Mumbai, June 12 : The United States Food and Drug Administration (USFDA) cleared Sun Pharma Industries Ltd of the issues it raised in December 2015 after inspecting its Halol facility in Gujarat, said the Indian drug maker on Tuesday.
"The agency (USFDA) concluded that the inspection is closed and the issues contained in the December 2015 warning letter have been addressed," said the city-based drug firm in a regulatory filing on the BSE.
The US regulator inspected the Halol plant on February 12-23 and sent its Establishment Inspection Report (EIR) to the leading company.
"This is an important development for us, as we remain committed to following the highest level of quality and 24x7 cGMP compliance at all our manufacturing facilities globally," said Sun Pharma Managing Director Dilip Shanghvi in the filing.
As the world's fifth largest generic drug maker, Sun Pharma has a global presence with 41 production units, research and development centres and multi-cultural workforce across six continents.
The company's blue-chip scrip of Re 1 face value gained Rs 5.50 to close at Rs 540.50 per share on the BSE at the end of Tuesday's trading as against the Monday's closing price of Rs 535 and opening rate of Rs 535.90.