08:51 AM, 10th May 2023
This is to inform the exchange that the Company has received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for the inspection carried out by them at our Solid Oral Formulation Facility (F-4) at Jarod Vadodara during the period from 8th December 2022 to 16th December 2022. This was pre-approval inspection to cover our Solid Oral drug products for which ANDAs were filed with USFDA. The Company had also started receiving approvals manufactured at this facility.Alembic has a total of five drug product manufacturing facilities and two drug substance manufacturing facilities. All these facilities are inspected and accepted by USFDA.