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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
28/03/2025 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 27483 BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE 2013-09-20 Active II Complete 2014-02-24 2013-09-25
28/03/2025 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 24823 BENDAMUSTINE HYDROCHLORIDE USP 2011-03-30 Active II Complete 2013-10-03 2012-11-29