Eugia Steriles, a subsidiary of Aurobindo Pharma, encounters five observations from the US FDA.

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On Friday (June 19), Aurobindo Pharma Ltd announced that the United States Food and Drug Administration (US FDA) has completed a pre-approval inspection (PAI) at Eugia Steriles Private Ltd, resulting in five observations.

The inspection took place at Eugia Steriles’ manufacturing facility in Parawada Mandal, Anakapalli District, Andhra Pradesh, from June 10, 2026, to June 19, 2026.

Eugia Steriles is a fully owned subsidiary of Eugia Pharma Specialities Ltd, which is itself a subsidiary of Aurobindo Pharma. The company reported that the inspection concluded with five observations and confirmed that responses to these observations will be provided within the required timeline.
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In its announcement, Aurobindo Pharma indicated that the inspection was part of the US FDA’s pre-approval inspection protocol. The company added that the inspection’s outcome does not affect its financial situation or operations.

Aurobindo Pharma reaffirms its dedication to upholding quality manufacturing standards at all its facilities and will alert stock exchanges regarding any further updates related to the inspection.

Last week, Aurobindo Pharma revealed that the US Food and Drug Administration (US FDA) has designated the inspection of Eugia Pharma Specialities’ Unit-III facility as “Official Action Indicated” (OAI).

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The facility, located at Phase-III, TSIIC, EPIP, IDA, Pashamylaram, Patancheru Revenue Mandal, Sangareddy District, Telangana, is operated by Eugia Pharma Specialities Ltd, which is a wholly owned subsidiary of Aurobindo Pharma. The inspection occurred from January 27 to February 6, 2026, ending with 11 observations.

“The company is committed to maintaining the highest quality manufacturing standards at all its global facilities. We will inform the stock exchanges if any further information about this matter arises,” it stated.

The US FDA issued the “Official Action Indicated” classification on June 12, 2026. Aurobindo Pharma highlighted that there is no effect on its financials or operations as a result of this development.

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Aurobindo Pharma Ltd shares closed at ₹1,493.60, declining by ₹50.55, or 3.50%, on the BSE.

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