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

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    Vonoprazan fumarate (JAN)

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    PRICE INFORMATION

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

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    REF. STANDARDS & IMPURITIES

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    $ API Ref.Price (USD/KG) : 1,787Xls 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 Metrochem API Private Limited
    India
    		 METROCHEM API PRIVATE LTD 35150 VONOPRAZAN FUMARATE 2020-08-31 Active II N/A
    26/09/2024 Shandong Chenghui Shuangda Pharmaceutical
    China
    		 SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO LTD 39107 VONOPRAZAN FUMARATE 2023-11-02 Active II N/A