Quality & Systems


AmbioPharm, Inc. has developed a unique business model that allows us to manufacture the highest quality peptides at the lowest possible prices for pharmaceutical and biotech companies.  We maintain the highest standards for quality and compliance.  We meet or exceed all FDA standards for manufacturing, with successful US FDA audits at both of our manufacturing sites.

GMP Manufacturing

The professionals at AmbioPharm have more than 150 years of cumulative experience in process development, scale up, and cGMP (Current Good Manufacturing Practice standards as defined by the FDA).

With fully-controlled cGMP systems, rigorous quality system, and experienced management, we can provide the lowest cost of manufacturing with either solution phase, solid phase or hybrid peptide synthesis.

Quality & Compliance

AmbioPharm maintains the highest level of quality and compliance in its manufacturing plants in North Augusta, SC, and Shanghai, China. As one of the world’s leading supplier of peptide APIs, we provide rigid quality controls, standard operating procedures (SOPs), training, and rigorous testing.

More than 50 experienced Quality Assurance staff and consultant review operations on a consistent basis.

FDA Inspection History

AmbioPharm complies with all FDA audits and PAIs (Pre-Approval Inspections) while demonstrating a consistent commitment to the highest levels of quality and compliance.

SETTING A NEW STANDARD

For Peptide API Manufacturing and Services

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