Lupin Shares Drop 3% Amidst USFDA Observations on Biotech Unit in Pune
Pharmaceutical giant Lupin's shares took a hit of 3% on Monday after the US Food and Drug Administration (USFDA) issued five observations during a Pre-Approval Inspection of its Biotech facility in Pune. The company assured a comprehensive response to the
LupinUsfdaBiotechPharmaceuticalPuneReal Estate PuneOct 07, 2024
In an exchange filing, Lupin stated, “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.”
The USFDA's inspection, which lasted from September 25 to October 4, 2024, resulted in five observations. Lupin assured stakeholders that they are addressing the observations comprehensively and will respond to the USFDA within the stipulated time frame.
Despite the recent setback, Lupin has reported a robust financial performance. In the June quarter of the financial year 2025 (Q1FY25), the company saw a 77.2% year-on-year (Y-o-Y) increase in profit after tax (PAT) to Rs 801 crore. Revenue from operations also grew by 16.2% Y-o-Y to Rs 5,514.3 crore. On a sequential basis, the company’s PAT grew by 122.9%, and revenue increased by 12.6%.
Lupin's share price has had a volatile year. As of the year-to-date, the share has surged by 65%, and it has gained 87% over the past year. However, in the past month, the Lupin scrip has fallen by about 2%, and it has slipped by 1.5% in the past five days.
Lupin Limited, founded in 1968 by Desh Bandhu Gupta, is a major pharmaceutical company based in India. Initially starting with a single manufacturing facility in Aurangabad, the company has expanded to 11 plants across India and operates in over 100 markets globally, including the US, South Africa, and Europe. Known for its diverse range of products, including generic and branded formulations, biotechnology products, and active pharmaceutical ingredients (APIs), Lupin is a global leader in the Anti-TB and Cephalosporins segments. The company also makes significant contributions to Cardiovascular health, Diabetology, Asthma, Pediatrics, and Central Nervous System disorders.
Research and development are at the core of Lupin’s operations, with two cutting-edge research centres located in Pune and Aurangabad. These facilities leverage advanced technologies to innovate and develop new pharmaceutical products, ensuring that Lupin remains a leader in the industry.
At 11 22 AM, Lupin shares were trading 1.31% lower at Rs 2,168.90 per share. In comparison, the BSE Sensex was trading 0.34% lower at 81,409.12 levels.
Frequently Asked Questions
Why did Lupin's shares drop?
Lupin's shares dropped by 3% after the US Food and Drug Administration (USFDA) issued five observations following a Pre-Approval Inspection of the company’s Biotech facility in Pune, India.
What is the USFDA's observation about Lupin's Biotech facility in Pune?
The USFDA conducted a Pre-Approval Inspection of Lupin's Biotech facility in Pune from September 25 to October 4, 2024, and concluded with five observations. Lupin is addressing these observations comprehensively and will respond within the stipulated time frame.
How has Lupin's financial performance been recently?
Lupin reported a 77.2% year-on-year increase in profit after tax (PAT) to Rs 801 crore in the June quarter of financial year 2025 (Q1FY25). Revenue from operations increased by 16.2% Y-o-Y to Rs 5,514.3 crore.
What is Lupin's share price performance over the past year?
Lupin's share price has surged by 65% this year-to-date and has gained 87% over the past year. However, it has fallen by about 2% in the past month and 1.5% in the past five days.
What is Lupin's focus on research and development?
Lupin prioritizes research and development, operating two cutting-edge research centres in Pune and Aurangabad. These facilities focus on utilizing advanced technologies to innovate and develop new pharmaceutical products, ensuring that Lupin remains at the forefront of the industry.
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