Cambrex Manufacturing Facility Completes Successful US FDA Inspection
Stephanie Harrison, Marketing Manager
East Rutherford, NJ – Cambrex Corporation (NYSE: CBM, "Cambrex") announced that the US Food and Drug Administration (FDA) completed an inspection of Cambrex’s active pharmaceutical ingredient (API) manufacturing facility in Paullo, Italy. The inspection found the site to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP) and no Form 483 observations were issued. The US FDA authorities inspected the facility in December 2013.
“We are very happy with the results of this US FDA inspection,” commented Aldo Magnini, Managing Director of Cambrex Profarmaco Milano. “Our track record of outstanding regulatory compliance is very important to us and our customers. Our goal each day is to maintain high quality standards and continuously improve quality platforms within Cambrex.”
The entire facility and the quality systems used for the manufacture and release of APIs were subject to a detailed compliance inspection by the US FDA. This follows successful inspections at Cambrex Profarmaco Milano made previously by ANVISA (Brazil) in March 2012, AIFA (Italy) in September 2011, the Korean FDA in July 2011 and the US FDA in March 2011, which also resulted in zero FDA 483 observations.
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.