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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
28/11/2024 Chunghwa Chemical Synthesis & Biotech
Taiwan
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD 38511 DIFELIKEFALIN ACETATE 2023-06-19 Active II N/A
28/11/2024 ALP Pharm
China
ALP PHARM BEIJING CO LTD 38645 DIFELIKEFALIN ACETATE 2023-08-02 Active II N/A