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Company Profile

American Peptide Company, Inc. (APC) has been manufacturing peptides for the past 20 years. APC offers comprehensive selections of pre-manufactured catalog peptides in convenient aliquots, a complete spectrum of non-GMP custom synthesis services from array screens to mg and kg of research-grade peptides from our Sunnyvale, California facility. APC also owns and operates a large-scale peptide manufacturing plant located in Vista, California (North San Diego County). This state-of-the-art facility produces grams to kilograms of peptidic Active Pharmaceutical Ingredients under cGMP conditions.

Our FDA-licensed and registered facilities are designed for manufacturing pharmaceutical drug substances for use in clinical research and commercial supply. Manufacturing is performed under strict adherence to FDA regulations 21 CFR, parts 210 and 211. In the past 4 years we had 3 FDA inspections with no 483s! Standard Operating Procedures are strictly followed and meticulously documented during the manufacturing by our trained staff of highly qualified specialists.

Starting materials of the highest quality are purchased from qualified vendors and carefully evaluated by our Quality-Assurance Department prior to use. Our Quality-Control Department subjects the final bulk peptide drug substance to a battery of analytical tests using validated methods to assure consistent, reliable and timely supplies of ultra-pure pharmaceutical-grade peptides. We provide complete documentation and regulatory support for IND and NDA. APC is experienced in solid-phase and solution-phase synthesis and conjugations to proteins and PEG. As a wholly-owned subsidiary of Ito Life Sciences, Inc. (Itoham Foods) of Japan with offices in the USA, Japan, United Kingdom, China, Korea, APC remains dedicated to delivering high-quality peptides to pharmaceutical and biotech companies worldwide.