Ongoing FDA issues aren't stopping Ranbaxy

Ranbaxy Laboratories counsels patience. The Indian drugmaker, which has been negotiating with FDA over manufacturing problems since last year [1], says discussions with the agency are still in process. "Issues with the USFDA will take long and cannot be resolved in a day," CEO Atul Sobti told reporters at the India Economic Summit (as quoted by the Economic Times).

Predictably, the company's shares dropped on Sobti's comment. After all, some 30 Ranbaxy drugs were banned after FDA inspectors uncovered irregularities at two India manufacturing plants. And after that, the agency stopped even considering approval applications for drugs slated to be made at its Paonta Sahib plant.

Also predictably, Ranbaxy's U.S. sales have fallen preciptiously since the ban, to $44 million in the third quarter. That's a drop of 53 percent year over year.

Thankfully, Ranbaxy has its new parent company [2], Japan's Daiichi Sankyo. Together with Daiichi, Ranbaxy has been making progress in markets outside the U.S. It's getting ready to launch Eli Lilly's osteoporosis drug Evista in Romania, under Daiichi's European license for that drug. It's planning to introduce Daiichi's blood pressure med Olvance in India. In fact, Ranbaxy is working with Daiichi on a three-year growth plan, the Wall Street Journal reports. "It'll be a comprehensive arrangement, which will cover manufacturing and even new chemical entities, Sobti told the Journal. So stay tuned.

- see the WSJ story [3]
- check out the news [4] from the Economic Times

Related Articles:
Daiichi chief 'confident' in Ranbaxy's future [5]
Ranbaxy Labs awaits FDA re-inspection [6]
Ranbaxy's "corrective" plan under FDA review [7]
Daiichi exerts control as Ranbaxy chief exits [8]