PCI Synthesis Named Best NCE API Manufacturer in 2016


The market for contract manufacturing organizations (CMOs) is getting increasingly competitive. At PCI Synthesis, we’ve taken a long-term approach to developing and implementing a vision to continually improve the services we offer and to strategically expand our offerings.

This year, we announced the formation of a cGMP Advanced Polymer Development and Manufacturing Group and obtained registration and certification from the U.S. Drug Enforcement Administration (DEA) to handle Schedule II, III, IV and V controlled substances.

As the largest independent cGMP-equipped CMO in New England, our advanced polymer-based materials development and manufacturing capability significantly expands the company’s customer base and reach within this growing market. Our group is currently developing and manufacturing more than a dozen advanced polymer-based projects. The applications for the polymer projects we have engaged in have included medical devices (510k), drug delivery technologies, therapeutics, excipients, and medical grade coatings.

All of these projects begin in our laboratories enabling our teams to not only improve many of our polymerization processes, but also to adopt the latest analytical techniques to support their development. PCI also has the capacity to produce all of our cGMP polymers in our Newburyport facility from kilos to tons.

Another result of our expansion and ongoing improvement is being named the “Best NCE Manufacturer” in the 2016 Healthcare & Pharmaceuticals Awards.

Conducted by Global Health & Pharma, a global information sharing platform & a multi-disciplinary community of more than 260,000 readers, the Healthcare & Pharmaceuticals Awards seek to spotlight the talent and dedication of the individuals, departments and organizations that work tirelessly throughout the industry. GHP established “the awards (to) recognize all levels and all aspects of the healthcare and pharmaceutical sectors, choosing to focus not just on the obvious candidates – the practitioners and scientists at the cutting edge of these rapidly evolving industries – but also on the supporting cast … without whom many of the life-changing innovations and developments we see on an almost daily basis would simply not be possible.”

PCI Synthesis, which provides small and mid-sized companies with the expertise to manufacture complex small molecules to be used as APIs, offers three class 100,000 cGMP suites for pre-clinical and clinical manufacturing and 23 reactors with a total of 20,000 gallons of manufacturing capacity.

One thing that helps us win industry recognition – like the Best NCE Manufacturer in the 2016 Healthcare & Pharmaceuticals Awards or the eight CMO Leadership Awards – isn’t just having the latest deploying the latest technologies. To be the Best NCE Manufacturer takes a skilled and dedicated staff that includes method development scientists, chemical process engineers, QA specialists, quality control analysts, regulatory affairs specialists, lab personnel, production operators and maintenance staff. Together, we’ve been able to achieve great things for our clients.

You can find more information about our API manufacturing capabilities by clicking here: capacity/.