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    Annexure-Ii: Active Ingredients

    Uploaded by

    Muhammad Abdul Gaffar (Executive I-Regulatory Affairs)
    This document contains information on two drug products approved for manufacture by Popular Pharmaceuticals Ltd. It lists the composition, specifications, and quantities of ingredients for Hyprogel Eye Gel and Cicloderm Cream. Hyprogel Eye Gel contains hypromellose, carbomer, sorbitol, sodium perborate, sodium hydroxide, and water. Cicloderm Cream contains ciclopirox olamine, cetomacrogol A25, cetomacrogol A6, cetostearyl alcohol, liquid paraffin, benzyl alcohol, lactic acid, propylene glycol, and purified water. The director general of the drug regulatory authority has approved the inclusion of these products

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    Annexure-Ii: Active Ingredients

    Uploaded by

    Muhammad Abdul Gaffar (Executive I-Regulatory Affairs)
    72 views2 pages
    This document contains information on two drug products approved for manufacture by Popular Pharmaceuticals Ltd. It lists the composition, specifications, and quantities of ingredients for Hyprogel Eye Gel and Cicloderm Cream. Hyprogel Eye Gel contains hypromellose, carbomer, sorbitol, sodium perborate, sodium hydroxide, and water. Cicloderm Cream contains ciclopirox olamine, cetomacrogol A25, cetomacrogol A6, cetostearyl alcohol, liquid paraffin, benzyl alcohol, lactic acid, propylene glycol, and purified water. The director general of the drug regulatory authority has approved the inclusion of these products

    Original Title

    Annexure 260619

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    This document contains information on two drug products approved for manufacture by Popular Pharmaceuticals Ltd. It lists the composition, specifications, and quantities of ingredients for Hyprogel Eye Gel and Cicloderm Cream. Hyprogel Eye Gel contains hypromellose, carbomer, sorbitol, sodium perborate, sodium hydroxide, and water. Cicloderm Cream contains ciclopirox olamine, cetomacrogol A25, cetomacrogol A6, cetostearyl alcohol, liquid paraffin, benzyl alcohol, lactic acid, propylene glycol, and purified water. The director general of the drug regulatory authority has approved the inclusion of these products

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    72 views2 pages

    Annexure-Ii: Active Ingredients

    Uploaded by

    Muhammad Abdul Gaffar (Executive I-Regulatory Affairs)
    This document contains information on two drug products approved for manufacture by Popular Pharmaceuticals Ltd. It lists the composition, specifications, and quantities of ingredients for Hyprogel Eye Gel and Cicloderm Cream. Hyprogel Eye Gel contains hypromellose, carbomer, sorbitol, sodium perborate, sodium hydroxide, and water. Cicloderm Cream contains ciclopirox olamine, cetomacrogol A25, cetomacrogol A6, cetostearyl alcohol, liquid paraffin, benzyl alcohol, lactic acid, propylene glycol, and purified water. The director general of the drug regulatory authority has approved the inclusion of these products

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 2

    ANNEXURE-II

    ANNEXURE TO 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 100 ml (g)
    Hyprogel Eye Gel Active Ingredients
    10 g Hypromellose USP 0.300
    Sterile (Hydropxypropyl
    ophthalmic gel Methylcellulose), Sterile
    Excipients
    in

    Tube Carbomer (Acrypol 980) BP 0.220


    (Sterile)

    Liquid Sorbotol (Non- BP 1.000


    crystallizg)

    Sodium Perborate BP 0.028

    Sodium Hydroxide (Sterile) BP 0.028

    Water for Injections BP qs to 100 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
    Dhaka

    ANNEXURE-II
    ANNEXURE TO 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 /100g Overage


    Product Cream (g)
    CICLODERM Active Ingredients
    Cream
    Ciclopirox Olamine USP 1.000
    10 g
    in
    Excipients
    Tube
    Cetomacrogol Pharma 1.500
    (Cremophor A25) Grade

    Cetomacrogol Pharma 1.500


    (Cremophor A6) Grade

    Cetostearyl Alcohol BP 8.000

    Liquid Paraffin (Heavy) BP 1.000

    Benzyl Alcohol BP 1.000

    Lactic Acid BP 0.250

    Propylene Glycol BP 8.000

    Purified Water BP 66.650

    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
    Dhaka

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