Alembic Pharma gets EIR from USFDA for its solid oral formulation facility at Jarod
This was pre-approval inspection to cover Alembic’s solid oral drug products for which ANDAs were filed with USFDA
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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