IHS Chemical Week

Markets :: Fine Chemicals/Biotech :: Pharmaceutical ingredients

FDA issues warning letter to Smruthi Organics’ API plant in India

9:38 AM MDT | March 26, 2014 | Deepti Ramesh

FDA issued a warning letter earlier this month to the active pharmaceutical ingredient (API) manufacturing facility of Smruthi Organics (Solapur, India) located at Solapur, for violations of cGMP. An FDA inspection from 15–18 October 2013 at the Solapur facility identified deviations from cGMP for the manufacture of APIs, FDA says. The warning letter was published in the FDA Web site earlier this week. The FDA has conducted a detailed review of Smruthi's 4 November 2013 response, but it lacks sufficient corrective actions, FDA says. The violations at the...

This information is only available to Chemical Week subscribers.


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 © 2015 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