Ranbaxy halts generic Lipitor production after recall: FDA

Fri Nov 30, 2012 12:54am IST

Related Topics

Stocks

   

REUTERS - Indian generic drugmaker Ranbaxy Laboratories (RANB.BO) will stop manufacturing its version of Pfizer Inc's (PFE.N) cholesterol fighter, Lipitor, while it gets to the bottom of the cause of a recent recall, the U.S. Food and Drug Administration said on its website.

Earlier this month, Ranbaxy recalled certain lots of the widely used cholesterol lowering medicine known generically as atorvastatin at doses of 10 milligrams, 20 mg and 40 mg after the company discovered contamination with tiny glass particles.

There have so far been no reports of patients being harmed due to the glass particulates, the FDA said.

The agency said it does not anticipate drug shortages due to the recall as several other companies also produce generic Lipitor, while Pfizer still sells its branded version.

FDA said it was monitoring the situation and working with other manufacturers to ensure adequate supply in order to avoid shortages of atorvastatin as a result of the recall.

During its first six months on the market, when it enjoyed marketing exclusivity, atorvastatin generated sales of nearly $600 million for Ranbaxy, according to Bhagwan Singh Chaudhary, a research associate at the brokerage IndiaNivesh

FDA said it will continue to oversee the recall process and work with the Ranbaxy to resolve pharmaceutical quality issues.

The recall is the latest in a series of manufacturing problems at Ranbaxy, which is operating under heightened scrutiny due to past problems that nearly derailed it ability to sell atorvastatin in the United States.

In 2008, the FDA banned the company from importing about 30 drugs after it found manufacturing deficiencies at two of the company's facilities in India, and Ranbaxy was later accused of falsifying data used in drug applications.

Under a proposed settlement earlier this year, Ranbaxy agreed to engage a third party to conduct a review of its facilities, implement procedures to ensure data integrity in its marketing applications, and ensure it meets good manufacturing practices.

(Reporting by Bill Berkrot)

FILED UNDER:
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.

  • Most Popular
  • Most Shared

Market Eye

Sensex, Nifty rise to second consecutive record high

Sensex, Nifty rise to second consecutive record high

The BSE Sensex and Nifty on Friday rose to their second consecutive record highs. The 30-share Sensex surged as much as 1.52 percent to an all-time high of 27,762.13. The broader Nifty gained as much as 1.49 percent to a record of 8,291.65.  Full Article 

REUTERS SHOWCASE

Ban on E-Cigs?

Ban on E-Cigs?

Govt considers ban on e-cigarettes, sale of single smokes.  Full Article 

Commodities

Commodities

Silver futures in India hit four-year low on global cues.  Full Article 

BOJ Policy

BOJ Policy

BOJ shocks markets with surprise easing as inflation slows.  Full Article 

Cost Cutting

Cost Cutting

PM Narendra Modi boots officials out of the first class cabin  Full Article 

Leisure Riding

Leisure Riding

Harley-Davidson woos affluent young Indians with bike culture  Full Article 

Shadow Banking

Shadow Banking

China's shadow banking sector growing rapidly, third largest in world - FSB.  Full Article 

Moody's on India

Moody's on India

Moody's welcomes India's policy steps, but wants to see more.  Full Article 

Reuters India Mobile

Reuters India Mobile

Get the latest news on the go. Visit Reuters India on your mobile device  Full Coverage