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FDA Approves New Manufacturing Facility for Collagenase SANTYL® Ointment
Date:12/8/2010

FORT WORTH, Texas, Dec. 8, 2010 /PRNewswire/ -- Healthpoint today announced that the U.S. Food and Drug Administration has granted approval to manufacture commercial supplies of Collagenase SANTYL® Ointment, a biologic enzymatic debriding agent, at DPT Laboratories' Center of Excellence for Sterile & Specialty Products facility in Lakewood, New Jersey. DPT Laboratories is one of Healthpoint's contract manufacturers for the brand.

"The approval of this second production facility marks a significant milestone for the SANTYL® brand, allowing us to immediately double our manufacturing capacity for this important therapeutic agent," said Travis E. Baugh, President and Chief Operating Officer of Healthpoint. "The approval culminates a multi-year effort undertaken to ensure continuous, uninterrupted supply to the healthcare community of the only FDA-approved enzymatic debrider available in the United States."

About Collagenase SANTYL® Ointment

Collagenase SANTYL® Ointment is a selective enzymatic debriding agent that contains 250 collagenase units per gram of white petrolatum USP. It is indicated for debriding chronic dermal ulcers and severely burned areas.* The enzyme collagenase is derived from the fermentation by Clostridium histolyticum and possesses the ability to liquefy collagen in necrotic tissue.

*Occasional slight transient erythema has been noted in surrounding tissue when applied outside the wound. One case of systemic hypersensitivity has been reported after 1 year of treatment with collagenase and cortisone. See complete prescribing information online at: http://www.santyl.com/prescribing.

About DPT Laboratories

DPT, a DFB Pharmaceuticals, Inc. affiliate company, is a contract development and manufacturing organization (CDMO) providing companies the best solutions to their sterile and non-sterile drug development and manu
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SOURCE Healthpoint
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