Ranbaxy Laboratories Ltd. (500359.BY) said Friday it has resumed manufacturing generic copies of the cholesterol-lowering drug Lipitor for the U.S. market, following a production suspension late last year after tiny glass particles were found in the product.
Ranbaxy voluntarily recalled about 480,000 bottles of generic Lipitor, also known as atorvastatin calcium, in the U.S. in November, after discovering the glass fragment problem.
An Indian unit of Japan's Daiichi Sankyo Co. (DSNKY, 4568.TO), Ranbaxy said Friday it's working with the U.S. Food and Drug Administration as it implements corrective actions designed to prevent future manufacturing problems.
Ranbaxy has commenced production of the drug substance for its atorvastatin product, as part of the first step toward resuming supplies to the U.S. market, the company said in a statement.
The recall didn't affect Ranbaxy's generic Lipitor product outside the U.S.
In January, Ranbaxy said it completed an investigation of the manufacturing problem that caused the glass particles to turn up in the product. The company previously said it suspected that a faulty tank at a facility in India caused the problem.
Ranbaxy was one of the biggest sellers of generic Lipitor in the U.S. after Pfizer Inc. (>> Pfizer Inc.) lost exclusivity for the branded product in late 2011.
But Ranbaxy's share of the generic Lipitor market has plunged to 2% from about 45% before the recall, according to J.P. Morgan, which cited data from IMS Health. Other generic companies including Mylan Inc. (>> Mylan Inc.) and Apotex Inc. have gained share of the generic Lipitor market.
Write to Peter Loftus at [email protected]
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