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:5/4/2016)... ... 04, 2016 , ... IsoComforter, Inc., one of the Nations ... newly improved Iso-Hip Wrap. The newly designed hip wrap has been specifically ... enables the patient to enjoy the benefits of cold therapy while resting, sitting, ...
(Date:5/4/2016)... ... ... A new collaboration will give more researchers access to the largest and ... leader SAS will provide researchers worldwide with data management and analytics tools to explore ... , The DCRI and SAS share the goal of greater transparency and openness in ...
(Date:5/4/2016)... ... May 04, 2016 , ... Slepkow Slepkow & ... one of the top website design companies to create a state of the ... to the law firm's main practice areas. These practice areas include: real estate, ...
(Date:5/4/2016)... ... , ... Francesca Loparco, Co-Founder of Queen City Dream Cars, an exotic car ... procedure at Christenbury Eye Center. The entrepreneur struggled with her computer, riding horses ... day as her in-office consultation and eye exam. Francesca’s eyesight was restored to 20/20 ...
(Date:5/4/2016)... ... 2016 , ... Advanced Spine & Sport Medical Rehabilitation Center, which is renowned ... a free seminar on stem cell injections. The seminar is scheduled for Wednesday, May ... Telephone Road, Suite 110, Ventura, CA. There are only 10 seats available. , ...
Breaking Medicine News(10 mins):
(Date:5/3/2016)... 2016 Intec Pharma Ltd. (NASDAQ: ... company, today announced the appointment of Pnina Strauss-Levy ... "Ms. Strauss-Levy has 15 years of experience in ... outstanding track record, having supported the advancement of several ... in the United States and ...
(Date:5/3/2016)... PUNE, India , May 3, 2016 /PRNewswire/ ... Market 2016 Research Report provides a basic overview ... manufacturing technology, post which the surgical mesh report ... the market. Complete report on Surgical ... company profiles and 98 tables and figures is ...
(Date:5/2/2016)... May 2, 2016 Kalorama Information noted the ... Records) market in a recent white paper.  The healthcare ... physician usage, a growing market are among the top ... Kalorama,s report EMR 2016: The Market for ... seventh complete study of the EMR industry, and the ...
Breaking Medicine Technology: