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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 |