Lupin Limited Gains U.S. FDA Approval and Launches Sugammadex Injection

Lupin Limited Gains U.S. FDA Approval and Launches Sugammadex Injection

Lupin Limited Gains U.S. FDA Approval and Launches Sugammadex Injection​

Global pharmaceutical major Lupin Limited announced that it has successfully launched Sugammadex Injection in the United States, following approval from the United States Food and Drug Administration (U.S. FDA). The launch marks a significant milestone for the company in its focus on respiratory and critical care markets.

The U.S. FDA granted approval for Abbreviated New Drug Application (ANDA) for Lupin’s Sugammadex Injection. This bioequivalent medication is designed to reverse neuromuscular blockade induced by rocuronium bromide and vecuronium bromide. It has been launched in two forms: a 200 mg/2 mL (100 mg/mL) Single-Dose Vial and a 500 mg/5 mL (100 mg/mL) Single-Dose Vial.

Sugammadex Injection is indicated for use in adults and pediatric patients aged 2 years and older who are undergoing surgery, serving as the bioequivalent to Bridion® Injection of Merck Sharp & Dohme LLC.

Profile of Lupin Limited​

Lupin Limited is a pharmaceutical leader with global operations, headquartered in Mumbai, India, and products distributed across more than 100 markets. The company specializes in various pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

Lupin maintains a strong position in the U.S. and India, catering to multiple therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. The company operates 15 state-of-the-art manufacturing sites and 7 research centers globally, supported by a workforce exceeding 26,000 professionals.

Lupin’s commitment to improving patient outcomes is extended through its dedicated subsidiaries: Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

LUPIN Stock Price Movement​

Shares of Lupin Limited are creeping up to ₹2421.7 as of 11:22 AM today, advancing by 0.02% in live trading. The stock trades on a volume of 292,052 shares as investors monitor the movement in the pharmaceutical sector.
 

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