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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 Jiangsu Sinopep Allsino Biopharmaceutical
China
SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTD 31220 DECOQUINATE 2017-02-12 Inactive II N/A
28/03/2025 UBE Industries
Japan
UBE INDUSTRIES LTD 13909 ETHYL L-CYCLOPROPY-6,7-DIFLUORO-1,4-DIHYDRO-8-METHOXY-4-OXO-3-QUINOLINECARBOXYLATE(6,7-DIFLUOROESTER FORM) DRUG SUBSTANCE 1998-12-18 Inactive II N/A