DPT granted FDA approval to manufacture Collagenase SANTYL Ointment for wound care

Dec 9 2010

DPT Laboratories, Ltd., a pharmaceutical contract development and manufacturing organization, announced today that it received FDA approval to manufacture commercial supplies of a leading sterile ointment for wound care at its Center of Excellence for Sterile & Specialty Products in Lakewood, N.J. Beginning this month, Healthpoint will ship commercial lots of Collagenase SANTYL^® Ointment produced at DPT's Lakewood facility to its North American customers.

“Receiving FDA approval to manufacture this leading wound care product underscores our commitment to serve the healthcare community and improve patient health and quality of life.”

"We are very excited to achieve this important milestone," stated Travis E. Baugh, President and Chief Operating Officer of Healthpoint. "DPT and Healthpoint have had a long and mutually beneficial relationship over the years, with DPT having been our preferred manufacturing partner on a variety of products. The recent FDA approval of DPT's Lakewood facility to produce Collagenase SANTYL^® Ointment allows Healthpoint to immediately double its production capacity, thereby helping assure continuous, uninterrupted supply for this important therapeutic agent."

Building on its reputation as the industry leader for semi-solids and liquids, DPT's Sterile & Specialty Products center focuses on aseptic production of sterile dosage forms to include small-volume parenterals, ophthalmic preparations, preservative-free nasal sprays and sterile ointments.

The SANTYL^® approval is the third commercial approval for the Lakewood facility since launching its full-scale sterile operation in early 2010. The first approval was for a new sterile product that is launching in North America and Europe; the second approval was for manufacturing an existing product used for ophthalmic therapy. The company will begin manufacturing small-volume parenterals and additional ophthalmic preparations in early 2011 and expects to successfully complete several site transfers and new product launches over the next 24 months.

"Our team in Lakewood has executed this project from the ground up and demonstrated a solid commitment to best practices in developing and commercializing sterile products," said Gene Ciolfi, DPT General Manager for Sterile & Specialty Products. "Receiving FDA approval to manufacture this leading wound care product underscores our commitment to serve the healthcare community and improve patient health and quality of life."

DPT recently invested more than $30 million in infrastructure to enhance the 175,000-square-foot center in Lakewood.

Source DPT Laboratories