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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 | Amphastar Pharmaceuticals |
U.S.A |
AMPHASTAR FRANCE PHARMACEUTICALS SAS | 15262 | RECOMBINANT HUMAN INSULIN | 2001-02-05 | Active | II | N/A | ||
| 30/12/2025 | SANOFI AVENTIS DEUTSCHLAND GMBH |
Gabon |
SANOFI AVENTIS DEUTSCHLAND GMBH | 13945 | HR1799 - RECOMBINANT HUMAN INSULIN | 1999-01-15 | Inactive | II | N/A |
