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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
24/02/2025 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 34164 SAFINAMIDE METHANESULFONATE 2019-09-30 Active II N/A
24/02/2025 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 35201 SAFINAMIDE MESYLATE 2020-09-28 Active II Complete 2020-11-05 2020-09-28