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(20 Mar 2026, 12:27)

Aurobindo Pharma’s Telangana arm receives US FDA EIR

Aurobindo Pharma has announced that its Telangana arm has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration, classifying its facility as Voluntary Action Indicated (VAI) and marking the inspection as closed.


The US FDA had inspected Unit-V, an active pharmaceutical ingredient (API) manufacturing facility operated by Apitoria Pharma, a wholly owned subsidiary of Aurobindo Pharma, located at the Industrial Development Area, Chemical Zone, Pashamylaram Village, Patancheru Mandal, Sangareddy District, Telangana. The inspection was conducted from 1 December to 12 December 2025.

At the conclusion of the inspection, the regulator issued a Form 483 with three observations.

Aurobindo Pharma is principally engaged in the manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals, and related services.

The company’s consolidated net profit rose 7.6% to Rs 910.29 crore on a 9% increase in net sales to Rs 8,604.51 crore in Q3 FY26 over Q3 FY25.

Shares of Aurobindo Pharma advanced 2.28% to Rs 1,276.35 on the BSE.

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