* Certain drug batches found to contain glass particles
* Recall could cause shortage of generic Lipitor
By Kaustubh Kulkarni
MUMBAI, Nov 23 Indian drugmaker Ranbaxy
Laboratories Ltd has recalled its generic version of
Pfizer Inc's cholesterol-lowering drug Lipitor in the
United States after certain batches were found to contain glass
Ranbaxy's U.S. subsidiary, Ranbaxy Pharmaceuticals Inc, said
the recall affects certain lots of 10-, 20- and 40-milligram
doses of the drug, known generically as atorvastatin calcium.
The 80-milligram dosage is not affected.
The company is conducting an investigation which it expects
will take two weeks. It did not report any injuries connected to
the tainted pills and did not say how the problem was
The recall could cause shortages of the drug in the United
States, analysts said. Ranbaxy, the first company to introduce
generic Lipitor after Pfizer's patent expired in November 2011,
controls about 60 percent of the market, according Ross Muken,
an analyst at ISI Group LLC.
"Given its dominant share of this high-volume drug, we are
certain to see supply shortages over the next two weeks," Muken
said. The near-term impact is likely to be felt most by retail
pharmacies and more modestly by wholesalers, he added.
The recall is the latest in a series of manufacturing
problems at Ranbaxy, which is operating under heightened
scrutiny following a long-running dispute with the U.S. Food and
In 2008 the FDA banned the company from importing about 30
drugs after it found manufacturing deficiencies at two of the
company's facilities in India. In 2009 the U.S. government
accused Ranbaxy of falsifying data used in drug applications.
Last December, Ranbaxy agreed to make changes to its
manufacturing plants in the United States and India. And it said
it would set aside $500 million to resolve any potential civil
or criminal charges stemming from an investigation by the U.S.
Department of Justice.
Under a proposed settlement earlier this year, Ranbaxy
agreed to engage a third party to conduct a review of its
facilities, implement procedures to ensure data integrity in its
marketing applications, and ensure it meets good manufacturing
During its first six months on the market, when it enjoyed
marketing exclusivity, atorvastatin generated sales of nearly
$600 million for Ranbaxy, according to Bhagwan Singh Chaudhary,
a research associate at the brokerage IndiaNivesh.
"The (recall) will impact the company's credibility," said
Chaudhary. "A recall suggests corrective measures suggested by
the U.S. FDA are not being implemented."
Other drugmakers, including Indian rival Dr. Reddy's
Laboratories Ltd, have launched their own versions of
Lipitor, and the market has become more competitive.
In 2008, Japan's Daiichi Sankyo Co acquired a
majority stake in Ranbaxy in a deal valued at $4.2 billion.
Shares of Ranbaxy, which is valued at $3.93 billion, fell 3.3
pct to 496 rupees in Mumbai.