Aurobindo Pharma says US FDA inspection at subsidiary ends with 11 procedural observations

Aurobindo Pharma Ltd on Friday (February 6) said the United States Food and Drug Administration (US FDA) has completed an inspection at Unit-III of Eugia Pharma Specialities Ltd, its wholly owned subsidiary.

The US FDA inspected Unit-III, a formulation manufacturing facility located at Phase-III, TSIIC, EPIP, IDA, Pashamylaram, Patancheru Revenue Mandal, Sangareddy district in Telangana, from January 27 to February 6, 2026.

According to the company’s filing, the inspection concluded with 11 observations. Aurobindo Pharma said the observations are procedural in nature and will be responded to within the stipulated time.

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The company stated that there is no impact on its financials or operations due to the inspection outcome. It added that it remains committed to maintaining quality manufacturing standards across its facilities globally and will keep the stock exchanges informed of any further developments related to the matter.

Last year, Aurobindo Pharma said the United States Food and Drug Administration (FDA) had completed its inspection of Unit-V, an API manufacturing facility of its wholly-owned subsidiary Apitoria Pharma Private Limited, in Telangana.

The inspection was conducted from December 1-12, 2025, at the facility located in the Industrial Development Area, Chemical Zone, Pashamylaram Village, Patancheru Mandal, Sangareddy District.

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At the conclusion of the inspection, the FDA issued a Form 483, citing three observations, described by the company as procedural in nature. Aurobindo Pharma said it will respond to the regulator within the stipulated timelines.

The company added that the development does not impact the operations of the facility. It reaffirmed its commitment to maintaining the highest quality manufacturing standards across all its global facilities.

Shares of Aurobindo Pharma Ltd ended at ₹1,195.00, up by ₹12.50, or 1.06%, on the BSE.