Alembic Pharmaceuticals said it has received the establishment inspection report (EIR) for its solid oral formulation facility (F-4) at Jarod, Gujarat, as per a regulatory filing.
Alembic said the inspection was carried out by the US Food and Drug Administration (FDA) for the period between December 8 and December 16, 2022.
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The company said this was a pre-approval inspection to cover Alembic’s solid oral drug products for which Abbreviated New Drug Applications (ANDAs) had been filed with the USFDA. The company has also started receiving approvals for products manufactured at this facility, it said.