Lupin Limited has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Sugammadex Injection and has commenced commercial launch of the product in the United States. The approval marks another milestone in the company’s strategy to strengthen its portfolio of complex injectable medicines in one of the world’s largest pharmaceutical markets.
The newly launched Sugammadex Injection is available in two single-dose vial presentations—200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL). The product has been approved as a bioequivalent version of Bridion® Injection, marketed by Merck Sharp & Dohme LLC, offering healthcare providers an additional treatment option for reversing neuromuscular blockade during surgical procedures.
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged two years and above undergoing surgery. The medicine is designed to facilitate recovery from muscle relaxation following anesthesia, helping clinicians manage patient care during the post-operative phase.
The US FDA approval and commercial launch further reinforce Lupin’s commitment to expanding its specialty and hospital product portfolio while addressing the growing demand for high-quality, cost-effective pharmaceutical solutions. The company continues to focus on bringing complex generic products to market through sustained investment in research, manufacturing, and regulatory capabilities.
Headquartered in Mumbai, India, Lupin is one of the world’s leading pharmaceutical companies, with a presence in more than 100 countries. Its business spans branded and generic medicines, complex generics, biotechnology products, and active pharmaceutical ingredients, serving healthcare providers and patients across developed and emerging markets.
The company has built a strong presence in key therapeutic segments, including respiratory care, cardiovascular medicine, diabetes management, anti-infectives, gastroenterology, central nervous system disorders, and women’s health. Its diversified product portfolio and global commercial network have enabled Lupin to establish a significant position in both the Indian and U.S. pharmaceutical markets.
Lupin supports its global operations through 15 advanced manufacturing facilities and seven research and development centers located across multiple countries. Backed by a workforce of more than 26,000 professionals, the company continues to invest in scientific innovation, product development, and manufacturing excellence.
In addition to its core pharmaceutical business, Lupin is expanding its healthcare ecosystem through subsidiaries focused on diagnostics, digital health, and manufacturing solutions. These initiatives reflect the company’s broader objective of improving patient outcomes by delivering innovative healthcare products and services while strengthening access to quality treatment across global markets.
