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

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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 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 34413 OBETICHOLIC ACID 2019-12-27 Active II Complete 2020-02-10 2019-12-30
26/09/2024 Moehs Iberica
Spain
MOEHS IBERICA SL 38221 OBETICHOLIC ACID 2023-03-27 Active II N/A