Hyderabad: Aurobindo Pharma has announced that t he United States Food and Drug Administration (USFDA) concluded the inspection with three observations at the Unit-V, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Industrial Development Area, Chemical Zone, Pashamylaram Village, Patancheru Mandal, Sangareddy District, 502307, Telangana.

The inspection was held 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 we will respond to the USFDA within the stipulated timelines," the company stated in a BSE filing. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an inve

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