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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
28/03/2025 Sanofi
France
SANOFI AVENTIS DEUTSCHLAND GMBH 4846 HUMAN INSULIN-SEMISYNTHETIC, BULK MATRLS & FINISHED DOS. FORM 1983-03-11 Inactive II N/A
28/03/2025 Biocon
India
BIOCON BIOLOGICS INDIA LTD 23892 HUMAN INSULIN-BULK (RDNA ORIGIN) (ANIMAL ORIGIN FREE) 2010-06-07 Active II N/A