Aurobindo Pharma US FDA Raleigh Plant VAI Classification

Date: August 17, 2026

The United States Food and Drug Administration (USFDA) inspected the Raleigh Plant in North Carolina, USA, owned by Aurolife Pharma LLC (a wholly owned step-down subsidiary of Aurobindo Pharma Limited)
Inspection period: March 24, 2025 to April 10, 2025
Facility purpose: Manufacturing Inhalers, Dermatology and Transdermal products
At the end of inspection, Form 483 was issued with a total of 11 observations
The unit has now received Establishment Inspection Report (EIR) classifying the facility as "Voluntary Action Indicated" (VAI)
The USFDA has concluded that this inspection is now closed
As the unit is classified as VAI, pending applications for multiple inhalers and other dosage forms filed from this facility can now progress through the USFDA's review process

Financial Results: Not specified

Dividend Declaration: Not specified

KMP / Board / Auditor Changes: Not specified

Board Meeting Outcomes: Not specified

Auditor's Report: Not specified

Disinvestment / Strategic Actions: Not specified

Media Release / Investor Communication: Not specified

Other Operational / Legal / Strategic Disclosures: Not specified