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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
28/03/2025 ALP Pharm
China
ALP PHARM BEIJING CO LTD 38773 TIRZEPATIDE 2023-08-30 Active II N/A
28/03/2025 Apicore
India
APICORE US LLC 40123 TIRZEPATIDE 2024-07-27 Active II N/A