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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 | 
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Polpharma | Poland | ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 32347 | BREXPIPRAZOLE | 2017-12-21 | Active | II | N/A | ||
| 31/10/2025 | 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 | 
