New Delhi: Ranbaxy Laboratories Ltd has appointed a third party consultant to assess and review issues raised by the US Food and Drug Administration (FDA). The consultant will play an integral role in taking an independent view of FDA’s concerns with Ranbaxy and submitting a report to FDA. This comes after the regulator invoked its application integrity policy (AIP) on the company’s Paonta Sahib plant in February.
In September, FDA had imposed an import alert on two of its plants—Dewas (Madhya Pradesh) and Paonta Sahib (Himachal Pradesh).
“The appointment of the consultant is part of the corrective action plan required by the FDA for the AIP on Paonta Sahib,” said a Ranbaxy official.
“The consultant would be conducting a review over the next several months. Ranbaxy believes that issues at Dewas (import alert) could be easier to resolve than Paonta (import alert and AIP),” wrote Prashant Nair, analyst with Citi Investment Research in a note on 25 June.