Gland Pharma has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Sugammadex Injection in 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial presentations.

The approved product is bioequivalent and therapeutically equivalent to Bridion Injection, the reference listed drug marketed by Merck Sharp & Dohme LLC.

Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and paediatric patients undergoing surgery.

Following the approval, Gland Pharma has commercially launched the product in the United States through its marketing partner. According to IQVIA data, the reference product recorded approximately USD 1.6 billion in US sales during the 12-month period ending April 2026.

Gland Pharma has evolved from a contract manufacturer of small-volume liquid parenteral products into one of the world's largest injectable-focused pharmaceutical companies. The company has established a presence across 60 countries, including the United States, Europe, Canada, Australia, India, and several other international markets.