The US FDA concluded that the issues contained in the warning letter issued in December 2015 have been addressed, Sun Pharma said in a regulatory filing to the BSE.
Sun Pharma managing director Dilip Shanghvi described the approval as an "important development" for the company. "We remain committed to following the highest levels of quality and 24x7 cGMP compliance at all our manufacturing facilities globally," said Mr Shanghvi.
This is a positive development for Sun Pharma, said Angel Broking, which maintains a 'buy' call on the pharma company. "Sun Pharma will now be able to restart supplies to its largest market, the US, from the Halol facility, which contributed around 15 per cent to the company's US revenue in 2015 (i.e FY2016)," the brokerage said.
"Halol getting resolved takes out a big overhang from the stock. It had been stuck for last 3-4 years which also hit important product approvals like Makena, lupron Depot as well as Sparc products. More importantly, the intermittent supplies due to ongoing remediation actions undertaken impacted market share gains which should now resume," said Praful Bohra, research analyst at Equirus Securities.
At 10:07 am, Sun Pharma shares were trading 2.9 per cent higher at Rs 556.25 apiece on the BSE, whose benchmark index Sensex was up 73 points, or 0.2 per cent, at 35,765 level.
In September 2015, the FDA had first notified the company of its concerns after an inspection.
In December 2015, the US regulator had issued a warning letter to Sun Pharma indicating dissatisfaction with the remedial measures the company had implemented.