Lupin Limited has announced a significant milestone with the receipt of tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Sugammadex Injection. This approval pertains to the Abbreviated New Drug Application for Sugammadex Injection, available in 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vials.
The U.S. FDA’s tentative approval recognises Lupin‘s Sugammadex Injection as bioequivalent to Merck‘s Bridion® Injection. The drug is intended for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in both adult and paediatric patients aged two years and older who are undergoing surgery.
Lupin Limited, a global pharmaceutical leader headquartered in Mumbai, India, distributes its products across more than 100 markets. The company specialises in a range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. It holds a strong market position in India and the U.S. across various 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 seven research centres globally, supported by a dedicated workforce of over 22,000 professionals. Lupin is committed to enhancing patient health outcomes through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
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Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).