There was a joint inspection carried out during the quarter ending March, 2020 by the Swissmedic and European Directorate for the Quality of Medicines & HealthCare (EDQM), due to which there were certain audit observations issued deficient to EU GMP Part II and other relevant Annexes for Dishman Carbogen Amcis Limited's Bavla site.

Further, pursuant to implementation of the Corrective Action Plan submitted to the EDQM on 21st August, 2020, the Company had informed the EDQM on 18th October, 2022 regarding its readiness for a re-inspection of its Bavla site with an objective of getting a clearance for this site by the EDQM and in this regard the re-inspection by the EDQM of the Bavla site was scheduled from 18th September, 2023 to 20th September, 2023.

The company's Bavla site was successfully jointly inspected by the EDQM and Italian Medicines Agency (AIFA) during the above period though the final report is awaited.