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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 MSN Laboratories
India
MSN LIFE SCIENCES PRIVATE LTD 33268 BEDAQUILINE FUMARATE 2018-10-30 Active II N/A
28/03/2025 Viatris
U.S.A
TIANISH LABORATORIES PRIVATE LTD 35426 BEDAQUILINE FUMARATE 2020-12-14 Active II N/A