Sun Pharma says FDA to lift ban on Mohali drug plant
MUMBAI - India's largest drugmaker Sun Pharmaceutical Industries Ltd said on Tuesday that U.S. regulators plan to lift a ban on its Mohali plant in northern India, allowing the company to restart supplies from there after four years.
Sun gained the plant along with its acquisition of Ranbaxy Laboratories in 2015 and has been attempting to fix quality control problems there that the U.S. Food and Drug Administration (FDA) identified in 2013.
Sun said the FDA informed it on Monday that it plans to lift the ban. "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 company said in a statement to stock exchanges.
Sun's shares were up 6 percent at 722 rupees at 822 GMT in Mumbai on Tuesday.