AMRI was issued a GMP certificate from the Medicines and Healthcare Regulatory Agency (MHRA) for its manufacturing facility in Holywell, Wales, UK. The MHRA inspection in October 2011, with a formal closeout in January 2012, follows a FDA audit of the facility in June 2011, in which no formal observations were issued. As a result of the successful inspections, AMRI can produce registered intermediates and active ingredients for use in humans and can expand the range of projects it can conduct at the Holywell facility.
 
The MHRA certificate covers general GMP manufacturing operations, and laboratory controls designed for the production and release of APIs and intermediates.
 
Steven R. Hagen, Ph.D., AMRI vice president, Pharmaceutical Development and Manufacturing, said, “This certification completes an excellent year of regulatory cGMP audits for the Holywell facility and places it in a prime position to attract new business. The certification also closes a highly successful year of numerous audits across our global facilities that align us with best industry practices.”