US regulator okays Ranbaxy's R&D centres

Ranbaxy will eventually get delisted from bourses by end of year, when merger of Sun Pharma and Ranbaxy is expected to be complete

A few research units of Ranbaxy Laboratories in India and Romania, inspected by the US Food and Drug Administration last month, have got the agency’s approval, a Ranbaxy official said.

These include some units of the company’s research and development (R&D) centre at Gurgaon and its clinical research centre at Terapia in Romania.

A Ranbaxy spokesperson declined to comment.

The development comes in the wake of the proposed transaction earlier this week between Sun Pharma and Japan’s Daiichi Sankyo, the parent of Ranbaxy since 2008.

Under the agreement, Sun will buy Ranbaxy in a deal worth $4 billion.

The Gurgaon-headquartered company has been facing enforcements from the US agency since 2006.

Following deviations in the manufacturing norms, four of its factories in India are barred from supplying to the US.

Despite a consent decree and remediation measures, Ranbaxy has so far failed to restore supplies from these factories to the US.

The latest development involving approvals for R&D units might help Sun gain resources. However, these units are not meant for making medicines, the official said.

Ranbaxy will eventually get de-listed from the bourses by the end of the year, when the merger of Sun Pharma and Ranbaxy is expected to be complete.