Ranbaxy slips as USFDA refuses request to allow exports from banned units

MUMBAI: Shares of Ranbaxy Laboratories are likely to give away the gains made over last three sessions after the head of the USFDA turned down its plea to allow drugmakers to continue exporting from banned manufacturing facilities.

According to reports, Ranbaxy’s Managing Director Arun Sawhney had requested USFDA Commissioner Margaret Hamburg to lift the ban on its manufacturing facilities as the company was taking remedial measures to rectify the issues flagged.

In her polite but detailed response, Hamburg said USFDA cannot change the laid-down rules to make such concessions and while companies were engaged in talks for one-off lapses, persistent mistakes were taken very seriously.

The USFDA prohibited Ranbaxy Laboratories from manufacturing and distributing active pharmaceutical ingredients ( APIs) from its Toansa plant for FDA-regulated drug products.

The import alert on Toansa plant is in addition to the alerts already in place on its Dewas, Paonta Sahib, and Mohali facilities. Toansa is the key active pharmaceutical ingredients or API facility and an alert is likely to put further pressure on business atleast in short term, say analysts.

“Toansa facility accounted for only 10-12 per cent of API requirement for the US and 15 per cent globally. Ranbaxy is adopting significant measures to address regulatory challenges. We have nonetheless reduced US sales by 15 per cent for next fiscal and cut API sales by 40 per cent,” comment HSBC on the Toansa plant in its results update report.

At 09:45 a.m.; the stock was at Rs 348.05, down 1.04 per cent, on the NSE. It touched a high of Rs 351.35 and a low of Rs 345.10 in trade today.