Ranbaxy Laboratories to Get Guidance Soon for Remedial Steps on Dewas Unit
Published: Nov 12, 2012
Drug maker Ranbaxy Laboratories is expecting the consultant assessment of its Dewas manufacturing facility, which is under scanner of the US Food and Drugs Administration (US FDA) since 2008, to be over by December. The move is significant because the assessment report will provide a definite guidance to the company towards the corrective measures to meet the regulator’s requirements. In May, Ranbaxy hired two US-based consultants to advise it on remedial work to be done at its manufacturing units in India. This was part of a consent decree signed with the US FDA to revoke ban imposed on the company’s various products that were produced in India after it was found guilty of violating the US manufacturing rules. “Management is working closely with third party experts and US FDA with respect to consent decree. The consultant assessment report for the first phase is expected to by December. After that we will see what needs to be done,” Chief Executive Officer and Managing Director Arun Sawhney told analysts after announcing its earnings for the quarter ended September.