Alembic Pharmaceuticals Limited on Monday announced that it has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA).
The development comes after the recent inspection conducted at its Oncology (Injectable and Oral Solid) Formulation Facility located at Panelav in Gujarat.
As per the earlier intimation dated 8th March, 2024, the US FDA conducted a thorough inspection at Alembic Pharmaceuticals Limited’s Oncology (Injectable and Oral Solid) Formulation Facility (F-2) from 28th February, 2024, to 8th March, 2024, the company said in a statement.
With this latest development, Alembic Pharmaceuticals Limited holds EIRs for all its US FDA-regulated facilities, it added.