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List of Drug Master Files (DMF) of Bisoprolol 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 Supriya Lifescience
India
SUPRIYA LIFESCIENCE LTD 35650 BISOPROLOL FUMARATE USP 2021-02-16 Active II N/A
26/09/2024 Moehs Iberica
Spain
MOEHS IBERICA SL 15083 BISOPROLOL FUMARATE 2000-10-10 Active II Complete 2015-09-11 2015-09-04