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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
31/03/2026 Gangwal Healthcare
India
GANGWAL HEALTHCARE PRIVATE LTD 23816 HYDROXYPROPYL BETADEX 2010-05-15 Active IV N/A
31/03/2026 Hubei Gedian Humanwell Pharmaceutical
China
HUBEI GEDIAN HUMANWELL PHARMACEUTICAL EXCIPIENTS CO LTD 42091 HYDROXYPROPYL BETADEX 2025-12-25 Active IV N/A