**Lupin Secures Tentative Green Light from US FDA for Generic Janumet Tablets**
Lupin Limited, a prominent player in the global pharmaceutical sector, recently shared news of its tentative approval from the United States Food and Drug Administration (FDA). This nod pertains to their Abbreviated New Drug Application for sitagliptin and metformin hydrochloride tablets available in dosages of 50 mg/500 mg and 50 mg/1000 mg, marking them as a generic substitute for Janumet tablets, specifically 50 mg/500 mg and 50 mg/1000 mg, originally from Merck Sharp & Dohme LLC. Production of these tablets will occur at Lupin’s manufacturing facility situated in Pithampur, India.
**Purpose and Maximum Market Value**
The sitagliptin and metformin hydrochloride tablets, in doses of 50 mg/500 mg and 50 mg/1000 mg, serve as an adjunctive therapy to diet and exercise, enhancing glycemic control in adult patients living with type 2 diabetes mellitus. These tablets, known commercially as Janumet, have seen impressive financial success, with an estimated yearly sale hitting USD 1.145 billion in the US market, according to the September 2024 report from IQVIA MAT.
**About Lupin Limited**
Based in Mumbai, India, Lupin Limited stands out as a global pharmaceutical leader, with its products reaching over 100 different markets. The company dedicates its expertise to a diverse range of pharmaceutical categories, including branded and generic drug formulations, complex generics, biotechnology innovations, and active pharmaceutical ingredients.