Concord Biotech has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) indicating closure of inspection at its manufacturing Unit III, Gujarat. The company’s facility has been classified as ‘no action indicated’ (NAI). Based on this inspection and the USFDA NAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP). USFDA had conducted an inspection from June 26, 2023 to June 30, 2023.
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.
