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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.

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.

Oligo 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.

Years Experience

Employees

Capacity (MT/yr)

GMP Faclities

Complete Lifecycle Support

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

Stage Peptide Platform Oligo Platform Small Molecule Platform
Discovery & Preclinical
  • Lead sequence optimization & SAR studies
  • SPPS/LPPS route selection & fragment strategy
  • Analytical method scouting & impurity profiling
  • Sequence design & synthesis screening
  • Modification chemistries (GalNAc, lipids, PS links)
  • Milligram-scale purity & analytical method development
  • Route scouting & retrosynthetic analysis
  • Polymorph, salt & co-crystal screening
  • Early process safety & hazard assessment
Clinical Development (Phase I–III)
  • Process chemistry & green synthesis optimization
  • Large-scale HPLC purification & lyophilization
  • Characterization & clinical batch release
  • Process optimization & scale-up (gram to kg scale)
  • Solid-phase synthesis & downstream purification
  • Method validation & stability testing (ICH)
  • Kilolab to pilot scale-up (cGMP API)
  • Impurity identification & purge studies
  • Specifications setting & ICH stability testing
Commercial Manufacturing
  • Multi-kilogram commercial production
  • Process validation (PPV) & global regulatory compliance
  • Continuous lifecycle management & capacity planning
  • Commercial scale synthesis & supply chain security
  • Validation batches & regulatory filing support (DMF/NDA)
  • Commercial fill-finish & release testing
  • Commercial scale multi-ton API production
  • Process validation (PPV) & regulatory filings (DMF/NDA)
  • Continuous process verification & supply security

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