USFDA Issues VAI Classification for Aurobindo Pharma's Apitoria Facility
New Delhi: Drug maker Aurobindo Pharma on Wednesday said its wholly owned subsidiary, Apitoria Pharma, received a "Voluntary Action Indicated" classification for its Telangana API facility from the US health regulator.
The US Food and Drug Administration (US FDA) had inspected Unit-II, an active pharmaceutical ingredient (API) manufacturing facility of Apitoria Pharma Pvt Ltd, located at Gaddapotharam, Industrial Development Area -- Kazipally Industrial Area, Jinnaram Mandal in Sangareddy District, Telangana, from September 7-15, 2026.
In a regulatory filing, Aurobindo Pharma said the unit has now received an Establishment Inspection Report (EIR) classifying the facility as "Voluntary Action Indicated" (VAI).
A VAI classification means that objectionable conditions or practices were observed during the inspection, but the agency is not prepared to take or recommend administrative or regulatory action, and corrective measures are left to the company to carry out voluntarily.
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