Lupin unveils Rocuronium Bromide Injection in US

Mumbai: Global pharma major Lupin Limited today 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 received an approval for its ANDA from the United States Food and Drug Administration (U.S. FDA).

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. and 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).

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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites.

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