Date: August 21, 2026
Regulatory Compliance Update
Inspection Details
- Entity Inspected: AuroPeptides Ltd, described as a manufacturer of Peptide APIs and a subsidiary/business arm of Aurobindo Pharma Limited
- Location: Indrakaran Village, Kandi Mandal, Sangareddy District, Telangana - 502329, India
- Inspection Period: August 17 to August 21, 2026
- Inspection Type: Routine inspection conducted by the United States Food and Drug Administration (US FDA)
Inspection Outcome
- Result: The inspection concluded with only one (1) observation
- Nature of Observation: Relates to facility and equipment maintenance
- Critical Exclusion: The observation does not pertain to data integrity or related GMP compliance issues
- Corrective Actions: Corrective action was already initiated during the course of the inspection
- Formal Response: The company will submit its formal response within the stipulated timeline
Company Statement
The outcome reaffirms the Company's continued commitment to maintaining robust quality and compliance standards across its manufacturing facilities.
Future Communications
The Company will keep the Stock Exchanges informed of any further developments in this regard, as required under applicable regulations.