US FDA classifies Sun Pharma’s Halol facility as official action indicated

Drug major Sun Pharmaceutical on Sunday said the US health regulator has classified its Halol facility in Gujarat as Official Action Indicated (OAI).The United States Food and Drug Administration (USFDA) had inspected the facility from December 03-13, 2019 and had issued eight observations, the company had earlier said in a regulatory filing in December.

“The company has received a communication from the USFDA indicating that the Halol facility has been classified as OAI,” Sun Pharma said in a BSE filing.

The OAI classification implies inter-alia that the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved, it added.

Sun Pharma continues to manufacture and distribute existing products for the US market, thereby not likely to have any adverse impact on current business from the facility, the drug major said.

“Sun Pharma continues to cooperate with the US FDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company’s remedial action,” it added.

The company remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally, Sun Pharma said.