Under watchful parent Daiichi Sankyo, generics-maker Ranbaxy continues its reform and its attempts to make nice with the FDA. The Indian drugmaker, with help from consultants, has submitted an internal report to the agency to get back on track in the U.S.
The Japanese parent deserves the credit, in large part for its housecleaning efforts, says the Economic Times of India. The late August departure of Atul Sobti--the second CEO to quit since Daiichi took over--follows a difference of opinion on strategy, reports Reuters. Daiichi has also indicated it may be willing to pay a fee to help get the drugmaker-regulator relationship back on track, as reported.
The FDA in 2008 blocked from the U.S. market 30 drugs made by Ranbaxy at facilities in India following high-violation-count inspections and warning letters, as we've reported. The regulator expressed its concern over manufacturing practices and data integrity; it directed Ranbaxy to reassess its U.S. supply operations and vowed to keep watch until it was satisfied.
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