FDA lifts block on Sun Pharma facility
Sun Pharma has announced that the FDA informed it that the Import Alert in place upon its Mohali manufacturing facility was lifted alongside the Official Action Initiated status. The block had been in place for four years, originally in place when Ranbaxy Laboratories had held the plant.
Sun Pharma acquired the facility, alongside Ranbaxy Laboratories, after the two completed their $4 billion merger in a deal announced at the end of 2014. The factory was originally placed on hold in 2013 after a 2012 FDA inspection revealed: “significant CGMP violations at Ranbaxy’s Mohali facility, including failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality.”
The news saw Sun Pharma’s shares rise by 6%. Sun Pharma announced in a statement that: “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 US market is a key region for Sun Pharma, with it being the largest market that Sun Pharma sells its products into. The news is particularly welcome for Sun Pharma, given that at the end of last year its Halol plant had received a 14-page critical report – this is amongst other issues at other plants.