Aurobindo Pharma declines 6% on USFDA warning letter for Dayton facility

The company said it would engage with the regulator and would try to resolve the issue at the earliest

Shares of Aurobindo Pharma were down 6 per cent to Rs 755 on the BSE on Thursday after the company's arm has received a warning letter from the US health regulator for its oral solid manufacturing facility situated at Dayton, New Jersey. In comparison, the S&P BSE Sensex was down 0.34 per cent at 40,567 points at 10:40 am.

"The AuroLife Pharma LLC, a wholly owned stepdown subsidiary of the Company, has received a warning letter from the US Food and Drug Administration (USFDA) for its oral solid manufacturing facility situated at Dayton, New Jersey," Aurobindo Pharma said in exchange filing. READ FILING HERE

The USFDA had inspected the facility between January 13 and February 12, 2020. At the end of the inspection, a 'Form 483' was issued with 9 observations. On June 4, 2020, with respect to the mentioned inspection, the company had received a letter from USFDA classifying the inspection as "Official Action Indicated".

Aurobindo Pharma believes that the existing business from this facility will not be impacted. The exclusive sales from this facility are around 2 per cent of the group turnover. The Company said it would engage with the regulator and are fully committed in resolving this issue at the earliest.