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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
28/11/2024 Axplora
Germany
FARMABIOS SPA 25791 MELPHALAN HYDROCHLORIDE 2012-02-14 Active II Complete 2014-02-21 2013-09-05
28/11/2024 ChemWerth Inc
U.S.A
CHEMWERTH INC 25644 MELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE 2011-12-29 Active II Complete 2013-06-21 2012-11-21