FDA Approves CMO Facilities for Halozyme Product

October 20, 2014

FDA approved a Cook Pharmica facility and a Patheon facility for manufacturing of Halozyme products.

Halozyme Therapeutics received FDA approval for two new contract manufacturing facilities used in the production of Hylenex recombinant (hyaluronidase human injection), a tissue permeability modifier indicated as an adjuvant to increase the dispersion and absorption of other injected or subcutaneously infused drugs. 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.

Source: Halozyme