ZH
Zhejiang Huahai Pharmaceutical Co., Ltd.
Manufacturer · Linhai, China
GMP
Open FDA warning letter 320-25-78 dated 2025-06-06 (CGMP, finished pharmaceuticals, Xunqiao/Linhai site); no close-out letter found. See the FDA enforcement tracker
Overview
Zhejiang Huahai Pharmaceutical was founded in 1989, is headquartered in Zhejiang and is listed on the Shanghai Stock Exchange. It makes APIs, intermediates and finished generics, and the FDA list shows more than 100 DMFs in its name, including active Type II DMFs for semaglutide and semaglutide intermediate P29. FDA inspected its Xunqiao, Linhai finished-dosage site in January 2025 and issued a CGMP warning letter on 2025-06-06. An earlier 2018 warning letter was closed out in November 2021.
Capabilities
- Semaglutide API and P29 intermediate
- Large-scale small-molecule APIs
- Finished generic dosage forms
- Pharmaceutical packaging
Quality signals
| GMP evidence | Yes |
|---|---|
| Certificates of analysis | Not found |
| Third-party testing | Not found |
| ISO certification | Not found |
| Makes own product | Yes, in-house production |
Sources
- huahaipharm.com/
- fda.gov/drugs/drug-master-files-dmfs/list-drug-master-files-dmfs
- fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhe
- fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhe
- finance.sina.com.cn/realstock/company/sh600521/nc.shtml