Sun Pharma said the US FDA will lift the import alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from official action initiated (OAI) status. 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 company said in a BSE filing on Tuesday. Sun Pharma scrip jumped by over 5% on the BSE.
The Mohali facility was inherited by Sun Pharma as part of its acquisition of Ranbaxy in 2015. The US FDA had taken action against the facility in 2013 when it ordered it 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, the company added.