FDA approves Renagel production at Genzyme plant in Ireland
The US FDA has approved the production of Renagel (sevelamer hydrochloride) tablets at Genzyme's new cGMP manufacturing facility in Waterford, Ireland.
The US FDA has approved the production of Renagel (sevelamer hydrochloride) tablets at Genzyme's new cGMP manufacturing facility in Waterford, Ireland.
The approval allows Genzyme to begin shipping Renagel produced in Waterford to markets around the world. Genzyme Ireland will be creating 50 highly skilled jobs in 2004 bringing total employment in the facility to 180.
'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. He also said that the Phase 2 project in Waterford is on schedule for completion in December this year, representing an investment of €10m in the construction of an 80,000 square foot fill and finish plant for the formulation and filling of biological proteins and enzymes.
Phase 1 involved the transformation of a 125,000 sq. ft. building into a state-of-the-art processing facility for the production of Renagel. This €50m phase was completed on schedule and the plant became operational in September 2002.