Ranbaxy Rejects Allegations

NJBIZ, Jul 21, 2008

Indian generic drug maker Ran- baxy Laboratories Ltd., which has its U.S. offices in Plainsboro, said last week it has agreed to produce specific documents sought by the U.S. Department of Justice in an investigation into alleged falsification of data relating to generic drugs. On July 3, the Justice Department filed a motion in the U.S. District Court of Maryland seeking the court's intervention in obtaining the records, according to court papers.

The Justice Department said in its filing that "allegations from reliable sources and supporting documents indicate a pattern of systemic fraudulent conduct, including submissions by Ranbaxy to the U.S. Food and Drug Administration that contain false and fabricated information" about the efficacy of unspecified generic drugs manufactured by the company.

Ranbaxy described the allegations as "baseless" in its statement last week. The FDA has been investigating the company for about three years and no charges have been filed against the company, according to Ranbaxy.

Ranbaxy further said it plans to respond last week to the Justice Department's motion at the Maryland court. Laura Sweeney, a Justice Department spokeswoman, declined comment.

The investigation would have no bearing on Japanese drug maker Daiichi Sankyo's plans, announced last month, to buy the majority stake in Ranbaxy for between $3.4 billion and $4.6 billion, Ranbaxy said. - Shankar P.