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:8/21/2014)... 21, 2014Popular fiction that normalizes and glamorizes violence against ... be associated with a greater risk of potentially harmful ... new study are presented in the article " Fiction ... in Adolescent and Young Adult Females ," published in ... from Mary Ann Liebert, Inc., publishers . The ...
(Date:8/21/2014)... Individuals with schizophrenia often have trouble engaging in daily ... study from San Francisco State University suggests the reason ... effort required to complete tasks. , The research, detailed ... Journal of Abnormal Psychology , can assist health professionals ... help those patients function normally by breaking up larger, ...
(Date:8/21/2014)... August 21, 2014 Entries are now ... the only comprehensive national awards program totally dedicated to ... development and executive leadership. The entry deadline is Oct. ... Real Estate Insights™, the first and only national magazine ... and investment. , “We launched the HREI Insights Awards ...
(Date:8/21/2014)... York, New York (PRWEB) August 21, 2014 ... Medical Cannabis Network that a company located in Massachusetts ... be the only marijuana patient verification system ... to welcome this new entity to our growing and ... to our belief that these claims are inaccurate. ...
(Date:8/21/2014)... Steven Reinberg HealthDay Reporter ... shows promise in treating respiratory syncytial virus (RSV), a leading ... finally making major progress in being able to treat human ... viral pneumonia, second only to influenza virus," said study author ... of Tennessee College of Medicine in Memphis. "There ...
Breaking Medicine News(10 mins):Health News:Women's health and Fifty Shades: Increased risks for young adult readers? 2Health News:Difficulty assessing effort drives motivation deficits in schizophrenia, study finds 2Health News:Entries Open for 2014 HREI Insights Awards™ 2Health News:Entries Open for 2014 HREI Insights Awards™ 3Health News:Entries Open for 2014 HREI Insights Awards™ 4Health News:MarijuanaDoctors.com Responds to Massachusetts Company's Claim 2Health News:New Drug May Fight Serious Respiratory Virus in Infants 2Health News:New Drug May Fight Serious Respiratory Virus in Infants 3
... Denmark, Thursday 11 June 2009: Nulliparous women (those who ... chronic arthritides (including ankylosing spondylitis, psoriatic arthritis and rheumatoid ... women (those who have given birth to children), according ... the Annual Congress of the European League Against Rheumatism ...
... As Congress prepares to debate a major overhaul of the ... support of several proposals to expand coverage that have been ... Health Confidence Survey released today. But attitudes could change as ... , Between 68 percent and 88 percent of Americans either ...
... SYK ) announced today that it will host a conference ... to discuss the Company,s operating results for the quarter ended June ... quarter ended June 30, 2009 will be released at 4:00 p.m. ... dial 866-700-0133 (domestic) or 617-213-8831 (international) and ...
... in whether women decide to go for cancer screening or not, ... wrongly assume that they will ask for information if they want ... study published in the June issue of the UK-based Journal ... and Dr Stephanie Preston reviewed 19 studies that between them explored ...
... Quality of Life of Injured Veterans , , ... by Kessler Foundation Research Center published in Brain ... Injury Association, uncovered the possible cause of cognitive fatigue ... fatigue has been shown to be one of the ...
... at August Luncheon , , DENVER, June 11 ... of kidney care services for those diagnosed with chronic kidney ... the Los Angeles Business Journal ,s 2009 "Best Places ... 67 companies chosen for their impact on the region,s economy, ...
Cached Medicine News:Health News:Diagnosis of arthritis 5 years earlier in childless women compared to those with children 2Health News:12th Annual Health Confidence Survey: Americans Show Support for Several Health Coverage Options, But Their Views Could Change as More Details Emerge 2Health News:12th Annual Health Confidence Survey: Americans Show Support for Several Health Coverage Options, But Their Views Could Change as More Details Emerge 3Health News:Stryker to Host Conference Call on July 21, 2009 2Health News:Cancer screening fear is fueled by lack of information says review covering nearly 6,000 women 2Health News:Kessler Foundation Research Center Study Provides Insight into One of the Most Challenging Symptoms Following a Traumatic Brain Injury 2Health News:Kessler Foundation Research Center Study Provides Insight into One of the Most Challenging Symptoms Following a Traumatic Brain Injury 3Health News:DaVita Named to List of 'Best Places to Work in Los Angeles' by the Los Angeles Business Journal 2
(Date:8/20/2014)... , Aug. 20, 2014  The National ... the latest results achieved by the real-time, pseudoephedrine ... the National Precursor Log Exchange (NPLEx), automatically blocks ... track down meth offenders and make arrests. Data ... Kentucky blocked the sale of ...
(Date:8/20/2014)...  The National Association of Drug Diversion Investigators ... the real-time, pseudoephedrine (PSE) blocking system in Missouri. The ... (NPLEx), automatically blocks unlawful pseudoephedrine sales and helps ... make arrests. Data released by NPLEx shows electronic ... the sale of more than 19,030 boxes of medicine ...
(Date:8/20/2014)... -- PTC Therapeutics, Inc. (NASDAQ: PTCT ) today ... - FBR 1 st Annual Healthcare Conference ... on Wednesday, September 3 rd - Citi,s 9 ... on Thursday, September 4 th In ... of America Merrill Lynch Global Healthcare Conference at the Bank ...
Breaking Medicine Technology:Kentucky's Stop-Sale System Achieves Significant Results In Battle Against Meth 2Missouri's Stop-Sale System Achieves Significant Results In Battle Against Meth 2PTC Therapeutics to Participate at Upcoming Investor Conferences 2
... , MINNETONKA, Minn. , July 14 ... a leading provider of world-class devices and therapies for both ... prospective, multi-center study on their market leading MiniArc Single-Incision Sling ... concludes that MiniArc efficacy rates for negative cough stress test ...
... CINCINNATI , July 14 Kendle (Nasdaq: KNDL ) announced today ... Wednesday, Aug. 4, 2010 . The Company will host a telephone conference call and simultaneous ... question and answer session will follow. , , ... , , , ...
Cached Medicine Technology:12-Month Study Reports 90% Success Rate for AMS' MiniArc Single-Incision Sling 212-Month Study Reports 90% Success Rate for AMS' MiniArc Single-Incision Sling 3Kendle Announces Details Regarding Second Quarter 2010 Earnings Conference Call and Webcast 2Kendle Announces Details Regarding Second Quarter 2010 Earnings Conference Call and Webcast 3
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: