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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 30/12/2025 | Lupin Manufacturing Solutions |
India |
LUPIN MANUFACTURING SOLUTIONS LTD | 31498 | DARUNAVIR ETHANOLATE (PROCESS-B) | 2017-04-15 | Active | II | Complete | 2017-11-28 | 2017-10-10 |
| 30/12/2025 | Arene Lifesciences |
India |
ARENE LIFE SCIENCES PRIVATE LTD | 37916 | DARUNAVIR ETHANOLATE | 2023-03-10 | Active | II | N/A |
