Ranbaxy Allocates $500 Million to Resolve Compliance Dispute

Japanese drug maker, Daiichi Sankyo, announced that its Indian unit, pharmaceutical giant, Ranbaxy Laboratories, Ltd., had reached an agreement with the U.S. Food and Drug Administration regarding its manufacturing practices. The company’s settlement with the FDA outlines its intent to improve procedures and policies in its production facilities in order to ensure data integrity and comply with good manufacturing practices.

After the FDA banned more than 30 of Ranbaxy’s generic drug products in 2008 due to poor quality conditions at several of their manufacturing facilities, the company now appears to be going the extra mile to strengthen its relationship with the FDA, as well as to bolster compliance with federal regulations.

Additionally, in 2009, federal regulators accused Ranbaxy of falsifying test results and drug data. Given these claims, Ranbaxy announced that it will set aside a provision of $500 million in order to resolve any criminal and civil action stemming from the related investigation by the U.S. Department of Justice.

Ranbaxy recently began selling a generic version of Pfizer’s drug, Caduet, a treatment for high cholesterol and high blood pressure.

(Source: Reuters.com)

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