Zhejiang Guobang Pharmaceutical is an API manufacturer based in China. It holds 13 active US drug master files and 13 valid CEPs across a filed portfolio of 18 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 3 March 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Shangyu, China | Not on file |
| Shaoxing, China | Not on file |
| China, China | 3008617115 |
| Molecule | Regulators | Docs |
|---|---|---|
| Ciprofloxacin | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Clarithromycin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Azithromycin | EDQM, US FDA | 2 |
| Moxifloxacin | EDQM, US FDA | 2 |
| Rivaroxaban | EDQM, US FDA | 2 |
| Apixaban | US FDA | 1 |
| Brexpiprazole | US FDA | 1 |
| Diclazuril For Veterinary Use | EDQM | 1 |
| Edoxaban | US FDA | 1 |
| Enrofloxacin For Veterinary Use | EDQM | 1 |
| Guanfacine | US FDA | 1 |
| Lanthanum Carbonate | US FDA | 1 |
| Macitentan | US FDA | 1 |
| Marbofloxacin For Veterinary Use | EDQM | 1 |
| Roxithromycin | EDQM | 1 |
| Solifenacin Succinate | EDQM | 1 |
| Topiroxostat | US FDA | 1 |
| Vonoprazan | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | None | 2 |
| US FDA | None | 1 |
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