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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
04/06/2025 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 33947 SELEXIPAG 2019-06-18 Active II N/A
04/06/2025 Honour Lab
India
HONOUR LAB LTD 33061 SELEXIPAG (AMORPHOUS) 2018-12-31 Active II Complete 2019-03-01 2019-01-28