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news.Albany Molecular Research Inc (AMRI) has received the Italian Medicines Agency (AIFA) approval for its Burlington, MA, facility to manufacture the commercial drug product octreotide for a customer in the European Union (EU).
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The certification was subject to the successful completion of AIFA audit of AMRI’s sterile fill and finish facility in Burlington, MA.
This approval 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.
AMRI chairman, president and CEO Thomas D’Ambra said 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.