Cambrex Manufacturing Facility Completes Successful FDA Inspection
Rick Offerman, Ph.D., Associate Director, Marketing Services
East Rutherford, NJ – Cambrex Corporation (NYSE: CBM, "Cambrex") announced that the United States Food and Drug Administration (“FDA”) has completed an inspection at its active pharmaceutical ingredient (“API”) manufacturing facility in Charles City, Iowa. FDA authorities inspected the facility from March 23 to March 26, 2010, as a general inspection and found the site to be compliant with the principles and guidelines of GMP. The entire facility was inspected and the quality systems used for manufacturing and release of APIs and Food Grade Products were audited in detail for compliance. At the completion of the four-day inspection there were no Form 483 observations made.
The inspection follows two successful FDA inspections of the facility in 2008 and a successful inspection by the Medicines and Healthcare Products Regulatory Agency (“MHRA”) of the UK in July, 2009, after which a Good Manufacturing Practice (GMP) certificate for a drug product intermediate was issued.
Joe Nettleton, Vice President Operations and Charles City Site Director commented, “The Cambrex Charles City staff has demonstrated our commitment to adhering to the highest quality standards in the manufacture of APIs. We are obviously pleased with the results of the FDA inspection and our other recent inspections by regulatory agencies. We work diligently to maintain high quality standards and we have once again demonstrated our efforts to sustain and continuously improve quality platforms within Cambrex.”
Cambrex Corporation is an innovative life sciences company that provides products, services and technologies to accelerate the development and commercialization of small molecule therapeutics. The Company offers Active Pharmaceutical Ingredients (APIs), advanced intermediates and enhanced drug delivery products for branded and generic pharmaceuticals. Development and manufacturing capabilities include enzymatic biotransformations, high potency APIs, high energy chemical synthesis, controlled substances and formulation of finished dosage form products. For more information, please visit www.cambrex.com.