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

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    Darifenacin

    ACTIVE PHARMA INGREDIENTS

    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

    ANALYTICAL

    PharmaCompass
    $ API Ref.Price (USD/KG) : 4,535Xls 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 Megafine Pharma (P) Limited
    India
    		 MEGAFINE PHARMA P LTD 26533 DARIFENACIN HYDROBROMIDE (NON STERILE DRUG SUBSTANCE) 2012-09-30 Active II Complete 2013-07-23 2013-03-20
    26/09/2024 Alembic Pharmaceuticals Limited
    India
    		 ALEMBIC PHARMACEUTICALS LTD 26138 DARIFENACIN HYDROBROMIDE 2012-06-27 Active II Complete 2014-04-18 2013-09-26