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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 | Hainan Poly Pharm |
China |
ANHUI POLY PHARM CO LTD | 38852 | TECOVIRIMAT MONOHYDRATE | 2023-09-20 | Active | II | N/A | ||
28/03/2025 | TOPHARMAN SHANDONG CO LTD |
China |
TOPHARMAN SHANDONG CO LTD | 39308 | TECOVIRIMAT | 2024-01-04 | Active | II | N/A |