Apitoria Pharma receives 3 observations from USFDA for Unit-V

The company will respond to the US FDA within the stipulated timelines

The United States Food and Drug Administration (US FDA) inspected Unit-V, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma, situated at Industrial Development Area, Chemical Zone, Sangareddy, Telangana from December 01 to December 12, 2025.

At the end of the current inspection, a 'Form 483' was issued with 03 observations which are procedural in nature, and the company  will respond to the US FDA within the stipulated timelines.