Alembic Pharmaceuticals has received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for the inspection carried out at the company’s solid oral formulation facility (F-4) at Jarod, Vadodara during the period from December 8 -16, 2022.
This was pre-approval inspection to cover Alembic’s 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.
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