Generic maker Ranbaxy announces consent decree with FDA, reserve of $500 million to settle manufacturing charges

by Ben Vernia | December 29th, 2011

On December 21, the Indian generic drug manufacturer Ranbaxy Laboratories, Ltd., announced that it had entered into a consent decree with the Food and Drug Administration, and taken an accounting reserve of $500 million in anticipation of a settlement with the Department of Justice. According to the company’s announcement:

Ranbaxy Laboratories Ltd. (RLL, NSE: RANBAXY, BSE: 500359) (“Ranbaxy”) today announced that it has signed a consent decree with the U.S. Food and Drug Administration (“FDA”). Ranbaxy has committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. The consent decree is subject to approval by the United States District Court for the District of Maryland.

Separately, Ranbaxy also announced that it intends to make a provision of $500 million in connection with the investigation by the U.S. Department of Justice, which the company believes will be sufficient to resolve all potential civil and criminal liability.

Neither the FDA nor DOJ have made an announcement in connection with the case. The company’s announcement came nearly three weeks after the FDA approved its application to sell a generic atorvastatin, the equivalent of Pfizer’s Lipitor anticholesterol drug.

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