Hisun Pharmaceutical (Hangzhou) 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.1, Haizheng Road, Xukou Town, Fuyang District, Hangzhou, Zhejiang 311404, China (CHN)
- Operations here
- api manufacturemanufacture
- FDA identifiers
- FEI 3008481334 · DUNS 421250870
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-03-26
- VAIDrug Quality Assurance2021-07-20
- VAIDrug Quality Assurance2018-03-06
- OAIDrug Quality Assurance2016-10-27
- VAIDrug Quality Assurance2014-04-11
- VAIDrug Quality Assurance2012-07-06
Drugs this plant is listed as making
2 distinct drugs across 3 products name this site in their FDA label.
- dactinomycinHisun Pharmaceuticals USA, Inc.
- daunorubicin hydrochlorideHisun Pharmaceuticals USA, Inc.
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.