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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
27/02/2026 Actavis Inc
Ireland
TAPI NL BV 30553 ALVIMOPAN DIHYDRATE 2016-05-24 Active II Complete 2016-07-19 2016-05-18
27/02/2026 ALP Pharm
China
ALP PHARM BEIJING CO LTD 24035 ALVIMOPAN DIHYDRATE 2010-07-26 Inactive II N/A