Shares of Biocon Ltd rose 1% to a day’s high of Rs 364.80 on 5th September, after the company announced that the US Food and Drug Administration (FDA) had completed a routine current Good Manufacturing Practice (cGMP) inspection at Biocon Biologics’ drug substance facility at its Biocon Campus in Bengaluru, India.

The US FDA inspected Biocon Biologics’ Bengaluru facility between 26th August and 3rd September, 2025. The inspection covered manufacturing units, quality control labs, microbiology labs, and warehouses.

At the end of the inspection, the FDA issued a Form 483 with five procedural observations. Biocon clarified that these do not involve data integrity, systemic non-compliance, or quality oversight.

The company said it will submit a Corrective and Preventive Action (CAPA) plan within the required timeline. It is confident of resolving the issues quickly. It also assured that the findings will not affect the supply of its commercial products.

Biocon Biologics reiterated its commitment to maintaining the highest standards of quality and compliance while working closely with global regulators.

At 1:42 PM, the shares of Biocon Ltd were trading 1.33% higher at Rs 361.60 on NSE.

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