After the US FDA raised concerns about a Malaysian business, Biocon's stock drops 4%

18 Oct 2023 , 02:45 PM

The Biocon share fell 4% in early trading on October 18 after the Indian pharmaceutical company said that the US Food and Drug Administration (FDA) had designated its Malaysian insulin production plant as ‘OAI’ (Official Action Indicated).

The plant at Johor was inspected in July 2023, which led to the categorization. The facility’s pending product approvals or supplements may be delayed or withheld as a result of the OAI status, the business said.

The business informed exchanges on October 18 that Biocon Sdn Bhd, a step-down subsidiary of Biocon Biologics Limited, is in charge of the factory.

According to Biocon, company has sent the FDA a thorough Corrective and Preventive Action (CAPA) plan in response to findings from the inspection in July and is on pace to perform all activities as promised.

The business will also keep in contact with the US regulator in order to comprehend any unresolved issues and collaborate closely to find quick solutions.

The business stated that it doesn’t think this will materially affect how its commercial products are produced and distributed for the US market.

The US drug regulator published two observations for the delivery devices unit in July along with six observations for the drug substance, product units, and quality control laboratories.

On November 10, Biocon will announce its earnings for July through September.

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