The USFDA conducted General GMP inspection at Piramal Pharma Limited's Turbhe facility from 11th February, 2025 to 17th February, 2025.

On conclusion of the inspection, a Form-483 was issued with 6 observations. Observations are largely around improvement of procedures and practices and not related to data integrity. The Company is preparing a detailed response to said observations, which will be submitted to agency within stipulated timelines.