The US Food & Drug Administration (FDA) will lift the import alert imposed on Sun Pharma’s 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 Ltd in 2015. The US FDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to