Aurobindo Pharma Shares Fall After FDA Warning Letter to Telangana Facility
NEW DELHI — Shares of Aurobindo Pharma fell more than 2 percent Friday after the U.S. Food and Drug Administration issued a warning letter to a Telangana manufacturing facility operated by subsidiary Eugia Pharma Specialities Ltd.
The warning concerns Eugia’s Unit-I formulation facility, which was inspected by the FDA from Feb. 16 through Feb. 27, according to a regulatory filing by Aurobindo Pharma.
The company said the inspection resulted in regulatory observations and the facility was subsequently classified as Official Action Indicated, or OAI, meaning the FDA believes the findings may warrant regulatory action.
“Subsequent to OAI, the unit has received a warning letter,” Aurobindo Pharma said.
The drugmaker said the warning is not expected to disrupt products currently supplied to the U.S. market.
“There is no impact on the existing supplies to the U.S. markets,” the company said.
Aurobindo added that the affected facility accounts for about 2 percent of the group’s total revenue, limiting its overall financial exposure to the site.
The company said it plans to continue working with the FDA while strengthening its compliance systems and addressing the regulator’s concerns.
FDA warning letters are generally issued when the agency identifies significant regulatory violations and expects a manufacturer to take corrective action.
The Telangana facility had already drawn regulatory scrutiny earlier this year. In March, Aurobindo said the inspection resulted in a Form 483 containing nine observations. The FDA later assigned the facility an OAI classification.
The regulatory development weighed on Aurobindo Pharma shares, which fell more than 2 percent to an intraday low of Rs 1,621.30 on the BSE.
The stock has traded between Rs 1,017 and Rs 1,682 over the past 52 weeks.
For the first quarter of fiscal 2027, Aurobindo Pharma reported net profit of Rs 1,032 crore on revenue from operations of Rs 9,150 crore. (Source: IANS)
