Ranbaxy restarts generic Lipitor production for US market

Pharma major Ranbaxy Laboratories today 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% cent from its previous close.

Post new comment

E-mail ID will not be published
CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.

EDITORIAL OF THE DAY

  • Sebi must not be lax in weeding out mutual fund houses

    Last May, capital market regulator Securities and Exchange Board of India (Sebi) amended the Sebi (mutual funds) regulations, 1996, directing all fund

FC NEWSLETTER

Stay informed on our latest news!

INTERVIEWS

GV Nageswara Rao

MD & CEO, IDBI Federal Life

Timothy Moe

Goldman Sachs

Chander Mohan Sethi

CMD, Reckitt Benckiser India

COLUMNIST

Arun Nigavekar

New model for effective education

After interacting with students and teaching community on a ...

Rajgopal Nidamboor

Let the spirit of sport pervade everyday life

Sport, like meditation, is nothing short of a spiritual act. ...

Shona Adhikari

Pop art is truly a feast for the eyes

The internationally reknowned Bruno Art Group’s presence in India had ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture