Lupin bags USFDA nod for generic equivalent of Nascobal Nasal Spray
Mumbai:Global pharma major, Lupin Limited, has announced that the Company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Cyanocobalamin Nasal Spray, 500 mcg/spray (One Spray per Device).
The product is a generic equivalent of Nascobal Nasal Spray, 500 mcg/spray of Par Pharmaceutical, Inc. This product will be manufactured at Lupin’s Somerset facility in the US.
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023).
Cyanocobalamin is a form of vitamin B12 used for the treatment of deficiency of vitamin B12.
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, 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.
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