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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 | Granules India Limited |
India |
GRANULES INDIA LTD | 39695 | CALCIUM OXYBATE | 2025-03-31 | Active | II | Complete | 2025-05-12 | 2025-04-22 |
| 31/10/2025 | Cambrex Corporation |
U.S.A |
CAMBREX CHARLES CITY INC | 35873 | CALCIUM OXYBATE | 2022-06-10 | Active | II | Complete | 2022-06-30 | 2022-05-17 |
