PCI Synthesis Announces 8th Successful FDA Inspection

PCI Synthesis, Inc., a 12-year-old custom chemical manufacturer of new chemical entities, generic active pharmaceutical ingredients, and other specialty chemical products, announced the successful completion of its eighth FDA inspection of the company's commercial manufacturing site in Newburyport, Mass.

Additionally, PCI received its sixth product pre-approval; with that pre-approval, PCI's partner expects to launch a new drug in Q1/Q2 2012. Over the past year, PCI launched five new proprietary APIs in the laboratory for the generic and OTC markets with exclusive supply agreements -- exceeding its goal of four per year.

"The latest successful FDA audit validates the ongoing investments we have made in our people, our cGMP systems, our technology, 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."