FDA Warns Ranbaxy: Shares Fall by 5%

FDA Warns Ranbaxy: Shares Fall by 5%Shares of Ranbaxy Laboratories have fell down following the issue regarding criticism being faced by the drug maker for not putting in extra efforts to meet manufacturing standards despite warnings. The shares declined more than 7% in intra-day trade to 395.10 rupees; however they later improved by end of the day 5.0% lower at 404.85 rupees. The stock opened at Rs 416 and dipped to Rs 402.

The US Food and Drug Administration (FDA) have asked the company to evaluate the manufacturing practices at its plants as soon as possible. The Drug Regulator complained that adequate corrective measures are not being taken by Ranbaxy in order to chase regulatory requirements even after warning letters were sent by them. Ranbaxy was held responsible for violating norms of current good manufacturing practice (CGMP) on December 21, 2009 according to the warning letter issued by the US FDA.

Sales in Ranbaxy's biggest overseas market US have been suffering since long time because of dearth in manufacturing practices at some of its plants. In a statement on Dec. 24, Ranbaxy admitted that it got a FDA warning letter and that it will resolve its matter with FDA.

The FDA letter said that "Ranbaxy's attempts to make global corrections after past regulatory actions by the FDA have been inadequate. We remind you that Ranbaxy is responsible for ensuring that all Ranbaxy drug manufacturing operations comply with applicable U. S. requirements, including the CGMP (current good manufacturing practices) regulations".