Lupin Limited (LUPIN) has received tentative approval from the U.S. FDA for its generic Sugammadex Injection, available in 200 mg/2 mL and 500 mg/5 mL single-dose vials. The product is a generic equivalent of Merck's Bridion Injection.
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by the muscle relaxants rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older.
The tentative approval means Lupin can launch the product in the U.S. once the reference drug's patent and exclusivity periods expire.
The company said the injection will be manufactured at its Nagpur facility in India. Lupin continues to expand its U.S. injectable and hospital-focused portfolio, with Sugammadex marking another addition to its pipeline of complex generics.
Lupin is a global pharmaceutical company headquartered in Mumbai, with a presence in more than 100 markets. Its portfolio spans generics, complex generics, biosimilars, and specialty products, supported by 15 manufacturing sites and seven R&D centers worldwide.
LUPIN.NS has traded between INR 1,795 and INR 2,377 over the past year. The stock closed yesterday's trading (March 30, 2026) at INR 2,313, down 0.90%.
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