Gland Pharma Wins USFDA Approval for Generic Bridion Injection, Launches Product in US
Hyderabad: Gland Pharma Limited has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sugammadex Injection in strengths of 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vials.
The approved product is bioequivalent and therapeutically equivalent to BRIDION (Sugammadex) Injection, the reference listed drug (RLD) of Merck Sharp & Dohme LLC.
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery.
Gland Pharma said it has commercially launched the product in the United States on the first day of approval through its marketing partner.
According to IQVIA data cited by the company, the reference product recorded U.S. sales of approximately $1.6 billion for the 12-month period ending April 2026, highlighting the significant market opportunity for the generic version.
Established in 1978 and headquartered in Hyderabad, Gland Pharma is an injectable-focused pharmaceutical company with operations across more than 60 countries, including the United States, Europe, Canada, Australia, and India. The company primarily operates under a business-to-business (B2B) model and develops, manufactures, and markets a broad portfolio of sterile injectable products, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powder injectables, infusions, oncology products, and ophthalmic solutions. It is also recognized for pioneering Heparin technology in India.
