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    List of Drug Master Files (DMF) of Umeclidinium 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

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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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    $ API Ref.Price (USD/KG) : 193,644Xls 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 Inke S.A
    Spain
    		 INKE SA 36482 UMECLIDINIUM BROMIDE 2023-06-16 Active II Complete 2023-07-12 2023-01-09
    26/09/2024 Cipla
    India
    		 CIPLA LTD 38002 UMECLIDINIUM BROMIDE 2023-03-03 Active II N/A