AMRI Receives AIFA Approval to Manufacture Commercial Drug Product in EU

AMRI AMRI announced today that it has received approval from the Italian Medicines Agency for its facility in Burlington, MA to manufacture the commercial drug product octreotide for a customer in the European Union. This approval was subject to the successful completion of an AIFA audit of AMRI's sterile fill and finish facility in Burlington, MA; AIFA is the government entity responsible for drug regulation and approval in Italy. This certification specifically applies to laboratories and manufacturing areas at the company's Burlington facility designed for the production of aseptic and lyophilized vials, affirming the facility's compliance with EU GMP standards.