
AmbioPharm
Setting a New Standard for Peptide API Manufacturing and Services
FDA-inspected peptide API manufacturer offering GMP custom synthesis, process development, analytical method validation, and vaccine peptide manufacturing from preclinical through commercial scale. Headquartered in North Augusta, United States.
Modalities
Development & manufacturing
Structured CDMO capabilities from verified public sources.
Development (D)
Manufacturing (M)
Regulatory clearances
Services
About this organization
AmbioPharm is a specialized peptide API CDMO focused on custom peptide synthesis and manufacturing services for pharmaceutical and biotech companies. The company operates FDA-inspected facilities with more than 500 chemists and industry professionals across two locations, providing services across all phases of development from preclinical to commercialization.
Core Services:
- GMP Manufacturing and Custom Peptide Synthesis (solid phase, liquid phase, and hybrid strategies)
- Custom Organic Synthesis
- Biologically Active Peptides
- Non-GMP process development and analytical services
- Vaccine peptide ingredient manufacturing
- Cosmetic peptide formulation and manufacturing
- Analytical Development & Validation (HPLC method development and validation protocols)
Regulatory & Quality: The company emphasizes FDA-inspected quality systems meeting global regulatory standards for clinical and commercial use. Over 200 years of cumulative team experience in process development, scale-up, and GMP manufacturing supports the API Model—designed to accelerate the path from Phase II trials to commercialization.
Capacity & Growth: AmbioPharm is investing $121.9 million to expand its North Augusta, South Carolina campus, bringing commercial-scale peptide API production to U.S. soil by 2027. The company positions itself as one of the largest peptide capacity manufacturers worldwide.
Locations
North Augusta
North Augusta · South Carolina · United States
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