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List of Drug Master Files (DMF) of Melphalan 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 ChemWerth Inc
U.S.A
CHEMWERTH INC 21237 MELPHALON USP 2008-01-11 Active II N/A
26/09/2024 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 28300 MELPHALAN 2014-05-24 Active II Complete 2014-08-10 2014-05-28