The USFDA 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.
The US health regulator has proposed to lift the import alert on Sun Pharma’s Mohali (Punjab) based manufacturing plant. The drug major has been informed by the US Food and Drug Administration (USFDA) that it will lift the import alert imposed on the Mohali plant and remove the facility from the Official Action Initiated (OAI) status, Sun Pharmaceutical Industries said in a regulatory filing.
“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 USFDA regulatory requirements,” it added. The Mumbai-based drug major had inherited the Mohali facility as part of its acquisition of Ranbaxy Laboratories Ltd in 2015.
The USFDA 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, Sun Pharma said.
“This development illustrates Sun Pharma’s commitment to work closely with the USFDA and strive for 100 per cent current good manufacturing practices (cGMP) compliance at its manufacturing facilities. The stock of Sun Pharma was trading up 3.80 per cent at Rs 709.50 on BSE.