The approval covers 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 Merck Sharp & Dohme's BRIDION Injection. It is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery.

The company said it has commercially launched the product in the U.S. on the first day of approval through its marketing partner.

According to IQVIA, Sugammadex Injection recorded U.S. sales of about $1.6 billion during the 12 months ended April 2026, highlighting a sizeable market opportunity.

Gland Pharma is a Hyderabad-based pharmaceutical company focused on generic injectables and ophthalmics. It operates in more than 60 countries under a business-to-business model and offers a broad portfolio of sterile injectable products, including vials, ampoules, pre-filled syringes, lyophilized vials, infusions, oncology and ophthalmic solutions.

On a consolidated basis, Gland Pharma's net profit surged 96.57% to Rs 366.68 crore while net sales rose 22.31% to Rs 1742.79 crore in Q4 March 2026 over Q4 March 2025.