Chunghwa Chemical Synthesis & Biotech (CCSB)
Chunghwa Chemical Synthesis & Biotech (CCSB) is a peptide CDMO based in Taiwan (New Taipei). Direct manufacturer. Founded 1964. Holds US DMFs for difelikefalin, plecanatide, setmelanotide API.
Listing reviewed October 2026.
About Chunghwa Chemical Synthesis & Biotech (CCSB)
One of Taiwan's largest API manufacturers, founded in 1964, offering contract research and cGMP contract manufacturing alongside its own API range, which includes peptide drugs. Its New Taipei site has had four FDA inspections since 2018, each classed VAI. Holds active US Drug Master Files for difelikefalin, plecanatide and setmelanotide API.
Directory assessment: Chunghwa Chemical Synthesis & Biotech (CCSB) is listed as a CDMO in the peptide supply chain, serving Asia markets from Taiwan (New Taipei). As a direct manufacturer, this supplier controls its own production process from synthesis through purification and quality control release testing. This profile lists 3 sources for reference. This supplier has a strong confidence score, indicating a high level of verification and reliability for B2B sourcing.
- Difelikefalin: DMF 38511 (Type II, active), submitted 2023-06-19
- Plecanatide: DMF 41493 (Type II, active), submitted 2025-03-31
- Setmelanotide: DMF 41490 (Type II, active), submitted 2025-03-28
DMF numbers from the FDA quarterly DMF list. A filed DMF is not FDA approval; its contents are confidential. Reviewed 2026-10-23.