Daiichi Sankyo intends meeting US FDA to sort out Ranbaxy plant’s regulatory problems

Daiichi SankyoTakashi Shoda, the President and CEO of the Japanese pharmaceutical company Daiichi Sankyo - which bought a majority stake in Ranbaxy Laboratories last year - said that the company soon intends meeting officials of US Food and Drugs Administration to sort out regulatory problems at the Ranbaxy plant at Poanta Sahib in India.

Nearly 30 drugs manufactured at the plant in question, as well as Ranbaxy's Dewas plant, have been banned from sale in the US, following an investigation by the FDA, which revealed Ranbaxy's fallacious test results on its drugs. Along with banning the contentious drugs, the US agency also refrained from approving the pending and new marketing applications from both the plants.

At a research and development meeting in Tokyo, Shoda briefed reporters and analysts, saying: "We have set a meeting with the FDA for early April to clear the concerns the FDA has stated. Daiichi Sankyo aims to provide leadership and resolve the issue early."

Daiichi Sankyo had struck a deal with Ranbaxy in November last year, with the aim of diversifying its business operations into the generic drug and up-and-coming markets, due to escalating competition and slimming growth opportunities in the brand drug market.

Meanwhile, in a Tuesday-announced development on the Daiichi Sankyo-Ranbaxy front, Ranbaxy will promote the Japanese company's anti-hypertensive drug, Olvance, in India.

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