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The inspection had concluded with four observations and the USFDA had determined the facility as ‘official action indicated’ (OAI). | Photo Credit: cueapi

Aurobindo Pharma on Friday said the US health regulator has issued a warning letter to a formulation manufacturing facility of its arm, Eugia Pharma Specialities Ltd, in Telangana.

In May this year the company had stated that the US Food and Drug Administration (USFDA) inspected Unit-I, a formulation manufacturing facility of Eugia Pharma Specialities Ltd located at Telangana from February 16 to February 27, 2026.

The inspection had concluded with four observations and the USFDA had determined the facility as 'official action indicated' (OAI).

"Subsequent to OAI, the unit has received a warning letter," Aurobindo Pharma said in a regulatory filing.

There is no impact on the existing supplies to the US markets, it added.

The company further said the Unit I of Eugia Pharma Specialities Ltd, is contributing to about 2 per cent to company's overall group revenue.

Aurobindo Pharma said it remains committed to working closely with the USFDA and continues to enhance its compliance on an ongoing basis.

Published on August 14, 2026

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