Hebei Changshan Biochemical Pharmaceutical is an API manufacturer based in China. It holds 2 active US drug master files and one valid CEP across a filed portfolio of 2 molecules. Its filings concentrate with RCETH (BY) and UZPHARM (UZ). Its GMP standing is certified by UZPHARM (UZ), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 5 April 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Shijiazhuang, China | Not on file |
| China, China | 3010849972 |
| Molecule | Regulators | Docs |
|---|---|---|
| Heparin Sodium | EDQM, US FDA | 2 |
| Enoxaparin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| RCETH (BY) | 1 | None |
| UZPHARM (UZ) | 1 | 1 |
| US FDA | None | 1 |
| EMA | None | 1 |
Choose your molecules and target markets. Hebei Changshan Biochemical Pharmaceutical comes back tiered against every other supplier able to file there.
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