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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 | Nuray Chemicals Private Limited |
India |
SS PHARMA LLC | 38577 | CEVIMELINE HYDROCHLORIDE USP | 2023-09-28 | Active | II | Complete | 2023-11-13 | 2023-09-27 |
| 31/10/2025 | Apicore |
India |
APICORE LLC | 40223 | CEVIMELINE HYDROCHLORIDE USP | 2024-07-23 | Active | II | Complete | 2024-09-12 | 2024-08-24 |
