Gland Pharma Limited announced receipt of approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sugammadex Injection in two dosage strengths: 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) Single-Dose Vials.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), BRIDION® Injection manufactured by Merck Sharp & Dohme LLC.
Product Indication
The injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery.
Market Launch and Size
The company successfully launched the product on Day 1 through its marketing partner. According to IQVIA data, the product had US sales of approximately USD 1.6 billion for the twelve months ending April 2026.
Company Background
Gland Pharma, established in 1978 in Hyderabad, has grown into one of the largest injectable-focused companies with a global footprint across 60 countries. The company operates primarily under a business-to-business (B2B) model and has expertise in developing, manufacturing, and marketing sterile injectables including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.