PCI Synthesis, Inc. (www.pcisynthesis.com), a 14-year-old pharmaceutical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products, today announced the launch of four new proprietary APIs that were initiated during 2012. Those four new products means the company now has 13 exclusive generic APIs in its pipeline.
At Informex USA 2013, PCI Synthesis will exhibit at Booth 1059.
PCI, which provides dozens of emerging pharma clients with access to expertise for the development and manufacturing of complex small molecules to be used as NCEs, expects the current set of generic APIs to be commercialized over the next three to four years. The company has also committed to developing another three to four new products in 2013. In 2012, the company continued the clinical development of more than half dozen different NCEs for many of its Boston area partners. Many of these products are now in the process of being scaled up in its Newburyport plant for later stage clinical development.
The commitment to developing generic APIs is part of a long-standing effort by the company to invest in and develop capacity for aggressive growth. Last year, PCI completed the buildout of its Devens (Mass.) facility, growing capacity by 30 percent, bringing on new hires, implementing new cGMP systems and purchasing new equipment.
The contract research organization (CRO) and contract manufacturing organization (CMO) is currently involved in the development of four additional late stage products that were included in MM&M’s “Pipeline 2011” list of top launch prospects.
“We have a smart team that understands the complex dynamics of small molecules, from developing the routes of synthesis, optimizing molecules, performing process improvements, and scaling up,” said Ed Price, President of PCI. “The investment in developing our capacity has been paying off for our clients and PCI Synthesis itself by enabling us to expand our experience and expertise. Our location has had a major impact in accelerating timelines and reducing costs for the companies we work with.”
About PCI Synthesis
PCI Synthesis is a 14-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.