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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 |
SS PHARMA LLC | 32444 | RAMELTEON | 2018-06-06 | Active | II | Complete | 2018-07-27 | 2018-06-04 |
28/03/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 34414 | RAMELTEON | 2019-12-31 | Active | II | Complete | 2020-11-12 | 2020-09-24 |