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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 Nuray Chemicals Private Limited
India
SS PHARMA LLC 31385 TREPROSTINIL DIOLAMINE 2017-02-28 Active II Complete 2017-03-17 2017-02-13
25/04/2025 Apotex Pharmachem
Canada
APOTEX PHARMACHEM INC 32086 TREPROSTINIL DIETHANOLAMINE 2017-10-05 Active II Complete 2018-03-09 2017-09-27