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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 Fuxin Long Rui Pharmaceutical
China
FUXIN LONG RUI PHARMACEUTICAL CO LTD 33491 LEDIPASVIR: PVP (1:1) 2019-07-09 Active II N/A
28/03/2025 Lupin Ltd
India
LUPIN LTD 34446 LEDIPASVIR 2019-12-31 Inactive II N/A