Hubei Biocause Heilen Pharmaceutical is a contract manufacturer based in China. It holds 16 active US drug master files and 5 valid CEPs across a filed portfolio of 14 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 14 November 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Jingmen City, China | Not on file |
| Jingmen City, China | Not on file |
| China, China | 3007268407 |
| Molecule | Regulators | Docs |
|---|---|---|
| Ibuprofen | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Fludarabine | EDQM, US FDA | 3 |
| Abiraterone | SFDA (Saudi Arabia), US FDA | 2 |
| Cladribine | EDQM, US FDA | 2 |
| Dexibuprofen | SFDA (Saudi Arabia), US FDA | 2 |
| Dexmedetomidine | US FDA | 2 |
| Granisetron | EDQM, US FDA | 2 |
| Atropine | US FDA | 1 |
| Flumazenil | US FDA | 1 |
| Homatropine | US FDA | 1 |
| Homatropine Methylbromide | US FDA | 1 |
| Hyoscyamine | US FDA | 1 |
| Milrinone | US FDA | 1 |
| Torasemide | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 2 | None |
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
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