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

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    Apriso

    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

    ANALYTICAL

    PharmaCompass
    $ API Ref.Price (USD/KG) : 47Xls 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 Axplora
    Germany
    		 PHARMAZELL GMBH 8070 5-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE) 1989-05-09 Active II Complete 2014-12-16 2014-11-28
    26/09/2024 Zhejiang Hengkang Pharmaceutical
    China
    		 ZHEJIANG HENGKANG PHARMACEUTICAL CO LTD 37319 MESALAMINE USP 2022-08-17 Active II Complete 2022-10-20 2022-09-16