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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
02/01/2026 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 41014 ASCIMINIB HYDROCHLORIDE PREMIX 2024-12-31 Active II Complete 2025-06-20 2025-05-29
30/12/2025 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 41393 ASCIMINIB HYDROCHLORIDE PREMIX-I 2025-02-28 Active II Complete 2025-06-25 2025-05-29