The USFDA conducted a Good Manufacturing Practices (GMP) Inspection of Piramal Pharma Limited's Bethlehem facility from 18th September 2023 to 27th September 2023.

On conclusion of the inspection, a Form-483 was issued with 2 observations. Both observations relate to system improvement only, and none are related to data integrity. The Company is preparing a detailed response to said observations, which will be submitted to the US FDA within stipulated timelines.

The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all observations.