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AMRI Receives AIFA Certification

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.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 certific...

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