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Department of Justice files consent decree of permanent injunction against Ranbaxy
Date:1/25/2012

SILVER SPRING, Md., Jan. 25, 2012 /PRNewswire-USNewswire/ -- The Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a consent decree of permanent injunction against generic drug manufacturer Ranbaxy in the U.S. District Court of Maryland. The consent decree was filed against Ranbaxy Laboratories, Ltd., an Indian corporation; its subsidiary Ranbaxy Inc., headquartered in Princeton, N.J. Ranbaxy Labs.' Dale Adkisson, senior vice president, head of global quality, and Arun Sawhney, chief executive officer and managing director, and Ranbaxy, Inc.'s Venkatachalam Krishnan, regional director Americas, were also named as defendants. The consent decree will address outstanding current good manufacturing practice (CGMP) and data integrity issues at Ranbaxy's Paonta Sahib, Batamandi and Dewas, India facilities as well as CGMP issues at Ranbaxy Inc.'s wholly owned subsidiary Ohm Laboratories facility located in Gloversville, N.Y.  

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Ranbaxy's Paonta Sahib, Batamandi, and Dewas, India facilities have been on FDA import alert since 2008 and Ranbaxy has closed its Gloversville facility. The public should not be concerned that any drugs from those facilities are currently in the U.S. market. FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Individuals who are concerned about their medications should talk with their health care professional.

The consent decree requires that Ranbaxy comply with detailed data integrity provisions before FDA will resume reviewing drug applications containing data or other information from the Paonta Sahib, Batamandi, and Dewas facilities.  Specifically, Ranbaxy must:

(1) hire a third party expert to conduct a thorough internal review at the facilities and audit applications containing data from t
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SOURCE U.S. Food and Drug Administration
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