Genzyme Polyclonals, a subsidiary of French Pharma Giant Sanofi, manufactures the product used in the prevention and treatment of acute rejection in organ transplantation from its site in Lyon,France, and has now received validation from the US Food and Drug Administration (FDA) after applying to the agency in December 2012.
The US has become the 44th country to validate the site which Sanofi says can produce lots of Thymoglobulin to treat over 15,000 patients per year.
"This approval is a source of immense satisfaction for our teams on a daily basis, working to the very many patients awaiting transplant can benefit from our treatments, in the best conditions," site manager Stéphane Piquand said.
Thymoglobulin is an anti-thymocyte globulin (ATG) - an infusion of rabbit-derived antibodies against human T cells.