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Lupin’s partner Caplin receives US FDA approval for rocuronium bromide injection

Our Bureau, Mumbai
Monday, March 20, 2023, 17:40 Hrs  [IST]

Global pharma major Lupin Limited (Lupin) announced that its alliance partner Caplin Steriles Limited (Caplin) has received final approval from the United States Food and Drug Administration (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 (Zemuron) had an annual sale of approximately USD 53 million in the US (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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.


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