US FDA Inspects Aurobindo's Subsidiary; Facility Receives 'Official Action Indicated' Classification

US FDA Inspects Aurobindo's Subsidiary; Facility Receives 'Official Action Indicated' Classification

US FDA Inspects Aurobindo's Subsidiary; Facility Receives 'Official Action Indicated' Classification​

The United States Food and Drug Administration (US FDA) has concluded an inspection of Eugia Unit-III, a formulation manufacturing facility belonging to Eugia Pharma Specialities Ltd., a wholly owned subsidiary of Aurobindo Pharma Limited. The inspection process highlighted several observations regarding the manufacturing site in Telangana.

The US FDA conducted the inspection at the Pashamylaram facility located at Phase-III, TSIIC, EPIP, IDA, Pashamylaram, Patancheru Revenue Mandal, Sangareddy District, 502307, Telangana. The inspection took place from January 27 to February 06, 2026.

Following the assessment by the FDA, the facility has been classified as 'official action indicated' (OAI).

A summary of the regulatory event is provided below:

ParticularsDetails
AuthorityUnited States Food and Drug Administration (US FDA)
Inspection FacilityEugia Unit-III, Formulation manufacturing facility of Eugia Pharma Specialities Ltd.
Inspection DatesJanuary 27 to February 06, 2026
Observations/ActionThe inspection concluded with 11 observations, and the classification is 'official action indicated' (OAI).

Aurobindo Pharma Limited stated that there is no impact on the Company's financials or operations due to the outcome of this action.

The company affirmed its commitment to maintaining the highest quality manufacturing standards across all its global facilities and advised that stakeholders would be kept informed should any further information emerge relating to the matter.

AUROPHARMA Stock Price Movement​

Today, Aurobindo Pharma Limited shares edged higher to close at ₹1472.8 after gaining 0.27%. The stock traded within a range of ₹1462.5 to ₹1481 during the session, with 669,347 shares recorded in volume.
 

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