East Rutherford, NJ – Cambrex Corporation (NYSE: CBM, “Cambrex”) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK government has issued a Good Manufacturing Practice (GMP) certificate for Cambrex’s manufacturing site in Charles City, Iowa, following an inspection conducted in October 2011. The MHRA approval is applicable to product filings for the UK as well as product filings for the entire European Union.
MHRA authorities inspected the facility on October 6 and 7, 2011 in connection with the production of a drug product intermediate and found the site to be compliant with the principles and guidelines of GMP. There were zero critical and zero major observations noted by the MHRA. The MHRA inspection follows a successful US FDA inspection of the facility in March 2010.
Joe Nettleton, Vice President, Operations and Charles City Site Director, commented, “We are obviously pleased with the results of the MHRA inspection. Our staff works diligently to maintain high quality standards and we believe this certificate is a further reflection of our efforts to sustain and continuously improve quality platforms within Cambrex.”