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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | Yangtze River Pharmaceutical Group |
China |
YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTD | 42267 | SITAFLOXACIN NON-STERILE DRUG SUBSTANCE | 2025-07-07 | Active | II | N/A | ||
| 29/11/2025 | Zhejiang Ausun Pharmaceutical |
China |
ZHEJIANG AUSUN PHARMACEUTICAL CO LTD | 40808 | SITAFLOXACIN HYDRATE | 2024-12-09 | Active | II | N/A |
