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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 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 38766 | DIACEREIN | 2023-09-15 | Active | II | N/A | ||
| 31/10/2025 | Archimica |
Italy |
EUTICALS SPA | 23961 | DIACEREIN (PROCESS II) | 2010-07-13 | Active | II | N/A |
