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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 | 34169 | NITAZOXANIDE | 2019-10-01 | Active | II | Complete | 2020-08-28 | 2020-08-06 |
28/03/2025 | Cambrex Corporation |
U.S.A |
CAMBREX PROFARMACO MILANO SRL | 31541 | NITAZOXANIDE | 2016-12-06 | Inactive | II | N/A |