Ranbaxy sings consent decree with US FDA

Ranbaxy sings consent decree with US FDAIndian pharmaceutical major, Ranbaxy Laboratories has signed a consent decree with the US Food and Drugs Administration [FDA] in order to make it possible to sell drugs produced at its plans in India, which are facing a fan in the US.

Ranbaxy has said in a filing to the stock exchanges that it is setting aside $500 million in a provision to meet the possible expense in the case involving investigation by the US Department of Justice.

"The company intends to make a provision of $500 million 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," the filing read.

It also said that it has signed an agreement with the US FDA to improve its procedures and policies in order to meet requirements for good manufacturing practices and ensure data integrity. The agreement signed with the FDA is yet to be approved by the US District Court for the District of Maryland.

The agreement signed in the form of a consent decree is a voluntary, final and binding settlement between the company and the FDA. IT involves curtains changes and compliance by the company for being allowed to sell drugs manufactured at two of the company's plants that were banned by the US authority.

The shares of the company were trading 2.2% lower at Rs 386.70 earlier morning at the Bombay Stock Exchange.



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