Daiichi Sankyo's increasing involvement in the regulatory matters of Ranbaxy, its 2008 acquisition, are kindling hope that the Indian generics maker may soon see an end to the FDA's import ban on 30 of its products. Press reports indicate that Ranbaxy may offer to pay a one-time penalty to settle with the regulator and reset their relationship.
Reports also indicate that an FDA inspection of the company's plants at Dewas and Paonta Sahib, where the troubles began, would follow before matters are resolved. The first inspection would be at the Dewas facility, "because the issue is less complicated there," Moneycontrol reports.
The ban stretches back to 2008 when GMP violations lingered at the two Indian facilities. And in early 2009, the FDA halted review of drug applications from Paonta Sahib, alleging Ranbaxy had falsified data.
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