Concord Biotech gets EIR from USFDA for API facility at Dholka

The said inspection was conducted from April 28, 2025 till May 02, 2025

Concord Biotech has received an establishment inspection report (EIR) from the US Food and Drug Administration (USFDA) for the inspection carried out by them at its API facility at Dholka. The said inspection was conducted from April 28, 2025 till May 02, 2025. The USFDA has officially concluded its inspection. This closure indicates that no regulatory action is required, and the facility is permitted to continue its operations without any restrictions.

Concord Biotech is an India-based biopharma company and one of the leading global developers and manufacturers of select fermentation-based APIs across Immunosuppressants and oncology.