CONGERS, N.Y., July 12, 2011 /PRNewswire/ -- Chartwell Pharmaceuticals announced that effective March 15, 2011 the company is a registered pharmaceutical manufacturer with the Federal Drug Administration agency. The registration, filed under 962619982, is an important step for the company, which is in the process of executing a successful restructuring and expansion in the generic pharmaceuticals market.
Chartwell's Senior Director of Quality and Regulatory, Kimberly Ezdebski , said, "Chartwell has all the Quality Systems (as outlined in the Code of Federal Regulations) and Good Manufacturing Practices 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 assumed ownership of a 40,000 square foot manufacturing facility. With new management in place and state-of-the-art manufacturing capabilities, Chartwell began positioning itself to enter the generics market. The company is led by Chief Operating Officer, David I. Chipkin, who has over 30 years of experience working for both Fortune 500 and privately held companies. Chipkin has held key leadership roles in orchestrating the start-up, turnaround, expansion, and restructuring of a variety of businesses and is responsible for Chartwell's production strategies to meet the needs of its diverse customer base.
SOURCE Chartwell Pharmaceuticals