PCI Synthesis, a custom chemical manufacturer of new chemical entities (NCE), generic active pharmaceutical ingredients (API), and other specialty chemical products, announced the completion of the sixth inspection of the company’s cGMP site in Newburyport, MA by the FDA.
During the multi-week inspection, the FDA conducted a general cGMP compliance review as well as Pre-Approval Inspections (PAIs) for two active pharmaceutical ingredients (APIs) filed by two different clients earlier this year. PCI now has a total of eight products that have been successfully Pre-Approved and/or commercialized to date.
PCI, which provides small and mid-sized companies with the expertise to manufacture complex small molecules to be used as active pharmaceutical ingredients (APIs), currently has four new chemical entities in clinical development that were recently included in the “Top 50 Drugs in Development to Watch” list. In addition, over the past two years, PCI has launched more than five new proprietary APIs for the generic market with exclusive supply agreements — bringing its total to 17 exclusive APIs in its overall pipeline.
“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,” said Edward S. Price, President of PCI Synthesis. “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.”