Saturday, January 03, 2015 8:25:07 AM
facilities in Elizabeth, NJ; Little Falls, NJ; Totowa, NJ; and Lincolnton, NC.
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aGPUsUfmiEbI
Actavis Inc. Reintroduces Oxycodone
Business Wire
MORRISTOWN, N.J. -- April 17, 2009
Actavis Inc. today announced the reintroduction by its Actavis Totowa
subsidiary of Oxycodone 15 mg and 30 mg tablet products to pharmacies and
customers. Oxycodone is the first product to be manufactured at Actavis’
Little Falls, NJ facility following a recently completed FDA inspection.
In December 2008, Actavis Inc. announced that it reached agreement on a
Consent Decree of Permanent Injunction with the Food and Drug Administration
(FDA) regarding the company’s Actavis Totowa LLC subsidiary. This Decree only
impacted operations at Actavis Totowa’s three facilities: two in Totowa, NJ
and one in Little Falls, NJ.
Actavis agreed to not distribute any products from the Actavis Totowa
facilities until it certified completion of certain enumerated requirements
that demonstrate compliance with FDA’s current good manufacturing practice
(cGMP) and has passed follow-up FDA inspections of the facilities.
“Through an extensive process, Actavis re-qualified all equipment and
utilities for production and packaging – and we re-qualified and revalidated
all methods used to release products from our Totowa facilities,” said Nasrat
Hakim, Vice President of Quality Compliance and Technical Services for Actavis
Inc. “This is a very positive step and took incredible team work. The next
step in the process will involve additional interaction with the FDA so that
we can continue to introduce products as outlined in the Consent Decree.”
The FDA completed its inspection and approved the release of the first two
products as outlined in the Decree: Oxycodone 15 mg and 30 mg tablets.
Subsequent inspections, also as outlined in the Decree, will follow.
“Our customers come first,” said Doug Boothe, CEO of Actavis Inc. “We are
sorry for the inconvenience the recall caused for some but as a company, we
are committed to producing high quality pharmaceuticals, and that’s what we
will continue to do.”
Actavis, a leading manufacturer of generic pharmaceuticals, announced a
voluntary product recall in August 2008 after determining that three of its
facilities did not meet the highest standards for quality manufacturing.
Following the recall, the company enacted a comprehensive remediation program
and engaged an outside firm to assess Actavis Totowa facilities.
“Our long and successful history with Oxycodone made it the right medication
to produce first,” added Boothe. “It is one of the many quality products that
Actavis will have back on the market in the coming months and we are pleased
that our customers have responded so positively to its reintroduction.”
About Actavis Inc.
Actavis Inc. is the U.S. subsidiary of Actavis Group hf. Approximately one
quarter of Actavis’ sales are generated in North America, Actavis' single
largest market. Based in Morristown, NJ, Actavis has U.S. manufacturing
facilities in Elizabeth, NJ; Little Falls, NJ; Totowa, NJ; and Lincolnton, NC.
Actavis also has a research and development facility in Sunrise, FL and a
packaging facility in Totowa, NJ. For more information, please visit
www.actavis.us.
About Actavis Group
Actavis is one of the world’s leading generic pharmaceutical companies
specializing in the development, manufacture and sale of generic
pharmaceuticals. Based in Iceland, the company has operations in 40 countries,
with more than 10,000 employees.
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