Biocon share jumps 6% on USFDA's 'VAI' tag to Bengaluru facility; details

The surge in Biocon share price came after the company announced that United States Food and Drug Administration (USFDA) has classified Biocon Biologics' Biocon Park Site in Bengaluru as VAI

Biocon share price: Pharmaceutical company Biocon share price rose up to 5.69 per cent to hit an intraday high of Rs 339.55 per share on Monday, November 11, 2024. 

 

The surge in Biocon share price came after the company announced that United States Food and Drug Administration (USFDA) has classified Biocon Biologics’ Biocon Park Site in Bengaluru as Voluntary Action Inidicated (VAI).

 

This is related to the combined current good manufacturing practices (cGMP) inspection and Pre-Licensing Inspection (PLI) conducted by the USFDA between July 15 – 26, 2024. 

 

“The inspection scope had included six (6) separate Biologics manufacturing units comprising of four (4) Drug Substance and two (2) Drug Product manufacturing plants as well as five (5) Analytical Quality Control Laboratories, four (4) Microbiology Laboratories, and two (2) Warehouses,” the company spokesperson said in a statement.

 

 

Biocon Biologics remains committed to global standards of Quality and Compliance, the company spokesperson added.

 

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. 

 

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. 

 

The market capitalisation of Biocon is Rs 40,736 crore, according to BSE. The company falls under the BSE 200 category.

 

At 10:44 AM, Biocon shares were trading 5.62 per cent higher at Rs 339.30 per share. In comparison, BSE Sensex was trading 0.28 per cent higher at 79.705.53 levels.