As informed earlier vide our letter dated 25th April, 2020, 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 the company's Bavla site.
In this regard, we would like to provide an update that pursuant to implementation of the Corrective Action Plan submitted to the EDQM on August 21, 2020, the Company has informed the EDQM on October 18, 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. The Company expects the re-inspection to happen within a maximum period of six months and is confident of receiving the necessary clearance.
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