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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 | 26446 | ZILEUTON | 2012-09-26 | Active | II | Complete | 2014-06-16 | 2014-06-05 |
| 28/03/2025 | Emcure Pharmaceuticals |
India |
EMCURE PHARMACEUTICALS LTD | 25805 | ZILEUTON USP | 2012-03-26 | Active | II | Complete | 2016-12-09 | 2016-10-17 |
