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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 | 34751 | EDARAVONE | 2020-06-16 | Active | II | Complete | 2024-02-27 | 2024-01-22 |
28/03/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 34449 | EDARAVONE | 2019-12-31 | Active | II | Complete | 2020-11-01 | 2020-09-21 |