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
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 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 percent cGMP compliance at its manufacturing facilities,” said Sun Pharma
in a press release.