The United States Food and Drug Administration (US FDA) inspected Unit-I, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, situated at Borpatla Village, Hatnoor Mandal, Sangareddy District, 502296, Telangana from August 21 to August 29, 2025.

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported. We will respond to the US FDA within the stipulated timelines.

The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.