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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 Biocon
India
BIOCON SA 27093 INSULIN GLARGINE (RDNA ORIGIN) 2013-05-24 Active II N/A
31/10/2025 Tonghua Dongbao Pharma
China
TONGHUADONGBAO PHARMACEUTICAL CO LTD 36695 INSULIN GLARGINE 2022-02-16 Active II N/A