Sinopep is a trusted CDMO specializing in end-to-end CMC development and cGMP manufacturing of peptide and oligonucleotide APIs for NCEs, from early-phase development to commercialization. Since 2009, Sinopep has passed four U.S. FDA inspections and adheres strictly to FDA/ICH guidelines. Our expertise covers process and analytical method development/validation, stability studies, and regulatory support for global filings (IND/NDA).
Beyond NCEs, we are the top global supplier of Semaglutide, Tirzepatide, and Liraglutide, leading in export volume.
With one of the world's largest and most flexible production capacities, Sinopep supports projects from milligram-scale discovery to 200+ kg commercial batches. By prioritizing early-phase CMC readiness—including Phase 3-ready packages by Phase 2b—we accelerate timelines for fast-track and breakthrough therapies.