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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/08/2025 | Changzhou Pharmaceutical Factory |
China |
CHANGZHOU PHARMACEUTICAL FACTORY | 36657 | BALOXAVIR MARBOXIL | 2021-12-31 | Active | II | Complete | 2022-04-06 | 2022-02-25 |
| 28/08/2025 | Jiangsu Sinopep Allsino Biopharmaceutical |
China |
SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTD | 41794 | BALOXAVIR MARBOXIL | 2025-04-18 | Active | II | N/A |
