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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
24/02/2025 Fermion Oy
Finland
FERMION OY 12444 ENTACAPONE 1997-03-26 Active II N/A
24/02/2025 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 23937 ENTACAPONE USP 2010-06-30 Active II Complete 2016-05-24 2015-09-29