Aurobindo Pharma subsidiary receives minor FDA observations

Aurobindo Pharma Limited announced the completion of a US Food and Drug Administration (US FDA) inspection at Unit-V of Apitoria Pharma Private Limited, its wholly-owned subsidiary. The inspection, which took place from December 1 to December 12, 2025, at the API manufacturing facility in Pashamylaram Village, Telangana, resulted in a 'Form 483' with three observations.

The observations are described as procedural. Aurobindo Pharma stated it will respond to the US FDA within the stipulated timelines and reaffirmed its commitment to maintaining high-quality manufacturing standards across all its global facilities.

This development is not expected to impact the operations or financial activities of the facility. Aurobindo Pharma will continue to keep stock exchanges informed of any further relevant information.