Alembic Pharmaceuticals receives US FDA EIR for Panelav oncology facility
US FDA inspection for injectable and oral solid formulation unit conducted in October 2024 has been successfully closed
Alembic Pharmaceuticals has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its oncology formulation facility located at Panelav. The facility manufactures both injectable and oral solid dosage forms.
The announcement follows a US FDA inspection conducted at the site from 7 October to 8 October 2024. The company had previously communicated the successful completion of this inspection.
According to the company, the receipt of the EIR signifies the formal closure of the inspection process. Alembic stated that this development reinforces its “commitment to global regulatory compliance and high-quality manufacturing standards.”