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List of Drug Master Files (DMF) of Icatibant Acetate 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 30526 ICATIBANT ACETATE 2016-09-27 Active II Complete 2016-12-21 2016-09-27
26/09/2024 Bachem AG
Switzerland
BACHEM AG 20862 ICATIBANT ACETATE 2007-09-17 Active II N/A