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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | 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 |
| 31/10/2025 | Honour Lab Limited |
India |
HONOUR LAB LTD | 33928 | SAPROPTERIN DIHYDROCHLORIDE | 2019-08-06 | Active | II | Complete | 2019-09-20 | 2019-07-26 |
