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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 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 36600 | BINIMETINIB | 2021-12-30 | Active | II | Complete | 2022-05-13 | 2022-04-19 |
| 31/10/2025 | MSN Laboratories |
India |
MSN LABORATORIES PRIVATE LTD | 36434 | BINIMETINIB | 2021-12-09 | Active | II | Complete | 2022-02-15 | 2022-01-06 |
