New Delhi — Shares of Aurobindo Pharma fell as much as 2% Friday after the U.S. Food and Drug Administration issued a warning letter to a manufacturing facility operated by subsidiary Eugia Pharma Specialities Ltd. in Telangana.
The warning letter relates to Eugia’s Unit-I formulation manufacturing facility, which was inspected by the FDA between Feb. 16 and Feb. 27, according to a regulatory filing by Aurobindo Pharma.
Following the inspection, the FDA issued observations and classified the facility as “Official Action Indicated,” or OAI. The unit subsequently received a warning letter from the regulator, the company said.
Aurobindo said the regulatory action is not expected to affect existing supplies to the U.S. market. The facility accounts for about 2% of the group’s overall revenue.
The drugmaker said it remains committed to working with the FDA and continuing to strengthen its compliance systems.
An FDA warning letter generally identifies significant regulatory violations and calls on a manufacturer to take corrective action. An OAI classification indicates that the agency believes issues identified during an inspection may warrant regulatory or enforcement action.
Aurobindo had previously said in March that the inspection resulted in a Form 483 containing nine observations before the facility was classified as OAI.
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.
The company’s shares fell more than 2% to an intraday low of Rs 1,621.30 on the BSE. The stock has traded between a 52-week high of Rs 1,682 and a low of Rs 1,017. (Source: IANS)
