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    List of Drug Master Files (DMF) of Sulfobutylether-β-Cydodextrin (SBECD) Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Sulfobutylether-β-Cydodextrin (SBECD)

    ACTIVE PHARMA INGREDIENTS

    MARKET PLACE

    REF. STANDARDS & IMPURITIES

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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 Hubei Gedian Humanwell Pharmaceutical
    China
    		 HUBEI GEDIAN HUMANWELL PHARMACEUTICAL EXCIPIENTS CO LTD 36347 BETADEX SULFOBUTYL ETHER SODIUM 2023-07-12 Active IV N/A
    26/09/2024 Asymchem Laboratories
    U.S.A
    		 ASYMCHEM LIFE SCIENCE TIANJIN CO LTD 29379 BETADEX SULFOBUTYL ETHER SODIUM 2015-05-11 Active IV N/A