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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
25/04/2025 Jiangxi Synergy Pharmaceutical
China
JIANGXI SYNERGY PHARMACEUTICAL CO LTD 21700 REBAMIPIDE 2008-06-09 Inactive II N/A
25/04/2025 Otsuka Chemical Co Ltd
Japan
OTSUKA PHARMACEUTICAL CO LTD 15001 REBAMIPIDE(OPC-12759) DRUG SUBSTANCE 2000-08-10 Inactive II N/A