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    List of Drug Master Files (DMF) of Epoetin Alfa Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Epoetin Alfa

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    REF. STANDARDS & IMPURITIES

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    Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
    26/09/2024 ALP Pharm
    China
    		 ALP PHARM BEIJING CO LTD 22163 EPO (RECOMBINANT HUMAN ERYTHROPOIETIN) 2008-10-27 Inactive II N/A
    26/09/2024 Shandong Kexing Bioproducts
    China
    		 SHANDONG KEXING BIOPRODUCTS CO LTD 25698 RECOMBINANT HUMAN ERYTHROPOIETIN 2011-12-30 Inactive II N/A