Qilu Antibiotics Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 5 active US drug master files across a filed portfolio of 10 molecules. Its filings concentrate with JFDA (JO), MINSA (CR) and EDE (AE). Its GMP standing is certified by ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 30 May 2023 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 |
| China, China | 3009831352 |
| Molecule | Regulators | Docs |
|---|---|---|
| Cefixime | SFDA (Saudi Arabia), US FDA | 3 |
| Ceftazidime | SFDA (Saudi Arabia), US FDA | 3 |
| Cefepime Dihydrochloride | SFDA (Saudi Arabia) | 2 |
| Avibactam | SFDA (Saudi Arabia) | 1 |
| Cefazolin | SFDA (Saudi Arabia) | 1 |
| Cefepime | US FDA | 1 |
| Cefpodoxime | US FDA | 1 |
| Cefprozil | US FDA | 1 |
| Ceftriaxone | SFDA (Saudi Arabia) | 1 |
| Cefuroxime | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| JFDA (JO) | 4 | None |
| MINSA (CR) | 3 | None |
| EDE (AE) | 3 | None |
| ARCSA (EC) | 1 | None |
| DIGEMAPS (DO) | 1 | None |
| ANVISA (Brazil) | None | 1 |
| US FDA | None | 1 |
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