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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 | 28262 | NILUTAMIDE | 2014-06-23 | Active | II | Complete | 2015-03-12 | 2014-12-24 |
28/03/2025 | Kekule Pharma |
India |
KEKULE PHARMA LTD | 25465 | NILUTAMIDE | 2011-09-29 | Active | II | Complete | 2014-11-18 | 2014-06-17 |