The FDA has taken further action against Ranbaxy Laboratories Ltd. of India, following inspections between January 5 and 11, prohibiting it from manufacturing or selling drug ingredients from its Toansa, India plant for the U.S. market. Ranbaxy, a subsidiary of Japan's Daiichi Sankyo Co., is a major supplier of raw materials for the generic drug market, including the U.S., and has been cited for a series of FDA violations in the past couple of years.
The FDA has blocked the company from distributing any raw materials in the U.S. from the Toansa facility, including the sale of materials to other companies that distribute products in the U.S. According to the FDA, Ranbaxy retested raw materials after failing earlier tests “in an effort to produce acceptable findings," and that the company didn't investigate the failures.
In January 2012, Ranbaxy reached a consent decree with the U.S. Department of Justice regarding manufacturing quality issues. The decree required the company to take steps to ensure the integrity of production at three plants in Paonta Sahib, Batamandi and Dewas, India, as well as at the company's unit in Gloversville, NY. Also, in September, the FDA blocked imports from Ranbaxy's newest plant, at Mohali in northern India.
Ranbaxy has five manufacturing facilities in India that are registered with the FDA: Paonta Sahib, Mohali, Toansa, Gurgaon and Dewas, all of which are now covered under the consent decree. The Toansa site would have supplied ingredients for Ranbaxy’s generic of Novartis’ Diovan, which will now need to be outsourced.
FDA Takes Action Against Fourth Ranbaxy Site
By Kristin Brooks
Published January 24, 2014
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