Ranbaxy recalls generic Lipitor in US
According to an analyst, the company generated sales of USD 600 million during its exclusive marketing period.
Atorvastatin, the generic equivalent of Pfizer's Lipitor drug, generated total annual sales of USD 7.89 billion in the United States through September, 2011.
At present, the company is in the process of settling issue with the USFDA which in 2008 banned import of 30 generic drugs manufactured at its facilities at Dewas (Madhya Pradesh), and Paonta Sahib and Batamandi units in Himachal Pradesh for gross violation of manufacturing norms.
In January this year, the US Justice 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
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