update - US FDA confirms lifting of import alert
Sun says US FDA poised to lift Mohali import alert
The Mumbai-headquartered drug manufacturer said the US Food and Drug Administration (FDA) had notified it of its intention to lift the import ban on March 13.
Sun said it “was informed by the US FDA yesterday 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.”
The firm added: “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.”
Sun acquired the Mohali plant when it bought Ranbaxy Laboratories Ltd in 2015.
The site has been banned from shipping drugs to the US since 2013 when the US FDA imposed the import alert and added it to the list of plants subject to the conditions of the consent decree it issued Ranbaxy in 2012.
Sun said the FDA decision illustrates its “commitment to work closely with the US FDA and strive for 100% cGMP compliance at its manufacturing facilities.”
The firm did not respond to a request for comment or say when the import alert will be lifted.
Update
The US FDA confirmed Sun's announcement, telling us in an email: "After FDA received certification from Sun’s expert that the Mohali site was operating in compliance with CGMP, FDA inspected the facility in November 2016. FDA thoroughly reviewed the information collected during the inspection and additional information provided by Sun Pharmaceuticals, and has determined that the Mohali facility appears to be in compliance with CGMP.
"Because the agency is satisfied that Sun Pharmaceuticals has addressed its manufacturing issues at the Mohali facility, the company is now permitted to resume manufacturing and distribution of FDA-regulated drugs at and from that facility and FDA has lifted the import alert for the Mohali facility."
