GMP Manufacturing Request
GMP Peptide
Manufacturing
Services
We specialize in GMP manufacturing of peptide NCEs, CMC development for early- and late-phase programs, and commercial-scale production.
True Commercial Capacity
20+ Years of
Experience
Accelerated NCE Development
Regulatory Filing Experience
Full-Service Peptide CDMO
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.
Years Experience
Employees
Capacity (MT/yr)
GMP Faclities
GMP Peptide Manufacturing Video
Sinopep delivers scalable GMP peptide manufacturing from milligram R&D to commercial supply exceeding hundreds of kilograms, supporting complex therapeutics from discovery through commercial launch. Our global infrastructure guides client programs through sequence optimization, preclinical evaluation, IND-enabling CMC support, and clinical trials. By integrating fully automated Solid-Phase Peptide Synthesis (SPPS) platforms with proprietary hybrid technologies, our facilities overcome structural bottlenecks in multi-agonist and ultra-long peptides. Operations leverage Distributed Control System (DCS) automation, real-time PAT, and close-control feedback loops to ensure maximum coupling efficiency, minimize deletions, and guarantee rigid batch-to-batch reproducibility.
Watch our video to learn more about Sinopep's manufacturing capabilities and partner with us for reliable, cutting-edge GMP peptide production and seamless scale-up.
Why Partner with Sinopep?
- Large-Scale SPPS Reactors: Automated solid-phase synthesis up to 3,000 L capacity for multi-kilogram batches.
- High-Volume LPPS Platforms: Liquid-phase reactors up to 10,000 L for commercial scale-up.
- Advanced TIDEs Hybrid Synthesis: Combines SPPS and LPPS methodologies to maximize yield, purity, and process efficiency.
- Large-Diameter DAC Purification: Up to 1,200 mm dynamic axial compression columns for commercial API isolation.
- High-Capacity Spray Drying: 32 kg/h throughput delivering over 200 kg per single production batch.
- Centralized DCS Automation: Distributed Control System managing operations from a central control room.
- Intelligent Process Controls: Real-time automated feedback loops ensuring batch-to-batch reproducibility and speed.
- OEB5 Potency Containment: High-containment isolation systems engineered for safe handling of highly potent APIs.
- Global GMP Compliance: End-to-end quality standards supporting drug supply from preclinical R&D through commercial launch.
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 Product | Inspection Type | Result |
|---|---|---|---|
| Apr 2014 | Peptide API (Eptifibatide) | FDA CGMP | Pass |
| Apr 2016 | Peptide API (Eptifibatide, Lanreotide acetate) | FDA CGMP | Pass |
| Jan 2019 | Peptide API (Eptifibatide, Lanreotide acetate, Bivalirudin, Octreotide acetate) | FDA CGMP | Pass |
| Nov 2023 | Small Molecule & Peptide API | MFDS CGMP | Pass |
| Sep 2024 | Peptide API (Tirzepatide, Semaglutide, Liraglutide, Cetrorelix acetate, Eptifibatide, Octreotide acetate, Bivalirudin, Lanreotide acetate, Desmopressin Acetate) - Unannounced Inspection | FDA CGMP | Pass |
| July 2025 | Semaglutide & Liraglutide | ANVISA CGMP | Pass |
