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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 27/09/2025 | Fermion Oy |
Finland |
FERMION OY | 25541 | OSPEMIFENE | 2011-11-30 | Active | II | N/A | ||
| 27/09/2025 | Honour Lab Limited |
India |
HONOUR LAB LTD | 30858 | OSPEMIFENE | 2016-10-17 | Active | II | Complete | 2016-12-07 | 2016-09-07 |
