With global sales of more than $1 billion annually, Ranbaxy Laboratories is one of the biggest names in the collection of pharmaceutical companies that international giant Daiichi Sankyo has gathered over the past decade. Founded and operating in India, Ranbaxy has made its name as a developer of off-patent prescription medication, meaning that it produces and sells generic versions of popular drugs after the original manufacturers’ patents have expired. Most recently, in 2011, Ranbaxy was granted approval by the U.S. Food and Drug Administration to produce a generic version of Pfizer’s Lipitor, which is used in lowering patients’ cholesterol. However, Ranbaxy has a tumultuous history when it comes to product safety, and that came to light once again last week with a very concerning recall.
On Friday, Ranbaxy announced that it was recalling 10-, 20- and 40-milligram dosage strengths of Atorvastatin calcium tablets, or generic Lipitor, because the pills may contain traces of glass particles. Earlier this year, the company also recalled batches of the drug Pantoprazole in the Netherlands because of issues regarding impurities, and both scenarios have raised more concerns with the manner in which the company produces its drugs. According to ABC News, this recall is simply the latest in a string of controversies for Ranbaxy.
Since 2006, the FDA has been dealing with a variety of issues stemming from Ranbaxy’s questionable production methods, from failure to test the shelf life of medications in 2006 to an importation ban in the U.S. in 2008 because the company allegedly lied about drug ingredients. By 2009, the FDA was officially disregarding any new applications from Ranbaxy, and in 2011, the administration reached a settlement with Ranbaxy in the form of a consent decree, which means that the pharmaceutical company had to subject its entire operation to an independent party for five years to ensure that it was meeting acceptable standards.
While it is unclear how this latest recall will affect the company’s standing with the FDA, Ranbaxy officials are assuring its global markets that this problem is not widespread.
“The recall is limited to the U.S. market only and affects specific lots numbers and strengths of this molecule manufactured by Ranbaxy only for sale in the U.S.”
“Atorvastatin calcium tablets or any other product containing this molecule distributed outside the US is not affected in any way by this recall. The activities taking place in the U.S. will not affect Ranbaxy's ability to continue to supply product in any other markets.”
While Ranbaxy’s U.S. representatives have revealed very little additional information, the company has still moved forward with the launch of its new acne treatment medication, Absorica.