The U.S. Food and Drug Administration said on Thursday it has banned more products from Indian drugmaker Ranbaxy Laboratories Ltd from entering the United States due to manufacturing violations.
The FDA said Ranbaxy is prohibited from making and distributing pharmaceutical ingredients from its facility in Toansa, India, "to prevent substandard quality products from reaching U.S. consumers."
Ranbaxy is majority owned by Japan's Daiichi Sankyo Co Ltd, whose shares at one point fell as much as 5.8 percent in Tokyo on Friday and were down 3.9 percent at 1,827 yen in late morning trade.
Daiichi Sankyo said in a statement that it was "confirming the situation with Ranbaxy" and would issue a statement when it had more details.
The move follows an FDA inspection of the facility which identified significant violations of sound manufacturing practices.
Staff at the Toansa facility were found to have re-tested raw materials and other ingredients after the items failed analytical testing "in order to produce acceptable findings," and did not report or investigate the failures, the FDA said.
The ban is the latest in a series of measures taken by the FDA to keep substandard products made by Ranbaxy out of the U.S. market. The FDA previously banned products from the company's facilities in Paonta Sahib, Dewas and Mohali as part of a consent decree designed to ensure compliance with good manufacturing practices.
The FDA's latest move means Ranbaxy's products are all but entirely banned from the United States.
The FDA said Ranbaxy is prohibited from making and distributing pharmaceutical ingredients from its facility in Toansa, India, "to prevent substandard quality products from reaching U.S. consumers."
Ranbaxy is majority owned by Japan's Daiichi Sankyo Co Ltd, whose shares at one point fell as much as 5.8 percent in Tokyo on Friday and were down 3.9 percent at 1,827 yen in late morning trade.
Daiichi Sankyo said in a statement that it was "confirming the situation with Ranbaxy" and would issue a statement when it had more details.
The move follows an FDA inspection of the facility which identified significant violations of sound manufacturing practices.
Staff at the Toansa facility were found to have re-tested raw materials and other ingredients after the items failed analytical testing "in order to produce acceptable findings," and did not report or investigate the failures, the FDA said.
The ban is the latest in a series of measures taken by the FDA to keep substandard products made by Ranbaxy out of the U.S. market. The FDA previously banned products from the company's facilities in Paonta Sahib, Dewas and Mohali as part of a consent decree designed to ensure compliance with good manufacturing practices.
The FDA's latest move means Ranbaxy's products are all but entirely banned from the United States.
© Thomson Reuters 2014
