The inspection was conducted at Eugia Steriles’ manufacturing facility located in Parawada Mandal, Anakapalli District, Andhra Pradesh, from June 10, 2026, to June 19, 2026.
Eugia Steriles is a wholly owned subsidiary of Eugia Pharma Specialities Ltd, which in turn is a subsidiary of Aurobindo Pharma. The company said the inspection concluded with five observations. It added that the observations will be responded to within the stipulated timeline.
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In its disclosure, Aurobindo Pharma stated that the inspection was carried out by the US FDA as part of a pre-approval inspection process. The company further said there is no impact on its financials or operations due to the outcome of the inspection.
Aurobindo Pharma said it remains committed to maintaining quality manufacturing standards across its facilities and will keep stock exchanges informed of any further developments related to the inspection.
Last week, Aurobindo Pharma said the US Food and Drug Administration (US FDA) has classified the inspection of Eugia Pharma Specialities’ Unit-III facility as “Official Action Indicated” (OAI).
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The facility is located at Phase-III, TSIIC, EPIP, IDA, Pashamylaram, Patancheru Revenue Mandal, Sangareddy District, Telangana, and is operated by Eugia Pharma Specialities Ltd, a wholly owned subsidiary of Aurobindo Pharma. The inspection was conducted from January 27 to February 6, 2026, and concluded with 11 observations.
“The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe. We will keep the stock exchanges informed if there is any further information relating to the above in the future,” it said.
The US FDA communicated the “Official Action Indicated” classification on June 12, 2026. Aurobindo Pharma said there is no impact on its financials or operations due to the development.
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Shares of Aurobindo Pharma Ltd ended at ₹1,493.60, down by ₹50.55, or 3.50%, on the BSE.
