Sun Pharma says USFDA issues at Halol over, two specialty drugs may get nod

While the plant was served warning letter by US regulator in December 2015, product approvals were frozen in September 2014

Sun Pharmaceutical Industries today announced the resolution of regulatory compliance issues at Halol plant.

Halol plant was served a warning letter by US Food and Drug Administration in
December 2015. No new products manufactured at the facility have been approved since September 2014 when it received adverse observations from the US regulator.
 

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

"The agency concluded that the inspection is now closed and the issues contained in the warning letter issued in December 2015 have been addressed," the company said.
 

In a statement Dilip Shanghvi, managing director, 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 manufacturing facilities globally."

The announcement was made by the company after market hours. Sun Pharma stock gained one per cent and closed at Rs 540.50. 

The resolution of Halol plant is important for revival of Sun Pharma's US business which contributed around 35 per cent of its consolidated sales in last fiscal. The company has guided for low double digit growth in FY 19 and is targeting growth from all markets.

The resolution of issues could lead to approvals for two specialty products - eye drug Xelpros and anti epileptic drug Elepsia. Both products have been filed from Halol plant and have been denied approval so far because of regulatory issues.