Biocon slumps 4% after US FDA red flags Malaysia unit

The official action indicated or an “OAI” classification of the insulin unit by the FDA can delay or withhold approvals for products manufactured at the facility

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The Biocon share slumped 4 percent in the early trade on October 18 after the Indian pharma firm said that its Malaysian insulin manufacturing facility was classified as “OAI” (Official Action Indicated) by the US Food and Drug Administration (FDA).

The classification came after a July 2023 inspection of the facility at Johor. The OAI status may cause delay or withhold pending product approvals or supplements from the facility, the company said.

At 9.21 am, shares of Biocon were trading nearly 3 percent lower from the previous day at Rs 247.55 on the NSE.

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The plant is controlled by Biocon Sdn Bhd, a step-down subsidiary of Biocon Biologics Limited, the company informed exchanges on October 18.

Biocon said it has submitted a comprehensive Corrective and Preventive Action (CAPA) plan to the FDA in response to observations from the July inspection and is on track to complete all actions as committed.

The company will also continue to engage with the US regulator to understand any outstanding concerns and work closely to address them expeditiously.

The company said that it does not believe that this will have a material impact on the manufacturing and distribution of its commercial products for the US market.

In July, the US drug regulator issued six observations for drug substance, product units and quality control laboratories and two observations for the delivery devices unit.

Biocon will release its July-September earnings on November 10.

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