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

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    Buprenorphine

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    PRICE INFORMATION

    INTERMEDIATES

    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) : 15,127Xls 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 Noramco
    U.S.A
    		 NORAMCO LLC 23684 BUPRENORPHINE BASE (R371605) DRUG SUBSTANCE 2010-04-05 Active II Complete 2013-02-15 2012-11-23
    26/09/2024 Veranova
    U.S.A
    		 MACFARLAN SMITH LTD A JOHNSON MATTHEY CO 26448 BUPRENORPHINE 2012-09-17 Active II Complete 2013-11-08 2012-12-12