Global pharma major Lupin Limited on Wednesday announced the launch of Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Multiple-Dose Vials, after Lupin’s alliance partner Caplin Steriles Limited (Caplin) received an approval for its ANDA from the United States Food and Drug Administration (U.S. FDA).
According to the company’s statement, Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Multiple-Dose Vials is the generic version of Zemuron Injection, 50 mg/5 mL and 100 mg/10 mL of Organon USA Inc.
It is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Rocuronium Bromide Injection (RLD: Zemuron) had estimated annual sales of USD 54 million in the U.S. (IQVIA MAT August 2023).