Lupin Limited today announced that its alliance partner Caplin Steriles Limited has received final approval from the United States Food and Drug Administration (U.S.FDA) for its Abbreviated New Drug Application (ANDA) Rocuronium Bromide Injection, via an exchange filing.
The approved dosages are 10mg/mL in 5 mL and 10 mL Multi-Dose Vials, to market a generic version of Zemuron Bromide Injection, 50 mg/5 mL and 100 mg/10 mL of Organon USA Inc.
Rocuronium Bromide Injection (RLD: Zemuron) had an annual sale of approximately USD 53 million in the U.S. (IQVIA MAT December 2022).
