Two founders of drug firm are indicted

July 17, 1992|By Norris P. West | Norris P. West,Staff Writer

A federal grand jury indicted two of the founders of Par Pharmaceutical Inc. on charges of conspiracy to defraud the U.S. Food and Drug Administration and filing false statements to get generic drugs approved, the U.S. attorney's office said.

The indictments returned yesterday in U.S. District Court in Baltimore charge R. K. Patel and Ashok H. Patel, each a founder and former senior vice president of Par, with federal violations of using unapproved ingredients for drugs and falsifying government documents.

Also charged were Barry S. Geller, Par's former vice president for regulatory affairs; Satish R. Shah, former head of research and development; and Nandlal G. Rana, a manager in the quality control laboratory.

They are charged with using the unapproved ingredients for the company's hypertension medicine, Triamterene/Hydrochlorothiazide, a generic version of the drug Maxide.

The indictment alleges the Spring Valley, N.Y., company made a sample research and development batch without sodium bicarbonate, a batch that met requirements. When the product failed to pass stability testing, sodium bicarbonate allegedly was added without FDA approval.

The company already has been convicted of paying illegal gratuities to FDA inspectors and has pleaded guilty to a 10-count indictment on conspiracy and fraud charges. It has been fined $2.65 million.

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