Annexure-Ii: White Film Coated Hormonal Tablet Active Ingredients

ANNEXURE-II
ANNEXURE BIOLOGICAL DRUG MANUFACTURING LICENSE NO.: 250 OF M/S POPULAR

PHARMACEUTICALS LTD. 164, TONGI INDUSTRIAL AREA, TONGI, GAZIPUR – 1711.
DAR No. Name of the Composition Specification Quantity Overage

Product /Tablet (mg)
WHITE FILM COATED HORMONAL TABLET
336-378-039 LEVOPIL Active Ingredients
Tablet Levonorgestrel BP/USP 0.150 -
Ethinyl Estradiol BP/USP 0.030 2%
Excipients
1 x 28’s
Microcrystalline Cellulose (PH101) BP 8.000
(21’s+7’s)
Lactose Monohydrate (Spray Dried) BP 68.752
2 x 28’s
Croscarmellose Sodium BP 2.000
(21’s+7’s)
Colloidal Anhydrous Silica (Aerosil BP
3 x 28’s 0.400
200)
(21’s+7’s) Mgnesium Stearate BP 0.667
in Blister
Coating Materials
Opadry White OY-C-7000A Pharma 2.400
Grade
Methanol* BP 12.912
Dichloromethane (Methylene BP 24.000
Chloride)*
Carnuba Wax (Powdered) BP 0.0375
* Will not appear in the final product
BROWN FILM COATED IRON TABLET

Active Ingredient
Ferrous Fumarate BP 75.000 -
Excipients
Lactose Monohydrate BP 29.530
Povidone (Kollidon 30) BP 2.400
Maize Starch BP 11.670
Mgnesium Stearate BP 1.400
Coating Materials
Opadry II Brown 85G 565967 Pharma
3.480
Grade
Carnuba Wax (Powdered) BP
0.013
DATE OF INCLUSION : 26.11.2009
PRODUCT VALID UP TO : 25.11.2024 Major General Md. Mahbubur Rahman

Director General
Directorate General of Drug Administration
&
Licensing Authority (Drugs)
Govt. of the People’s Republic of Bangladesh
ANNEXURE-II

WHITE FILM COATED HORMONAL TABLET
336-379-039 NORPIL Active Ingredients
Tablet Norgestrel BP/USP 0.300 -
Ethinyl Estradiol BP/USP 0.030 2%
Excipients
1 x 28’s
(21’s+7’s)
Cropovidone (Kollidon CL) BP 12.000
2 x 28’s
Povidone (Kollidon K 30) BP 2.000
(21’s+7’s)
3 x 28’s
Purified Talc BP 1.500
(21’s+7’s)
Acetone* BP 0.001 ml
in Blister
*Will not appear in the final product.
BROWN FILM COATED IRON TABLET

Active Ingredient
Ferrous Fumarate BP 75.000 -
Excipients
Maize Starch BP 15.750
Povidone (Kollidon 30) BP 2.700
DATE OF INCLUSION : 26.11.2009
PRODUCT VALID UP TO : 25.11.2024

Major General Md. Mahbubur Rahman
Director General
&
Licensing Auth
ANNEXURE-I
ANNEXURE NON-BIOLOGICAL DRUG MANUFACTURING LICENSE NO.: 473 OF M/S POPULAR

336-380- Active Ingredient
Sulindac BP 200.000 -
064 LINDAC 200
Tablet
Excipients
2 x 10’s Maize Starch BP 83.200
3 x 10’s
Microcrystalline Cellulose (PH 101) BP 55.200
5 x 10’s
6 x 10’s Hypromellose (Methocel E15 LV
BP 3.600
10 x 10’s Premium)
In Blister
Sodium Starch Glycolate (Type A) BP 14.400
Magnesium Stearate BP 3.600
Coating Materials
Pharma
Opadry II Blue 85G50642 10.440
Grade
Pharma
Opadry fx Blue 65F99189 5.400
Grade
DATE OF INCLUSION : 09. 12. 2009
PRODUCT VALID UP TO : 08. 12. 2024

Director General
&

ANNEXURE-II

Product /100 ml (g)
ZEMICEF DS 4.480 5%
023 Cefixime (Micronised) BP (equivalent to 4 g
Powder for Cefixime)
Suspension
Excipients
30 ml Sodium Benzoate BP 0.075
40 ml
Carmellulose Sodium BP 0.500
50 ml
(Sodium CMC 10000 cps)
In Glass/Pet
Colloidal Anhydrous Silica
Bottle BP 0.800
(Aerodsil 200)
With Diluent
Pharma
Vanilla Flavour Powder 8116 0.200
Grade
qs to 50.000
Sucrose BP
g

Director General
&

ANNEXURE-I
DAR NO. NAME OF THE COMPOSITION SPECIFICATION QUANTITY OVERAGE

PRODUCT /Tablet (mg)
SODICARB Sodium Bicarbonate BP 600.000 -
007
Tablet
Excipients
25’s/30’s/60’s/10
0’s in Bottle
& Hypromellose (Methocel E15 LV BP 50.000
2 x 10’s Premium)
3 x 10’s Stearic Acid BP 5.000
5 x 10’s
6 x 10’s Colloidal Anhydrous Silica (Aerodsil
BP 5.000
10 x 10’s 200)
In Blister Peppermint Flavour Powder Pharma
0.220
290147 Grade

Director General
&

ANNEXURE-I

336-385- F - ZOL 50 Active Ingredient
Capsule Fluconazole USP 50.000 2.5%
020
3 x 6’s Excipients
2 x 10’s
4 x 6’s Anhydrous Lactose BP 41.000
5 x 6’s
3 x 10’s
In Blister Sodium Starch Glycolate (Type A) BP 8.000
Sodium Lauryl Sulphate BP 1.500
Empty Hard Gelatin Capsule Shell Pharma

1 Pc
Size#4 Grade

Director General
&

ANNEXURE-I

336-386- F – ZOL 150 Active Ingredient
Capsule Fluconazole USP 150.000 2.5%
020
2 x 6’s Excipients
3 x 6’s
2 x 10’s Anhydrous Lactose BP 35.000
4 x 6’s
3 x 10’s
In Blister Sodium Starch Glycolate (Type A) BP 10.000
Sodium Lauryl Sulphate BP 2.500
Empty Hard Gelatin Capsule Shell Pharma

1 Pc
Size#2 Grade

Director General
&

ANNEXURE-I

PRODUCT /100 ml (g)*
F - ZOL Fluconazole USP 1.000 5%
020 Powder for
Suspension Excipients
15 ml Xanthan Gum BP 0.100
20 ml
Anhydrous Citric Acid BP 0.065
35 ml
50 ml Sodium Citrate BP 0.012
70 ml Sodium Benzoate BP 0.200
In Glass/Pet Bottle
With Diluent Aspartame BP 0.150
Sodium Chloride BP 0.050
Colloidal Anhydrous Silica (Aerodsil

BP 0.900
200)
Pharma
Pineapple Flavour Powder 6490 0.200
Grade
Pharma
Orange Flavour Powder 0.150
Grade
Sucrose BP 62.838
* After reconstitution with Diluent

Director General
&
ANNEXURE-II
DAR No. Name of the Product Composition Specification Quantity / Overage

100 ml (g)
336-388-041 Active Ingredient
GADOSCAN
Gadodiamide US 33.372
Injection (equivalent to 28.7 g
P
Gadodiamide)
10 ml Excipients
10 x 10 ml
inVial/ Bottle Caldiamide Sodium Pharma Grade 1.200
Edetate Calcium BP
0.039
Disodium
Sodium Hydroxide/ BP qs to adjust pH
Hydrochloric Acid
Water for Injections BP qs to 100.00 ml

Director General
&

ANNEXURE-II

10 ml (g)
336-388-041 Active Ingredient
GADOSCAN
Gadodiamide US 3.3372
Injection (equivalent to 2.87 g
P
Gadodiamide)
10 ml Excipients
10 x 10 ml
inVial/ Bottle Caldiamide Sodium Pharma Grade 0.120
Edetate Calcium BP
0.004
Disodium
Sodium Hydroxide/ BP qs to adjust pH
Hydrochloric Acid
Water for Injections BP qs to 10.00 ml

Director General
&

ANNEXURE-I
DAR NO. NAME OF THE COMPOSITION SPECIFICATION QUANTITY / OVERAGE

PRODUCT Bag (g)*
VIEWGUT
Barium Sulphate (Micronized) BP/USP 150.000
020 Powder for
Suspension
Excipients
1 x 150.75 g Xanthan Gum BP 0.200
2 x 150.75 g
Saccharin Sodium BP 0.075
3 x 150.75 g
5 x 150.75 g Orange Flavour Pharma
0.012
in HDPE Bag Powder4827 Grade
Methyl Hydroxybenzoate BP 0.150
* To be reconstituted with boiled and cold water

as advised by a registered Doctor/Radiologist.

Director General
&

ANNEXURE-II
DAR No. Name of the Product Composition Specification Quantity Overage

/Vial (g)
336-395- VANOBAC 1 g Active Ingredient
023 Powder for Vancomycin US 1.030 5%
Injection (IV/IM) Hydrochloride P (equivalent to 1 g
(Sterile) Vancomycin)
Combipack:
1 Vial of
Vancomycin+
250 ml of 0.9%
Sodium Chloride
Injection
1 x 1‘s Combipack
5 x 1‘s Combipack
10 x 1‘s
Combipack

Director General
&

ANNEXURE-II

Vial (mg)
336-395- VANOBAC 500 Active Ingredient
023 Powder for Vancomycin US 515.000 5%
Injection (IV/IM) Hydrochloride P (equivalent to 500 mg
(Sterile) Vancomycin)
Combipack:
1 Vial of
Vancomycin+
100 ml of 0.9%
Sodium Chloride
Injection
1 x 1‘s Combipack
5 x 1‘s Combipack
10 x 1‘s
Combipack

Director General
&

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ANNEXURE-II

ANNEXURE BIOLOGICAL DRUG MANUFACTURING LICENSE NO.: 250 OF M/S POPULAR

DAR No. Name of the Composition Specification Quantity Overage

BROWN FILM COATED IRON TABLET

DATE OF INCLUSION : 26.11.2009

PRODUCT VALID UP TO : 25.11.2024 Major General Md. Mahbubur Rahman

DAR No. Name of the Composition Specification Quantity Overage

BROWN FILM COATED IRON TABLET

DATE OF INCLUSION : 26.11.2009

PRODUCT VALID UP TO : 25.11.2024

DAR No. Name of the Composition Specification Quantity Overage

Magnesium Stearate BP 3.600

DATE OF INCLUSION : 09. 12. 2009

PRODUCT VALID UP TO : 08. 12. 2024

Major General Md. Mahbubur Rahman

Licensing Authority (Drugs)

DAR No. Name of the Composition Specification Quantity Overage

DATE OF INCLUSION : 09. 12. 2009

PRODUCT VALID UP TO : 08. 12. 2024

Major General Md. Mahbubur Rahman

Licensing Authority (Drugs)

DAR NO. NAME OF THE COMPOSITION SPECIFICATION QUANTITY OVERAGE

DATE OF INCLUSION : 09. 12. 2009

PRODUCT VALID UP TO : 08. 12. 2024

Major General Md. Mahbubur Rahman

Licensing Authority (Drugs)

DAR NO. NAME OF THE COMPOSITION SPECIFICATION QUANTITY OVERAGE

Sodium Lauryl Sulphate BP 1.500

Magnesium Stearate BP 3.600

Empty Hard Gelatin Capsule Shell Pharma

DATE OF INCLUSION : 23. 12. 2009

PRODUCT VALID UP TO : 22. 12. 2024

Major General Md. Mahbubur Rahman

Licensing Authority (Drugs)

DAR NO. NAME OF THE COMPOSITION SPECIFICATION QUANTITY OVERAGE

Sodium Lauryl Sulphate BP 2.500

Magnesium Stearate BP 5.000

Empty Hard Gelatin Capsule Shell Pharma

DATE OF INCLUSION : 23. 12. 2009

PRODUCT VALID UP TO : 22. 12. 2024

Major General Md. Mahbubur Rahman

Licensing Authority (Drugs)

DAR NO. NAME OF THE COMPOSITION SPECIFICATION QUANTITY OVERAGE

Sodium Chloride BP 0.050

Colloidal Anhydrous Silica (Aerodsil

* After reconstitution with Diluent

DATE OF INCLUSION : 23. 12. 2009

PRODUCT VALID UP TO : 22. 12. 2024

Major General Md. Mahbubur Rahman

DAR No. Name of the Product Composition Specification Quantity / Overage

DATE OF INCLUSION : 22. 11. 2009

PRODUCT VALID UP TO : 21. 11. 2024

Major General Md. Mahbubur Rahman

Licensing Authority (Drugs)

DAR No. Name of the Product Composition Specification Quantity / Overage

DATE OF INCLUSION : 22. 11. 2009

PRODUCT VALID UP TO : 21. 11. 2024

Major General Md. Mahbubur Rahman