LISBON, Portugal, July 31, 2014 /PRNewswire/ --
Hovione today announced that its API plant in Cork, Ireland has successfully passed a
pre-approval inspection by the US Food and Drug Administration
(FDA).
The inspection, carried out by the FDA Consumer Safety Officer,
Ms. Britanny Terhar, lasted 5 days
as initially planned, started on 21st July and concluded
on the 25th. The inspection confirmed the site to be
compliant with the principles and guidelines of Good Manufacturing
Practices (GMP) and no Form 483 observations were issued. At the
closing meeting the inspector informed that she was satisfied with
what she had seen and complimented Hovione on its GMP system,
inspection organization and the knowledge of its team members.
On the outcome of the inspection, Luisa
Paulo, Hovione's Compliance Director, said: "The
pre-approval inspection was triggered by a client NDA filing, it
also covered the manufacturing of a commercial NDA and a generic
antibiotic, doxycycline. It is an extremely satisfying result for
our team and for our customers. The Hovione Team members have
again demonstrated their commitment and ability to meet the highest
quality standards in the manufacturing of APIs and pre-formulated
drug products."
Jim Harvey, Hovione's General
Manager at the Cork site, said:
"We are very proud of the result achieved during this flawless FDA
inspection. I am very satisfied that the FDA inspector reported no
observations and I want to congratulate the entire team. This is
another important step for our site in Cork as it confirms our ability to comply with
high engineering, manufacturing and quality standards across all of
the Hovione sites."
About Hovione. Hovione is an international company with
over 50 years' experience in Active Pharmaceutical Ingredient
development and compliant manufacture. With four FDA inspected
sites in the U.S., China,
Ireland, and Portugal, the company focuses on the most
demanding customers, in the most regulated markets. The company
also offers branded pharmaceutical customers services for the
development and compliant manufacture of innovative new drugs, is
able to support highly potent compounds and offers all customers
proprietary product development and licensing opportunities for
drug products. In the inhalation area, Hovione is the only
independent company offering such a broad range of services.
For more information about Hovione, please visit
http://www.hovione.com or contact Marketing &
Communication, Isabel Pina,
+351-21-982-9362, e-mail: ipina@hovione.com
SOURCE Hovione