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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 | 36785 | LAROTRECTINIB SULFATE | 2022-03-31 | Active | II | Complete | 2025-04-02 | 2025-03-28 |
| 31/10/2025 | Olon S.p.A |
Italy |
OLON SPA | 37066 | LAROTRECTINIB SULFATE | 2022-05-27 | Active | II | Complete | 2022-07-11 | 2022-05-05 |
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