Hubei Gedian humanwell Pharmaceutical is an API manufacturer based in China. It holds 19 active US drug master files across a filed portfolio of 19 molecules. Its filings concentrate with MINSA (CR) and DAV (Vietnam). Its GMP standing is certified by MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 7 November 2025 as OAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| China, China | 3004117486 |
| Molecule | Regulators | Docs |
|---|---|---|
| Progesterone | SFDA (Saudi Arabia), US FDA | 3 |
| Budesonide | SFDA (Saudi Arabia), US FDA | 2 |
| Dutasteride | US FDA | 2 |
| Finasteride | SFDA (Saudi Arabia), US FDA | 2 |
| Apalutamide | US FDA | 1 |
| Clascoterone | US FDA | 1 |
| Cyproterone | SFDA (Saudi Arabia) | 1 |
| Desonide | US FDA | 1 |
| Dienogest | US FDA | 1 |
| Drospirenone | US FDA | 1 |
| Eslicarbazepine Acetate | US FDA | 1 |
| Estradiol | US FDA | 1 |
| Ganciclovir | SFDA (Saudi Arabia) | 1 |
| Lasmiditan | US FDA | 1 |
| Levonorgestrel | US FDA | 1 |
| Medroxyprogesterone Acetate | US FDA | 1 |
| Mirabegron | US FDA | 1 |
| Oxcarbazepine | US FDA | 1 |
| Valganciclovir | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 3 | None |
| DAV (Vietnam) | 1 | None |
| MFDS (Korea) | None | 4 |
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