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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 35438 TEDUGLUTIDE 2020-12-08 Active II N/A
28/03/2025 AmbioPharm
U.S.A
AMBIOPHARM INC 30583 TEDUGLUTIDE NON-STERILE 2016-08-12 Active II Complete 2016-11-04 2016-08-01