Lupin’s alliance partner Caplin Steriles (Caplin) has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated new Drug Application (ANDA) Rocuronium Bromide Injection, 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 around $53 million in the U.S. (IQVIA MAT December 2022).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.