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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 | 33948 | NITISINONE | 2019-07-17 | Active | II | Complete | 2020-08-28 | 2020-08-06 |
28/03/2025 | Nuray Chemicals Private Limited |
India |
NOVITIUM PHARMA LLC | 31250 | NITISINONE | 2017-01-02 | Active | II | Complete | 2017-02-01 | 2016-12-26 |