Ranbaxy hit with second generic Lipitor recall
pharmafile | March 10, 2014 | News story | Manufacturing and Production, Sales and Marketing | Daiichi Sankyo, FDA, Ranbaxy, hamburg, manufacturing
India’s largest native generic drugmaker Ranbaxy has come under greater pressure this week after the US has again sent out a recall for one its medicines.
The company, which is a unit of Japan’s Daiichi Sankyo, is withdrawing pills in 64,626 bottles of generic Lipitor – also known as atorvastatin – from the US market.
The FDA has made the recall after a product complaint was received by a pharmacist who discovered a 20 milligram tablet in a sealed bottle marked for 10 milligram pills.
Ranbaxy has not received any product complaints related to the recalled batches, it told Bloomberg. The firm added: “Ranbaxy is proactively recalling the lots out of an abundance of caution, keeping the safety of its patients in mind and with the full knowledge of the US FDA.”.
This is not the first time Ranbaxy has been hit and comes after it recalled atorvastatin in November 2012 for possibly containing small particles of glass.
Indian manufacturing
Quality at manufacturing sites in India has come under the spotlight in the past month, after the FDA commissioner Margaret Hamburg visited the country over concerns that some medicines being made there were not up to scratch.
India provides around 40% of all generic and OTC drugs in the US, which accounts for around 80% of all medicines in the country.
But manufacturing issues emanating from India have been a source of frustration to the FDA, that has had to issue a number of recalls and prohibitive measures against Indian drugmakers – with Ranbaxy being one of the main culprits.
In January, the FDA prohibited the firm from manufacturing and distributing active pharmaceutical ingredients (APIs) from Toansa, Punjab, for FDA-regulated drug products over safety concerns.
The company’s woes have rumbled on over the last couple of years, with six Ranbaxy facilities now found to have problems meeting current good manufacturing practice standards – and at four of these the issues have been serious enough for the FDA to take direct enforcement action.
The FDA consent decree issues earlier this year also encompasses the Ranbaxy facilities in Paonta Sahib, Dewas and Mohali.
Last May, the company was also forced by the US government to pay $500 million in fines and penalties to settle criminal and civil charges related to charges of selling adulterated drugs.
Access to the US market is particularly important, because Ranbaxy has marketing exclusivity for the first generic version of Novartis’ big-selling high blood pressure drug Diovan (valsartan) – but the company has been unable to capitalise given the ongoing manufacturing concerns.
Ben Adams
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