Daiichi Sankyo's message to the world: Don't worry, we have Ranbaxy Laboratories under control. Daiichi, which owns controlling interest in the Indian drugmaker, says it's making progress on lifting that U.S. ban on some Ranbaxy-made drugs.
A Daiichi spokesman tells Reuters that Ranbaxy has now submitted a required report to the FDA. The internal report, which Ranbaxy officials put together with input from outside experts, had been requested by the agency as a prerequisite for getting the Ranbaxy factories back online for production for the U.S. market.
The forward movement has been a long time coming; drugs made at Ranbaxy's Indian facilities have been shut out of the U.S. market since November 2008. The FDA troubles continued in late 2009, when the agency, dissatisfied with the company's attempts to fix its manufacturing woes, demanded that Ranbaxy reassess all its operations that supply the U.S.
The potential end to Ranbaxy's woes also comes just after Atul Sobti became the second CEO of the company to quit since Daiichi took control, Reuters notes. He resigned after just over a year, citing a difference of opinion on strategy with Daiichi. His predecessor, Malvinder Singh, stepped down before the end of his contract.
- read the Reuters story