USFDA issues warning letter to Aurobindo Pharma's Telangana facility; stock dips 2 pc

New Delhi, Aug 14 (AHN) Shares of Aurobindo Pharma declined up to 2 per cent on Friday after the U.S. Food and Drug Administration (USFDA) issued a warning letter to a formulation manufacturing facility operated by its subsidiary -- Eugia Pharma Specialities Ltd -- in Telangana.

According to the company’s exchange filing, the warning letter pertains to Unit-I, a formulation manufacturing facility of Eugia Pharma Specialities that was inspected by the USFDA between February 16 and February 27 earlier in the year.

Following the inspection, the USFDA issued four observations and classified the facility under ‘official action indicated’ (OAI) status, the company added.

"Subsequent to OAI, the unit has received a warning letter," Aurobindo Pharma said.

However, the drugmaker said the development will not affect existing product supplies to the US market.

"There is no impact on the existing supplies to the U.S. markets," the company said.

In addition, Aurobindo Pharma said that Unit-I contributes about 2 per cent to the group's overall revenue.

The company said it remains committed to working closely with the USFDA and continues to strengthen its compliance systems on an ongoing basis.

A warning letter is issued by the USFDA when it identifies significant regulatory violations and seeks corrective actions from the manufacturer.

Earlier in March, the company also said that at the end of the inspection the regulator issued a Form 483 with nine observations.

“Subsequently, US FDA has now determined the inspection classification status of this unit as ‘Official Action Indicated’ (OAI),” it added.

The OAI classification means that the regulator believes certain issues found during the inspection may require regulatory action.

In Q1 FY27, the company’s net profit came at Rs 1,032 crore. Its revenue from operations stood at Rs 9,150 crore.

Following this, shares of Aurobindo Pharma slumped more than 2 per cent to Rs 1,621.30, hitting an intraday low on Friday on the BSE.

The pharma sector stock has recorded a 52-week high of Rs 1,682 and a 52-week low of Rs 1,017.