Drug maker Ranbaxy Laboratories Ltd is expecting the consultant assessment of its Dewas manufacturing facility in Madhya Pradesh, under the scanner of the US Food and Drugs Administration (US FDA) since 2008, to be over by December.
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 FDA to revoke a ban imposed on the company's various products produced in India, after it was found guilty of violating US manufacturing rules.
"The management is working closely with third-party experts and FDA with respect to consent decree. The consultant assessment report for the first phase is expected by December. After that, we will see what needs to be done," Arun Sawhney, chief executive officer and managing director, told analysts after announcing its earnings for the quarter ended September.
Ranbaxy's three key Indian facilities at Paonta Sahib and Batamandi (both in Himachal Pradesh) and Dewas have been on the US regulator's import alert since 2008.
FDA had banned 30 generic drugs produced by Ranbaxy at these three units, citing gross violation of approved manufacturing norms. The regulator had also stopped marketing approval of new products from the company's Indian facilities after it found violations.
However, after negotiating for over two years, Ranbaxy signed a consent decree with the American authorities in December last year, putting an end to the long-running
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