Shandong Xinhua Pharmaceutical Co., Ltd. FDF Plant
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. 1 Lutai Road, High-tech District, Zibo, Shandong 255086, China (CHN)
- Operations here
- analysismanufacturepack
- FDA identifiers
- FEI 3015917315 · DUNS 554507599
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-12-08
- VAIDrug Quality Assurance2023-09-20
Drugs this plant is listed as making
2 distinct drugs across 5 products name this site in their FDA label.
- IbuprofenAiPing Pharmaceutical, Inc.
- Sevelamer CarbonateShandong Xinhua 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.