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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 42887 MITAPIVAT SULFATE 2025-10-31 Active II N/A
29/01/2026 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 39774 MITAPIVAT SULFATE 2024-03-31 Active II N/A