Mumbai, Nov. 23: In a development that may tarnish its image further, Ranbaxy Laboratories has voluntarily recalled its cholesterol-lowering drug atorvastatin in the US.
The Daiichi Sankyo subsidiary did not provide any reasons for the recall.
In a terse announcement to the bourses, the company said the recall would cause temporary disruption of the product. It went on to add that the investigation into the issue was likely to be completed in two weeks, after which it expected to resume supplies.
However, its US subsidiary Ranbaxy Pharmaceuticals Inc (RPI) had more details on its website. RPI said it was conducting a voluntary recall for atorvastatin calcium tablets, in connection with its 10mg 20mg and 40mg dosage strengths, packaged in 90’s and 500 count bottles and only with respect to certain select lot numbers. The recall will not affect or relate to the 80mg strength.
“The recall is being conducted at the retail level for such select batches that may contain a foreign substance (small glass particles approximately less than 1mm in size). Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind. This recall is being conducted with the full knowledge of the US Food and Drugs Administration (US FDA),” RPI added.
Atorvastatin is a type of drug that lowers cholesterol by blocking an enzyme in the liver. It thus lowers the risk of heart attack, stroke and other related ailments.
Ranbaxy Laboratories was the first to market the generic (off-patented drug) version of Pfizer Inc’s blockbuster drug Lipitor (atorvastatin) last December. While the company enjoyed six months of exclusivity post launch, other generic players entered the market subsequently. However, it has still managed to grab a solid market share even as prices of the drug have crashed because of the entry of various players. For instance during the period ended September 30, its market share stood at 50 per cent.
Analysts said while generic Lipitor contributed $600 million to Ranbaxy revenues, the current recall should be seen in the context of action taken by the US FDA against the company in the past. In 2008, the drug regulator had banned Ranbaxy from selling 30 different drugs in the US from two plants in India for violating US manufacturing practices.
The Ranbaxy stock fell 3.27 per cent to close at Rs 495.95 on the BSE today.