Lupin gets USFDA approval for two diabetes care injections

Mumbai, July 24, 2025 – Lupin Ltd (NSE: LUPIN, BSE: 500257) has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Applications (ANDAs) for Liraglutide Injection and Glucagon for Injection, both complex injectable products aimed at enhancing diabetes care in the United States.

Key Highlights

• Liraglutide Injection (18mg/3mL) corresponds to the reference drug Victoza® by Novo Nordisk Inc.
  • It is used as an adjunct treatment to diet and exercise for managing type 2 diabetes in patients aged 10 years and above.
  • The US market size for this product is approximately USD 458 million, as per IQVIA MAT data from May 2025.
• Glucagon for Injection (1mg/vial) corresponds to the reference drug Glucagon by Eli Lilly & Co.
  • It is prescribed for the treatment of severe hypoglycemia and also serves as a diagnostic aid in radiologic procedures.
  • This product has a US market size of USD 124 million, based on IQVIA MAT data from May 2025.

Both products will be manufactured at Lupin’s dedicated injectable facility in Nagpur, India, reaffirming the company’s focus on complex generics and injectable therapies.

Strategic Context

Notably, the RLD for Glucagon Eli Lilly’s formulation has been discontinued in the U.S. However, the FDA clarified that the product was not withdrawn for safety or efficacy reasons, thereby allowing approval of Lupin’s ANDA under 21 CFR §314.161.

Management Commentary

“We are pleased to obtain the USFDA approvals for two of our complex injectable products. This is a meaningful enhancement to our portfolio and reaffirms our commitment to expanding access to critical therapies for our patients,” said Dr. Shahin Fesharaki, Chief Scientific Officer, Lupin.

Lupin Stock Performance

Lupin shares have gained 1.36% on July 24, 2025, at 2:38 PM IST, trading at ₹1,946. Lupin shares have gained 7.22% in the last year, down 17% in the year-to-date, and up 0.82% in the previous month.

Lupin Ltd. opened the day at ₹1,921.50, with intraday movement between a low of ₹1,914.70 and a high of ₹1,955.90. The company’s market capitalisation stands at ₹88,910 crore. It currently trades at a price-to-earnings (P/E) ratio of 27.16. The dividend yield is 0.62%, with a quarterly dividend payout of ₹3.02 per share. Over the past 52 weeks, the stock has reached a high of ₹2,402.90 and a low of ₹1,792.00.

About Lupin

Lupin Limited is a leading Indian pharmaceutical company with a global footprint spanning over 100 markets. The company operates across several key therapeutic areas including respiratory, cardiovascular, anti-diabetic, CNS, and women’s health. With 15 manufacturing facilities and 7 research centers worldwide, Lupin employs over 24,000 professionals and continues to expand its complex generics and specialty portfolio.

REF:https://www.bseindia.com/xml-data/corpfiling/AttachLive/7888730c-1664-4f93-8499-9d4d60b51649.pdf

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