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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
28/03/2025 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 34751 EDARAVONE 2020-06-16 Active II Complete 2024-02-27 2024-01-22
28/03/2025 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 34449 EDARAVONE 2019-12-31 Active II Complete 2020-11-01 2020-09-21