FDA Hits Sun Pharma With 14-page Notice Over Halol Plant Concerns

Dec 07, 2016

The U.S. Food and Drug Administration (FDA) informed Sun Pharmaceutical Industries Ltd. about more concerns found at its Halol manufacturing plant.

Approval of several key drugs in the United States depends on the clearance on the Gujarat-based plant. A warning letter issued by the FDA last year over violations was already impacting sales. This comes at a time when India pharma stocks have already plunged.

According to Sun, the Form 483 notice, which are issued when conditions at a drug plant violate U.S. rules, was issued to Sun after a December 1 inspection. While the findings have not been disclosed, the findings ran 14 pages long.

Read the Reuters report