US FDA to lift import alert on Mohali plant

The move will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market

Sun Pharmaceutical Industries was informed by the US FDA, that it will lift 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 illustrates Sun Pharma’s commitment to work closely with the US FDA and strive for 100 per cent cGMP compliance at its manufacturing facilities.

Keywords: Sun Pharmaceutical Industries,MohaliOfficial Action Initiated,US FDA