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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 | 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 |
| 31/10/2025 | MSN Laboratories |
India |
MSN LABORATORIES PRIVATE LTD | 42260 | ASCIMINIB HYDROCHLORIDE | 2025-07-18 | Active | II | Complete | 2025-09-18 | 2025-07-23 |
