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List of Drug Master Files (DMF) of Am-Fam 400 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 12Xls 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 IOL Chemicals and Pharmaceuticals
India
IOL CHEMICALS AND PHARMACEUTICALS LTD 22431 IBUPROFEN USP 2009-01-15 Active II Complete 2014-06-13 2014-06-09
26/09/2024 Adare Pharma Solutions
U.S.A
ADARE PHARMACEUTICALS INC 10165 IBUPROFEN GELATIN/CAP 1993-03-26 Active II N/A