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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 33845 DANTROLENE SODIUM 2019-06-17 Active II N/A
28/03/2025 Veranova
U.S.A
VERANOVA LP 20779 DANTROLENE SODIUM (DTE) 2007-08-16 Active II N/A