MUMBAI, June 12 (Reuters) - India’s largest drugmaker Sun Pharmaceutical Industries Ltd said on Tuesday the U.S. Food and Drug Administration (FDA) cleared its Halol drug plant, which had been under supply restrictions due to quality control failures.
Sun will now be able to restart supplies to its largest market, the United States, from the Halol facility in western India which contributed around 15 percent to the company’s U.S. revenue in 2015.
The FDA issued the company with a warning letter that year following an inspection that revealed manufacturing quality failures at Halol.
The company has been working on fixing problems the agency identified. The FDA inspected the plant again in February.
“The agency concluded that the inspection is now closed and the issues contained in the Warning Letter issued in December 2015 have been addressed,” Sun said in a statement.
Reporting by Zeba Siddiqui in Mumbai; editing by Jason Neely