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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 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 31665 RIOCIGUAT 2017-06-16 Active II Complete 2017-07-18 2017-06-28
28/03/2025 MSN Laboratories
India
MSN LIFE SCIENCES PRIVATE LTD 38372 RIOCIGUAT USP [ROUTE CODE UJ] 2023-07-01 Active II Complete 2023-09-15 2023-08-08