Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- China
- Registered address
- No.317, Xinluo Road, High-tech Zone, Jinan, Shandong 250101, China (CHN)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3003802432 · DUNS 421279342
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-01-14
- NAIDrug Quality Assurance2019-09-27
- VAIDrug Quality Assurance2018-04-17
- VAIDrug Quality Assurance2017-09-20
- VAIDrug Quality Assurance2015-05-19
- VAIDrug Quality Assurance2013-07-18
Drugs this plant is listed as making
9 distinct drugs across 37 products name this site in their FDA label.
- CefazolinApotex Corp.
- CefepimeApotex Corp.
- Cefepime HydrochlorideQilu Pharmaceutical Co., Ltd.
- Ceftriaxone SodiumQilu Pharmaceutical Co., Ltd.
- cyclosporineUpsher-Smith Laboratories, LLC
- Icosapent EthylQilu Pharmaceutical Co., Ltd.
- OlanzapineUpsher-Smith Laboratories, LLC
- Solifenacin SuccinateApotex Corp.
- Tenofovir Disoproxil FumarateQuinn Pharmaceuticals
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.