Aurobindo Pharma arm Telangana facility gets 5 USFDA observations

Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded an inspection with five observations at Unit-I, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Borpatla Village, Hatnoor Mandal, Sangareddy District, 502296, Telangana. The inspection was conducted 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 stated in a BSE filing.