Cambrex Receives FDA Warning Letter

Share Name	Share Symbol	Market	Type	Share ISIN	Share Description
Cleantech Building Materials	LSE:CBM	London	Ordinary Share	GB00BV1VRR47	ORD GBP0.01

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LSE:CBM

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Cambrex Receives FDA Warning Letter

24/08/2009 7:53pm

PR Newswire (US)

Cleantech (LSE:CBM)
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From May 2019 to May 2024

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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CBM Cleantech Building Materials