Lupin Receives Tentative FDA Approval for Sugammadex Injection
Mumbai, India, Naples, FL, March 31, 2026 – Lupin Limited (BSE: 500257) (NSE: LUPIN) announced today it received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) Single-Dose Vial.The FDA’s tentative approval designates Lupin’s Sugammadex Injection as bioequivalent to Merck’s Bridion® Injection. This product is intended for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery.
Lupin Limited is a global pharmaceutical company based in Mumbai, India, with a presence in over 100 markets. The company focuses on pharmaceutical products including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin operates 15 manufacturing sites and 7 research centers worldwide, employing more than 22,000 professionals.
About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.Source:
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