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:10/12/2017)... CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... cold therapy products, announced today the introduction of an innovative new design of the ... multipurpose pad so you get maximum comfort while controlling your pain while using cold ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... delivery system that we intend to develop to enable prevention of a major ... to severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss is ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... D.C., for the 49th Congress of the International Society of Paediatric Oncology ... the Center for Cancer and Blood Disorders at Children’s National, and Stephen ...
(Date:10/12/2017)... ... October 12, 2017 , ... Health Literacy ... health literacy software tool, and the Cancer Patient Education Network (CPEN), an independent ... today announce a new strategic alliance. , As CPEN’s strategic partner, HLI ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... of California Berkeley, and other leading institutions in announcing the launch of the ... to change the way animals are raised for food. , Founding members of ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... , Oct. 12, 2017 AVACEN Medical , ... company with their  2017 New Product Innovation Award for ... extensive primary and secondary medical device market research by Frost ... its first-to-market OTC, drug-free pain relief product, the AVACEN 100, ... to treating fibromyalgia widespread pain. ...
(Date:10/11/2017)... , Oct. 11, 2017  True Health, ... has amplified its effort during National Breast Cancer ... hereditary cancer risks. ... Clinical Oncology calculated that more than 10 million ... inherited mutations in BRCA1 or BRCA2 and have not ...
(Date:10/5/2017)... Ill. , Oct. 5, 2017  In ... Association of Oral and Maxillofacial Surgeons (AAOMS) released ... opioids – to be used as a first-line ... pain. Recognizing ... the AAOMS White Paper "Opioid Prescribing: Acute and ...
Breaking Medicine Technology: