Alembic Pharmaceuticals Limited receives Establishment Inspection Report (EIR) for its Oncology Injectable Formulation Facility at Panelav.
US Food and Drug Administration (USFDA) for the inspection carried out by them at Alembic's Oncology Injectable Formulation Facility at Panelav during the period from 4th October, 2022 to 14th October, 2022.
This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA. The Company had also started receiving ANDA approval manufactured at this facility.
The Establishment Inspection Report article provides you information about the inspection visit report preparation after goods inspection or pre-shipment inspection.