The United States Food and Drug Administration (US FDA) has conducted Pre-Approval Inspection (PAI) for Seven (7) Products and Good Manufacturing Practice (GMP) Inspection at the Company's Pashamylaram Facility at Hyderabad between 15th June 2023 and 27th June 2023.

The inspection was concluded with ONE (1) 483 Observation. This observation is procedural in nature and the corrective and preventive actions for this observation will be submitted to the US FDA within the stipulated period. The observation issued is neither a repeated observation nor related to data integrity.