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

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    Alanine

    ACTIVE PHARMA INGREDIENTS

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    DIGITAL CONTENT

    MARKET PLACE

    REF. STANDARDS & IMPURITIES

    ANALYTICAL

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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 Evonik
    Germany
    		 EVONIK REXIM NANNING PHARMACEUTICAL CO LTD 19769 L-ALANINE 2006-08-28 Active II N/A
    26/09/2024 Ajinomoto Company
    Japan
    		 AJINOMOTO HEALTH AND NUTRITION NORTH AMERICA INC 31555 L-ALANINE 2017-03-21 Active II Complete 2021-07-30 2020-11-30