Department sought a permanent injunction against Ranbaxy, a move that required the Indian pharmaceutical major to make fundamental changes at its plants both in the US and India.
In December 2011, Ranbaxy had filed a consent decree with a US court as part of its settlement with the American authorities and said it had earmarked up to USD 500 million for settlement with the US authorities.
Ranbaxy's dosage forms facility at Mohali was approved by the US Food and Drug Administration (FDA) in October 2011.
Japanese drug-maker Daiichi Sankyo had acquired majority stake in Ranbaxy in 2008 for a total outgo of around Rs 22,000 crore.
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Ranbaxy recalls generic Lipitor from the US market
(Reuters) Laboratories Ltd has voluntarily recalled its cholesterol-lowering drug atorvastatin in the United States, a development that could dent its image further in the world's biggest prescription drug market where the company faced an earlier ban. Ranbaxy did not specify the reason for the recall of the drug, which largely drove the company's sales in the first of half the year. Shares of the company fell more than 4 percent following the announcement.
The recall of atorvastatin, a generic version of Pfizer Inc's Lipitor, will temporarily disrupt supplies in the US market while the company conducts an investigation that is expected to take two weeks, it said. Lipitor is considered as the world's best-selling drug ever and at its peak generated $13 billion in one year for Pfizer.Ranbaxy was the first company to launch generic Lipitor inthe United States after Pfizer's patent expired last year.
The Indian company enjoyed marketing exclusivity for the first six months that generics were allowed to be sold along with US-based Watson Pharmaceuticals Inc."The development will impact the company's credibility to an extent," said Bhagwan Singh Chaudhary, a research associate at the brokerage IndiaNivesh. "There have been issues in the past (about compliance) and a recall suggests, corrective measures suggested by the U.S. FDA are not being implemented.
"Generic Lipitor generated nearly $600 million in sales for Ranbaxy during its exclusive