PCI Synthesis Announces 8th Successful FDA Inspection

November 17, 2011

PCI Synthesis, Inc. (www.pcisynthesis.com), a 12-year-old custom chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), 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.

PCI, which provides small and mid-sized companies with access to expertise for the development and manufacturing of complex small molecules to be used as APIs, is currently involved in the development of four late stage products recently included in MM&M's "Pipeline 2011" list of top launch prospects.


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