Ranbaxy in settlement talks with USFDA: Reports

05 May 2011

Ranbaxy Laboratories and the US health regulator are said to be in the process of negotiating a settlement to lift a ban on the sale of the drugs produced at two of the company's plants in India. The payments could involve fines exceeding $1 billion.

According to a report in Fortune magazine report that quoted unnamed sources, the US Food and Drug Administration (USFDA) and the Gurgaon-based company would settle the long standing issue going back to 2008. 

Ranbaxy had been accused by the USFDA of falsifying data and test results in approved and pending drug applications, which it said could lead to defective products.

"... 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 report said, stating it "has learned from sources with knowledge of the negotiations".

When asked about reports of a negotiation with the regulators under way, a Ranbaxy spokesperson told The Economic Times that the company did not comment on speculation.

Ranbaxy shares retreated 6.25 per cent on the BSE to Rs 425.40 per share in afternoon trade.