The United States Food and Drug Administration (US FDA) conducted a Pre-Approval Inspection (PAI) for sterile APIs at the company’s facility in JNPC, Visakhapatnam from February 19, 2025, to February 25, 2025. The inspection concluded with three (3) Form 483 observations, which are procedural in nature. The company will submit corrective and preventive actions (CAPA) to the US FDA within the stipulated period. The observations are neither repeated nor related to data integrity.