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 ...