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

    Client Email Product
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    Brexanolone

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    PRICE INFORMATION

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    DIGITAL CONTENT

    PATENTS & EXCLUSIVITIES

    PharmaCompass
    $ API Ref.Price (USD/KG) : 236,107Xls 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 Curia
    U.S.A
    		 CURIA SPAIN SAU 34802 BREXANOLONE 2020-04-24 Active II Complete 2020-06-03 2020-05-15
    30/09/2024 Zhejiang Xianju Pharmaceutical Co. Ltd
    China
    		 ZHEJIANG XIANJU PHARMACEUTICAL CO LTD 39854 BREXANOLONE 2024-04-16 Active II N/A