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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 12/12/2025 | Lupin Manufacturing Solutions |
India |
LUPIN MANUFACTURING SOLUTIONS LTD | 26316 | RUFINAMIDE USP | 2012-10-09 | Active | II | Complete | 2013-04-23 | 2012-11-13 |
| 29/11/2025 | Alivus Life Sciences |
India |
ALIVUS LIFE SCIENCES LTD | 26209 | RUFINAMIDE | 2012-10-23 | Active | II | Complete | 2013-04-24 | 2012-11-06 |
