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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/08/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 41809 | MARALIXIBAT CHLORIDE | 2025-04-30 | Active | II | Complete | 2025-08-22 | 2025-07-14 |
| 28/08/2025 | Zhejiang Ausun Pharmaceutical |
China |
ZHEJIANG AUSUN PHARMACEUTICAL CO LTD | 41496 | MARALIXIBAT CHLORIDE | 2025-03-27 | Active | II | Complete | 2025-06-23 | 2025-03-21 |
