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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 | Dipharma |
Italy |
DIPHARMA FRANCIS SRL | 21444 | IBUPROFEN LYSINE SALT | 2008-03-20 | Active | II | N/A | ||
| 31/10/2025 | SMS Pharmaceuticals |
India |
SMS PHARMACEUTICALS LIMITED | 41175 | IBUPROFEN LYSINE | 2025-04-30 | Active | II | N/A |
