CorePharma Addresses Violations in FDA Warning Letter
Receives Closeout Letter from FDA
MIDDLESEX, N.J., May 28, 2013 /PRNewswire/ – CorePharma LLC (“CorePharma”), a developer, manufacturer, and marketer of targeted generic prescription pharmaceuticals, announced today that it has addressed the violations contained in its June 2010 Warning Letter issued by the Food and Drug Administration. These corrective actions provide a strong operational foundation for the business and have resulted in the FDA issuing a closeout letter to the firm, dated May 3, 2013.
Stephen White, the CEO of CorePharma said, “This is a significant achievement by CorePharma and is the result of a major commitment by our entire team to ensure compliance in a sustainable fashion. We look forward to continuing to serve our customers and growing our business while at all times adhering to the corrective actions we now have in place.”
CorePharma, Middlesex, NJ, is a developer, manufacturer and marketer of targeted generic prescription pharmaceuticals across a variety of dosage forms and therapeutic categories. CorePharma operates four state-of-the-art facilities, totaling 115,000 square feet of space, in Middlesex, NJ. The company actively seeks partnerships, licensing and acquisition opportunities to complement and expand its product portfolio. RoundTable Healthcare Partners, an operating-oriented private equity firm focused exclusively on the healthcare industry, owns a majority share of CorePharma.
SOURCE CorePharma LLC