Daiichi Sankyo Pledges “Bold Action” on Ranbaxy Ban
Japan's Daiichi Sankyo said it would send personnel to help resolve problems at a production facility of its drugmaking subsidiary Ranbaxy at Toansa in India's northern state of Punjab. The U.S. Food and Drug Administration has banned exports from the plants due to manufacturing violations. It is the fourth Ranbaxy plant to be shut out of the U.S. market.
Manabu Sakai, senior executive officer at Daiichi Sankyo, told an earnings briefing that the company wants to prepare "a more aggressive, more drastic response" to the ban.
Following an inspection completed on Jan. 11, the FDA said in late January that Ranbaxy is prohibited from making and selling pharmaceutical ingredients from Toansa "to prevent substandard quality products from reaching U.S. consumers."
The U.S. regulator had previously barred products from the company's facilities in Paonta Sahib, Dewas and Mohali in India as part of a 2012 consent decree designed to ensure compliance with good manufacturing practices.
At the Toansa facility the FDA said it found that Ranbaxy had re-tested raw materials and other ingredients after the items failed analytical testing in order to produce acceptable findings, but the company did not report or investigate the failures.