PEPTIDE NCE SERVICES
GMP PEPTIDE MANUFACTURING & DEVELOPMENT
Sinopep is a leading CDMO specializing in the development and GMP manufacturing of peptide NCEs. Our comprehensive platform offers end-to-end support for peptide projects of all scales—from preclinical research through commercial production. Leveraging advanced expertise in both solid-phase and liquid-phase peptide synthesis, we excel in the synthesis of complex and challenging peptides. With flexible manufacturing capacities, modular systems, and a track record of successfully advancing multiple peptide NCEs through Phase 1–3 clinical trials and commercial supply, Sinopep provides reliable, high-quality solutions to accelerate the development and commercialization of peptide-based therapeutics.
Complete Lifecycle Support
Sinopep offers research-grade and clinical-grade manufacturing services, supporting clients from early discovery through to commercial production.
Inspection History
Since 2014, Sinopep’s GMP manufacturing facilities have successfully passed four (4) inspections conducted by the U.S. FDA, demonstrating our strong commitment to global regulatory compliance and product quality. In addition to these FDA audits, Sinopep has also undergone inspections by the Korean MFDS and has successfully completed 20 regulatory audits conducted by the NMPA in China.
| Date | Inspected Type | Regulatory Agency | Result |
|---|---|---|---|
| Apr 2014 | Peptide API | FDA CGMP | Pass |
| Apr 2016 | Peptide API | FDA CGMP | Pass |
| Jan 2019 | Routine Inspection | FDA CGMP | Pass |
| Nov 2023 | Small Molecule & Peptide API | MFDS CGMP | Pass |
| Sep 2024 | Routine Inspection (Unannounced Inspection) | FDA CGMP | Pass |
| July 2025 | GLP-1 Product-Specific Inspections | ANVISA CGMP | Pass |