CC
Chunghwa Chemical Synthesis & Biotech Co., Ltd. (Cenra API Solutions)
CDMO · New Taipei City, Taiwan
GMP
Overview
Chunghwa Chemical Synthesis & Biotech, now trading as Cenra API Solutions, was founded in 1964 and makes APIs by chemical synthesis and fermentation at its New Taipei City base, with a US sales office in Pennsylvania. It offers contract research and manufacturing services. It holds active US Type II DMFs for Difelikefalin, Plecanatide, Setmelanotide. The company says it became the first Taiwanese API maker to pass a US FDA inspection, in 1984.
Capabilities
- Peptide APIs
- Chemical synthesis and fermentation APIs
- CMO/CDMO services
- DMF filings in multiple countries
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 |