Qilu Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 31 active US drug master files and 12 valid CEPs. Its filings concentrate with EMA, AIFA (IT) and US FDA. Its GMP standing is certified by EDQM, EMA and US FDA, among 6 authorities. 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, United Arab Emirates | Not on file |
| Dezhou City, China | Not on file |
| JINAN, China | Not on file |
| Hohhot, China | Not on file |
| JINAN, China | Not on file |
10 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Docetaxel | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Ondansetron | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Oxaliplatin | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Aripiprazole | US FDA | 4 |
| Carboplatin | EDQM, US FDA | 4 |
| Cisplatin | EDQM, US FDA | 4 |
| Irinotecan | EDQM, US FDA | 4 |
| Olanzapine | EDQM, US FDA | 4 |
| Solifenacin Succinate | EDQM, US FDA | 4 |
| Bortezomib | SFDA (Saudi Arabia), US FDA | 3 |
| Cefixime | SFDA (Saudi Arabia), US FDA | 3 |
| Ceftazidime | SFDA (Saudi Arabia), US FDA | 3 |
| Paliperidone | SFDA (Saudi Arabia), US FDA | 3 |
| Carfilzomib | US FDA | 2 |
| Cariprazine | US FDA | 2 |
| Cefepime Dihydrochloride | SFDA (Saudi Arabia) | 2 |
| Decitabine | US FDA | 2 |
| Granisetron | EDQM | 2 |
| Maribavir | US FDA | 2 |
| Nicardipine | US FDA | 2 |
| Palonosetron | US FDA | 2 |
| Amikacin | SFDA (Saudi Arabia) | 1 |
| Avibactam | SFDA (Saudi Arabia) | 1 |
| Cabazitaxel | 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 |
| Exemestane | SFDA (Saudi Arabia) | 1 |
| Flunixin Meglumine For Veterinary Use | EDQM | 1 |
| Hydroxyurea | SFDA (Saudi Arabia) | 1 |
| Meropenem | SFDA (Saudi Arabia) | 1 |
| Semaglutide | SFDA (Saudi Arabia) | 1 |
| Spinosad | US FDA | 1 |
| Tylosin Tartrate For Veterinary Use | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 140 | 23 |
| AIFA (IT) | 86 | None |
| US FDA | 47 | 3 |
| AEMPS (ES) | 25 | None |
| JFDA (JO) | 21 | None |
| MPA (SE) | 15 | None |
| EDQM | None | 34 |
| MHRA (UK) | None | 2 |
| MFDS (Korea) | None | 2 |
| ANVISA (Brazil) | 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.
Choose your molecules and target markets. Qilu Pharmaceutical comes back tiered against every other supplier able to file there.
Start for freeRanked by shared active ingredients where we have them, otherwise by country and comparable credentials.