Lupin bags USFDA nod for Chlorpromazine Hydrochloride Tablets
Mumbai: Global pharma major Lupin Limited has announced that its wholly-owned subsidiary, Lupin Inc., based in Somerset, New Jersey, has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg.
The product is a generic equivalent to the reference listed drug (RLD), Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg of Upsher-Smith Laboratories, LLC.
This product will be manufactured at Lupin’s Somerset facility in the U.S.
Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S. (IQVIA MAT Mar 2023).
Read also: Lupin Dolutegravir Tablets for Oral Suspension gets tentative USFDA nod for HIV/AIDS
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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