Ranbaxy recalls generic Lipitor in US

Nov 23 2012, 17:44 IST
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Laboratories Ltd has voluntarily recalled its cholesterol-lowering drug atorvastatin in the United States. (Reuters) Laboratories Ltd has voluntarily recalled its cholesterol-lowering drug atorvastatin in the United States. (Reuters)
SummaryRanbaxy neither specified reason for recall nor facility from where product is manufactured.

Drug major Ranbaxy today said it is recalling its generic version of cholesterol-lowering drug Lipitor from the US market leading to temporary disruption in the supply.

"The company has made a recall of Atorvastatin from the US market which will cause temporary disruption to that market of this product," Ranbaxy said in a filing to the BSE.

Ranbaxy, however, neither specified the reason for the recall nor the facility from where the recalled products are manufactured.

"The investigation with regard to the same... is expected to be completed within two weeks and thereafter the company expects to resume supplies," it added.

Shares of the company fell by 3.27 per cent to close at Rs 495.95 on the BSE.

The Gurgaon-headquartered firm supplies the generic version of Lipitor to the US market from its two facilities Ė NewBrunswick based Ohm Laboratories and Mohali plant in India.

According to sources close to the development, Ranbaxy has recalled a particular batch consisting of 10mg, 20mg and 40mg tablets from the US market.

Ranbaxy had launched generic atorvastatin in the US market in December last year after the USFDA gave final approval to to market its generic version of Lipitor produced at Ohm Laboratories facility in New Brunswick, New Jersey.

Ohm Laboratories is a wholly-owned subsidiary of Ranbaxy.

In April this year, the company started commencement of shipping of cholesterol lowering drug, atorvastatin calcium oral tablets from its Mohali SEZ plant in Punjab.

Ranbaxy was the first company to launch generic Lipitor in the US market after Pfizer's patent expired last year. The Indian company enjoyed marketing exclusivity for the first six months.

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 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 marketing period, Chaudhary said.Other drugmakers including Indian rival Dr. Reddy's Laboratories Ltd have since launched their own generic atorvastatin versions in the United States.Controlled by Japan's Daiichi Sankyo Co, Ranbaxy has had a troubled history in the United States where shipments from some of its manufacturing plants were banned from 2009 over a compliance-related probe.The ban was troubling for Daiichi Sankyo, which acquired a majority stake in the Indian company for $4.2 billion in 2008.Early this year, Ranbaxy agreed to make broader changes at it plants and agreed to appoint an external auditor to resolve the dispute with the US Food and Drug Administration.It has also set aside $500 million towards any settlement charges it might have to pay.Shares of Ranbaxy, which is valued at $3.93 billion, were down 3.5 percent at 494.85 rupees as of 0950 GMT,

underperforming a 0.07 percent fall in the Mumbai market.

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