PCI Synthesis, Inc. has successfully completed its eighth FDA inspection of its commercial manufacturing site in Newburyport, MA. The company has also received its sixth product pre-approval, which PCI’s partner expects to launch soon. PCI provides small and mid-sized companies with the development and manufacture of complex small molecules to be used as APIs.
“The latest successful FDA audit validates the ongoing investments we have made in our people, our cGMP systems, and our research, and to our continual process improvement. We have a smart team that understands the complex dynamics of small molecules, from making molecules, optimizing molecules, performing process improvements, and scaling up,” said Edward S. Price, president of PCI Synthesis. “Our focus and commitment to R&D is paying off, with our sixth product pre-approval, which assures the company of a steady stream of products in the years to come.”