Lupin Limited announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) and launched Sugammadex Injection in the United States.
The product is launched in 200mg/2 mL (100mg/mL) and 500mg/5 mL (100 mg\mL) Single-Dose Vials. Lupin’s Sugammadex Injection is the bioequivalent to Bridion® Injection of Merck, Sharp & Dohme LLC.
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery.
“The U.S. FDA approval and launch of Sugammadex Injection marks another key milestone in expanding our portfolio of complex generic formulations in the United States,” the company noted in its announcement. “We remain focused on bringing critical, high-quality generic treatments to healthcare providers and patients.”
Headquartered in Mumbai, India, Lupin is a global pharmaceutical leader whose products are distributed across more than 100 markets. The company specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin holds a strong market position in India and the U.S. across key therapeutic areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Armed with 15 state-of-the-art manufacturing facilities and 7 research centres globally, Lupin relies on a dedicated workforce of over 26,000 professionals.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
