The US Food and Drug Administration (US FDA) concluded its inspection of Aurobindo Pharma’s Unit-V, an API manufacturing facility owned by Apitoria Pharma Private Limited, from December 1 to December 12, 2025. The inspection resulted in a ‘Form 483’ being issued with 3 procedural observations. Aurobindo Pharma has stated its commitment to upholding high-quality manufacturing standards and will respond to the US FDA within the given timelines.
Inspection Overview
The United States Food and Drug Administration (US FDA) recently completed an inspection of Unit-V, an API (Active Pharmaceutical Ingredient) manufacturing facility of Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma. The site is located in the Industrial Development Area, Chemical Zone, Pashamylaram Village, Patancheru Mandal, Sangareddy District, Telangana.
Key Dates
The US FDA inspection took place from December 1, 2025, to December 12, 2025.
Observations and Next Steps
At the close of the inspection, a ‘Form 483’ was issued, noting 3 observations of a procedural nature. Aurobindo Pharma has confirmed that it will respond to the US FDA within the stipulated timelines.
Commitment to Quality
Aurobindo Pharma has reiterated its commitment to maintaining the highest quality manufacturing standards across all its facilities globally.
Source: BSE