Ranbaxy restarts generic Lipitor production

A.M. Jigeesh New Delhi | Updated on March 12, 2018

In November 2012, the company had recalled Atorvastatin for select batches from the US market due to presence of foreign particles.


Ranbaxy has restarted the production of its anti-cholestrol drug Atorvastatin for the United States market.

The company had, in November 2012, voluntarily recalled select batches and strengths of Atorvastatin calcium tablets in the US. The recall was for its 10mg, 20mg and 40mg dosage strengths.

"We are working with the US FDA, and have identified and implemented multiple corrective and preventative actions. As part of the first step in initiating the manufacturing process to resume supplies to the US market, we have commenced the production of the drug substance for our Atorvastatin product," a Ranbxy spokesperson said.

Ranbaxy said the tablet was recalled keeping the safety of its customers in mind and with the full knowledge of the US Food and Drug Administration.

"Atorvastatin calcium tablets or any other product containing this molecule distributed outside the US was not and is not affected in any way by this recall and Ranbaxy continues to supply this product in other markets across the world,'' the spokesperson added.

The company said it is committed to patient safety and remain confident in the continuing safety and quality of the drug products delivered to all of its customers worldwide.

Published on February 25, 2013

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