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Aurobindo Pharma Shares Drop 6% after Eugia unit-III receives USFDA warning letter

The EIR relates to Aurobindo Pharma's new injectable manufacturing facility in Parawada Mandal.

Shares of Aurobindo Pharma Ltd. dropped 6% after touching a day’s high of Rs 1,527 on 16th August, following the company’s disclosure that its Eugia Pharma Specialties Ltd. Unit-III received a warning letter from the USFDA.

The USFDA issues warning letters to companies to address concerns about their actions, such as poor manufacturing practices, product claims issues or incorrect instructions for use.

Earlier this year, in May, the same unit was issued an Official Action Indicated (OAI) status following USFDA observations.

An OAI status indicates that the USFDA found significant issues during its inspection that require regulatory or administrative action. Aurobindo Pharma stated that there is no impact on existing supplies to the US markets.

Aurobindo Pharma’s management, according to sources, expects Eugia’s sales to reach $600 million in FY 2025 and stated that the remediation of Eugia’s Unit-II and Unit-III is progressing well.

47% of Aurobindo Pharma’s total sales come from the US. For the June quarter, US sales were $426 million, slightly down from $432 million in the March quarter.

Aurobindo Pharma exports to over 150 countries, with 90% of its revenue coming from international markets. The company’s market capitalisation dropped to Rs 86,718 crore.

At 12:07 PM, the shares of Aurobindo Pharma were trading 2.86% lower at Rs 1,476.25 on NSE.

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