Aurobindo Pharma slips ~6% on USFDA warning to Eugia Unit III

16 Aug 2024 , 01:40 PM

The Hyderabad-based drugs producer, Aurobindo Pharma Ltd., told the exchanges on Friday that its Unit-III, a formulations manufacturing facility of Eugia Pharma Specialities Ltd., had received a warning notice from the United States Food and Drugs Administration (USFDA).

Eugia Pharma is a completely owned subsidiary of Aurobindo Pharma.

Following the USFDA observation, the Pashamylaram-based unit was granted Official Action Indicated (OAI) status in May of this year.

The USFDA sends warning letters to corporations to inform them of concerns about their behaviour. Warning letters can be issued for a variety of reasons, including bad manufacturing procedures, issues with product claims, and erroneous operating instructions, among others.

An OAI status indicates that the USFDA’s inspection discovered significant concerns that require regulatory or administrative action.

Aurobindo Pharma stated in the exchange filing that there will be no impact on existing shipments to the US market.

The U.S. market accounts for 47% of Aurobindo Pharma’s global sales. US sales for the June quarter were $426 million, a little decrease from the $432 Million recorded in March.

At around 12.11 PM, Aurobindo Pharma was trading 2.58% lower at ₹1,480.45 per piece, against the previous close of ₹1,519.70 on NSE. The counter touched an intraday high and low of 1,527, and ₹1,421.45, respectively.

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