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Statement By Dinesh Thakur Regarding US Government's Case Against Ranbaxy
Date:5/13/2013

falsified records and dangerous manufacturing practices that threatened to compromise the quality and safety of Ranbaxy drugs. Along the way, the government barred the importation of Ranbaxy drugs, held the company accountable for its data fraud under FDA's Application Integrity Policy, and required it to implement corrective measures to prevent the problems from recurring.

"As a senior pharmaceutical executive, I understand the importance of regulatory oversight in ensuring drug quality and safety. There are unique challenges in a global drug market, which is highly dependent on international manufacturing and distribution. In fact, approximately 78 percent of prescription drugs dispensed in the United States are generic, and a growing percentage of drugs – both generic and name brand – is manufactured overseas. This case highlights the need for effective regulation that applies to drugs sold in the United States, regardless where they are manufactured.

I would like to thank FDA's Office of Criminal Investigation, United States Attorney's Office for the District of Maryland, Department of Justice, USAID, and Andrew M. Beato , Bob Muse , and Rory Kelly of Stein Mitchell Muse & Cipollone LLP. I hope that our actions and this case have helped to improve the quality and safety of drugs in the United States and abroad."

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Please visit www.dineshthakur.com

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