Aurobindo Pharma’s Subsidiary Facility Classified as Voluntary Action Indicated by US FDA

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Aurobindo Pharma’s Subsidiary Facility Classified as Voluntary Action Indicated by US FDA​

Aurobindo Pharma Limited announced on March 20, 2026, that Unit-V of Apitoria Pharma Private Limited, a wholly-owned subsidiary, has been classified as ‘Voluntary Action Indicated’ (VAI) by the United States Food and Drug Administration (US FDA).

The US FDA inspected the API manufacturing facility, located in Pashamylaram Village, Patancheru Mandal, Sangareddy District, Telangana, from December 1 to December 12, 2025. Following the inspection, a ‘Form 483’ was issued, noting three observations.

The Establishment Inspection Report (EIR) has now classified the facility as VAI, marking the inspection as closed.

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Editorial Note

This news article was written and created by Karthik, and published on IST.
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