Ranbaxy Laboratories is denying allegations by the the U.S. Justice Department, filed earlier this month in U.S. District Court in Maryland, that it has falsified records in regard to the production and sale of generic medicines that did not meet U.S. quality standards. Ranbaxy, the largest pharmaceutial company in Indian and one of the largest in the world, has its U.S. headquarters in Plainsboro.
The recently filed motion is part of a wider probe by U.S. authorities, including the Justice Department and the Food and Drug Administration, into whether the drug maker made false claims and fabricated data to get FDA approval for its generic drugs in the U.S. market.
The probe was sparked when FDA inspectors toured one of Ranbaxy’s facilities in northern India in 2006 and found inconsistencies in the company’s manufacturing processes and maintenance of data, according to Indian press reports. Last year inspectors raided Ranbaxy’s U.S. offices in New Jersey.
Ranbaxy said in a statement that the FDA has analyzed over 200 random samples of products marketed in the U.S. and found no “systematic fraudulent conduct” concerning drugs manufactured in the company’s plant in India.
The allegations come at a particularly sensitive time for Ranbaxy. Less than a month before the Justice Department took its allegations to court Daaichi Sankyo, a Japanese pharmaceutical company, announced plans to acquire a majority stake in the company. Indian newspapers speculated on July 14 that the deal could be in jeopardy. On that day shares in both companies declined. Ranbaxy suffered a 10.5 percent drop, its biggest in seven years.
Ranbaxy Inc., 600 College Road East, Suite 2100, Princeton 08540; 609-720-9200; fax, 609-720-1155. Dipak Chattaraj, president. Home page: www.ranbaxyusa.com.
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Berkley Life Sciences, 200 Princeton South Corporate Center, Suite 250, Ewing 08628; 609-844-7800; fax, 609-844-7859. www.berkleyls.com.
Berkley Life Sciences, a member company of W.R. Berkley Corporation, is now doing business in Princeton.
The company underwrites casualty insurance products for life science companies.,
Progressive Commercial Auto, 100 Canal Pointe Boulevard, Suite 117, Box 7637, Princeton 08543; 609-750-2172; fax, 609-452-8812.
Progressive Insurance, a nationwide insurance agency, has opened Progressive Commercial Auto in Princeton.
Marilyn McMullen, 45, on July 12. She was an administrative assistant at Princeton University.
Amy Tucci, 55, on July 11. She was the co-owner and co-director of the Princeton Academy of Martial Arts.
Anne Stockton, 88, on July 8. She was the owner of Stockton Real Estate in Princeton for 30 years.
Steve Slaby, 86, on July 5. He was a member of Princeton University’s engineering faculty.