Aurobindo Pharma Limited has announced a positive outcome for its subsidiary, Apitoria Pharma Private Limited. Unit-V, an API manufacturing facility, was inspected by the US FDA from December 1 to December 12, 2025. Following the initial issuance of a ‘Form 483’ with three observations, the unit has now received an Establishment Inspection Report (EIR) classifying the facility as ‘Voluntary Action Indicated’ (VAI), officially closing the inspection.
Positive Regulatory Update for API Facility
Aurobindo Pharma Limited disclosed an important regulatory development concerning its wholly owned subsidiary, Apitoria Pharma Private Limited. The update confirms that the US Food and Drug Administration (US FDA) has concluded its inspection of Unit-V, an Active Pharmaceutical Ingredient (API) manufacturing facility located in Telangana.
Inspection Timeline and Outcome
The inspection period covered December 01 to December 12, 2025. Initially, at the conclusion of the site visit, the facility was issued a ‘Form 483’ detailing 03 observations. The company has since received the subsequent Establishment Inspection Report (EIR).
Crucially, the EIR now classifies the facility as ‘Voluntary Action Indicated’ (VAI). This classification signifies that the inspection is now officially “closed”, removing previous regulatory hurdles for the unit.
Source: BSE
