Halozyme Receives FDA OK for Contract Manufacturing Facilities

Halozyme Therapeutics Inc., a biopharmaceutical company headquartered in San Diego, California, reports that the US 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 the production of finished Hylenex product.

Hylenex recombinant is a tissue permeability modifier indicated as an adjuvant to increase the dispersion and absorption of other injected or subcutaneously infused drugs, to facilitate subcutaneous fluid administration, and in subcutaneous urography. Hylenex recombinant is contraindicated in patients with a known hypersensitivity to recombinant human hyaluronidase or any excipient used to make the drug. 

Source: Halozyme Therapeutics

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