AMRI Receives AIFA Certification for Drug Product
Albany Molecular Research, Inc. receives the GMP manufacture approval from the Italian Medicines Agency.
AMRI, a pharmaceutical company works on drug discovery and development projects and conducts manufacturing of active ingredients and pharmaceutical intermediates for many of the world’s leading healthcare companies, announced yesterday that it has received the GMP approval from the Italian Medicines Agency (AIFA) for its Burlington, MA facility to manufacture the commercial drug product octreotide for a customer in the EU.
This approval is a result of the successful completion of an AIFA audit of AMRI’s sterile fill/finish facility. This certification specifically applies to labs and manufacturing areas designed for the production of aseptic and lyophilized vials, affirming compliance with EU GMP standards.
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