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    List of Drug Master Files (DMF) of Risdiplam 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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    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 Biophore India Pharmaceuticals Pvt Ltd
    India
    		 BIOPHORE INDIA PHARMACEUTICALS PVT LTD 39602 RISDIPLAM 2024-03-08 Active II Complete 2024-05-07 2024-04-25
    26/09/2024 ALP Pharm
    China
    		 ALP PHARM BEIJING CO LTD 36897 RISDIPLAM 2022-04-07 Active II N/A