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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
31/10/2025 Chunghwa Chemical Synthesis & Biotech
Taiwan
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD 18985 TACROLIMUS 2005-11-28 Active II Complete 2016-04-01 2016-03-09
31/10/2025 Fishfa Biogenics
India
FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD) 41828 TACROLIMUS USP 2025-06-13 Active II N/A