Waterford-based Genzyme wins FDA approval
Genzyme announced yesterday that the US Food and Drug Administration (FDA) had approved the production of Renagel tablets.
This clearance for the drug allows Genzyme to begin shipping Renagel a phosphate binder for patients with end-stage renal disease to markets around the world.
"This is a major milestone for us in securing the approvals necessary to further expand our Renagel programme," said Dominic Carolan, general manager, Genzyme Ireland.
"It is a further vote of confidence in the Waterford facility which has delivered on all milestones to date. I am also delighted to announce that the Phase 2 project in Waterford is on schedule for mechanical completion in December this year."
In the second phase of development, the group is to invest €110m in the construction of an 80,000 square-foot fill and finish plant for the formulation and filling of biological proteins and enzymes for Genzyme's pipeline products and for third parties through manufacturing partnerships.
Genzyme Ireland will create 40 highly skilled jobs in 2004, bringing total employment in the facility to 180, Mr Carolan said.
In May 2001, Tánaiste Mary Harney announced a multi-phased project for Waterford, and, to date, all milestones have been achieved.
The initial project involved transforming a 125,000 square-foot building into a state-of-the-art processing facility for the production of Renagel.
That 50m development was completed on schedule and the plant became operational in September 2002 with full European Medicine Evaluation Agency approval granted in March 2003.
