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USFDA bans more products from Ranbaxy
The US Food and Drug Administration said on Thursday it has banned more products from Indian drugmaker Ranbaxy Laboratories Limited 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 per cent in Tokyo on Friday and were down 3.9 per cent at 1,827 yen in late morning trade.
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USFDA bans more products from Ranbaxy
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.
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USFDA bans more products from Ranbaxy
The ban is the latest in a series of measures taken by the FDA to keep substandard products made by Ranbaxy out of the US 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.
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USFDA bans more products from Ranbaxy
USFDA ban disappointing, says Ranbaxy
Terming the USFDA ban on its Toansa plant 'disappointing', Ranbaxy Laboaratories on Friday said it will take 'appropriate management action' for the lapses at the manufacturing facility after the conclusion of an internal investigation, said a PTI report.
The company is disappointed with the recent US Food and Drug Administration action and would like to apologise to all its stakeholders for the inconvenience caused by the
suspension of shipment, Ranbaxy Laboratories said in a statement.
"This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation," Ranbaxy CEO and Managing Director Arun Sawhney said.
USFDA has notified the company that it is prohibited from manufacturing and distributing active pharmaceutical ingredients from its facility in Toansa, India, for FDA-regulated drug products, it said.
The US health regulator had earlier this month issued the Form 483 to the company for its Toansa plant in Punjab for violations of the current good manufacturing practice.
"Subsequent to the Form 483 issued in early January 2014, Ranbaxy voluntarily and proactively suspended shipments of API from this facility to the US market when it received the inspection findings," the company said.
Ranbaxy’s other key facilities at Ponta Sahib (Himachal Pradesh) and Dewas (Madhya Pradesh) are already under an US import alert since 2008.
Last year, its other key facility at Mohali also came under USFDA import alert.
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