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List of Drug Master Files (DMF) of MolPort-001-783-406 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 Axplora
Germany
FARMABIOS SPA 25933 BUSULFAN 2012-03-27 Active II Complete 2013-08-08 2012-12-17
26/09/2024 Fareva
Luxembourg
EXCELLA GMBH AND CO KG 27006 BUSULFAN 2013-06-06 Active II Complete 2015-09-03 2014-07-10