Hyderabad: Gland Pharma Limited (Gland or Company), a generic injectable & ophthalmic- focusedpharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for itsAbbreviated New Drug Application filed for Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100mg/mL) Singlle-Dose Vials..
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD)),, BRIIDIOIONN®®Injection of Merck Sharp& Dohme LLC..
The Product is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuroniumbromide in adult and pediatric patients undergoing surgery.
The Company has successsffullly launched the Product on Day 1 through its marketing partner. According to IQVIA,theproduct had US salesof approximately USD1.6 billion for the twelve months ending April 2026.
