Alembic Pharmaceuticals has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its API-III manufacturing facility located in Karakhadi, Gujarat.
The USFDA inspection was carried out from 17 March 2025 to 21 March 2025.
The receipt of the EIR signifies that the inspection has been successfully closed by the regulatory authority. This development enables Alembic Pharmaceuticals to continue its supply of active pharmaceutical ingredients from the Karakhadi unit to the US market.