EMEA approves Renagel® production at Genzyme’s new plant in Ireland - marks a new phase of expansion in capacity.
The European Medicines Evaluation Agency has approved production of Renagel® (sevelamer hydrochloride) tablets at the company’s new cGMP manufacturing facility in Waterford, Ireland clearing the way for Genzyme to supply the product into the European market.
Renagel is a phosphate binder for patients with end-stage renal disease who are on hemodialysis. It is the only non-absorbed, calcium-free, metal-free phosphate binder available to patients. It is marketed by the Genzyme General division of the corporation.
The Waterford facility is a key component of Genzyme’s program of expanding its manufacturing capacity to support the growth of the Renagel market worldwide. The Irish Medicines Board approved the site in December 2002 and it is expected to gain US FDA approval later in the year.
Genzyme also expects mid-year approval from European and US regulatory authorities for the first of two new manufacturing sites in Haverhill, United Kingdom, built for bulk production of sevelamer hydrochloride, the primary active ingredient in Renagel. This would boost sevelamer production capacity at the site by five-fold
The investment signals confidence in the long-term outlook for Renagel, according to Mark Bamforth, Genzyme’s senior vice president for corporate operations. "This facility, and our new plants in the UK, will enable us to assume greater control over product supply."
Genzyme will continue to use several contract manufacturers as additional supply sources for sevelamer hydrochloride and Renagel formulations.
Keywords : Genzyme Renagel cGMP Manufacturing Europe Waterford Ireland Haverhill UK EMEA approval
