Shares of Biocon tumbled 4% on 18 October after the company’s Malaysia unit was red-flagged by the USFDA (US Food and Drug Administration).

The company announced that its Malaysian insulin manufacturing facility was classified as “Official Action Needed” (OIA) by the USFDA. The classification was assigned after an inspection of the facility at Johor was conducted in July 2023.

The OAI status given may cause a delay or withhold any pending product approvals from this facility.

The company said they have submitted a CAPA (Comprehensive Corrective and Preventive Action) plan to the regulator in response to the observation from the July inspection. The company further assured that they are on track to complete all actions as committed.

Moreover, the company will continue to engage with the regulator to address any outstanding concerns that may have been raised and work closely to address them.

Biocon said that it does not believe this will significantly impact the manufacturing and distribution of its commercial products within the US market. They added that the plant is controlled by a step-down subsidiary of the company, Biocon Sdn Bhd.

The quarterly results for the July-September quarter are set to be released on 10 November.

At 10:30 am, the shares of Biocon were trading 3.98% below its previous close at Rs 244.75 on NSE.