Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Genzyme has ended fill/finish operations within its Allston plant for products sold in the US, as required by the FDA consent decree.
Subscribe to our email newsletter
Genzyme said that all fill/finish activities for Cerezyme (imiglucerase for injection), Myozyme (alglucosidase alfa), Fabrazyme (agalsidase beta) and Thyrogen (thyrotropin alfa for injection) for the US market now take place at its Waterford, Ireland plant, and at an external contract manufacturer.
Genzyme claimed that, with this move, all previous restrictions on the marketing and distribution of Thyrogen within the US have been lifted.
Reportedly, all remaining fill/finish activities in Allston for products sold outside of the US must be ended by 31 August 2011 and Genzyme is working closely with regulatory authorities globally to achieve this goal.