Lupin Limited announced that it has received U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Sugammadex Injection. The company has now launched the bioequivalent injection in the United States. This approval allows Lupin to offer a critical medication used for the reversal of neuromuscular blockade in adult and pediatric patients undergoing surgery, expanding its U.S. market presence.
Lupin Secures U.S. FDA Approval for Sugammadex Injection
Global pharmaceutical major, Lupin Limited, announced on July 31, 2026, that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA). Following this approval, the company has launched Sugammadex Injection in the United States market. The product is available in 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vials.
Bioequivalent and Therapeutic Use
Lupin’s Sugammadex Injection is bioequivalent to Bridion® Injection, manufactured by Merck, Sharp & Dohme LLC. It is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide. The drug can be administered to both adult and pediatric patients aged 2 years and older who are undergoing surgical procedures requiring such reversal agents.
Company Profile and Market Reach
Headquartered in Mumbai, India, Lupin Limited is a global pharmaceutical leader with products distributed in over 100 markets. The company specializes in a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has a significant presence in India and the U.S. across various therapeutic 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 of over 26,000 professionals. Lupin is committed to enhancing patient health outcomes through its subsidiaries: Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
Source: BSE
