Navigation Links
Cambrex Receives FDA Warning Letter
Date:8/24/2009

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 www.cambrex.com.


'/>"/>
SOURCE Cambrex Corporation
Copyright©2009 PR Newswire.
All rights reserved

Page: 1

Related medicine news :

1. Cambrex To Announce Third Quarter 2007 Financial Results on November 1, 2007
2. Cambrex Signs Agreement To Acquire ProSyntest AS
3. Cambrex Reports Fourth Quarter and Full-Year 2007 Results
4. Cambrex Customer Announced Recall
5. Cambrex to Announce First Quarter 2008 Financial Results on May 1, 2008
6. Cambrex Presentation at The JPMorgan Healthcare Conference to be Webcast
7. Skinvisible and Cambrex Enter Into Agreement to Develop Acne Products
8. Cambrex to Announce Fourth Quarter 2008 Financial Results on February 11, 2009
9. Cambrex Reports Fourth Quarter and Full Year 2008 Results
10. Cambrex Regains Compliance With Revised NYSE Listing Standards
11. Cambrex To Announce Second Quarter 2009 Financial Results on August 4, 2009
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... ProVest Insurance ... greater Dallas, Miami, and Raleigh regions, is organizing an extended charity drive to ... and deadly chromosome abnormality. , After struggling since birth with several health challenges, ...
(Date:10/13/2017)... ... 2017 , ... While it’s often important to take certain medications during the ... Texas, has identified a solution. , She developed a prototype for MOTION LIGHT-UP PILL ... it eliminates the need to turn on a light when taking medication during the ...
(Date:10/13/2017)... Las Vegas, Nevada (PRWEB) , ... October 13, 2017 , ... ... of 7® Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum ... CBD dose required and providing a CBD form that can be easily incorporated into ...
(Date:10/13/2017)... ... 13, 2017 , ... Apple Rehab Shelton Lakes , which specializes in ... the facility as part of a disaster drill on October 3rd. , Apple Rehab ... City Emergency Manager, as well as the Connecticut Long Term Care Mutual Aid ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... Divoti USA will engrave and process all non-coated stainless ... FDA requirements, which stipulates new criteria regarding medical device manufacture and ... ID jewelry such as Medical ID Bracelets, can rest assured that ... the new FDA requirements . ... Divoti offers this dark mark fiber laser engraving process with ...
(Date:10/11/2017)... , Oct. 11, 2017  BioPharmX Corporation (NYSE ... team that developed an innovative way to use nonlinear ... the delivery of new drugs. ... Clinical Dermatology Conference will show how researchers from BioPharmX ... Harvard Medical School used a suite of imaging techniques ...
(Date:10/11/2017)... FRISCO, Texas , Oct. 11, 2017 /PRNewswire/ ... healthcare services, has amplified its effort during National ... patients about hereditary cancer risks. ... Journal of Clinical Oncology calculated that more than ... to have inherited mutations in BRCA1 or BRCA2 and ...
Breaking Medicine Technology: