Concord Biotech Limited has informed the Exchange about Concord Biotech limited receives Establishment Inspection Report (EIR) for it''s API facility at Dholka
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Concord Biotech has received the Establishment Inspection Report (EIR) from the US FDA for its API manufacturing facility at Dholka, Gujarat. The USFDA had inspected this facility from April 28, 2025 to May 2, 2025. The inspection has been officially closed under 21 CFR 20.64(d)(3), meaning the USFDA found no issues requiring regulatory action. The facility is free to continue its operations without any restrictions, which is a positive outcome for the company.
This is a positive development for shareholders as a clean USFDA inspection allows Concord Biotech to continue supplying APIs to the US market without disruption. It removes regulatory uncertainty around the Dholka facility and supports the company's export-driven business.