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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | 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 |
| 31/10/2025 | Apicore |
India |
APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC) | 41516 | MARALIXIBAT CHLORIDE | 2025-04-24 | Active | II | Complete | 2025-07-25 | 2025-06-18 |
