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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