Aurobindo Pharma's Manufacturing Unit Receives Satisfactory FDA Report

Aurobindo Pharma announced that its wholly-owned subsidiary's unit in Andhra Pradesh received a satisfactory Voluntary Action Indicated (VAI) classification from the USFDA, following an inspection in December 2025. This classification indicates minor issues were found, but no regulatory action is deemed necessary.

Aurobindo Pharma announced on Thursday that its Andhra Pradesh-based manufacturing unit has received an Establishment Inspection Report with a Voluntary Action Indicated (VAI) classification from the US Food and Drug Administration (USFDA). This status was granted following an inspection carried out from December 8-17, 2025.

The inspection at Unit-IV of APL Healthcare Ltd in Nellore district concluded with a Form 483, citing five observations. A VAI classification indicates that while objectionable conditions were identified, the FDA does not foresee any immediate administrative or regulatory actions against the facility.

With this satisfactory report, Aurobindo Pharma's inspection case is considered closed. Notably, the company's shares rose by 0.67%, closing at Rs 1,313.30 per share on the BSE by Thursday's end.

(With inputs from agencies.)