Genzyme Announces Regulatory Approvals of Expanded Waterford, Ireland Manufacturing Plant
Paris, France - May 3, 2012 - Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved a second operation for filling and finishing product at its Waterford, Ireland manufacturing plant.
With this approval, Genzyme has nearly doubled its ability to fill and finish Myozyme® and Lumizyme® (alglucosidase alfa) produced at the 4000 liter bioreactor scale. Genzyme will also begin the process to secure FDA and EMA approvals to fill and finish additional products in the second suite, with the long-term goal to use the Waterford site as a filling and finishing platform across its portfolio of products.
"The approval of the second filling and finishing suite in Waterford is another important milestone on our journey to build a robust manufacturing network capable of ensuring reliable and consistent supply of our products to patients," said Genzyme's Head of Global Manufacturing Operations, Bill Aitchison.
Genzyme's Waterford facility has been in operation for over ten years, and a $150 million expansion was completed earlier this year. The Waterford manufacturing site employs over 500 people and is considered Genzyme's center of excellence for aseptic manufacturing.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.