Lupin share down 3% as USFDA issues 5 observations for Biotech unit in Pune

Lupin share price: Pharmaceutical company Lupin shares dropped up to 2.64 per cent to hit an intraday low of Rs 2,139.55 per share on Monday, October 07, 2024. 

Lupin share price slipped in trade after the company announced that United States Food and Drug Administration (USFDA) has issued five observations for its Pune-based Biotech facility.

In an exchange filing, Lupin said, “We would like to inform you that the US FDA has completed a Pre-Approval Inspection of our Biotech facility located in Pune, India. The inspection was carried out from September 25, 2024 to October 4, 2024, and concluded with five observations.”

USFDA inspected the facility between September 25, 2024 until October 4, 2024, and concluded with five observations. 

“The company is addressing the observations comprehensively and will respond to the USFDA within the stipulated time frame,” Lupin said. 

Lupin financial performance

Lupin reported a 77.2 per cent year-on-year (Y-o-Y) increase in profit after tax (PAT) in the June quarter of financial year 2025 (Q1FY25) to Rs 801 crore. Lupin’s revenue from operations increased by 16.2 per cent Y-o-Y to Rs 5,514.3 crore. 

On a sequential basis, the company’s PAT grew 122.9 per cent while revenue soared 12.6 per cent. 

Lupin share price history 

Lupin share has zoomed over 65 per cent this year-to-date while it has gained over 87 per cent in the past year. However, the Lupin scrip has fallen about 2 per cent in the past month and about 1.5 per cent in the past 5 days. 

Lupin background 

Lupin Limited is a major pharmaceutical company, founded in 1968 by Desh Bandhu Gupta in India. 

Initially starting with a single manufacturing facility in Aurangabad, the company has since expanded to 11 plants across India and now operates in over 100 markets globally, including the US, South Africa, and Europe. 

Lupin has established itself as one of the largest generic pharmaceutical companies by revenue, specialising in a diverse range of products such as generic and branded formulations, biotechnology products, and active pharmaceutical ingredients (APIs).

Lupin is also recognised as a global leader in the Anti-TB and Cephalosporins segments, with considerable contributions in Cardiovascular health, Diabetology, Asthma, Pediatrics, and Central Nervous System disorders. 

The company prioritises research and development, operating two cutting-edge research centres in Pune and Aurangabad. These facilities focus on utilising advanced technologies to innovate and develop new pharmaceutical products, ensuring Lupin remains at the forefront of the industry.

At 11:22 AM, Lupin shares were trading 1.31 per cent lower at Rs 2,168.90 per share. In comparison, BSE Sensex was trading 0.34 per cent lower at 81,409.12 levels.