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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
29/11/2025 Chunghwa Chemical Synthesis & Biotech
Taiwan
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD 41494 TRILACICLIB DIHYDROCHLORIDE 2025-03-31 Active II N/A
29/11/2025 Hetero Drugs
India
HETERO LABS LTD 40409 TRILACICLIB DIHYDROCHLORIDE DIHYDRATE 2024-11-13 Active II Complete 2025-01-08 2024-11-14