Alembic Pharmaceuticals has received the Establishment Inspection Report (EIR) for the inspection conducted by the US Food and Drug Administration (USFDA) at its API-I and API-II facilities in Panelav.
The inspection was carried out between May 26, 2025 and May 31, 2025.
The company had received ANDA approval for its Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, last week.