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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
28/10/2024 Fermion Oy
Finland
FERMION OY 20649 IRINOTECAN HYDROCHLORIDE 2007-06-29 Active II Complete 2013-09-14 2013-09-05
28/10/2024 Emcure Pharmaceuticals
India
EMCURE PHARMACEUTICALS LTD 23220 IRINOTECAN HYDROCHLORIDE USP 2009-10-27 Active II N/A