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

Lupin Shares Drop 3% Amidst USFDA Observations on Biotech Unit in Pune
Real Estate Pune:Pharmaceutical company Lupin's shares fell by 3% on Monday, hitting an intraday low of Rs 2,139.55 per share. This decline came after the United States Food and Drug Administration (USFDA) issued five observations following a Pre-Approval Inspection of the company’s Biotech facility in Pune, India.

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.

Related News Articles

Aadhar Housing Finance Eyes Sustained Growth of Over 20% in Disbursements and Asset Base
real estate news

Aadhar Housing Finance Eyes Sustained Growth of Over 20% in Disbursements and Asset Base

Aadhar Housing Finance projects disbursements and assets under management to grow at over 20% this year

May 30, 2024
Read Article
No Reversal on Real Estate LTCG Tweaks: Government Stands Firm
Real Estate

No Reversal on Real Estate LTCG Tweaks: Government Stands Firm

Government sources have confirmed that there will be no reevaluation of the changes made to Long Term Capital Gains tax (LTCG) in the Union Budget, despite concerns over the removal of Indexation benefit on property sales.

July 24, 2024
Read Article
Navigating the Industrial REIT Landscape: A SWOT Analysis of EastGroup Properties
Real Estate

Navigating the Industrial REIT Landscape: A SWOT Analysis of EastGroup Properties

EastGroup Properties, a real estate investment trust (REIT) specializing in industrial properties, is at a crossroads in the ever-evolving industrial REIT landscape.

September 28, 2024
Read Article
Godrej Group Makes Major Move in Mumbai Real Estate by Acquiring Land for Rs 81 Crore
real estate news

Godrej Group Makes Major Move in Mumbai Real Estate by Acquiring Land for Rs 81 Crore

In a strategic move, Godrej Group, through its real estate subsidiary Anamudi Real Estates, has acquired a significant plot of land in the bustling city of Mumbai for Rs 81 crore. This acquisition marks a major step in the company's expansion plans in one

February 8, 2025
Read Article
Why Pattaya is the Next Big Thing for Indian Property Investors
Real Estate Mumbai

Why Pattaya is the Next Big Thing for Indian Property Investors

A luxury sea-view condo in Pattaya costs as much as a mid-range apartment in Mumbai. Discover why Pattaya is quickly becoming a hot spot for Indian property investors, offering exceptional value and potential returns.

February 24, 2025
Read Article
Akshaya Tritiya: Can It Spark a Surge in Real Estate Demand?
real estate news

Akshaya Tritiya: Can It Spark a Surge in Real Estate Demand?

With reduced EMIs making home loans more affordable, Akshaya Tritiya could be the catalyst for a surge in real estate demand, especially in the luxury and high-end market segments.

April 28, 2025
Read Article