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U.S. FDA Completes Pre-License Inspection at Biocon’s Biosimilars Site at Biocon Park, Bengaluru, India

  • Thu, 30-Apr-2026
  • Posted by: BIOCON
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NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

Bengaluru, Karnataka, India, April 30, 2026

The U.S. Food and Drug Administration (FDA) has completed a Pre-License Inspection (PLI) at Biocon’s biosimilars site at Biocon Park in Bengaluru, India. The inspection was conducted between April 20, 2026, and April 29, 2026, and covered 3 Biologics Manufacturing units, 5 Quality testing laboratories and 2 Warehouses.

At the conclusion of the inspection, the U.S. FDA issued a Form 483 with five observations. These observations are procedural in nature and do not pertain to data integrity or quality oversight. There were no repeat observations noted. The Company will submit a comprehensive Corrective and Preventive Action (CAPA) plan within the stipulated timeline and is confident all observations will be addressed fully and expeditiously.

Biocon remains committed to upholding the highest standards of Quality and Compliance and working collaboratively with global regulatory agencies to ensure the  safety, efficacy, and reliability of its products.

– Company Spokesperson


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