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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/01/2026 | Guangdong Raffles PharmaTech Co Ltd |
China |
GUANGDONG RAFFLES PHARMATECH CO LTD | 43177 | DABRAFENIB MESYLATE | 2025-12-31 | Active | II | N/A | ||
| 29/01/2026 | MSN Laboratories |
India |
MSN LABORATORIES PRIVATE LTD | 31080 | DABRAFENIB MESYLATE (FORM- 1) | 2016-11-10 | Active | II | Complete | 2025-07-28 | 2025-07-02 |
