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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 | Hetero Drugs |
India |
HETERO LABS LTD | 41270 | SOTORASIB (FORM-III) | 2025-03-03 | Active | II | Complete | 2025-04-20 | 2025-03-07 |
| 31/10/2025 | TAPI NL BV | 40038 | SOTORASIB | 2025-07-15 | Active | II | N/A |
