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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
25/04/2025 Chunghwa Chemical Synthesis & Biotech
Taiwan
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD 41494 TRILACICLIB DIHYDROCHLORIDE 2025-03-31 Active II N/A
25/04/2025 Olon S.p.A
Italy
OLON SPA 40022 TRILACICLIB DIHYDROCHLORIDE 2024-06-20 Active II Complete 2024-07-09 2024-06-13