Shandong Anxin Pharmaceutical is an API manufacturer based in China. It holds 19 active US drug master files and 12 valid CEPs across a filed portfolio of 18 molecules. Its filings concentrate with MINSA (CR) and EDE (AE). Its GMP standing is certified by EMA, ANVISA (Brazil) and MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 18 September 2019 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Jinan, United Arab Emirates | Not on file |
| JINAN, China | Not on file |
| Jinan, China | Not on file |
| Dongjia Town, China | Not on file |
| Dongjia Town, China | Not on file |
| China, China | 3004229375 |
| Molecule | Regulators | Docs |
|---|---|---|
| Piperacillin | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Amikacin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Tazobactam | US FDA | 4 |
| Aprepitant | SFDA (Saudi Arabia), US FDA | 2 |
| Capecitabine | EDQM, US FDA | 2 |
| Hydroxyurea | EDQM, US FDA | 2 |
| Imatinib | SFDA (Saudi Arabia), US FDA | 2 |
| Imatinib Mesilate | EDQM | 2 |
| Tadalafil | EDQM, US FDA | 2 |
| Azithromycin | EDQM | 1 |
| Celecoxib | EDQM | 1 |
| Docetaxel Trihydrate | EDQM | 1 |
| Fosaprepitant | US FDA | 1 |
| Olmesartan | US FDA | 1 |
| Olmesartan Medoxomil | EDQM | 1 |
| Piperacillin Sodium | EDQM | 1 |
| Sulbactam | US FDA | 1 |
| Tofacitinib | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 3 | None |
| EDE (AE) | 2 | None |
| EMA | None | 8 |
| ANVISA (Brazil) | None | 7 |
| MFDS (Korea) | None | 2 |
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