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

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    Betahistine Hydrochloride

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    PRICE INFORMATION

    FINISHED DOSAGE FORMULATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    REF. STANDARDS & IMPURITIES

    PharmaCompass
    $ API Ref.Price (USD/KG) : 149Xls 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 Disphar International B.V.
    Netherlands
    		 DISPHAR INTL BV 19593 BETAHISTINE.2HCL, 8MG AND 16MG TABLETS 2006-06-23 Inactive II N/A
    26/09/2024 Henan Purui Pharmaceutical
    China
    		 HENAN PURUI PHARMACEUTICAL CO LTD 36103 BETAHISTINE HYDROCHLORIDE 2021-07-14 Active II N/A