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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 30/12/2025 | Apextide |
China |
HANGZHOU APEXTIDE BIOMEDICAL TECHNOLOGY CO LTD | 41776 | INCLISIRAN | 2025-04-15 | Active | II | N/A | ||
| 12/01/2026 | Aurisco Pharmaceutical |
China |
YANGZHOU AURISCO PHARMACEUTICAL CO LTD | 42095 | INCLISIRAN SODIUM | 2025-09-24 | Active | II | Complete | 2025-10-23 | 2025-09-25 |
