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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
27/02/2026 Amphastar Pharmaceuticals
U.S.A
AMPHASTAR FRANCE PHARMACEUTICALS SAS 15262 RECOMBINANT HUMAN INSULIN 2001-02-05 Active II N/A
27/02/2026 SANOFI AVENTIS DEUTSCHLAND GMBH
Gabon
SANOFI AVENTIS DEUTSCHLAND GMBH 13945 HR1799 - RECOMBINANT HUMAN INSULIN 1999-01-15 Inactive II N/A