Chartwell Pharmaceuticals is now a registered pharmaceutical manufacturer with the FDA, effective March 15, 2011. The registration marks the company’s process of restructuring and expanding in the generic pharmaceuticals market.

Kimberly Ezdebski, Chartwell’s senior director of Quality and Regulatory, said, “Chartwell has all the quality systems (as outlined in the Code of Federal Regulations) and GMPs in place that are mandated to be registered with the FDA. We are confident that being registered with the FDA will expand our opportunities for growth and allow us to expand our client base.”

In 2009, the company acquired a 40,000-sq.-ft manufacturing facility and began positioning itself to enter the generics market. The company is led by chief operating officer David Chipkin, who is responsible for production strategies. Mr. Chipkin has more than 30 years of experience and held key leadership roles in orchestrating the start-up, turnaround, expansion, and restructuring of a variety of businesses.