Shandong Luye Pharmaceutical Co., LTD.
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.15 Chuangye Road, Hi-tech Industrial Development Zone,, Yantai, Shandong Province 264003, China (CHN)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3004330858 · DUNS 544705452
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2024-05-14
Drugs this plant is listed as making
2 distinct drugs across 7 products name this site in their FDA label.
- paliperidone palmitateShandong Luye Pharmaceutical Co., Ltd.
- RisperidoneShandong Luye Pharmaceutical Co., Ltd.
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.