BrightGene Bio-Medical is an API manufacturer based in China. It holds 41 active US drug master files and 3 valid CEPs. Its filings concentrate with MINSA (CR) and US FDA. Its GMP standing is certified by EMA, MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 20 January 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Suzhou, China | Not on file |
| China, China | 3011254184 |
| Taizhou, China | Not on file |
| Suzhou, China | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Micafungin | SFDA (Saudi Arabia), US FDA | 4 |
| Caspofungin | SFDA (Saudi Arabia), US FDA | 3 |
| Dalbavancin | SFDA (Saudi Arabia), US FDA | 3 |
| Entecavir | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Everolimus | EDQM, US FDA | 3 |
| Posaconazole | US FDA | 3 |
| Sugammadex | SFDA (Saudi Arabia), US FDA | 3 |
| Ａｒｇａｔｒｏｂａｎ | PMDA (Japan) | 3 |
| Anidulafungin | SFDA (Saudi Arabia), US FDA | 2 |
| Fidaxomicin | US FDA | 2 |
| Fondaparinux | US FDA | 2 |
| Oseltamivir | EDQM, US FDA | 2 |
| Pimecrolimus | US FDA | 2 |
| Saxagliptin | US FDA | 2 |
| (21R)-Argatroban | US FDA | 1 |
| Carboprost | US FDA | 1 |
| Eribulin | US FDA | 1 |
| Exatecan | US FDA | 1 |
| Ferric Carboxymaltose | US FDA | 1 |
| Isavuconazonium | US FDA | 1 |
| Lurbinectedin | US FDA | 1 |
| Molnupiravir | US FDA | 1 |
| Pemetrexed | US FDA | 1 |
| Sirolimus | US FDA | 1 |
| Trabectedin | US FDA | 1 |
| Voclosporin | US FDA | 1 |
| エリブリンメシル酸塩 | PMDA (Japan) | 1 |
| スガマデクスナトリウム | PMDA (Japan) | 1 |
| ミカファンギンナトリウム | PMDA (Japan) | 1 |
| ミカファンギンナトリウム（Ｔｍｃ） | PMDA (Japan) | 1 |
| Ａｒｇａｔｒｏｂａｎ（Ａｇ－Ｂ１） | PMDA (Japan) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 7 | None |
| US FDA | 1 | 1 |
| EMA | None | 6 |
| MFDS (Korea) | None | 2 |
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
Choose your molecules and target markets. BrightGene Bio-Medical comes back tiered against every other supplier able to file there.
Start for freeRanked by shared active ingredients where we have them, otherwise by country and comparable credentials.