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Discovery Services

Overview
Pre-clinical custom peptides and oligos

CDMO Services

Overview
GMP Manufacturing CDMO Services
GMP Peptides
NCE Development & CMC Peptide Manufacturing
Generic APIs
Generic peptide, oligo, and small molecule offerings
Formulation Services
Finished Dosage Form (FDF) Formulation Services

Quotation Request

Overview
Request for a peptide or oligo quotation
Research Peptide Quote
Quotation request for custom research-grade peptides
GMP Peptide Quote
GMP peptide manufacturing project proposal
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CDMO Services
Late-Phase and Commercial Production of Peptide, Oligonucleotide, and Small Molecule NCEs
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Services

Peptide and Oligo CDMO Services

Sinopep offers flexible, end-to-end CDMO services across a range of modalities, including peptides, oligonucleotides, small molecules, and related synthetic conjugates. The company specializes in API manufacturing and supports new chemical entity (NCE) development from early and late phases through to commercialization. When choosing a CDMO, manufacturing capacity is a key factor—and it’s where Sinopep excels. Our flexible, modular systems enable seamless scale-up from milligrams to hundreds of kilograms, ensuring reliable support from early discovery through full commercial production.

Discovery
Accelerating Discovery Research with High-Quality Custom Synthesis Services.
Peptides
GMP peptide CDMO services from early-phase through commercialization.
Oligos
Comprehensive  oligonucleotide services for ASOs, siRNA, and PMOs.
Conjugates
Advanced conjugate platforms, including PDCs, POCs, PMOs, and ADCs
Regulatory Affairs
Global regulatory affairs expertise across FDA, NMPA, EDQM, and PMDA.
Generic APIs
Custom API generics development tailored to specific requirements.
Formulation
Formulation and finished dosage manufacturing for oral and injectables.
GMP Requests
CDMO quotation requests for peptide and oligonucleotide services.
Peptide CDMO Services
Sinopep is a trusted Peptide CDMO specializing in end-to-end CMC development and cGMP manufacturing of peptide 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.
Oligonucleotide CDMO Services
Our new GMP oligonucleotide facility represents a major expansion in our ability to manufacture oligonucleotide API and NCE therapeutics, including antisense oligonucleotides (ASOs) and siRNA, at thousands of kilograms annually. Purpose-built to meet the growing global demand for advanced RNA-based medicines, this facility sets a new benchmark for large-scale oligo production.
Formulation Services
Since its founding in 2004, Sinopep has developed a robust and scalable formulation platform focused on delivering high-quality pharmaceutical products and CDMO solutions. Our recently expanded formulation facility provides even greater production capacity and an expanded range of services for our clients.
20+
Years Experience
2500+
Employees
50+
Capacity (MT/yr)
3
GMP Faclities

Complete Lifecycle Support

Sinopep offers research-grade and clinical-grade manufacturing services, supporting clients from early discovery through to commercial production.

Preclinical Phase 1 Phase 2 Phase 3 Commercial
Custom Synthesis Services
Process Development
Process Validation and Continuous Process Optimization
Clinical Batches Manufacturing (GMP), Testing and Stability Studies
Process Validation
Commercial Supply
Analyitcal Method Development and Quality Research
Analyical Method Validation
Registration and Application Support

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