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India,United States : RANBAXY calls back generic Lipitor in US market.

Ranbaxy Laboratories after finding small glass particles in some lots of Atorvastatin, the generic name for Pfizer's blockbuster drug Lipitor has called back some packages of its generic version of cholesterol-lowering drug Lipitor from the US market.

Pfizer has authorized Ranbaxy and US-based Watson Pharmaceuticals with exclusive rights to sell the generic version of Lipitor for six months in the US.

After this finding, Ranbaxy Pharmaceuticals Inc recalling certain select lot numbers of Atorvastatin calcium tablets of 10mg, 20mg, and 40mg dosage strengths, packaged in 90's and 500 count bottles.

According to Ranbaxy, the voluntary recall would cause a temporary supply disruption. However the shipments will restart after conducting an internal probe within two weeks.

The company has not reveal how it discovered the problem nor did it report any injuries or deaths tied to the recalled product. Watson did not require FDA approval since it has tied up with Pfizer for selling the drug under a royalty-payment scheme.

After Pfizer lost Lipitor's US patent protection on 30 November 2011 late last year, Ranbaxy was the first to market the generic version of Lipitor and received rights to 180 days of marketing exclusivity by the US Food and Drug Administration (FDA) for being the first to file for a generic equivalent.

The recall will benefit five other manufacturers in the US including Watson and Pfizer since Ranbaxy holds around 44 per cent Atorvastatin market share in the US.

Recently, Ranbaxy has been targeted by the FDA for its manufacturing practices and quality controls at several plants in India and the US. It has also been hauled up by the FDA for falsifying data and test results in approved and pending drug applications, which could lead to defective products.

The US Department of Justice in January obtained a decree from a federal judge banning Ranbaxy from producing some generic drugs, but not the generic version of Lipitor in the US market until it corrects the problems at its plants.

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Publication:Mena Report
Date:Nov 26, 2012
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