Aurobindo Pharma announced that the United States Food and Drug Administration (US FDA) inspected Unit-V, an API manufacturing facility, of Apitoria Pharma, a wholly owned subsidiary of the Company, situated at Industrial Development Area, Chemical Zone, Pashamylaram Village, Patancheru Mandal, Sangareddy District, 502307, Telangana from 01 December to 12 December 2025. At the end of the inspection, a ‘Form 483' was issued with 03 observations.
The Unit has now received an Establishment Inspection Report (EIR) classifying the facility as ‘Voluntary Action Indicated' (VAI) and this inspection is now “closed”.