Ranbaxy restarts generic atorvastatin production

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Ranbaxy restarts generic atorvastatin production

Generics/News | Posted 01/03/2013 0 Post your comment

India-based generics giant Ranbaxy Laboratories (Ranbaxy) announced on 25 February 2013 that it has restarted production of its generic cholesterol lowering drug atorvastatin after solving contamination problems.

In November 2012, Ranbaxy Pharmaceuticals, the US subsidiary of Ranbaxy, voluntarily recalled 41 batches of its atorvastatin calcium tablets, the generic version of Pfizer’s Lipitor, from the US market due to the presence of foreign particles (small glass particles less than 1 mm in size) [1].

Although FDA stated that the ‘possibility of adverse health problems related to the recalled atorvastatin [was] extremely low’, the recall, which affected the 10 mg, 20 mg and 40 mg dosage strengths of atorvastatin, was followed by a decision to halt production altogether until a full investigation was completed.

Since then, some consumers have sued Ranbaxy, claiming they suffered gastrointestinal problems after taking the drug. One patient claimed it caused internal bleeding and holes in her stomach. Ranbaxy dismissed the complaints as not credible and FDA said it has not received any reports of adverse events related to the glass particles in the pills.

In a statement Ranbaxy said that the company has been working with FDA to implement multiple corrective and preventive actions, which have led to this restart in the production of generic atorvastatin. The company also pointed out that initiating the manufacturing process for generic atorvastatin was the first step toward resuming supplies to the US market.

Ranbaxy also highlighted that this recall did not affect atorvastatin calcium tablets or any other product containing this molecule distributed outside the US, and that it remains confident in the continuing safety and quality of the drug products delivered to all of its customers worldwide.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy recalls generic atorvastatin in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 1]. Available from: www.gabionline.net/Generics/News/Ranbaxy-recalls-generic-atorvastatin-in-US

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Source: FDA, Ranbaxy, The New York Times, The Economic Times India, The Hindu Business Line