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

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    Entacapone

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    PRICE INFORMATION

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

    RELATED EXCIPIENT COMPANIES

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    GLOBAL SALES INFORMATION

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    REF. STANDARDS & IMPURITIES

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    $ API Ref.Price (USD/KG) : 225Xls 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 Fermion Oy
    Finland
    		 FERMION OY 12444 ENTACAPONE 1997-03-26 Active II N/A
    26/09/2024 Cohance Lifesciences
    India
    		 COHANCE LIFESCIENCES LTD 23937 ENTACAPONE USP 2010-06-30 Active II Complete 2016-05-24 2015-09-29