LOURES, Portugal, December 17, 2014 /PRNewswire/ --
Hovione today announced that the U.S. Food and Drug
Administration (FDA) performed a Pre-Approval Inspection to its
plant in Loures, Portugal,
covering two NDA filings. At the conclusion of the inspection, the
FDA issued a Form 483 with three inspectional observations.
The inspection carried out by the FDA Investigator Mr.
Ramon Hernandez and by the Chemist,
Mr. Jose A. Lopez Rubet, lasted 5
days as initially planned, started on 1st December and
concluded on the 5th. The inspection confirmed the site
to be compliant with the principles and guidelines of Good
Manufacturing Practices (GMP).
On the outcome of the inspection, Luisa
Paulo, Hovione's Compliance Director, said "Addressing these
observations is the top priority of the site management and the
points raised will be replied to within 15 working days from the
receipt of the Form 483. We are taking this result to improve our
quality system both here and at our other sites. The
investigators spoke positively of many of our initiatives. We have
a strong pipeline of products under development with new NDAs being
filed in the next 12 months, and we need to work diligently to
continue to deserve our clients' trust."
"We have a culture of quality that puts patient safety first.
This shapes our behaviors and motivates us to improve. This is a
Team effort, and I am very encouraged to see everyone so
committed," said Guy Villax, Chief Executive.
About Hovione
Hovione is an international company with over 50 years'
experience in the development and compliant manufacture of Active
Pharmaceutical Ingredients and Drug Product Intermediates. 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 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. Hovione is a member
of Rx-360, EFCG and participates actively in
industry quality improvement initiatives to lead new global
industry standards. http://www.hovione.com
Contact
Isabel Pina
Director of Corporate Communications
Tel.: +35121-982-9362
ipina@hovione.com
SOURCE Hovione