PCI Synthesis Announces 8th Successful FDA Inspection

FDA Greenlights the Company's 6th Product Pre-Approval

Posted: November 15, 2011

API Manufacturing and Pharmaceutical Manufacturing

NEWBURYPORT, MA–(Marketwire – Nov 15, 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.

“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. “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.”

About PCI Synthesis

PCI Synthesis is a 12-year-old custom chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products. A contract manufacturing organization (CMO), PCI provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules and APIs used in generic pharmaceuticals. To learn more about PCI Synthesis, its proprietary NCE development activities and process R&D capabilities, please visit www.pcisynthesis.com.


Margaret Bonilla
Birnbach Communications

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About the Author

Ed Price CEO of PCI Synthesis
Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.