USFDA nod to Caplin Steriles Rocuronium Bromide Injection
Mumbai: Pharma major Lupin Limited has announced that its alliance partner Caplin Steriles Limited 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.
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. The company invested 8.7% of its revenue in research and development in FY22.