Jewim Pharmaceutical (Shandong) is an API manufacturer based in China. It holds one active US drug master file. Its filings concentrate with ARCSA (EC), DIGEMAPS (DO) and MINSA (CR). Its GMP standing is certified by INVIMA (CO), NAFDAC (NG) and TMDA (TZ), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 19 July 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| SHANDONG, China | Not on file |
| China, China | 3006452789 |
| Tai-An City - Shandong Province, Colombia | Not on file |
| SHANDONG PROVINCE, Nigeria | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Fluvoxamine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 15 | None |
| DIGEMAPS (DO) | 5 | None |
| MINSA (CR) | 4 | None |
| NAFDAC (NG) | 3 | 1 |
| UZPHARM (UZ) | 3 | None |
| RCETH (BY) | 1 | None |
| INVIMA (CO) | None | 1 |
| TMDA (TZ) | None | 1 |
| US FDA | None | 1 |
| ANVISA (Brazil) | None | 1 |
| EAEU_EEC | None | 1 |
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
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