IHS Chemical Week

Regions :: North America

FDA Issues Warning Letter to Eli Lilly API Plant

6:38 AM MST | February 24, 2010 | Deepti Ramesh

The U.S. FDA has issued a warning letter to Eli Lilly’s active pharmaceutical ingredients (API) facility at Carolina, Puerto Rico, for a significant deviation from the current good manufacturing practice (cGMP). An FDA inspection of the facility last July identified a significant deviation from cGMP requirements for the manufacture of APIs, and the deviation causes Eli Lilly’s API lyspro insulin zinc crystals, used in Humalog for diabetes treatment, to be adulterated, FDA says. The response from Eli Lilly, which the FDA received last August, lacks...

This information is only available to Chemical Week subscribers.

Username:
Password:

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

Risk Free Trial

Email Address

First Name

Last Name

Click here to register and get your RISK-FREE access to chemweek.com

Not an IHS Chemical Week
24/7 member yet?

Here's why you should be:

  • Searchable online archive access of the last 2 years of Chemical Week.
  • Print or digital magazine subscription
  • Price and market change alerts
  • Economic data and statistics
  • Buyers' Guides
  • Webcasts | whitepapers

 

 

 













 
contact us | about us | customer care | privacy policy | sitemap | advertise

ihsCopyright © 2014 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