Ranbaxy Laboratories, Ltd., owned by Japan's Daiichi Sankyo Co. Ltd., is seeking sourcing ingredients suppliers for a generic version of AstraZeneca's heartburn drug Nexium, in order to sell the generic in the U.S. In January, the FDA prohibited Ranbaxy from selling drugs in the U.S. due to poor manufacturing practices, and from distributing any raw materials in the U.S. from its Toansa facility in India, including the sale of materials to other companies that distribute products in the U.S.
Ranbaxy was the first to seek approval from the FDA for a generic version of Nexium, gaining exclusive rights for six months after the patent expiry on May 27. Ranbaxy would need to file a new ANDA and gain regulatory approval for any new raw material supply, which could delay the launch of a Nexium generic. Nexium had global sales last year of $3.9 billion, and U.S. sales of $2.1 billion.
Ranbaxy Seeks Sourcing Suppliers for Generic Nexium
By Kristin Brooks
Published March 11, 2014
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