IHS Chemical Week

Regions :: Western Europe :: Italy

Cambrex Gets FDA Warning on Milan API Facility

10:11 PM MDT | August 25, 2009 | Deepti Ramesh

Cambrex (East Rutherford, NJ) says it has received a warning letter from the U.S. FDA, relating to the collection and maintenance of certain laboratory data at the company’s generic active pharmaceutical ingredients (API) manufacturing facility at Milan, Italy. The warning letter follows an FDA inspection of the Milan facility in March 2009. The warning letter indicated that until Cambrex corrects all the observations, the FDA may withhold approval of new applications or supplements listing the Milan facility as the API manufacturer, and products...

This information is only available to Chemical Week subscribers.


Forgot your user ID or password?
Click here to have it sent to you.

Not an IHS Chemical Week subscriber yet?

Here's why you should be:

  • 31 issues of Chemical Week magazine a year in print or digital format
  • Real time news and analysis on chemweek.com 
  • 20+ years of online archives
  • Topical e-newsletters that capture the most impactful events
  • Special issues with a regional or company focus
  • Global Outlook issue

Subscribe now


contact us | about us | privacy policy | sitemap

ihsCopyright © IHS, Inc.All rights reserved.Reproduction in whole or in part without permission is prohibited.

North Asia Russia Southeast Asia China India/Pakistan Middle East Eastern Europe Western Europe Central America Canada USA Australia/New Zealand South America Africa