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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 | Minakem (formerly Delmar Chemicals) |
Canada |
DELMAR CHEMICALS INC | 32140 | SORAFENIB HEMITOSYLATE | 2017-12-20 | Active | II | Complete | 2018-07-27 | 2018-01-19 |
28/03/2025 | Granules India Limited |
India |
GRANULES INDIA LTD | 37229 | SORAFENIB TOSYLATE USP | 2022-06-30 | Active | II | N/A |