Sinopharm Weiqida Pharmaceutical is an API manufacturer based in China. It holds 9 active US drug master files and 7 valid CEPs across a filed portfolio of 8 molecules. Its filings concentrate with PPB (KE), NAFDAC (NG) and ARCSA (EC). Its GMP standing is certified by US FDA and NAFDAC (NG). Its most recent recorded inspection, by US FDA, closed on 25 May 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Datong, China | Not on file |
| China, China | 3010166430 |
| Molecule | Regulators | Docs |
|---|---|---|
| Amoxicillin | EDQM, US FDA | 4 |
| Potassium Clavulanate | EDQM, SFDA (Saudi Arabia) | 4 |
| Clavulanic Acid | US FDA | 3 |
| Ampicillin | EDQM, US FDA | 2 |
| Amoxicillin Trihydrate | EDQM | 1 |
| Ceftriaxone | US FDA | 1 |
| Cefuroxime | US FDA | 1 |
| Lipoic Acid | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| PPB (KE) | 6 | None |
| NAFDAC (NG) | 5 | 1 |
| ARCSA (EC) | 2 | None |
| DAV (Vietnam) | 1 | None |
| CDSCO (India) | 1 | None |
| US FDA | None | 1 |
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