USFDA12 Dec 2025, 05:27 pm
Aurobindo Pharma's Unit-V Receives US FDA Inspection with 03 Procedural Observations
AI Summary
Aurobindo Pharma Ltd. has completed a US FDA inspection at Unit-V of Apitoria Pharma Private Limited, its wholly owned subsidiary. The US FDA inspection took place from December 01 to December 12, 2025, at the API manufacturing facility in Telangana. A 'Form 483' was issued with 03 procedural observations, to which the company will respond within the stipulated timelines. Aurobindo Pharma is committed to maintaining high-quality manufacturing standards across all its facilities.
Key Highlights
- US FDA inspection completed at Aurobindo Pharma's Unit-V
- Inspection held from December 01 to December 12, 2025
- Facility located at Industrial Development Area, Chemical Zone, Pashamylaram Village, Patancheru Mandal, Sangareddy District, 502307, Telangana
- A 'Form 483' issued with 03 procedural observations
- Company to respond within stipulated timelines