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    List of Drug Master Files (DMF) of MolPort-000-883-864 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    US, Europe turn to advanced manufacturing, stockpiling to strengthen drug supply chains

    Data Compilation
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    Pipeline Prospector Sept 2024: BMS wins landmark FDA approval for schizophrenia med; Sanofi’s Dupixent okayed for COPD

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    MolPort-000-883-864

    ACTIVE PHARMA INGREDIENTS

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    FINISHED DOSAGE FORMULATIONS

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    PharmaCompass
    $ API Ref.Price (USD/KG) : 78Xls 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 Cohance Lifesciences
    India
    		 COHANCE LIFESCIENCES LTD 25986 ITRACONAZOLE USP 2012-04-20 Active II Complete 2013-10-19 2013-03-11
    26/09/2024 Neuland Laboratories
    India
    		 NEULAND LABORATORIES LTD 15445 ITRACONAZOLE USP 2001-05-15 Active II Complete 2014-02-12 2013-06-19