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List of Drug Master Files (DMF) of Riociguat Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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
26/09/2024 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 31665 RIOCIGUAT 2017-06-16 Active II Complete 2017-07-18 2017-06-28
26/09/2024 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