Lupin unveils Diazepam Rectal Gel in US
Mumbai: Global pharma major Lupin Limited has announced the launch of Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System, after its wholly owned subsidiary, Novel Laboratories Inc., based in Somerset, New Jersey received an approval for its ANDA from the United States Food and Drug Administration (U.S. FDA).
Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System is the generic version of Diastat AcuDial Rectal Delivery System, 10 mg and 20 mg, of Bausch Health US, LLC.
Diazepam Rectal Gel (RLD Diastat AcuDial) had estimated annual sales of USD 37 million in the U.S. (IQVIA MAT September 2023).
Read also: Lupin secures tentative USFDA nod for Selexipag for Injection
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.
Read also: Lupin bags tentative USFDA nod for generic equivalent of Janssen Biotech Erleada Tablets
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