Aurobindo Pharma subsidiary Eugia Steriles faces five US FDA observations – CNBC TV18

Drug maker Aurobindo Pharma Ltd on Friday (June 19) mentioned the USA Meals and Drug Administration (US FDA) has accomplished a pre-approval inspection (PAI) at Eugia Steriles Non-public Ltd with five observations.

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

Eugia Steriles is an entirely owned subsidiary of Eugia Pharma Specialities Ltd, which in flip is a subsidiary of Aurobindo Pharma. The corporate mentioned the inspection concluded with five observations. It added that the observations shall be responded to throughout the stipulated timeline.

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In its disclosure, Aurobindo Pharma said that the inspection was carried out by the US FDA as a part of a pre-approval inspection course of. The corporate additional mentioned there isn’t a influence on its financials or operations because of the end result of the inspection.

Aurobindo Pharma mentioned it stays dedicated to sustaining high quality manufacturing requirements throughout its services and can maintain inventory exchanges knowledgeable of any additional developments associated to the inspection.

Final week, Aurobindo Pharma mentioned the US Meals and Drug Administration (US FDA) has labeled the inspection of Eugia Pharma Specialities’ Unit-III facility as “Official Motion Indicated” (OAI).

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The power is situated at Part-III, TSIIC, EPIP, IDA, Pashamylaram, Patancheru Income Mandal, Sangareddy District, Telangana, and is operated by Eugia Pharma Specialities Ltd, an entirely owned subsidiary of Aurobindo Pharma. The inspection was performed from January 27 to February 6, 2026, and concluded with 11 observations.

“The corporate is dedicated to sustaining the best high quality manufacturing requirements in any respect of its services throughout the globe. We are going to maintain the inventory exchanges knowledgeable if there may be any additional data regarding the above sooner or later,” it mentioned.

The US FDA communicated the “Official Motion Indicated” classification on June 12, 2026. Aurobindo Pharma mentioned there isn’t a influence on its financials or operations because of the improvement.

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Shares of Aurobindo Pharma Ltd ended at ₹1,493.60, down by ₹50.55, or 3.50%, on the BSE.