Daiichi Sankyo believes former shareholders of Ranbaxy concealed information during FDA probe
Ranbaxy Laboratories, India’s largest pharmaceutical manufacturer, has outlined some of the actions it has taken ‘to address certain conduct of the past’ to ensure the safety of its products.
The Gurgaon-based firm pleaded guilty last week to charges relating to data integrity and manufacturing processes at its plants in India and agreed to pay US$500m in fines under a settlement with the US Department of Justice.
Chief Executive Arun Sawhney said: ‘Ranbaxy is a different company today’ and the steps the company has taken in recent years ‘ensure that Ranbaxy moves forward with integrity and professionalism in everything we do’.
He added that all Ranbaxy products currently in the global market are safe and effective, and the company had made ‘significant improvements in the way we conduct our business to ensure greater quality control’. Ranbaxy has invested more than US$300m in its manufacturing facilities.
The firm has also instituted a rigorous new code of conduct for all staff, ‘with clear accountability for compliance’.
Daiichi Sankyo, Ranbaxy’s Japanese owner headquartered in Tokyo, said it continues to support the firm in its efforts to address and correct the conduct of the past, which led to investigations by the US Department of Justice (DOJ) and the US FDA.
Daiichi Sankyo said these efforts include significant changes to Ranbaxy’s management, culture, operations and compliance.
However, the firm added that it believes ‘certain former shareholders of Ranbaxy concealed and misrepresented critical information concerning the US DOJ and FDA investigations’.
The firm added that it is ‘currently pursuing its available legal remedies and cannot comment further on the subject at this time’.