Mumbai, Baltimore, March 20, 2023: Global pharma major Lupin Limited (Lupin) today announced that its alliance partner Caplin Steriles Limited (Caplin) 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, 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).
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 enjoys a leadership position 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. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 8.7% of its revenue in research and development in FY22.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information.
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*Safe Harbor Statement
Zemuron® is a registered trademark of Organon USA Inc.