GMP MANUFACTURING REQUEST
GMP Peptide Manufacturing Services
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.
- 20+
- Years Experience
- 2500+
- Employees
- 50+
- Capacity (MT/yr)
- 3
- GMP Faclities
GMP Peptide Manufacturing & API Production
Sinopep delivers scalable, high-quality GMP peptide manufacturing from milligrams to hundreds of kilograms, supporting every stage—from discovery through commercial supply.
Flexible Scale-Up Capabilities
- Solid-phase reactors: up to 3000 L
- Solution-phase reactors: up to 10,000 L
- DAC purification columns: up to 1,200 mm diameter
- Spray dryer throughput: 32 kg/h (200+ kg per batch)
Our advanced TIDEs Platform combines solid- and liquid-phase synthesis for superior efficiency, consistency, and reproducibility in complex peptide therapeutics. Full automation minimizes errors, accelerates timelines, improves safety, and ensures exceptional yield and purity under strict GMP standards—meeting rising global demand for premium peptide APIs.
Leading CDMO in Advanced GMP Peptide Manufacturing
- Large-scale automated synthesis
- Central control room
- Advanced DCS automation
- Intelligent close-control systems
- OEB5 occupational exposure containment
Need a Quotation for GMP Manufacturing?
Request QuoteInspection 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 |