USFDA issues EIR for Alembic's Panelav oncology injectable formulation unit

Alembic Pharmaceuticals has received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for the inspection carried out by them at the company's Oncology Injectable Formulation Facility at Panelav during the period from 4 October 2022 to 14 October 2022. This was 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.

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