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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 | Nuray Chemicals Private Limited |
India |
NURAY CHEMICALS PRIVATE LTD | 27125 | GLYCEROL PHENYLBUTYRATE | 2013-07-03 | Active | II | Complete | 2013-09-16 | 2013-07-02 |
28/03/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 40388 | GLYCEROL PHENYLBUTYRATE | 2024-09-18 | Active | II | Complete | 2024-11-15 | 2024-08-29 |