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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/03/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 34413 | OBETICHOLIC ACID | 2019-12-27 | Active | II | Complete | 2020-02-10 | 2019-12-30 |
28/03/2025 | Moehs Iberica |
Spain |
MOEHS IBERICA SL | 38221 | OBETICHOLIC ACID | 2023-03-27 | Active | II | N/A |