USFDA closes inspection at Alembic Pharma's Vadodara bioequivalence facility
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USFDA has issued an Establishment Inspection Report (EIR) and formally closed the inspection of Alembic Pharmaceuticals' Bioequivalence Facility at Vadodara, Gujarat. The inspection was conducted from March 3 to March 7, 2025. EIR closure means the facility has met USFDA standards, clearing a regulatory overhang and supporting continued US product approvals from this site.
Positive for shareholders: EIR closure removes regulatory uncertainty, supports ongoing US exports and future ANDA approvals from this facility.