Hainan Shuangcheng Pharmaceuticals 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. 16 Xingguo Road, Xiuying District, Haikou City, Hainan Province 570314, China (CHN)
- Operations here
- analysisapi manufacturelabelmanufacturepacksterilize
- FDA identifiers
- FEI 3009010397 · DUNS 421282282
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-01-26
- VAIDrug Quality Assurance2019-04-24
- VAIDrug Quality Assurance2016-01-28
- VAIDrug Quality Assurance2013-08-22
Drugs this plant is listed as making
3 distinct drugs across 4 products name this site in their FDA label.
- BivalirudinHainan Shuangcheng Pharmaceuticals Co., Ltd.
- EptifibatideHainan Shuangcheng Pharmaceuticals Co., Ltd.
- octreotide acetateHainan Shuangcheng Pharmaceuticals 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.