Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.BioMarin Pharmaceutical has received recommendation of approval for the company's manufacturing facility expansion in Novato, California, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Subscribe to our email newsletter
The two Novato facilities are said to support up to $1bn in revenue for BioMarin’s growing enzyme replacement therapy portfolio.
BioMarin CEO Jean-Jacques Bienaime said the company is happy to have received a positive opinion for the expanded Novato manufacturing facility on the heels of the FDA approval in late November.
"As our commercial products continue to grow and our pipeline advances, this state-of-the-art facility will help support the manufacturing requirements for anticipated peak sales of our commercial products and several of our clinical and pre-clinical programs," Bienaime added.
According to the company, the EMA is likely to give the final approval in the first quarter of 2012, which would allow for products manufactured at the facility to be distributed in the European Union.