Alvotech receives manufacturing licence for its biopharmaceutical facility
Facility to focus on developing and manufacturing the company's biosimilar portfolio.
Alvotech has received a manufacturing licence from the Icelandic Medicines Agency for its biopharmaceutical facility in Reykjavik, Iceland. The 13,000-m² facility, located in the science park of the University of Iceland in Reykjavik, is dedicated to the development and manufacturing of Alvotech’s broad biosimilar portfolio.
The granting of the manufacturing licence by the Icelandic Medicines Agency, in consultation with the Irish Health Products Regulatory Authority, is a significant milestone for Alvotech and confirms compliance with the principles and guidelines of Good Manufacturing Practices (GMP) laid out in directive 2003/94/EC.
Rasmus Rojkjaer, CEO of Alvotech, commented: “The issuance of the manufacturing licence from the Icelandic Medicines Agency is another important milestone on our journey to providing patients with more easily accessible and affordable high-quality biopharmaceuticals.
“It’s the product of a lot of hard work by the Alvotech team and reflects our commitment to becoming a leading player in the biosimilar industry. With a full-scale best-in-class manufacturing capability, we are well positioned to take on opportunities in the global biosimilar market.”
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