Halozyme Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has approved new contract manufacturing facilities used in the production of Hylenex recombinant (hyaluronidase human injection). The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville, North Carolina, for production of finished Hylenex product.
“The approval of new production sites enables us to substantially increase our manufacturing capacity for Hylenex recombinant,” stated Dr. Helen Torley, President and Chief Executive Officer. “Furthermore, the approvals demonstrate our capabilities in the manufacturing and operations area to ensure continuous supply of active ingredients and finished commercial drug products which are essential for our core strategy to commercialize our own proprietary products as well as partner our rHuPH20 technology with innovative companies.”
