Life Sciences

DOJ withdraws motion against Ranbaxy

Pharma Compliance Alert, October 15, 2008

Generic drug maker Ranbaxy agreed to turn over audits to the Department of Justice (DOJ), and in response the DOJ withdrew a motion against the company. Ranbaxy initially claimed the audits, which were conducted by Parexel, were privileged.

On July 3, the Department of Justice (DOJ) filed a motion in U.S. District Court in Maryland seeking documents from Ranbaxy. In its filing, the DOJ alleged some of the products Ranbaxy manufactured were too strong, too weak, or lacked the proper shelf life. The DOJ also claims the FDA knew about the alleged problems for 18 months and did nothing to remove the products.

In September, the FDA issued two warning letters to Ranbaxy and issued import alerts covering various dosage forms and amounts for more than 30 different generic drugs. The FDA alleged Ranbaxy failed to follow good manufacturing practices in two of its facilities in India.

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