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USFDA completes inspection at Concord Biotech’s formulation facility in Gujarat

18 Sep 2026 Evaluate

The U. S. Food & Drug Administration (USFDA) has completed inspection at Concord Biotech’s formulation facility located at Unit II, Valthera, Dholka, Ahmedabad, Gujarat, India. The inspection was successfully completed on September 18, 2026 and at the conclusion, the USFDA has issued one minor observation which is procedural in nature and not related to GMP.

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.

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