Ranbaxy Laboratories has refuted rumours that the company would be forced to cede control over its highly lucrative six month exclusivity period for a generic version of Pfizer’s Lipitor.
Stories had circulated that, owing to a US Food and Drug Administration (FDA) investigation into quality standards at the company’s manufacturing facilities, Ranbaxy would be unable to launch the drug on 30 November 2011 as scheduled.
Speaking to Japan’s Nikkei newspaper, Ranbaxy chairman Tsutomo Une confirmed that the company was still on track to meet the launch date.
In 2009, The FDA ordered Ranbaxy to conduct a thorough review of its manufacturing facilities, resulting in an import ban placed upon two Indian plants and the closure of a one in the US.