Drugmaker Ranbaxy Laboratories has stopped production of its generic version of cholesterol lowering drug Lipitor until it investigates the issue of contamination in certain lots, US health regulator said.
Batches of the company’s 10mg, 20mg and 40mg tablets of the drug were recalled voluntarily due to possible contamination with small glass particles similar to the size of a grain of sand (less than 1 mm in size), a statement by the US Food and Drug Administration said.
“The FDA continues to evaluate information associated with this recall and will notify the public as new information becomes available," it said.
Ranbaxy officials could not be reached for a comment.
Generic Lipitor has been one of the biggest bets for Ranbaxy, bringing in $600 million in December-May 2012 when the company monetised its exclusivity opportunity in the US.
Even post the completion of the exclusivity period, the company managed to retain a share of 45-50% on Lipitor.
An analyst said more than any impact on sales this issue can further damage the company’s reputation in the eyes of the US FDA.
“Ranbaxy has made up all it could in the six-month exclusivity period. Now since the market is open to competitors, anyways there would not be much sales impact. But the company has been trying to resolve its long pending manufacturing issues with the US FDA. So this instance can have an impact there,” said the analyst.
Since September 2008, Ranbaxy’s plants in Paonta Sahib and Dewas were under the FDA scanner due to manufacturing issues and the company has been trying to revolve the matter.
As Ranbaxy supplies generic Lipitor through its other facilities in New Brunswick and Mohali, experts say these facilities might also come under the US FDA scanner.
This recall impacts 41 batches of the company having expiry dates of July and August 2014.