The Waterford operation of US drugs group Genzyme has won approval from the Food and Drugs Administration for the production of Renagel, a drug for patients with kidney disease.
The US regulator's sanction allows the group to start shipping the drug from the plant worldwide. The US group, which came to Ireland in 2001, now employs 140 here and hopes to add a further 40 jobs next year.
Genzyme built a €50 million facility in Waterford specifically to produce the phosphate binder, Renagel. It is currently close to completing a second unit at a cost of €110 million.
"This is a major milestone for us in securing the approvals necessary to further expand our Renagel programme," said Mr Dominic Carolan, general manager of Genzyme Ireland. "It is a further vote of confidence in the Waterford facility."
Genzyme has previously won approval from the European Medicine Evaluation Agency to produce the drug at the Irish plant.
The group has global sales of more than $1 billion and a workforce of 5,300.
