Ranbaxy Runs Afoul Of FDA, Again | Chemical & Engineering News
Volume 92 Issue 5 | p. 13 | Concentrates
Issue Date: February 3, 2014

Ranbaxy Runs Afoul Of FDA, Again

Department: Business
Keywords: generics, India, FDA, import alert, cGMP, pharmaceuticals

FDA has banned U.S. imports of active pharmaceutical ingredients from Ranbaxy Laboratories’ plant in Toansa, India. The agency found that Toansa plant operators retested failed batches of raw materials, intermediates, and finished ingredients in the hope of obtaining acceptable results. Since January 2012, Ranbaxy has been operating under the terms of a consent decree that required the company to pay a fine of $500 million and follow current Good Manufacturing Practices (cGMP) at facilities that were in violation in both Paonta Sahib and Dewas, India.

Chemical & Engineering News
ISSN 0009-2347
Copyright © American Chemical Society

Leave A Comment

*Required to comment