Qilu Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 18 active US drug master files and 10 valid CEPs across a filed portfolio of 20 molecules. Its filings concentrate with US FDA, JFDA (JO) and MINSA (CR). Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 4 April 2025 as NAI.
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 | 3003674637 |
| Molecule | Regulators | Docs |
|---|---|---|
| Docetaxel | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Ondansetron | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Oxaliplatin | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Aripiprazole | US FDA | 2 |
| Bortezomib | SFDA (Saudi Arabia), US FDA | 2 |
| Carboplatin | EDQM, US FDA | 2 |
| Cisplatin | EDQM, US FDA | 2 |
| Irinotecan | EDQM, US FDA | 2 |
| Olanzapine | EDQM, US FDA | 2 |
| Paliperidone | SFDA (Saudi Arabia), US FDA | 2 |
| Solifenacin Succinate | EDQM, US FDA | 2 |
| Cabazitaxel | SFDA (Saudi Arabia) | 1 |
| Carfilzomib | US FDA | 1 |
| Cariprazine | US FDA | 1 |
| Decitabine | US FDA | 1 |
| Granisetron | EDQM | 1 |
| Maribavir | US FDA | 1 |
| Nicardipine | US FDA | 1 |
| Palonosetron | US FDA | 1 |
| Semaglutide | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 23 | 1 |
| JFDA (JO) | 17 | None |
| MINSA (CR) | 9 | None |
| EDE (AE) | 3 | None |
| ARCSA (EC) | 2 | None |
| Health Canada | 2 | None |
| EMA | None | 10 |
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