1. Name and address of M/s ABC Pharmaceuticals (Pvt.) Ltd. …….Lahore.

manufacturer / Applicant
Brand Name +Dosage Form + XYZ 5mg/1000mg Tablet
Strength
Composition Each Film Coated Tablet Contains:
Empagliflozin………. mg
Metformin HCl extended release…….mg
Diary No. Date of R& I & fee Dy. No.0000 dated 09-02-2020 , Fee Rs: 50,000/-
dated 03-02-2020 vide deposit slip No.0809686.
Pharmacological Group Antidiabetic (Sodium/glucose co transporter 2
(SGLT2) inhibitor and biguanide class)
Type of Form Form 5D
Finished product Specifications USP
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s, 30’s, (4×7’s); As per SRO
Approval status of product in ABC XR 5/1000mg film coated tablets
Reference Regulator Authorities (USFDA Approved)
Me-too status NA
GMP status GMP certificate issued based upon inspection
conducted in 14-06-2022
Remarks of the Evaluator
STABILITY STUDY DATA
Manufacturer of API (Empagliflozin) M/s Fuxin Long Rui Pharmaceutical Co., Ltd.
Fluoride Industrial Park, Fumeng Country (Yi Ma Tu), Fuxing City,
Liaoning Province, China.
(Metformin hydrochloride) M/s Wanbury limited, Doctors
Organic Chemicals Division, K. Illindalaparru – 534217,
Iragavaram Manadal, West Godavari District, Andra Pradesh,
India.
API Lot No. Empagliflozin: L-E-220-D0
Metformin Hydrochloride: MT010l
Description of Pack Alu-Alu blister packed in uni carton
(Container closure system)
Stability Storage Condition Real time: 30°C ± 2° C / 65% ± 5% RH
Accelerated: 40 °C ± 2 °C / 75% ± 5%
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: 0, 3, 6 (months)
Real Time: 0, 3, 6 (months)
Batch No. A B C
Batch Size 2000 tablets 2000 tablets 2000 tablets
Manufacturing Date 06-2020 06-2020 06-2020
Date of Initiation 31-06-2021 31-06-2021 31-06-2021
No. of Batches 03
Date of Submission 09-06-2021 (16007)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. No. Documents to Be Provided Status
1. Reference of previous approval of The firm has referred to previous inspection
applications with stability study data for authenticity of stability data of their
of the firm products conducted by the panel, on the
basis of which Registration Board in its 297th
meeting dated 12-15th January, 2021,
decided to approve registration of A Tablets
10mg.
Inspection date: 14-10-2018.
The report shows that:
 Finished Pharmaceutical Product stability
testing was conducted on HPLC R&D # 19
for A tablet which were 21 CFR compliant
for initial 6 months.
 Adequate monitoring and control were
available for stability chamber.
2. Certificate of Analysis of API from 1. Copies of COAs (Batch#L-E-209-D01-E06-
both API Manufacturer and Finished 01) of API (Empagliflozin) from M/s
Product manufacturer. Fuxin Long Rui Pharmaceutical Co., Ltd.
Liaoning Province, China and M/s ABC
pharmaceuticals (Pvt) Ltd. Lahore are
submitted.
2. Copies of COAs (Batch#MT00) of API
(Metformin hydrochloride) from M/s
Wanbury limited, Andra Pradesh India and
M/s ABC pharmaceuticals (Pvt) Ltd.
Lahore are submitted.
3. Method used for analysis of API Methods used for analysis of APIs from
from both API Manufacturer and both API Manufacturers and Finished
Finished Product Manufacturer Product Manufacturer are provided by the
firm.
4. Stability study data of API from API Empagliflozin: Firm has submitted stability
manufacturer study data of API as per zone IV-A. Stability
study is conducted at Real time conditions;
30°C ± 2°C / 65% ± 5%RH for 24 months and
at Accelerated conditions; 40°C ± 2°C / 75% ±
5%RH for 6 months at intervals 0, 3, 6, 9, 12,
18, 24 & 0, 1, 2, 3 & 6 months respectively.
Batches:(20166,2016,20169)
10 days stress stability study at conditions
60°C ± 2°C, Photolysis 4500 ± 500LX and
92.5%± 5%RH at 0, 5th & 10th days intervals
also provided.
Metformin hydrochloride: Firm has
submitted stability study data of API as per
 zone IV-A. Stability study is conducted at
° °
Real time conditions; 30 C ± 2 C / 65% ±
5%RH for 60 months and at Accelerated
conditions; 40°C ± 2°C / 75% ± 5%RH for 6
months at intervals 0, 3, 6, 9, 12, 18, 24, 36,
48, 60 & 0, 1, 2, 3 & 6 months respectively.
Batches:(MET-E-06648, MET-E-0668, MET-E-
0668)
5. Approval of API/ DML/GMP For Empagliflozin: Firm has submitted copy
certificate of API manufacturer of GMP certificate dated 24-08-2020 in the
issued by concerned regulatory name of M/s Long Rui Pharmaceutical Co.,
authority of country of origin. Ltd. Fluoride Industrial Park, Fumeng
Country (Yi Ma Tu), Fuxing City, Liaoning
Province, China issued by Liaoning Fuxin
Management committee, Fluoride Industrial
Development Zone. Valid till 23-08-2023.
For Metformin hydrochloride: The firm has
submitted copy of GMP certificate of M/s
Wanbury limited, Doctors Organic Chemicals
Division, K. Illindalaparru – 5317, Iragavaram
Manadal, West Godavari District, Andra
Pradesh, India issued on dated 06-02-2018
by Drugs Control Administration, Andra
Pradesh India valid for three (03) years from
the date of issue.
6. Documents for the procurement of For Empagliflozin: The firm has submitted
API with approval from DRAP (in copy of invoice No. HN200-H dated 03-06-
case of import). 2018 from exporter M/s Beijing Sino Hanson
Import & Export Col, Ltd. No.3, Zhonghe
road, Fengtai District, Beijing China, for
import of 1kgs of Empagliflozin (Batch No. L
-E-2029-D01-E06-01) in name of M/s ABC
Pharmaceuticals Private Ltd. Lahore
attested by AD (I&E) DRAP Lahore dated 18-
06-2018.
For Metformin hydrochloride: The firm has
submitted copy of invoice No. 9209 dated
29-02-2018 from Wanbury Limited, BSEL
Techpark, 'B' Wing, 10th Floor, Sector 30-A,
Opp. Vashi Railway Station, Vashi, Navi
Mumbai – 400703, India for import of 80gs
Metformin HCl in the name of ABC
Pharmaceuticals, Lahore attested by AD (I &
E) DRAP, Lahore dated 05-08-2018.
7. Protocols followed for conduction of Submitted
stability study
8. Method used for analysis of FPP Submitted
9. Drug-excipients compatibility Drug excipients compatibility study
 studies (where applicable) performed.
10. Complete batch manufacturing The firm has submitted Batch
record of three stability batches. Manufacturing record of following 03
Batches:
Batch No. Batch Size Mfg. Date

A 2000 tablets 08-2020

B 2000 tablets 08-2020
C 2000 tablets 08-2020

11. Record of comparative dissolution Provided

data (where applicable) Comparative dissolution was performed
against XR tablet (5/1000mg) Batch No.
318 & XR tablet (25/1000mg), Batch No.
3161 in HCl buffer (pH 1.2), Acetate buffer
(pH 4.5) & Phosphate buffer (pH 6.8)
12. Data of 03 batches will be supported Submitted
by attested respective documents
like chromatograms, Raw data
sheets, COA, summary data sheets
etc.
13. Compliance Record of HPLC Submitted
software 21CFR & audit trail reports
on product testing.
14. Record of Digital data logger for Submitted
temperature and humidity
monitoring of stability chambers
(real time and accelerated)
REMARKS OF EVALUATOR

Decision: