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news.Indian generic drugmaker Ranbaxy Laboratories has announced that it will restart the production of its atorvastatin drug, a generic version of Pfizer's cholesterol fighter Lipitor, for sale in the US after resolving the issues that led to recall of the drug in November 2012.
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Ranbaxy recalled its atorvastatin from the US marketplace and stopped manufacturing the cholesterol lowering medicine in November, after it was found that the certain lots of 10 mg, 20 mg and 40 mg doses of the drug was contaminated with tiny glass particles.
Ranbaxy spokesman Chuck Capriello was quoted by Reuters as saying that the firm is working with the US FDA, and has identified and implemented multiple corrective and preventative actions.
"As part of the first step in initiating the manufacturing process to resume supplies to the US market, we have commenced the production of the drug substance for our atorvastatin product," Capriello added.
According to the news agency, the recall and production halt did not affect Ranbaxy’s atorvastatin supply for markets outside the US, besides the drug registered sales of nearly $600m during its first six months on the market.
Ranbaxy said it is operating under heightened scrutiny to ensure that it would meet good manufacturing practices following a series of manufacturing problems that nearly derailed its ability to sell atorvastatin in the US.