Ranbaxy Laboratories and the U.S. Food and Drug Administration (USFDA) are reportedly negotiating a settlement to lift a ban on sale of 30 generic drugs produced at the company's two plants in India, which could involve payments and fines exceeding $1 billion.
In a report, the Fortune magazine, quoting unnamed sources, said the USFDA and the Gurgaon-based company were negotiating to settle the issue that had been dragging on since 2008.
“... Federal prosecutors have been negotiating a criminal and civil settlement with the company (Ranbaxy) that could lead to fines and payments exceeding $1 billion,” the Fortune report said, stating it “has learned from sources with knowledge of the negotiations.''
When contacted, a Ranbaxy spokesperson said: “We have been fully cooperating with the USFDA in seeking a resolution.” Comments from the USFDA could not be obtained immediately.
In 2008, the USFDA had banned the drugs, citing gross violation of approved manufacturing norms.
