Gland Pharma Wins USFDA Approval for Generic Bridion Injection, Launches Product in US
Written By : sheeba farhat
Published On 2026-07-29 17:02 GMT | Update On 2026-07-29 17:02 GMT
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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.
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