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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 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 32347 BREXPIPRAZOLE 2017-12-21 Active II N/A
28/03/2025 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 33704 BREXPIPRAZOLE 2019-03-20 Active II Complete 2019-04-16 2019-03-22