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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 Chirogate International
Taiwan
CHIROGATE INTERNATIONAL INC 28340 TREPROSTINIL SODIUM 2016-08-15 Active II N/A
28/03/2025 Nuray Chemicals Private Limited
India
SS PHARMA LLC 30861 TREPROSTINIL SODIUM 2016-09-27 Active II Complete 2017-02-16 2016-09-20