The approval covers strengths of 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) in single-dose vials, the company said in a statement.
The product has been deemed bioequivalent to Merck & Co.'s Bridion Injection. It 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.
Tentative approval indicates that the drug meets all regulatory requirements but cannot be marketed in the United States until the expiry of applicable exclusivities or patents.
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
The pharmaceutical company reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025.