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 /Vial Overage
Product (Single dose)
Ingredients
rFSH 75 IU Recombinant Human
Follicle Stimulating BP 0.5 ml
INJECTION
Hormone
(Freeze-Dried) (As sterile ready to fill
bulk)
Combipack: * Composition of Sterile Ready to fill Bulk Solution /0.5 ml Single

1 Vial of rFSH 75 IU Dose

Active Ingredient
INJECTION + 1 Recombinant Human
Ampoule of 0.5 ml Follicle Stimulating BP 75 IU
WFI Hormone
Excipients

1 x 1’s Combipack Anhydrous Disodium

BP 1.42 mg
2 x 1’s Combipack Hydrogen Phosphate
3 x 1’s Combipack Mannitol BP 30 mg
5 x 1’s Combipack Sucrose BP 10 mg
10 x 1’s Combipack
Methionine BP 0.2 mg
Tween 20 (Polysorbate BP 0.2 mg
20)
Sodium Hydroxide** BP q.s

Phosphoric Acid** BP q.s

BP
Water for Injection*** q.s

Note: IU = International Unit

**For pH adjustment
***Not present in finished product
Fill Volume /Vial: 0.5 ml and after reconstitution, final volume will be 0.5 ml

DATE OF INCLUSION:
PRODUCT VALID UP TO:

Major General Md. Mahbubur Rahman

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

Govt. of the People’s Republic of Bangladesh