
Composition Each capsule contains: -
Omeprazole enteric coated pellets eq. to
Omeprazole……40mg
Diary No. Date of R & I & fee Dy. No.2696 dated 22-06-2011, Rs. 15,000/- dated 22-
dated 15-03-2016.
Type of Form Form 5
Me-too status Parkoprazole Capsule 40mg of M/s Parkar Pharma,
Remarks of the Evaluator (PEC-XVII) • Firm specified the source/vendor of Omeprazole enteric
coated pellets as M/s Vision Pharmaceuticals,
Islamabad.
• Firm provided CoA of Omeprazole enteric coated pellets
22.5%.
studies) and 0, 3 & 6 months (for Accelerated Stability
Conditions).
official monograph.
• Firm has submitted fee of Rs: 7500/- vide on-line deposit
• Capsule (General) section available as per Licensing
Registration Board.
Brand Name + Dosage Form + Strength TERMED CREAM 1% (w/w)
Composition Each gm contains: -
Terbinafine as HCl ……. 1%
2011 (Challan photocopy), Dy.No.1641 dated 10-06-
2011 (Section Diary),
dated 15-03-2016.
Type of Form Form 5
Pack size & Demanded Price 10gm, As per SRO
Regulatory Authorities Terbinafine hydrochloride 1% w/w
Me-too status Limisil Cream 1% of M/s GSK OTC (Pvt) Ltd., Petaro
Road, Jamshoro. Registration No. 013210
• Firm revised label claim as per reference product as:
Each gm contains:
Terbinafine Hydrochloride…….10mg (1% w/w), along
with revision of master formulation/composition.
official monograph (Japanese Pharmacopoeia).
• Firm has submitted fee of Rs: 30000/- vide on-line
• Cream/ointment (General) section available as per
Licensing Division letter No.F.1-16/2005-Lic dated 15-
06-2011 for issuance of Drug Manufacturing License.
Decision: Approved with JP specifications and revised label claim as:
Each gm contains:
Terbinafine Hydrochloride…….10mg (1% w/w)
Registration Board.
Brand Name + Dosage Form + Strength Zois T CREAM 10% (w/w)
Composition Each gm cream contains: -
Benzoyl Peroxide ……. 10%
dated 15-03-2016.
Type of Form Form 5
Regulatory Authorities 2.5%, 5% & 10% w/w gel, face wash
10% lotion, wash
4%, 5% cream
Me-too status Aknekream 5% Cream of M/s Werrick Pharmaceuticals,
Aknekream 10% Cream of M/s Werrick
Pharmaceuticals, Islamabad. Registration No. 056768
Remarks of the Evaluator (PEC-XVII) • The firm was asked to provide evidence of approval of
authorities/agencies which were adopted by the
label claim/composition as per reference product and
submit revised master formulation accordingly as the
evidence Zitfree Cream 10% could not be verified in
USFDA database.
• So, the firm revised label claim as:
Each gm cream contains: -
Benzoyl Peroxide ……. 5% (w/w)
official monograph (BP) as in initial fee challan, the firm
has claimed manufacturer specifications.
& 13-07-2021.
• Cream/ointment (General) section available as per
Licensing Division letter No.F.1-16/2005-Lic dated 15-
06-2011 for issuance of Drug Manufacturing License.
Decision: Approved with BP specifications and revised label claim as:
Each gm cream contains:
Benzoyl Peroxide…….5% (w/w)
Registration Board.
(correction/change of formulation from 10% to 5% w/w), as per notification No.F.7-11/2012-
Brand Name + Dosage Form + Strength SCABINIL LOTION 1% (1% w/v)
Composition Each ml of lotion contains: -
Lindane ………. 10mg (1% w/v)
Diary No. Date of R & I & fee Dy. No. dated 09-06-2011, Rs. 8,000/- dated 09-06-
dated 15-03-2016.
could not be verified)
Pharmacological Group Anti-scabies
Type of Form Form 5
Approval status of product in Reference USFDA approved, status Discontinued
Regulatory Authorities Health Canada (Cancelled post market)
Me-too status Scafin Lotion 1% w/v of M/s Pharmasol Lahore.
official monograph (USP) as in initial fee challan, the
firm has claimed manufacturer specifications.
• Lotion (General) Section approved vide Licensing
Division letter No.F.1-16/2005-Lic dated 03-03-2022.
• The firm has submitted fee of Rs: 7500/- vide online
deposit slip No.55245388027.
were declared/approved by the Registration Board in its 275th meeting as approval status of
applied formulation in USFDA & Health Canada is “discontinued” & “Cancelled post market”
respectively.
• Verification of R & I record of initial submission of registration application as the same could
not be confirmed by the R & I Section.
Brand Name + Dosage Form + Strength Climed-T Lotion
Composition Each ml of lotion contains: -
Clindamycin as Phosphate…………10mg
dated 15-03-2016.
Pharmacological Group Anti-bacterial
Type of Form Form 5
Approval status of product in Reference (USFDA approved)
Regulatory Authorities Cleocin T® (Each ml contains clindamycin phosphate
equivalent to 10mg clindamycin).
Me-too status CDX-T T 1% Lotion of M/s Fresh Pharmaceutical,
Remarks of the Evaluator (PEC-XVII) • The firm revised pharmacological group as “Anti-
infectives for treatment of acne”.
• USP monograph for topical include solution, suspension,
gel. The firm has claimed manufacturer specifications.
• Lotion (General) Section approved vide Licensing
Division letter No.F.1-16/2005-Lic dated 03-03-2022.
deposit slip No.9934525740.
Decision: Approved with BP specifications with submission of fee for change in specifications.
Registration Board.
• Registration letter will be issued after submission of GMP audit report valid within last three
years.
903. Name and address of manufacturer/ M/s Nabiqasim Industries (Pvt.) Ltd. 17/24, Korangi
Applicant Industrial Area, Korangi, Karachi.
Brand Name + Dosage Form + Strength CARB 40/5 Tablets
Telmisartan ………40mg
Amlodipine as Besylate….5mg
2010 (Challan photocopy dated 12-10-2010),
dated 03-01-2017 submitted vide deposit slip
No.0569397 dated 01-12-2016.
“Duplicate dossier, verification of R & I for initial and
differential fee submission along with fee challans
required”.
Pharmacological Group Anti-hypertensive
Type of Form Form-5
Pack size & Demanded Price 10’s & 14’s, As per SRO
Approval status of product in Reference (USFDA approved) TWYNSTA® 40/5 mg, 40/10 mg,
Regulatory Authorities 80/5 mg, 80/10 mg uncoated bi-layer tablet Boehringer
Ingelheim International GmbH.
Me-too status Tiocardis-AM Tablet 40mg/5mg of M/s Atco
laboratories, Karachi. Registration No. 098764
GMP status Panel inspection for grant of cGMP certificate conducted
on 27-05-2022 with conclusion as:
Based on the people met, documents reviewed and
considering the observations made, panel recommends
the grant of GMP certificate in favor of M/s Nabi Qasim
Indsutries (Pvt.) Ltd. Korangi Industrial Area, Karachi.
Remarks of the Evaluator (PEC-XVII) • Firm revised the label claim as:
Each uncoated bi-layered tablet contains:
Amlodipine as Besylate….5mg, along with revision of
composition/master formulation and manufacturing
outlines.
• Tablet (General) Section available as per DML renewal
letter No.F.2-20/85-Lic (Vol-V) dated 27-04-2020.
• With regard to availability of bi-layered compression
machine, the firm replied as:
We have the machine/equipment ZPW23 II (I.D #
NQFC-P & M-TCM2) for the manufacturing of bi-
layered tablets and are manufacturing several bi-layered
tablets in this section. The firm provided copy of
purchase invoice for ZPW23 compression machine and
Good Declaration (GD-I) certificate.
deposit slip No.9226887964 for revision of finished drug
• The firm submitted remaining fee of Rs: 22,500/- vide
online deposit slip No.933234663.
application as the same could not be verified by the R & I Section
No.0569398 dated 01-12-2016.
Type of Form Form-5
Me-too status Tiocardis-AM Tablet 80mg/5mg of Atco Pharma,
deposit slip No.21709381 for revision of finished drug
online deposit slip No. 8929809185.
Registration Board.
• Registration letter will be issued after submission of Installation qualification, performance
qualification and operational qualification of bi-layered tablet compression machine.
No.0569399 dated 01-12-2016.
Type of Form Form-5
Me-too status Tiocardis-AM Tablet 40mg/10mg of Atco Pharma,
outlines.
online deposit slip No. 289447364517.
Registration Board.
• Registration letter will be issued after submission of Installation qualification, performance
qualification and operational qualification of bi-layered tablet compression machine.
Brand Name + Dosage Form + Strength PROVA 100mg Tablet
Modafinil…………...100mg
2011 (Challan photocopy provided),
No.0576421 dated 24-01-2017.
Pharmacological Group Wakefulness-promoting agent
Type of Form Form-5
Approval status of product in Reference (USFDA approved) PROVIGIL® (modafinil) uncoated
Regulatory Authorities tablets of Teva pharmaceuticals.
Me-too status Velert 100mg Tablet of M/s Bio-Labs, Islamabad.
Remarks of the Evaluator (PEC-XVII) • Firm revised pharmacological group as
“Psychostimulant, centrally acting sympathomimetic”.
Registration Board.
Brand Name + Dosage Form + Strength PROVA 200mg Tablet
Modafinil…………...200mg
2011 (Challan photocopy provided),
Dy.No.573 dated 08-02-2017, Differential fee Rs.
No.0576425 dated 24-01-2017.
Pharmacological Group Wakefulness-promoting agent
Type of Form Form-5
Approval status of product in Reference (USFDA approved) PROVIGIL® (modafinil) 100 &
Regulatory Authorities 200mg uncoated tablets of Teva pharmaceuticals.
Me-too status Velert 200mg Tablet of M/s Bio-Labs, Islamabad.
• Revise pharmacological group as “Psychostimulant,
centrally acting sympathomimetic”.
• Revise finished drug product specifications as per
Registration Board further decided to verify fee challan as per decision of 285 th meeting of
Registration Board.
Brand Name + Dosage Form + Strength NALGESIC 4mg Tablet
Lornoxicam …………….4 mg
2011 (Challan photocopy dated 16-03-2011 provided),
No.0576429 dated 03-02-2017.
Pharmacological Group Anti-rheumatics (anti-inflammatory agents)
Type of Form Form-5
Pack size & Demanded Price 5’s, 10’s & 20’s, As per SRO
Approval status of product in Reference (Xefo 4 mg - film-coated tablets of Takeda, Denmark
Me-too status Xefast 4mg tablet of M/s PharmEvo, Karachi. Reg.No.
067376
Remarks of the Evaluator (PEC-XVII) • Firm revised pharmacological group as “Anti-
rheumatics, Anti-inflammatory, non-steroids”.
• Firm revised master formulation by replacing Methylene
chloride with IPA as solvent for film-coating.
Registration Board.
Brand Name + Dosage Form + Strength NALGESIC 8mg Tablet
Lornoxicam …………….8 mg
Dy.No.1071 dated 13-02-2017, Differential fee Rs.
No.0576430 dated 03-02-2017.
Pharmacological Group Anti-rheumatics (anti-inflammatory agents)
Type of Form Form-5
Pack size & Demanded Price 5’s, 10’s & 20’s, As per SRO
Approval status of product in Reference (Xefo 8 mg - film-coated tablets of Takeda, Denmark
Me-too status Xefast 8mg tablet of M/s PharmEvo, Karachi. Reg.No.
067377
• Firm revised pharmacological group as “Anti-
rheumatics, Anti-inflammatory, non-steroids”.
Registration Board.
Brand Name + Dosage Form + Strength NITZIX 500mg Tablet
Nitazoxanide………...500mg
No.0576422 dated 24-01-2017.
Pharmacological Group Synthetic anti-protozoal agent
Type of Form Form-5
Approval status of product in Reference (USFDA approved) ALINIA® (nitazoxanide) film-
Regulatory Authorities coated tablets Romark, L.C.
Me-too status Tyzonix Tablet 500mg of M/s Wnsfield Hattar. Reg.No.
102916
Remarks of the Evaluator (PEC-XVII) • Firm revised master formulation by replacing Methylene
• Firm revised finished drug product specifications from
manufacturer to innovators specifications.
Registration Board.
Brand Name + Dosage Form + Strength NITZIX Suspension (100mg/5ml)
Composition Each 5ml when reconstituted as directed contains:
Nitazoxanide………...100mg
No.0576423 dated 24-01-2017.
Pharmacological Group Synthetic anti-protozoal agent
Type of Form Form-5
Pack size & Demanded Price 30ml & 60ml, As per SRO
Approval status of product in Reference (USFDA approved) ALINIA® (nitazoxanide) for oral
Regulatory Authorities Suspension 100 mg/5 mL Romark, L.C.
Me-too status Picato Dry Suspension 100mg/5ml of Pakistan
pharmaceutical products, Karachi. Reg.No. 102867
• Firm has claimed manufacturer specifications, while
• Dry powder (General/antibiotic) Section available as per
DML renewal letter No.F.2-20/85-Lic (Vol-V) dated 27-
04-2020.
& 13-07-2021.
Registration Board.
Brand Name + Dosage Form + Strength RELIEFAL SINUS Tablet
Paracetamol………………...500 mg
Pseudoephedrine HCl………30mg
No.0569400 dated 01-12-2016.
Pharmacological Group Analgesic, antihistamine
Type of Form Form-5
Approval status of product in Reference MHRA approved as (Panadol Cold & Sinus 500mg /
Regulatory Authorities 30mg (A bilayer (white/blue) film coated capsule shaped
tablet).
TGA Approved as (Panadol Sinus relief original formula
white capsule-shaped uncoated tablet).
Me-too status Couldn’t be confirmed
Remarks of the Evaluator (PEC-XVII) • Firm was asked to provide evidence of applied
formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand
name and name of firm. The replied that generic/me-too
for the applied formulation is not available.
official USP monograph for Acetaminophen and
Pseudoephedrine Hydrochloride Tablets
deposit slip No. 1050256175 for above revision.
alongwith registration number, brand name and name of firm or else submit stability study data
as per guidelines of 293rd meeting of Drug Registration Board.
Brand Name + Dosage Form + Strength STROMAX Sachet
Composition Each sachet contains:
Strontium ranelate …….2 gm
No.0576418 dated 05-01-2017.
Pharmacological Group Osteoporosis
Type of Form Form-5
Approval status of product in Reference Strontium Ranelate Aristo 2 G Granules for Oral
Regulatory Authorities Suspension (MHRA Approved)
Me-too status Orinta 2gm Sachet of Wnsfield pharmaceuticals, Hattar.
Reg. No. 075590
Remarks of the Evaluator (PEC-XVII) • In cover letter for differential fee submission and
differential fee challan, the product name mentioned is
“Siromax Sachet”, while the applied product is “Stromax
Sachet”. The firm regretted and termed it as
“typographical mistake”. The R & I record (Dy.No.255
dated 19-04-2011) showed the applied product as
“Stromax sachet”
• Firm revised pharmacological group as “Drugs affecting
bone structure and mineralization”.
• Firm revised finished drug product specifications from
manufacturer to Innovator’s specifications.
• Sachet (General) Section available as per DML renewal
deposit slip No. 0774897827 for above revision.
Registration Board.
914. Name and address of manufacturer/ M/s Pharmix Laboratories (Pvt) Ltd. 21-Km, Ferozepur
Brand Name + Dosage Form + Strength PRELIN Capsule
Pregabalin…………75mg
2009.
dated 17-03-2014.
“Duplicate dossier, verification of R & I for initial and
differential fee submission along with fee challans
required”.
Pharmacological Group GABA analogue
Type of Form Form-5
Approval status of product in Reference Lyrica (Pregabalin) capsule 75mg (USFDA approved)
Me-too status Pregra 75mg Capsule of M/s Mega pharmaceuticals,
Lahore. Reg. No. 100786.
GMP status GMP certificate dated 27-07-2021 issued on the basis of
evaluation conducted on 26-05-2021 & 07-07-2021.
Remarks of the Evaluator (PEC-XVII) • Firm has claimed manufacturer specifications, while the
• R & I record for initial submission could not be found.
The cover letter of initial submission does not bear R &
I stamp. Only has statistical officer stamp for 8000/- fee
submission dated 06-03-2009.
• Capsule section (General) available as per DML renewal
inspection report conducted on 30-05-2018 & 01-06-
2018.
& 13-07-2021.
Decision: Deferred for verification of R & I record of registration application submission as the
same could not be verified by R & I Section.
915. Name and address of manufacturer/ M/s Pharmix Laboratories (Pvt) Ltd. 21-Km, Ferozepur
Brand Name + Dosage Form + Strength NEURAL Syrup (500mg/5ml)
Citicoline as Sodium…500mg
2010.
vide challan No.0796978 dated 28-11-2018.
Pharmacological Group Neurotropics
Type of Form Form-5
Approval status of product in Reference Somazine 100 mg / ml oral solution. CIMA Spain
Me-too status E-Citi Syrupof M/s English pharmaceuticals, Lahore.
GMP status GMP certificate dated 27-07-2021 issued on the basis of
evaluation conducted on 26-05-2021 & 07-07-2021.
Remarks of the Evaluator (PEC-XVII) • Firm has claimed manufacturer specifications, while the
• Liquid Syrup Section (General) mentioned in Licensing
renewal of DML.
& 13-07-2021.
Decision: Approved with innovator’s specifications. Registration board further decided to verify
916. Name and address of manufacturer/ M/s Getz Pharma (Pvt) Limited, 29-30/27, Korangi
Brand Name + Dosage Form + Strength LINA 5mg Tablet
Linagliptin……….5 mg
Diary No. Date of R & I & fee Dy. No.621 dated 03-05-2012, Rs: 15000 /- dated 02-05-
2012 (Challan photocopy dated 25-04-2012 provided)
Dy. No. 311 dated 12-10-2015, Differential fee Rs:
dated 12-10-2015.
Dy.No.21154-R & I dated 27-07-2022, Differential fee
Rs: 25,000/- vide online deposit slip No.7421014973
(original).
Pharmacological Group Anti-diabetic (Dipeptidyl peptidase 4 inhibitor)
Approval status of product in Reference TRADJENTA® 5mg film-coated tablet, Boehringer
Regulatory Authorities Ingelheim International GmbH. (USFDA approved)
Me-too status Trajenta 5mg Film Coated tablet imported by M/s AGP,
Karachi. Reg. No. 078139 manufactured by Boehringer
Ingelheim, USA
GMP status GMP certificate issued on 17-01-2022 based on
• Tablet (General) Section mentioned in letter No.F.2-
5/86-Lic (Vol-II) dated 30-10-2019 for renewal of Drug
Manufacturing License.
• Firm has claimed manufacturer specifications.
• With reference to stability study data submission as per
guidelines provided in 293rd meeting of Drug
Registration Board, the firm has informed vide letter
RA-QR/196/0822 dated 10-08-2022 that the stability
studies for the product have already been initiated and
will be submitted upon completion of 6 months intervals
of long term and accelerated stability data.
column above. Firm also submitted further differential
fee of Rs: 25,000/- on 20-07-2022 vide online deposit
slip. 7421014973.
• Patent related issues of Linagliptin containing products
decided in 297th meeting of RB as:
After detailed deliberations, Registration Board decided
that grant of marketing authorization / registration has no
linkage with patent status of the originator’s product and
advised to process cases for issuance of registration
letters except for cases of restraining orders from any
court.
Decision: Deferred for submission of stability study data as per guidelines of 293 rd meeting of
Registration Board.
Brand Name + Dosage Form + Strength LINAMET Tablet (2.5/500mg)
Linagliptin……….2.5 mg
Metformin hydrochloride……500mg
Diary No. Date of R & I & fee Dy. No. 622 dated 03-05-2012, Rs: 15000 /- dated 02-
05-2012 (Challan photocopy dated 25-04-2012
provided)
dated 12-10-2015.
Rs: 25,000/- vide online deposit slip No. 865155619203
(original).
Pharmacological Group Anti-diabetic (Dipeptidyl peptidase 4 inhibitor +
Biguanide
Approval status of product in Reference JENTADUETO® film-coated tablets
Regulatory Authorities 2.5 mg linagliptin/500 mg metformin HCl
2.5 mg linagliptin/850 mg metformin HCl
2.5 mg linagliptin/1000 mg metformin HCl of
Boehringer Ingelheim International GmbH.
(USFDA approved)
Me-too status NA
Remarks of the Evaluator (PEC-XVII) • Tablet (General) Section mentioned in letter No.F.2-
column above.Firm also submitted further differential
slip. 0232392.
court.
Registration Board.
Diary No. Date of R & I & fee Dy. No.624 dated 03-05-2012, Rs: 15000 /- dated 02-05-
2012 (Challan photocopy dated 25-04-2012 provided)
dated 12-10-2015.
Rs: 25,000/- vide online deposit slip No.
152325838 (original).
Biguanide
(USFDA approved)
Me-too status NA
• R & I record is verified. Details incorporated in relevant
slip. 0232393.
court.
Registration Board.
Diary No. Date of R & I & fee Dy. No. 623 dated 03-05-2012, Rs: 15000 /- dated 02-
05-2012 (Challan photocopy dated 25-04-2012
provided)
dated 12-10-2015.
Rs: 25,000/- vide online deposit slip No.
6660667857 (original).
Biguanide
(USFDA approved)
Me-too status NA
• R & I record is verified. Details incorporated in relevant
slip. 6660667857.
court.
Registration Board.
920. Name and address of manufacturer/ M/s Hassan Pharmaceuticals (Pvt) Ltd. 99-A, Industrial
Brand Name + Dosage Form + Strength RTM tablet
Artemether…...20mg
Lumefantrine….120mg
2010 (Original),
Dy. No. 3202 dated 18-05-2017 Differential fee Rs:
12000/- dated 18-05-2017 vide deposit slip No. 0712155
(original).
“Original dossier”
Type of Form Form 5
Approval status of product in Reference Prequalified by WHO
Me-too status Ajmetlum Tablet 20/120mg of M/s AJM pharma,
GMP status Updated GMP compliance status required.
Remarks of the Evaluator (PEC-XVII) • Tablet Section (General) and Tablet Section
(Quinolone) available as per DML renewal inspection
report conducted on 13-03-2010.
• Provide most recent/last GMP inspection report
conducted within last 03 years.
official monograph available in International
Pharmacopoeia.
& 13-07-2021.
• Confirmation of GMP compliance status from QA & LT Division, since production of the firm
is suspended in all sections vide QA & LT Division letter No.F.4-3/96-QA dated 09-09-2022 on
account of FID inspection report dated 28-06-2022.
• Revision of finished drug product specifications as per official monograph (International
pharmacopoeia).
07-2021.
Brand Name + Dosage Form + Strength RTM DS tablet
Artemether…...40mg
Lumefantrine….240mg
2010 (Original), Dy. No. 3202 dated 18-05-2017
Differential fee Rs: 12000/- dated 18-05-2017 vide
deposit slip No. 0712153 (original).
Type of Form Form 5
Approval status of product in Reference Prequalified by WHO
Me-too status Ajmetlum Tablet 40/240mg of M/s AJM pharma,
Karachi. Registration No. 103050.
official monograph available in International
Pharmacopoeia.
& 13-07-2021.
• Revision of finished drug product specifications as per official monograph (International
pharmacopoeia).
07-2021.
Brand Name + Dosage Form + Strength MOXET 400mg tablet
Moxifloxacin HCl equivalent to moxifloxacin….400mg
Original dossier (Both original & differential)
Type of Form Form 5
• Revise the label claim as per reference product:
Moxifloxacin (as hydrochloride) …….400mg
official monograph available in USP.
& 13-07-2021.
• Revision of finished drug product specifications as per official monograph (USP).
Moxifloxacin (as hydrochloride) …….400mg
07-2021.
Brand Name + Dosage Form + Strength VOMA DONE 10mg tablet
Domperidone……...10mg
Original dossier (Both original & differential)
Pharmacological Group Antidopaminergic, propulsives
Type of Form Form 5
Approval status of product in Reference MHRA approved both as un-coated & film-coated tablet.
Regulatory Authorities Motilium is film-coated tablet
• Tablet Section (General) and Tablet Section
• Revise the label claim as per reference product:
Domperidone maleate equivalent to Domperidone……
10 mg.
official monograph available in BP.
& 13-07-2021.
• Revision of finished drug product specifications as per official monograph (BP).
Domperidone maleate equivalent to Domperidone …………10mg
07-2021.
Brand Name + Dosage Form + Strength FERRIMED 100mg tablet
Iron (III) hydroxide polymaltose complex equivalent to
elemental iron……...100mg
Type of Form Form 5
• Tablet Section (General) and Tablet Section
& 13-07-2021.
• Revision of label claim as:
Each chewable tablet contains:
Iron (III) hydroxide polymaltose complex equivalent to elemental iron……...100mg
07-2021.
Brand Name + Dosage Form + Strength VOMA DONE suspension
Composition Each 1ml of oral suspension contains:
Domperidone…...1mg
Pharmacological Group Antidopamingeric, propulsives
Type of Form Form 5
Approval status of product in Reference Domperidone 1mg/ml Oral Suspension
Me-too status Doperdone Oral Suspension 1mg/ml of Hiranis
Pharmaceuticals, Karachi. Registration No. 103162
• Liquid Section (Liquified suspension and syrups)
available as per DML renewal inspection report
& 13-07-2021.
Brand Name + Dosage Form + Strength FERRIMED Syrup
Iron (III) hydroxide polymaltose complex equivalent to
elemental iron……...50mg
(Original dossier)
Type of Form Form 5
Me-too status CK-Malt Syrup 50mg/5ml of M/s CKD
Pharmaceuticals, Karachi. Registration No. 101106
Remarks of the Evaluator (PEC-XVII) • Liquid Section (Liquified suspension and syrups)
available as per DML renewal inspection report
& 13-07-2021.
b. Deferred Cases
927. Name and address of manufacturer/ Shrooq Pharmaceuticals (Pvt) Ltd. 21-Km, Ferozepur
Brand Name + Dosage Form + Strength ZUCLO 25mg tablet
Zuclopenthixol (as Dihydrochloride) ……...25mg
Diary No. Date of R & I & fee Dy.No.8386 dated 14-09-2010, Fee Rs: 8,000/-Dated 14-
09-2010 (Challan photocopy dated 13-09-2010)
12,000 Dated 31-03-2015 vide challan No.0285719.
“Duplicate dossier, R & I of initial submission verified
from Section Diary”
Pharmacological Group Anti-psychotic drug
Type of Form Form-5
Me-too status Elana 25mg tablet of M/s Aries Pharmaceuticals,
10-2021 and 29-10-2021 and recommended renewal of
DML. cGMP certificate issued based on inspection
conducted for renewal of DML on 29-10-2021. Tablet
Sections (General and quinolone) are mentioned in DML
inspection report as well in GMP certificate.
• Firm provided analytical testing methods for the finished
drug product as per official monograph and submitted
requisite fee Rs: 7500/- vide on-line deposit slip
No.600875794114.
• Verification of R &I, initial and differential fee slips
required.
Decision of 316th DRB meeting: • Deferred for verification of R & I diary No./date, fee
challan as per decision of 285th meeting of Registration
Board.
Remarks of the Evaluator (PEC-XVII) • Record of initial submission of application verified from
Section Diary and differential fee submission verified by
the R & I section. The diary no. and date for both initial
application and differential fee submission incorporated
in relevant column above.
Decision: Approved. Registration board further decided to verify fee challans as per decision of
928. Name and address of manufacturer/ Shrooq Pharmaceuticals (Pvt) Ltd. 21-Km, Ferozepur
Brand Name + Dosage Form + Strength CLOVIR 250mg tablet
Famciclovir (USP) ……...250mg
Diary No. Date of R & I & fee Dy.No.9973 dated 27-10-2010, Fee Rs: 8,000/-Dated 27-
10-2010 (Challan photocopy dated 26-10-2010)
12,000 Dated 31-03-2015 vide challan No.0299394.
“Duplicate dossier, R & I of initial submission verified
from Section Diary”
Pharmacological Group Anti-viral drug
Type of Form Form-5
Me-too status Flovir 250mg tablet by Maxitech pharma Pvt ltd.
10-2021 and 29-10-2021 and recommended renewal of
DML. cGMP certificate issued based on inspection
conducted for renewal of DML on 29-10-2021. Tablet
Sections (General and quinolone) are mentioned in DML
inspection report as well in GMP certificate.
Remarks of the Evaluator (PEC-XVII) • The firm has claimed manufacturer specifications
while drug product monograph is available in USP42-
NF37 1S – 8688 and onward.
• Verification of R &I, initial and differential fee slips
required.
Decision of 316th DRB meeting: • Deferred for verification of R & I diary No./date, fee
challan as per decision of 285th meeting of Registration
Board.
Remarks of the Evaluator (PEC-XVII) • Record of initial submission of application verified from
Section Diary and differential fee submission verified by
the R & I section. The diary no. and date for both initial
application and differential fee submission incorporated
in relevant column above.
• The firm has claimed manufacturer specifications
while drug product monograph is available in USP42-
NF37 1S – 8688 and onward.
• Registration board further decided to verify fee challan as per decision of 285th meeting of
Registration Board.
929. Name and address of manufacturer/ M/s. Xenon Pharmaceuticals (Pvt.) Ltd. 9.5 km
Applicant Sheikhupura Road, Lahore.
Brand Name + Dosage Form + Strength METHYDATE Oral Solution

Methylphenidate HCl….5mg
Diary No. Date of R & I & fee Dy. No.2522 dated 21/06/2011 Rs. 8,000/- (photocopy)
R&I Verified
Differential fee (photocopy) of Rs. 12,000/- submitted on
16/11/2015 Dy.No.1495

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MINUTES OF 321ST MEETING OF REGISTRATION BOARD

HELD ON 20-22ND SEPTEMBER, 2022

Item Detail of Item Pages

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 1

Following members attended the meeting:

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 2

Pharmaceutical Evaluation Cell (PEC)

Sr. No Name of Evaluator Title

1. Mr. Farooq Aslam Evaluator PEC-I

3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III

4. Mst.Farzana Raja Evaluator PEC-IV

5. Mst. Iqra Aftab Evaluator PEC-V

6. Mr. Muhammad Umar Latif Evaluator PEC-VI

7. Dr. Sidra Khalid Evaluator PEC-VII

8. Dr. Hanif Ullah Evaluator PEC-IX

10. Mr. Shahid Nawaz Evaluator PEC-XIII

11. Mr. Ahsan Hafiz Evaluator PEC-XIV

14. Mr. Zia Ullah Evaluator PEC-XVII

16. Mr. Sarfraz Nawaz Evaluator PE&R

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 3

CDP – Not applicable

STABILITY STUDY DATA

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 5

4. Data of stability batches will be supported by attested Submitted

5. Compliance Record of HPLC software 21CFR & Audit Trail submitted

Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been

CDP – Not applicable

STABILITY STUDY DATA

4. Data of stability batches will be supported by attested Submitted

5. Compliance Record of HPLC software 21CFR & Audit Trail submitted

S. No Sections Observations/Deficiencies/ Response

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 9

3. Name, address of Applicant / Marketing M/s Sayyed Pharmaceutical ( Pvt) Ltd,Hattar.

Proposed Pack size 3×10’s

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 11

5. • As per relevant guidelines & As analysis of formulation

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 12

Details of fee submitted PKR 30,000/-: 25/02/2022 (#255776532)

The proposed proprietary name / brand name Antra 20mg Capsule

Strength / concentration of drug of Active Each Capsule Contains:

S. No Observations/Deficiencies/ Short- Reply

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 15

Details of fee submitted PKR 30,000/-: 25/04/2022 (#7178762428)

The proposed proprietary name / brand name Antra 40mg Capsule

Strength / concentration of drug of Active Each Capsule Contains:

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 16

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 17

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 18

API Lot No. EMZ046082

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 21

7. Name, address of Applicant / Marketing M/s Medasia Pharmaceuticals Nawashera Industrial

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 23

API Lot No. EMZ046082

4. Data of stability batches will be supported by

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 24

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 25

Strength / concentration of drug of Active Each film coated tablet contains:

STABILITY STUDY DATA

Minutes of of 321st meeting of Registration Board (20th -22nd September, 2022) 27

4. Data of stability batches will be supported by