Ranbaxy Laboratories gets USFDA approval for Lipitor

01 Dec 2011 Evaluate

Ranbaxy Laboratories has received US health regulator’s approval to produce generic version of cholesterol lowering drug Lipitor, a move that will help the India-based firm to launch the drug in the American market. The company has gained approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths. The drug will be manufactured by Ohm Laboratories in New Brunswick, NJ.

Settling the issue with the USFDA was of immense importance to Ranbaxy as the firm has exclusive rights to the off-patent version of Lipitor, Pfizer’s blockbuster cholesterol lowering drug which had sales of over $10 billion for the year ended September, 2010. However, Ranbaxy and Pfizer had settled all their mutual litigations worldwide over the Lipitor patent in 2008.

In 2008, the USFDA had banned 30 generic drugs produced by Ranbaxy at its Dewas (Madhya Pradesh) and Paonta Sahib and Batamandi unit in Himachal Pradesh, citing gross violation of approved manufacturing norms. It was, however, not clear whether the US Food and Drug Administration (USFDA) had resolved pending issue of manufacturing norm violation by some of the company’s plants in India.

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