USFDA to lift import alert on Sun Pharma’s Mohali facility

Regulator will permit the supply of products from Mohali facility inherited by Sun Pharma from Ranbaxy, to the US market


Mumbai: Sun Pharma in a statement issued on March 14, 2017, mentioned that it was informed by the US FDA a day earlier, about the lifting of the ‘Import Alert’ imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the 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 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.

This development as per Sun Pharma, illustrates its commitment to work closely with the US FDA and strive for 100% cGMP compliance at its manufacturing facilities.