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List of Drug Master Files (DMF) of Glargine Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 86,245Xls download

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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
26/09/2024 Biocon
India
BIOCON SA 27093 INSULIN GLARGINE (RDNA ORIGIN) 2013-05-24 Active II N/A
26/09/2024 Tonghua Dongbao Pharma
China
TONGHUADONGBAO PHARMACEUTICAL CO LTD 36695 INSULIN GLARGINE 2022-02-16 Active II N/A