Alembic Pharmaceuticals Limited has announced the closure of its USFDA inspection at its Bioequivalence Facility in Vadodara, Gujarat. The inspection, conducted between March 3 and March 7, 2025, has been concluded with the issuance of an Establishment Inspection Report (EIR) by the US Food and Drug Administration. This confirmation signifies the facility’s compliance with regulatory standards.
USFDA Inspection Concluded
Alembic Pharmaceuticals Limited has officially been notified by the US Food and Drug Administration (USFDA) regarding the closure of an inspection conducted at its Bioequivalence Facility located in Vadodara, Gujarat. The inspection took place from March 3, 2025, to March 7, 2025.
Establishment Inspection Report Issued
Following the inspection, the USFDA has issued an Establishment Inspection Report (EIR) to Alembic Pharmaceuticals. This report communicates the closure of the inspection, indicating that the company’s Bioequivalence Facility in Vadodara has met the required regulatory standards. The company views this as a significant step in maintaining its operational compliance and global market access.
Source: BSE
