The United States Food and Drug Administration (US FDA) has conducted a GMP inspection of the Solid Oral Formulation Facility (Plant 1) at Goa. The inspection was conducted from January 16 to 20, 2023.

The US FDA has issued Form 483 with 9 observations, which will be addressed within a stipulated time. We believe that this will not have an impact on the supplies and the existing revenues from this facility. The Company is committed to maintaining compliance across all our facilities with cGMP quality standards at all times.