Daiichi, Ranbaxy form team to face FDA charges

27 February 2009

Daiichi Sankyo, the new owner of India's largest drugmaker Ranbaxy Laboratories, said it has 'formed a team' to solve the issues raised after the US Food and Drug Administration accused Ranbaxy of falsifying data and test results of over two dozen drugs made in its Poanta Sahib plant in Himachal Pradesh, and said it would halt approval of pending and new drugs from the plant.

The FDA has stopped granting approval to the sale of medicines produced in the facility since September 2008 pending investigation. The agency suspended the evaluations after findings at the facility raised ''significant questions about the reliability'' of data used to support requests to sell drugs in the US, the regulator said.

A Daiichi Sankyo statement said the company takes the issue very seriously. ''Both Daiichi and Ranbaxy have already formed a team to solve the issue,'' it said.

Referring to the Abbreviated New Drug Applications (ANDAs) applied for by the factory, the Japanese company said that FDA letter gives the opportunity to Ranbaxy to cooperate with the agency to address the issues or withdraw the application.

''After carefully analysing the letter and information, Ranbaxy will be responding to the FDA,'' Daiichi added.

Ranbaxy has been facing an FDA probe since 2006, allegedly for non-compliance with US regulatory standards. The latest ban on one of Ranbaxy's plants means it cannot sell drugs made there plant in the US, its single largest market accounting for about a quarter of its annual sales of $1.7 billion.

In September last year, the US FDA banned 30 of Ranbaxy's drugs made in its Poanta Sahib and Dewas plants and stopped fresh marketing approvals of drugs made in both the facilities.