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    Annex

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    Annex

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    16 views1 page

    Annex

    Uploaded by

    GaFf Ar
    Annex

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    © All Rights Reserved
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    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

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