Aurobindo Pharma Ltd. announced that the U.S. Food and Drug Administration (US FDA) has classified the inspection at its wholly owned subsidiary, Apitoria Pharma Private Limited’s Unit V, as “Voluntary Action Indicated” (VAI).
The inspection was conducted at the API manufacturing facility in Pashamylaram Village, Telangana, between December 9 and December 17, 2024. The VAI classification indicates that while some issues were identified, they do not require immediate regulatory action.
This update comes after Aurobindo Pharma had initially informed exchanges about the inspection in December 2024. The company has now received the Establishment Inspection Report (EIR), confirming the VAI status.
Investors and stakeholders will closely monitor further regulatory developments at Aurobindo Pharma’s manufacturing units, as compliance with US FDA standards remains crucial for exports to the United States.
