Biocon Share: US FDA inspected the plant - shares will be monitored

News Topical, Digital Desk : Biotech company Biocon Limited informed after the stock market closed on Thursday that the US Food and Drug Administration (FDA) has completed the routine Current Good Manufacturing Practices (cGMP) inspection of Biocon Biologics' drug substance facility located at the Bengaluru Biocon Campus. The inspection was conducted between August 26 and September 3, 2025 and included drug substance manufacturing units, analytical quality control labs, microbiology labs and warehouses.

After the inspection, the FDA has issued Form 483 with 5 observations. Biocon said that these objections are only procedural and are not related to data integrity, systemic non-compliance or quality oversight. The company said that Biocon Biologics will submit a Corrective and Preventive Action (CAPA) plan within the stipulated time frame and is confident of entering all objections quickly. The company also said that the result of the inspection will not affect the supply of its commercial products. Share performance The company's stock closed at Rs 357.50 on Thursday with a decline of 1.12 percent. In the last one year, the company's stock has seen a decline of 5.77 percent. 

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