Aurobindo Pharma (NSE:AUROPHARMA, BOM:524804) said Unit-V of its wholly-owned subsidiary, Apitoria Pharma, has been classified as "voluntary action indicated" by the U.S. Food and Drug Administration (US FDA), according to a Friday filing to the Indian stock exchanges.
The US FDA inspected the facility, based in the Sangareddy district of Telangana, India, between Dec. 1, 2025, and Dec. 12, 2025.
At the end of the inspection, the regulator issued a 'Form 483' with three observations.
The unit has now received an establishment inspection report classifying the facility as 'voluntary action indicated', marking the inspection as closed.
The company's shares were up nearly 3% in recent trade.