Daiichi says to help Ranbaxy overcome US FDA woes

Published on Tue, Nov 10, 2009 at 07:56 |  Source : NewsWire18

Updated at Tue, Nov 10, 2009 at 11:37  

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Daiichi says to help Ranbaxy overcome US FDA woes

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Reported by Rajesh Kumar Singh and Sourav Sen, edited by Ranjana Chauhan/NewsWire18

Japan's Daiichi Sankyo, which controls Ranbaxy Laboratories , said it will help the Indian drug maker overcome its problems with the US Food and Drug Administration. "We will work together, and help Ranbaxy overcome its issues," Daiichi Senior Executive Officer and member of the board Tsutomu Une said on the sidelines of India Economic Summit organised by the World Economic Forum. Earlier, Ranbaxy Chief Executive Officer Atul Sobti said the company is cooperating with FDA to get regulatory clearance for the two plants.

US FDA has questioned the company's plants in Dewas and Paonta Sahib on alleged lack of good manufacturing practices and has barred import of drugs made at these plants. Ranbaxy hopes to launch GlaxoSmithKline 's anti-viral drug with a six-month exclusivity if its Dewas plant is re-certified by the US drug regulator. Une said Daiichi Sankyo and Ranbaxy will soon come out with a three-year synergy programme, which will detail mutual cooperation in drug innovation, marketing and manufacturing. "We will help each other take our products in countries where we are not present." The launch of Ranbaxy products in Japan is due any time soon, he said. Japan is the only major drug market where Ranbaxy does not have a strong presence. Whether some Ranbaxy products can be manufactured at Daiichi's plants to help their launch in the US, he said, "There are many options". Daiichi Sankyo had bought controlling stake in Ranbaxy last year, underpinning the growing trend of innovators harnessing the generics potential. The deal led industry experts to speculate that more companies from Big Pharma could be eyeing potential targets, such as Dr Reddy's Laboratories and Piramal Healthcare , among others.
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