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

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    Leuprolide

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    PRICE INFORMATION

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS & EXCLUSIVITIES

    REF. STANDARDS & IMPURITIES

    PharmaCompass
    $ API Ref.Price (USD/KG) : 128,417Xls download

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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 Bachem AG
    Switzerland
    		 BACHEM AG 13822 LEUPROLIDE ACETATE 1998-11-06 Active II Complete 2016-09-02 2016-04-29
    26/09/2024 Sanofi
    France
    		 GENZYME CORP 14440 LEUPROLIDE ACETATE 1999-10-08 Inactive II N/A