By: IPP Bureau
Last updated : July 30, 2026 8:53 am
Day-1 launch targets USD 1.6 billion US market for neuromuscular blockade reversal drug
Gland Pharma Lminited has received approval from the US Food and Drug Administration (USFDA) 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 (Sugammadex) Injection of Merck Sharp & Dohme LLC and is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and paediatric patients undergoing surgery.
Gland Pharma said it has successfully executed a Day-1 commercial launch of the product in the US 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, presenting a significant market opportunity for the company.
The approval further strengthens Gland Pharma's portfolio of complex injectable products in the US market and reinforces its strategy of expanding its presence in high-value generic injectables.