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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
29/01/2026 Fermion Oy
Finland
FERMION OY 20649 IRINOTECAN HYDROCHLORIDE 2007-06-29 Active II Complete 2013-09-14 2013-09-05
29/01/2026 ALP Pharm
China
ALP PHARM BEIJING CO LTD 23949 IRINOTECAN HYDROCHLORIDE 2010-06-18 Inactive II N/A