US FDA lifts import ban on Sun Pharma's Mohali facility

Indian drug major Sun Pharmaceutical Industries (BSE: 524715) said yesterday that the US Food and Drug Administration will lift the Import Alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status.

The news sent the firm’s share up as much as 7% to 729 rupees in intra-day trading, though they were up just 3% at 708 rupees by close.

This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal US FDA regulatory requirements. The Mohali facility was inherited by Sun Pharma as part of its acquisition of Ranbaxy Laboratories in 2015. The US FDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy’s Consent Decree of Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to the Mohali facility.