AFP – Indian drug giant Ranbaxy has ceased production of its generic version of cholesterol-busting drug Lipitor until it probes the issue of “possible” glass particles in some lots, a statement said on Saturday.
The problem is the latest to beset the generics heavyweight, India’s largest drug firm by sales, which reached a deal with US regulators earlier this year over a lengthy quality compliance dispute in which it promised tighter checks.
Ranbaxy on November 9 informed its customers of a “voluntary recall” of some lots of its atorvastatin tablets — the generic version of Lipitor, the US Food and Drug Administration (USFDA) said in statement on its website.
The lots of atorvastatin, packaged in bottles of 90 and 500 tablets, are being recalled “due to possible contamination with very small glass particles similar to the size of a grain of sand”, the statement added.
“Ranbaxy decided to stop making atorvastatin until the company has thoroughly investigated the cause of the contamination and remedied the problem,” the US agency said.
Demand for the cholesterol lowering drug in the United States has been a big boost to Ranbaxy’s sales.
The firm, headquartered in the New Delhi satellite city of Gurgaon, supplies the generic version of Lipitor to the US market from two facilities — New Jersey-based Ohm Laboratories and its Mohali plant in India.
“At this time, we have not received any reports of patient harm due to glass particulates that may be in the recalled product,” USFDA added.
Ranbaxy, bought by Japan’s Daiichi Sankyo for $4.6 billion in 2008, launched the drug in the US market a year ago. Ranbaxy’s recall involves 41 lots with mid-2014 expiry dates.
Ranbaxy, which has factories in eight countries, has grown by selling cheap copies of branded drugs that have gone off-patent, and through challenges to patents owned by Western companies.
Daiichi Sankyo bought control of the Indian firm to diversify globally and to break into the fast-growing generics market.
But Daiichi Sankyo faced an uphill battle to turn around Ranbaxy after US authorities alleged the company falsified data, failed to prevent contamination of medicines and kept poor records.