Lupin receives US FDA Approvals for Liraglutide and Glucagon Injectable Products

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Applications for Liraglutide Injection Single-Patient-Use Prefilled Pens and Glucagon for Injection vials. Both these products will be manufactured at Lupin's Injectable facility at Nagpur, India.

Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen is bioequivalent to Victoza® Injection, 18 mg/3 mL (6 mg/mL) of Novo Nordisk Inc. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older, with type 2 diabetes mellitus. Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen (RLD Victoza®) had an estimated annual sale of USD 458 million in the U.S. (IQVIA MAT May 2025).

Glucagon for Injection USP, 1 mg/vial, packaged in an emergency kit1, is bioequivalent to Glucagon for Injection, 1 mg/vial of Eli Lilly and Company. It is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus and as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Glucagon for Injection USP, 1 mg/vial, had an estimated annual sale of USD 124 million in the U.S. (IQVIA MAT May 2025).

Dr. Shahin Fesharaki, Chief Scientific Officer, Lupin said, "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."

Shares of Lupin Limited was last trading in BSE at Rs. 1950.95 as compared to the previous close of Rs. 1943.40. The total number of shares traded during the day was 21631 in over 2368 trades.

The stock hit an intraday high of Rs. 1960.55 and intraday low of 1925.30. The net turnover during the day was Rs. 42221872.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals USFDA Approvals Liraglutide Glucagon InjectableProducts