Cambrex Receives FDA Warning Letter
2009年8月25日 - 3:53AM
PRニュース・ワイアー (英語)
EAST RUTHERFORD, N.J., Aug. 24 /PRNewswire-FirstCall/ -- Cambrex
Corporation (the "Company") announced that it has received a
warning letter from the U.S. Food and Drug Administration ("FDA")
relating to an inspection of the Company's generic active
pharmaceutical ingredient ("API") manufacturing facility located in
Milan, Italy in March 2009. The observations noted in the warning
letter are primarily related to the collection and maintenance of
certain laboratory data. The Company has already addressed a number
of observations following the inspection and is fully committed to
working with the FDA to resolve all of the outstanding issues
expeditiously. While the warning letter indicated that until the
Company demonstrates that the observations have been corrected, the
FDA may withhold approval of new applications or supplements
listing the Milan, Italy facility as the API manufacturer, and may
deny entry into the U.S. of products manufactured at the site, the
Company anticipates satisfactorily responding to the letter within
the time period prescribed by the FDA and correcting all
observations. The Company noted that the observations cited in the
warning letter pertain only to its Milan, Italy facility and do not
relate to its other manufacturing facilities. About Cambrex Cambrex
provides products and services to accelerate the development and
commercialization of small molecule therapeutics including active
pharmaceutical ingredients ("API"), advanced intermediates,
enhanced drug delivery, and other products for branded and generic
pharmaceuticals. For more information, please visit
http://www.cambrex.com/. DATASOURCE: Cambrex Corporation CONTACT:
Stephanie LaFiura, Investor Relations Associate, +1-201-804-3037,
Web Site: http://www.cambrex.com/
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