Ranbaxy slumps 16 pct as FDA says data falsified
NEW DELHI |
NEW DELHI Feb 26 (Reuters) - Shares in India's Ranbaxy Laboratories (RANB.BO) slumped 16 percent on Thursday after U.S. regulators said a plant owned by the drugmaker had falsified data.
The U.S. Food and Drug Administration said it halted reviews of drug applications from Ranbaxy's Paonta Sahib plant in India after test results submitted in approved and pending drug applications were found to have been falsified. [ID:nN25490477]
The action applies to about 25 approved drug applications that contain data from the plant, an official of the agency said.
"It indicates that more drugs produced from Paonta Sahib will be put under review. It might have an incremental (negative) impact on Ranbaxy," said Sarabjit Kour, a Mumbai-based analyst with Angel Broking.
By 0639 GMT, Ranbaxy shares were down 15.8 percent at 174.50 rupees, after falling as much as 16.1 percent, in a Mumbai market that dropped 0.9 percent.
Last September, the FDA had banned more than 30 generic drugs from entering the United States that were made at Ranbaxy plants in Paonta Sahib and Dewas, India. These included cholesterol-lowering drugs, AIDS medications and antibiotics.
Paonta Sahib and Dewas together account for 30-40 percent of Ranbaxy's U.S. sales, Kour estimated. The drugmaker gets about a quarter of its sales from the United States.
FDA officials said they had not identified any health risks from Ranbaxy drugs on the market, but were continuing to investigate products associated with the plant.
Ranbaxy, which is nearly two-thirds owned by Japan's Daiichi Sankyo (4568.T), said it would cooperate with the FDA and that some of the applications are "first-to-file" applications, which can win 180 days of market exclusivity if approved.
"No effort or action will be spared to timely protect key (generic drug applications) from Paonta Sahib," the company said in a statement.
The market now values Ranbaxy at about $420 million, sharply below about $5 billion that Daiichi paid for its 64 percent stake last year. (Reporting by Devidutta Tripathy; Editing by Ranjit Gangadharan)
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