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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/07/2025 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 37912 | DAROLUTAMIDE | 2023-03-30 | Active | II | Complete | 2023-04-20 | 2023-03-30 |
| 29/07/2025 | Changzhou Pharmaceutical Factory |
China |
CHANGZHOU PHARMACEUTICAL FACTORY | 42127 | DAROLUTAMIDE | 2025-06-30 | Active | II | N/A |
