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news.Indian based Ranbaxy Laboratories has agreed to pay approximately $500m as civil and criminal fines under the settlement agreement with the US Department of Justice (DOJ).
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The company and its affiliates agreed to settle the alleged civil violations of the False Claims Act with the US.
Ranbaxy USA has agreed to plead guilty to three felony counts related to drug manufacturing at two Indian locations that did not meet safety standards and to four counts of making material false statements.
Ranbaxy CEO and managing director Arun Sawhney said the company will continue bringing safe, effective and quality medicines to market for the benefit of consumers in the US and other parts of the world.
"While we are disappointed by the conduct of the past that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxy’s stakeholders; the conclusion of the DOJ investigation does not materially impact our current financial situation or performance
"Ranbaxy has successfully launched several generic products recently and is well-positioned for future growth in the U.S. and around the world with a robust pipeline of important products as it continues to build a strong global portfolio of branded and generic prescription and OTC pharmaceuticals," Sawhney added.
According to the DOJ, this is the largest-ever drug safety settlement with a generic drugmaker.
Earlier, a consent decree was signed by the company with the FDA to strengthen procedures and policies ensuring data integrity and to comply with current good manufacturing practice.