Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road 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
- 38 Huanghe Road, Economic and Technological Development Zone,, Lianyungang, Jiangsu 222047, China (CHN)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 3007373503 · DUNS 421251868
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2024-01-16
- VAIDrug Quality Assurance2018-05-14
- VAIDrug Quality Assurance2016-11-02
- NAIDrug Quality Assurance2014-05-13
- NAIDrug Quality Assurance2012-07-26
Drugs this plant is listed as making
5 distinct drugs across 8 products name this site in their FDA label.
- CarmustineSandoz Inc.
- GadobutrolFresenius Kabi USA, LLC
- gadoterate meglumineFresenius Kabi USA, LLC
- irinotecan hydrochlorideSagent Pharmaceuticals
- oxaliplatinSagent 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.