Aurobindo Pharma Gets 11 USFDA Observations at Eugia Unit
New Delhi: Aurobindo Pharma Limited has informed stock exchanges that the US Food and Drug Administration (USFDA) has completed an inspection at Unit-III of Eugia Pharma Specialities Ltd., its wholly owned subsidiary, located at Pashamylaram in Telangana, with the audit concluding with 11 procedural observations.
In a regulatory filing made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, the company stated that the US FDA conducted the inspection at the formulation manufacturing facility from January 27 to February 06, 2026. The facility is situated at Phase-III, TSIIC, EPIP, IDA, Pashamylaram, Patancheru Revenue Mandal, Sangareddy District, Telangana.
According to the disclosure, the inspection ended with 11 observations, all of which have been described as procedural in nature. The company clarified that it will submit its responses to the regulator within the stipulated timeline prescribed by the US FDA.
Aurobindo Pharma further emphasized its continued focus on compliance and quality, stating that it remains committed to maintaining the highest manufacturing and quality standards across all its facilities globally. The company also assured that it would keep the stock exchanges informed in case of any further developments related to the inspection.
The company confirmed that there has been no financial or operational impact arising from the US FDA inspection or the observations issued. The date of receipt of communication from the US FDA was noted as February 06, 2026.
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