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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 Rusan Pharma
India
RUSAN PHARMA LTD 31780 EFLORNITHINE HYDROCHLORIDE MONOHYDRATE 2017-06-29 Active II N/A
28/03/2025 Lonza Group
Switzerland
LONZA AG 11932 DL-2-(DIFLUOROMETHYL) ORNITHINE MONOHYDROCHLORIDE MONOHYDRATE 1996-04-17 Inactive II N/A