Ranbaxy settles with USFDA, may pay $500 mn

Ranbaxy settles with USFDA, may pay $500 mn
New Delhi: Drug-maker Ranbaxy Laboratories on Wednesday said it has signed an agreement with the US health regulator to lift a ban on the import of drugs from certain manufacturing plants in India and will pay up to USD 500 million to settle a case lodged by the Department of Justice.
     
"Ranbaxy Laboratories today announced that it has signed a consent decree with the US Food and Drug Administration (USFDA). Ranbaxy has committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices," the company said in a statement.
     
"Separately, Ranbaxy also announced that it intends to make a provision of USD 500 million (approximately Rs 2,638.74 crore) in connection with the investigation by the US Department of Justice, which the company believes will be sufficient to resolve all potential civil and criminal liability," it added.
     
In 2008, the USFDA had banned 30 generic drugs produced by Ranbaxy at its Dewas (Madhya Pradesh) and Paonta Sahib and Batamandi unit in Himachal Pradesh, citing gross violation of approved manufacturing norms.
     
In the same year, the US Department of Justice had moved a motion against the company in a local court alleging forgery of documents and fraudulent practice.
     
Commenting on the development, Ranbaxy CEO and Managing Director Arun Sawhney said: "While we were disappointed by the conduct that led to the FDA's investigation, we are proud of the systematic corrective steps we have taken to upgrade and enhance the quality of our business and manufacturing processes."
     
The settlement with the USFDA follows the recent launch of a generic version of Lipitor, a cholesterol-lowering drug, by the Gurgaon-based company in the American market.
     
Shares of Ranbaxy were trading at Rs 389.20 apiece on the BSE in morning trade, down 1.56 percent from their previous close.

PTI