Zhuhai Rundu Pharmaceutical is an API manufacturer based in China. It holds 10 active US drug master files and 10 valid CEPs across a filed portfolio of 12 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 February 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Zhuhai City, China | Not on file |
| Sanzao Town, China | Not on file |
| Zhuhai, China | Not on file |
| China, China | 3009954717 |
| Molecule | Regulators | Docs |
|---|---|---|
| Irbesartan | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Valsartan | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Candesartan Cilexetil | EDQM, SFDA (Saudi Arabia) | 3 |
| Olmesartan Medoxomil | EDQM, SFDA (Saudi Arabia) | 3 |
| Hydroxychloroquine | EDQM, US FDA | 2 |
| Sacubitril | US FDA | 2 |
| Voriconazole | EDQM, US FDA | 2 |
| Candesartan | US FDA | 1 |
| Losartan | EDQM | 1 |
| Olmesartan | US FDA | 1 |
| Sacubitril/Valsartan | US FDA | 1 |
| Telmisartan | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
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