Sanofi's (SNY) Genzyme Gets EMA, FDA Approval for Second Suite at Irish Plant
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Genzyme, a Sanofi company (NYSE: SNY), announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved a second suite 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.
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.
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