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Global pharma major Lupin Limited (Lupin) announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for sitagliptin and metformin hydrochloride tablets, 50 mg/500 mg and 50 mg/1000 mg, to market a generic equivalent of Janumet tablets, 50 mg/500 mg and 50 mg/1000 mg of Merck Sharp & Dohme LLC. This product will be manufactured at Lupin’s Pithampur facility in India.
Sitagliptin and metformin hydrochloride tablets, 50 mg/500 mg and 50 mg/1000 mg are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
Sitagliptin and metformin hydrochloride tablets, 50 mg/500 mg and 50 mg/1000 mg (Janumet tablets) had an estimated annual sale of USD 1,145 million in the US (IQVIA MAT September 2024).
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
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