Regulatory

USFDA closes inspection at Alembic Pharma’s Vadodara bioequivalence facility

The regulator has issued Establishment Inspection report following inspection conducted in March 2025

  • By IPP Bureau | September 17, 2026

Alembic Pharmaceuticals Limited has announced that the US Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) and communicated the closure of its inspection conducted at the company’s bioequivalence facility in Vadodara, Gujarat.

The inspection was carried out from March 3 to 7, 2025. The company had earlier informed the stock exchanges about the completion of the inspection on March 7, 2025.

Alembic Pharmaceuticals said the issuance of the EIR marks the formal closure of the USFDA inspection at the facility.

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