Drug factory · FDA FEI 3014576629
Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)
8888 Lvyou Road, High-tech Zone, Jinan, China
Problems found, fixed voluntarily at FDA's last inspection, May 8, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2026: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Abiraterone | Makes it, tests it and packages it | Apotex Corp., Florida Pharmaceutical Products, LLC. | 60505-4764, 71921-178 |
| Amikacin | Makes it and tests it | Mullan Pharmaceutical Inc., Qilu Pharmaceutical Co., Ltd. | 83301-0022, 83301-0023, 67184-0569 +1 |
| Cisplatin | Makes it, tests it and packages it | Apotex Corp. | 60505-6277, 60505-6279 |
| Exemestane | Makes it, tests it and labels it | Florida Pharmaceutical Products, LLC. | 71921-190 |
| Ganirelix | Makes it and tests it | Mullan Pharmaceutical Inc., Qilu Pharmaceutical Co., Ltd. | 83301-0082, 67184-0574 |
| Hydroxyurea | Makes it, tests it and packages it | Qilu Pharmaceutical Co., Ltd., Somerset Therapeutics, LLC | 67184-0607, 70069-820 |
| Mirabegron | Makes it and tests it | Qilu Pharmaceutical Co., Ltd. | 67184-0571, 67184-0572 |
| Olanzapine | Makes it, tests it and packages it | Hikma Pharmaceuticals USA Inc., Qilu Pharmaceutical Co., Ltd. | 0143-9199, 67184-0561, 67184-0562 +5 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 8, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.