Ranbaxy to restart production of generic version of cholesterol-lowering drug Lipitor
25 Feb 2013
Ranbaxy Laboratories, the Indian unit of Japan's Daiichi Sankyo, will restart production of its generic version of cholesterol-lowering drug Lipitor for supply to the US market, three months after it recalled the drug from the US.
In November last year, Ranbaxy's US subsidiary, Ranbaxy Pharmaceuticals Inc, recalled 41 lots of its generic version of Lipitor from the US market after finding small glass particles in some lots of Atorvastatin, the generic name for Pfizer's blockbuster drug Lipitor. (See: Ranbaxy recalls generic Lipitor in US market over glass particles in bottles)
The recall was select lot numbers of Atorvastatin of 10mg, 20mg, and 40mg dosage strengths, packaged in 90's and 500 count bottles. The recall did not affect the 80mg strength dosage.
The recall was only for the US market and not other markets across the world.
In a filing with the stock exchanges, the Haryana-based company said, "We are working with the US FDA, and have identified and implemented multiple corrective and preventative actions (CAPA).
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."
