Aurobindo Pharma arm receives VAI classification from USFDA for Telangana unit

Aurobindo Pharma Ltd on Friday, March 20, said its wholly owned subsidiary, Apitoria Pharma Pvt Ltd, has received a ‘Voluntary Action Indicated’ (VAI) classification from the US Food and Drug Administration (USFDA) for its Unit-V manufacturing facility.

The USFDA inspected the API manufacturing facility in Telangana between December 1 and December 12, 2025, following which a Form 483 with three observations was issued.

Subsequently, the unit has now received an Establishment Inspection Report (EIR) classifying the facility as VAI, indicating that the inspection is closed.
The VAI classification means that while certain observations were noted during the inspection, they do not warrant regulatory or enforcement action by the USFDA.
The development marks the closure of the inspection process for the facility.

Earlier this week, the USFDA classified another one of the company’s subsidiaries, Eugia Pharma Specialities Ltd, as ‘Official Action Indicated’ (OAI) following an inspection.

For the December quarter, Aurobindo Pharma reported a 7.5% year-on-year increase in its net profit to ₹909.8 crore from ₹846 crore, inclusive of a one-time cost of ₹65 crore due to a change in the labour code.

Revenue for the quarter rose 8.4% YoY to ₹8,646 crore from ₹7,979 crore in Q3FY25. EBITDA was 12.4% up at ₹1,773.6 crore from ₹1,577.5 crore a year ago. EBITDA margin expanded to 20.5% from 19.8% in the same quarter last year.

Shares of Aurobindo Pharma were trading 2.12% up at ₹1,274 as of 10.43 am. The stock has gained nearly 10% over the past month.