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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 39342 | MIROGABALIN BESYLATE | 2023-12-29 | Active | II | N/A | ||
| 29/11/2025 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 41196 | MIROGABALIN BESYLATE (PROCESS-II) | 2025-02-12 | Active | II | N/A |
