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Pharmaceutical

US Justice Department files consent decree in Ranbaxy case

January 26, 2012
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WASHINGTON — The U.S. Justice Department filed a "ground-breaking" consent decree in court for a permanent injunction mandating Indian drug-maker Ranbaxy to adhere to U.S. manufacturing standards and ensure integrity of data at its plants in the U.S. and India, reports Blooomberg.

The consent decree requires Ranbaxy to hire an outside expert to conduct a thorough internal review at the affected facilities and to audit applications containing data from those facilities, withdraw any applications found to contain false data, set up a separate office of data reliability within Ranbaxy and hire an outside auditor to audit the affected facilities in the future, the Justice Department said.

These are part of a wide range of actions to correct its violations and ensure that they do not happen again, it added.
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