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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 27/09/2025 | Centrient Pharmaceuticals |
Netherlands |
CENTRIENT PHARMACEUTICALS NETHERLANDS BV | 31410 | ROSUVASTATIN CALCIUM | 2017-03-28 | Active | II | Complete | 2017-11-17 | 2017-05-23 |
| 27/09/2025 | Minakem (formerly Delmar Chemicals) |
Canada |
DELMAR CHEMICALS INC | 29190 | ROSUVASTATIN CALCIUM | 2015-12-03 | Active | II | Complete | 2016-04-08 | 2015-09-25 |
