Lupin secures USFDA tentative nod for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets
Mumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (U.S.FDA) for its Abbreviated New Drug Application for Empagliflozin, Linagliptin and Metformin Hydrochloride Extended-Release (ER) Tablets, 5 mg/2.5 mg/1,000 mg, 10 mg/5 mg/1,000 mg, 12.5 mg/2.5 mg/1,000 mg, and 25 mg/5 mg/1,000 mg, to market a generic equivalent of Trijardy XR Extended-Release Tablets, 5 mg/2.5 mg/1,000 mg, 10 mg/5 mg/1,000 mg, 12.5 mg/2.5 mg/1,000 mg, and 25 mg/5 mg/1,000 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India.
Empagliflozin, Linagliptin and Metformin Hydrochloride Extended-Release (ER) Tablets (RLD Trijardy XR) had an estimated annual sale of USD111million in the U.S. (IQVIA MAT April 2024).
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 7.8% of its revenue in research and development in FY24.
Lupin has 15 manufacturing sites, 7 research centers.
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