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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
24/02/2025 Axplora
Germany
FARMABIOS SPA 25933 BUSULFAN 2012-03-27 Active II Complete 2013-08-08 2012-12-17
24/02/2025 Apicore LLC
India
APICORE US LLC 23924 BUSULFAN USP 2010-08-05 Active II Complete 2015-06-10 2015-05-27