Aurobindo Pharma’s Unit-2 API Facility Gets VAI in US FDA Inspection

Aurobindo Pharma’s wholly-owned subsidiary, Apitoria Pharma Private Limited, has received a Voluntary Action Indicated (VAI) classification in the US FDA’s Establishment Inspection Report (EIR) for its Unit-2 API facility in Sanga Reddy, Telangana. The inspection was conducted from September 23–27, 2025. A VAI indicates minor issues were found, but not severe enough for regulatory action—allowing the company to address them voluntarily. This is a positive outcome, reflecting adherence to manufacturing standards. This follows a recent FDA inspection at Unit-XII, which resulted in eight procedural observations. Despite the scrutiny, Aurobindo reaffirmed its commitment to maintaining high-quality standards across its global facilities. The VAI status reinforces confidence in Aurobindo’s regulatory compliance and strengthens its position in the US generics market, where quality benchmarks are critical. The company continues to engage proactively with regulators to ensure sustained compliance.