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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
29/01/2026 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 41810 GADOXETATE DISODIUM 2025-07-31 Active II Complete 2025-11-12 2025-09-17
29/01/2026 Bayer AG
Germany
BAYER AG 20414 EOB-DTPA 2007-05-14 Active II N/A