Concord Biotech receives EIR from USFDA for Dholka API facility, no regulatory action required
Concord Biotech Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility located in Dholka, Gujarat.
The inspection was conducted by the USFDA from April 28 to May 2, 2025. Following the detailed evaluation, the USFDA has formally concluded the inspection and issued the EIR, indicating that the facility meets the agency's standards of compliance.
According to Concord Biotech, the inspection has been officially closed under 21 CFR 20.64(d)(3), confirming that no regulatory or corrective action is required. This positive outcome allows the company to continue operations at the Dholka site without any restrictions or compliance-related concerns.
This development marks a crucial step in reinforcing Concord Biotech's reputation for maintaining high-quality manufacturing standards in line with global regulatory expectations
Ahmedabad Plane Crash
Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at BusinessUpturn.com
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