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(R) Ointment
produced at DPT’s Lakewood
facility to its North American customers.
“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(R) 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(R) 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.”
