Ranbaxy Lab drops after reports of suing USFDA for revoking drug approvals

Ranbaxy Laboratories declined 2.03% to Rs 629.10 at 15:25 IST on BSE on reports company has sued the US Food and Drug Administration for revoking approvals granted to the firm to launch copies of two drugs.

Meanwhile, the S&P BSE Sensex was down 24.44 points or 0.09% at 28,153.44.

On BSE, so far 84,833 shares were traded in the counter as against average daily volume of 1.6 lakh shares in the past one quarter.

The stock hit a high of Rs 651.30 and a low of Rs 629 so far during the day. The stock had hit a record high of Rs 697.50 on 10 November 2014. The stock had hit a 52-week low of Rs 306.05 on 27 January 2014.

The large-cap pharma firm has an equity capital of Rs 212.29 crore. Face value per share is Rs 5.

Two drugs for which USFDA reportedly revoked approvals included AstraZeneca Plc's heartburn pill Nexium. The FDA told Ranbaxy this month that it believed its decisions to grant the company tentative approvals for copies of Nexium and Roche AG's antiviral Valcyte were "in error", after it found that Ranbaxy's plants at the time were not compliant with the FDA's manufacturing quality standards. The agency also stripped Ranbaxy of a six-month market exclusivity on the launch of generic Valcyte.

In the suit filed in the District Court for the District of Columbia, Ranbaxy reportedly said the FDA's move violated constitutional rights, exceeded the agency's statutory authority, and was "arbitrary, capricious, and otherwise contrary to law." "FDA has no power to correct an alleged mistake it made six years ago," Ranbaxy reportedly said.

Ranbaxy in the lawsuit also requested the court to restrain FDA from approving any other generic versions of Valcyte or Nexium until its six-month exclusive periods on the launch of the drugs has ended.

Ranbaxy, which is being acquired by larger local rival Sun Pharmaceutical Industries for $3.2 billion, has been hit by a series of regulatory sanctions in the past year due to poor production practices at its India-based plants.

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