AAIPharma has received its second certification from a European Union (EU) regulatory body that the company’s operations are in compliance with EU Good Manufacturing Practice (GMP) regulations. Following an audit of AAIPharma’s manufacturing, testing and stability operations located in Wilmington, North Carolina, USA, Sweden’s Medical Products Agency (MPA) notified the company that tablet, capsule and other solid dose drug manufacturing and testing operations can be certified as meeting EU GMPs. This certification by an EU Member State regulatory authority allows AAIPharma’s Wilmington plant to produce these products for shipment to countries in Europe.
Along with successful inspections by the US Food and Drug Administration (FDA) and EU GMP certification for AAIPharma’s sterile manufacturing operations in Charleston, South Carolina, this action positions the company to deliver global contract manufacturing and testing services for both solid dose and sterile drug products to customers wishing to supply both commercial and clinical products throughout the US and Europe.
“Certification of our Wilmington operations in addition to the approval of our Charleston manufacturing plant by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in January, is a testament to AAIPharma’s goal to provide high quality pharmaceutical contract manufacturing services to the global market,” stated Lee Karras, Sr. Vice President of Global Pharmaceutical Services at AAIPharma.
AAIPharma Inc. is a global drug development company that provides services to the pharmaceutical, biotechnology and medical device industries.AAIPharma’s service offerings include:analytical services, product development services, oral drug delivery technologies, contract manufacturing (solids and parenterals), clinical packaging and distribution, early clinical development services including bioanalysis and phase I clinics in the US and Germany and phase II-IV clinical services with therapeutic specialization in oncology.