Aurobindo Pharma shares gain after USFDA classifies Telangana facility as VAI

Shares of Aurobindo Pharma Ltd. gained nearly 2% in early trade on Wednesday, May 6, after the company said the US Food and Drug Administration (USFDA) has classified its Unit-VII facility in Telangana as “Voluntary Action Indicated” (VAI).

The facility, which manufactures oral solid dosage products, is located at the Special Economic Zone (Pharma), TSIIC, Green Industrial Park in Polepally Village, Jedcherla Mandal, Telangana.

The USFDA had inspected the facility from January 28 to February 10, 2026. At the end of the inspection, the regulator had issued a Form 483 with nine observations.

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In an exchange filing, Aurobindo Pharma said the unit has now received the Establishment Inspection Report (EIR) classifying the facility as VAI, adding that the USFDA has concluded the inspection and closed the matter.

A VAI classification indicates that although objectionable conditions were found during the inspection, the regulator does not recommend or undertake administrative or regulatory action at the facility.

In April, Aurobindo Pharma's subsidiary, TheraNym Biologics Pvt Ltd, expanded its collaboration with Merck Sharpe & Dohme Singapore Trading Pte Ltd (MSD) by signing an additional product schedule under their existing contract manufacturing (CMO) agreement dated May 2024.

Under the new agreement, TheraNym Biologics will set up a greenfield facility for large-scale mammalian drug substance manufacturing (Unit 2), with a total bioreactor capacity of 60 KL. The company plans to invest around $150-175 million to establish this facility.

Shares of Aurobindo Pharma gained in early trade and were trading 1.6% up at ₹1,450.90 as of 9.22 am. The stock has surged 8% in the past month and more than 27% in the last six months.