Lupin’s alliance partner gets USFDA’s final approval for Rocuronium Bromide Injection

20 Mar 2023 Evaluate

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.

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