The public registers hold a second record for Brightgene Pharmaceutical. The fuller profile, with 41 active US DMFs and 3 valid CEPs, is at BrightGene Bio-Medical. Figures on this page cover only this record.
Brightgene Pharmaceutical is an API and finished-dose manufacturer based in China. It appears in 5 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR) and US FDA. Its GMP standing is certified by EMA.
| Site | FDA FEI |
|---|---|
| Suzhou, China | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Caspofungin | SFDA (Saudi Arabia) | 2 |
| Anidulafungin | SFDA (Saudi Arabia) | 1 |
| Entecavir | SFDA (Saudi Arabia) | 1 |
| Micafungin | SFDA (Saudi Arabia) | 1 |
| Sugammadex | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 4 | None |
| US FDA | 1 | None |
| EMA | None | 2 |
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