Regulatory issues at Halol plant over: Sun Pharma

Sun Pharmaceutical Industries on Tuesday announced that it has resolved regulatory compliance issues at its Halol plant. The Halol plant was served a warning letter by the US Food and Drug Administration (USFDA) in December 2015. No new products have been approved from the facility since September 2014, when it received adverse observations from the US regulator.

In a stock exchange notification on Tuesday, the company said it had received the Establishment Inspection Report (EIR) from the US FDA for the inspection conducted at its Halol plant during February 12-23.

“The agency concluded that the inspection was now over and the issues contained in the warning letter, issued in December 2015, have been addressed,” the company said.

Dilip Shanghvi, managing director of Sun Pharma, said, “This is an important development for Sun Pharma. We remain committed to following the highest levels of quality, and 24x7 good manufacturing practices compliance at all our facilities.” The announcement was made by the firm after market hours. The Sun Pharma stock gained 1 per cent and closed at ~540.50.

Resolution of the Halol plant is important for revival of Sun Pharma’s US business, which contributed around 35 per cent to its consolidated sales in the last fiscal year. The company has given guidance for a low double-digit growth in FY19, and is targeting growth from all markets.