Manufacturing License Granted to Alvotech for Biopharma Facility

September 28, 2018

Specialist biopharmaceutical company, Alvotech, has announced receipt of a manufacturing license from the Icelandic Medicines Agency, applying to its biopharmaceutical facility based in Reykjavik, Iceland.

Specialist biopharmaceutical company, Alvotech, has announced receipt of a manufacturing license from the Icelandic Medicines Agency, applying to its biopharmaceutical facility based in Reykjavik, Iceland.

Founded in 2013, Alvotech is focused on the development and manufacture of high quality biosimilar products. The Icelandic facility, which is 13,000 m2in size, is located within the science park of the University of Iceland and dedicated to developing and manufacturing the company’s broad biosimilar portfolio.

Through this manufacturing license, granted by the Icelandic Medicines Agency in consultation with the Irish Health Products Regulatory Authority, the company has confirmed its compliance with the good manufacturing practice (GMP) directive 2003/94/EC guidelines and principles.

“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,” explained the company’s CEO, Rojkjaer Rasmus, in a press release. “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.”

Source: Alvotech