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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.

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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