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news.The US FDA has granted approval for BioMarin Pharmaceutical's manufacturing facility expansion in Novato, California.
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According to the company, the facility is expected to support around $1.0bn in revenue for the company’s enzyme replacement therapy portfolio including complex glycoprotein products produced by mammalian cells.
BioMarin CEO Jean-Jacques Bienaime said the approval would support the manufacturing requirements as well as their clinical and pre-clinical programs.
"The facility expansion will also be the initial site of commercial production for GALNS for MPS IVA, if pivotal Phase 3 results are positive in the second half of 2012," Bienaime added.
The manufacturing facility in Novato was first licensed to produce Aldurazyme for MPS I in 2003, then Naglazyme for MPS VI in 2005.