PCI Synthesis Inc. announced the 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 the first and second quarters of 2012. Over the past year, PCI launched five APIs in the laboratory for the generic and OTC markets with supply agreements, exceeding its goal of four per year.

PCI is currently involved in the development of four late stage products recently included in MM&M's "Pipeline 2011" list of top launch prospects.

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

Release Date: Nov 15, 2011
Source: PCI Synthesis