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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 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 36147 | SAPROPTERIN DIHYDROCHLORIDE | 2021-07-31 | Active | II | Complete | 2021-10-18 | 2021-09-28 |
28/03/2025 | Asymchem Laboratories |
China |
ASYMCHEM LABORATORIES TIANJIN CO LTD | 28416 | SAPROPTERIN | 2014-06-20 | Active | II | N/A |