The FDA has completed the sixth inspection of PCI Synthesis‘ cGMP site in Newburyport, MA. During the multi-week inspection, the FDA conducted a general cGMP compliance review, as well as Pre-Approval Inspections (PAIs) for two APIs filed by clients earlier this year. PCI now has a total of eight products that have been successfully Pre-Approved and/or commercialized.

PCI currently has four NCEs in clinical development that were recently cited among the “Top 50 Drugs in Development to Watch” by one industry source. In addition, over the past two years, PCI has launched more than five new proprietary APIs for the generic market with exclusive supply agreements, giving it a total of 17 exclusive APIs in its overall pipeline.

Edward S. Price, president of PCI Synthesis, remarked, “Everyone at PCI is continuously working to improve the quality systems throughout our organization. Our efforts and investments in our facilities, training and new technologies, have been validated by another successful FDA inspection. More than that, the latest PAI pre-approvals further substantiate that our team understands the complex dynamics of small molecule development, including manufacturing, process optimization, scale up and comprehensive analytical support. The focus on product approvals and approved APIs is part of our commitment to full scale R&D, which further positions PCI as an innovative CMO.”