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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 | Apicore |
India |
APICORE LLC | 35828 | TRABECTEDIN | 2021-04-19 | Active | II | Complete | 2021-07-13 | 2021-06-07 |
28/03/2025 | BrightGene Bio-Medical Technology Co.,Ltd |
China |
BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD | 39165 | TRABECTEDIN | 2023-12-13 | Active | II | N/A |