You can't fault Ranbaxy Laboratories for lack of ambition. Or for lack of faith. The Indian generics company, majority owned by Japan's Daiichi Sankyo, refuses to let regulatory snafus dampen its desire to grow in the United States.
The company's tangle with the FDA is a familiar story: Back in 2008, soon after Daiichi swooped in to buy its stake, the agency barred 30 products from the country and confiscated shipments at the border. Plants in India had flopped FDA inspections, and the agency accused Ranbaxy managers of falsifying records. Ranbaxy labored for almost three years to settle its differences with FDA, and now it's operating under a consent decree with the agency.
The ongoing wrangle threatened to interfere with one of Ranbaxy's biggest drug launches ever: The exclusive rollout of an independently made Lipitor generic. Because it was first to ask FDA for approval of a Lipitor copycat, Ranbaxy had 6-month exclusivity to sell its version. If it hadn't worked out FDA approval at the last minute, it wouldn't have reaped the big benefits of that first-to-file monopoly.
And Ranbaxy CEO Arun Sawhney is well aware of the importance of first-to-file status. As he tells the Associated Press, gaining 180-day exclusivity is a linchpin of his plans for expanding in the U.S. Already, Ranbaxy is making headway, thanks in part to its Lipitor copy; the company's strong U.S. sales fueled 55% revenue hike worldwide in the first quarter, AP notes.
Two other strategies, as reported by the AP: Brand-name sales--the company just rolled out its first branded product, the malaria treatment Synriam--and new delivery methods for existing drugs. "The US, as a total business, will remain the most important to us," Sawhney told the news service.
- read the story from the AP