Zhuhai United Laboratories is an API manufacturer based in China. It holds one active US drug master file and 11 valid CEPs across a filed portfolio of 12 molecules. Its filings concentrate with MINSA (CR), ARCSA (EC) and TMDA (TZ). Its GMP standing is certified by EMA, MFDS (Korea) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 3 August 2023 as OAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| ZHUHAI - TAIWAN, China | Not on file |
| Sanzao Town, China | Not on file |
| Zhuhai, China | Not on file |
| China, China | 3006531950 |
| Molecule | Regulators | Docs |
|---|---|---|
| Potassium Clavulanate | EDQM | 4 |
| Amoxicillin | SFDA (Saudi Arabia) | 2 |
| Amoxicillin Sodium | EDQM | 2 |
| Amoxicillin Trihydrate | EDQM | 2 |
| Ampicillin | SFDA (Saudi Arabia), US FDA | 2 |
| Sulbactam | EDQM, SFDA (Saudi Arabia) | 2 |
| Ampicillin Sodium | EDQM | 1 |
| Ampicillin Trihydrate Compacted | EDQM | 1 |
| Cefoperazone | SFDA (Saudi Arabia) | 1 |
| Cefotaxime | SFDA (Saudi Arabia) | 1 |
| Ceftriaxone | SFDA (Saudi Arabia) | 1 |
| Meropenem | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 1 | None |
| ARCSA (EC) | 1 | None |
| TMDA (TZ) | 1 | None |
| EMA | None | 3 |
| MFDS (Korea) | None | 2 |
| ANVISA (Brazil) | None | 1 |
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