East Rutherford, NJ – Cambrex Corporation (NYSE: CBM, “Cambrex”) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has issued a Good Manufacturing Practice (GMP) certificate for its manufacturing site in Charles City, Iowa, following an audit conducted in July 2009. The MHRA approval not only covers product filings for the UK but also applies to product filings for the entire European Union.
MHRA authorities inspected the facility in July 2009 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 and the facility was classified as low risk and assigned an inspection frequency of 30 months, the longest allowable time period. The MHRA inspection follows successful U.S. Food and Drug Administration (FDA) inspections of the facility in 2008.
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.”