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Biocon share falls 4% after USFDA issues VAI tag for Bengaluru's API unit

Biocon's Bengaluru API facility was inspected between September 23 to September 27, 2024

biocon
SI Reporter New Delhi
3 min read Last Updated : Dec 09 2024 | 10:38 AM IST
Biocon share price: Shares of biotechnology company Biocon slipped up to 4.14 per cent to hit an intraday low of Rs 364.15 per share on Monday, December 9, 2024.
 
The fall in Biocon share price came after the company announced that it has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the United States Food and Drug Administration (USFDA), for its active pharmaceutical ingredient (API) facility (Site 2), located at Special Economic Zone (SEZ) Plot number 2,3,4 and 5 Bommasandra-Jigani link road, Bengaluru, Karnataka. 
 
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 company’s Bengaluru API facility was inspected between September 23 to September 27, 2024.
 
About Biocon
 
Biocon is among the leading global biotechnology companies, focused on manufacturing innovative biotechnology products and providing research services. The company operates through several business segments, including Biosimilars, Research Services, Generics, and Novel Biologics. 

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Biocon Biologics, its biosimilars arm, holds a portfolio of 20 biosimilars spanning across critical therapeutic areas such as oncology, immunology, and diabetes, with significant market share in advanced markets. The company also has a robust pipeline of over 20 molecules expected to be launched by 2030. 
 
Syngene, its research services arm, is an independent entity that offers comprehensive discovery, development, and manufacturing services to various industries, including pharmaceuticals, biotechnology, and consumer goods.
 
The company’s generics division specialises in the manufacture of active pharmaceutical ingredients (APIs) with an extensive portfolio of over 50 products, including high-potency molecules. Biocon has made strides in novel biologics, with the introduction of India’s first indigenously produced monoclonal antibody, Nimotuzumab, and Itolizumab for treating psoriasis. 
 
The company continues to expand its manufacturing capacity globally, including a recent acquisition of a US oral solid dosage facility and a biologics manufacturing facility through Syngene. 
 
Biocon share price history
 
Biocon shares have gained about 5 per cent in the past month. The scrip has surged nearly 8 per cent in the last six months. In comparison, BSE Sensex has gained about 6.5 per cent in the past six months.
 
The market capitalisation of Biocon is Rs 43,845.91 crore, according to BSE. The company falls under the BSE 200 category.
 
At 10:22 AM, Biocon shares were trading 3.87 per cent lower at Rs 365.20 per share. By comparison, BSE Sensex was trading 0.24 per cent lower at 81,511.40 levels.

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Topics :Buzzing stocksBSE NSENSE Nifty50 benchmark indexIndian stock exchangesPharma stocksBiocon stocksBioconUSFDA

First Published: Dec 09 2024 | 10:30 AM IST

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