Alembic Pharma's Vadodara Bioequivalence Facility Gets USFDA Inspection Closure, EIR Issued
Vadodara: 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 conducted by the USFDA from March 3, 2025, to March 7, 2025, at Alembic Pharmaceuticals Limited’s Bioequivalence Facility located in Vadodara, Gujarat.
The company had earlier informed the stock exchanges on March 7, 2025, regarding the completion of the USFDA inspection at the facility.
In its latest communication dated September 16, 2026, Alembic Pharmaceuticals stated that the USFDA has now issued the Establishment Inspection Report (EIR) and communicated the closure of the inspection carried out at the Vadodara facility. The company has communicated the development to the Indian stock exchanges and requested that the information be taken on record.
The inspection update pertains specifically to the company’s Bioequivalence Facility situated in Vadodara, Gujarat. The USFDA inspection took place over a five-day period in March 2025, and the subsequent issuance of the EIR and communication of inspection closure represent the latest regulatory update provided by Alembic Pharmaceuticals concerning the facility.
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