East Rutherford, NJ – Cambrex Corporation (NYSE: CBM, “Cambrex”) announced that the Medical Products Agency (MPA) of Sweden completed an inspection of Cambrex’s active pharmaceutical ingredient (API) manufacturing facility in Karlskoga, Sweden. The inspection found the site to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP) and the site’s GMP certificate was renewed. The MPA authorities inspected the facility in September 2013.
Bjarne Sandberg, Managing Director of Cambrex Karlskoga AB commented, “We are extremely pleased with the results of this latest MPA inspection. The renewing of our GMP certificate demonstrates continuing dedication to outstanding regulatory compliance at Cambrex Karlskoga.” Cambrex commits significant resources and works diligently to maintain high quality standards and continuously improve quality platforms at all its facilities worldwide.
The entire Karlskoga facility and the quality systems used for the manufacture and release of APIs were subject to a detailed compliance inspection. This follows successful inspections of Cambrex Karlskoga AB made previously by the MPA in November 2010, which also resulted in a renewed GMP certificate and the US Federal Drug Administration (FDA) in January 2011.