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Ranbaxy restarts generic Lipitor production for US market

Feb 25 2013, 22:08 IST
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SummaryRanbaxy had launched generic Atorvastatin in the US market in December 2011 after the USFDA gave final approval.

Pharma major Ranbaxy Laboratories on Monday said it has restarted production of generic cholesterol lowering drug Atorvastatin as it looks to resume supplies to the American market.

In November last year the company had recalled Atorvastatin, the generic version of Pfizer's Lipitor, for select batches in the strengths of 10mg, 20mg and 40mg tablets from the US market due to presence of foreign particles.

Since then it has been working with the US Food and Drug Administration (USFDA) to implement multiple corrective and preventive actions.

"As part of the first step in initiating the manufacturing process to resume supplies to US market, we have commenced the production of drug substance for our Atorvastatin product," the company said in a statement.

The recall had affected 41 lots of Atorvastatin Calcium tablets (10 mg, 20 mg and 40 mg), which is a solid oral dosage form, up to the retail level.

"The recall did not affect or relate to the 80 mg strength," Ranbaxy said.

Ranbaxy had launched generic Atorvastatin in the US market in December 2011 after the USFDA gave final approval to market its generic version of Lipitor produced at Ohm Laboratories facility in New Brunswick, New Jersey.

Ohm Laboratories is a wholly-owned subsidiary of Ranbaxy. In April last year, the company started commencement of shipping of cholesterol lowering drug, Atorvastatin calcium oral tablets from its Mohali SEZ plant in Punjab.

Shares of Ranbaxy Laboratories were trading at Rs 426.30 per scrip in the afternoon on the BSE, up 3.15 per cent cent from its previous close.

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