AMRI has received 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.

“Receiving AIFA certification demonstrates AMRI’s continued commitment to provide customers with products that meet the highest standards for quality, regulatory, safety and environmental compliance,” said AMRI chairman, president and chief executive officer Thomas E. D’Ambra, Ph.D. “AMRI remains vigilant in its quality practices to ensure that the same level of excellence is delivered and adhered to at all times at all locations around the globe.”


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