Shares of Biocon Ltd slumped 4% on Monday, 9 December, after the company’s  Bengaluru Unit received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the United States Food and Drug Administration (USFDA).

In an exchange filing, Biocon said, “This is to inform you that the Company has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (US FDA), for our API facility (Site 2), located at SEZ Plot no. 2,3,4 and 5 Bommasandra-Jigani Link Road, Bengaluru, Karnataka.”

The inspection of the company’s Bengaluru API facility took place from 23 September to 27 September 2024.

One of the top biotechnology companies in the world, Biocon is dedicated to producing cutting-edge biotechnology goods and offering research services. The business is divided into various segments, such as Novel Biologics, Generics, Research Services, and Biosimilars.

With 20 biosimilars in its portfolio covering important therapeutic categories, including diabetes, immunology, oncology, and Biologics, its biosimilars business commands a sizeable market position in advanced markets. The business also has a strong pipeline with more than 20 compounds that should be released by 2030.

Its research services division, Syngene, is a stand-alone company that provides extensive search, development, and production services to a range of sectors, including consumer goods, biotechnology, and pharmaceuticals.

The company’s generics segment specializes in producing active pharmaceutical ingredients (APIs), including high-potency compounds, and has a broad portfolio of more than 50 items. With the release of Nimotuzumab, India’s first domestically produced monoclonal antibody, and Itolizumab, a treatment for psoriasis, Biocon has advanced in the field of new biologics. 

The business has recently acquired a biologics manufacturing plant through Syngene and an oral solid dosage facility in the US as part of its ongoing worldwide manufacturing capacity expansion. 

At 12:42 pm, the shares of Biocon were trading 3.04% lower at Rs 368.50 on NSE.

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