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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
29/11/2025 Chirogate International
Taiwan
CHIROGATE INTERNATIONAL INC 37975 DINOPROSTONE 2023-04-26 Active II N/A
29/11/2025 EUROAPI
France
EUROAPI HUNGARY LTD 11563 DINOPROSTONE (PROSTAGLANDIN E2) 1995-07-06 Active II Complete 2025-10-01 2025-09-26