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List of Drug Master Files (DMF) of Selexipag 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 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 33947 SELEXIPAG 2019-06-18 Active II N/A
26/09/2024 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 33974 SELEXIPAG 2019-07-30 Active II Complete 2019-09-12 2019-07-16