Indian Economy News

Lupin Limited launches generic anti-diabetic tablets in United States

Global pharmaceutical major Lupin Limited has launched its generic anti-diabetic medication, Dapagliflozin and Metformin Hydrochloride extended-release tablets, in the United States, marking a further expansion of its generics portfolio in a key international market. The launch follows approval from the US Food and Drug Administration (USFDA) under the abbreviated new drug application (ANDA) pathway. The product is bioequivalent to the reference drug Xigduo XR and will be marketed for the same indications, primarily targeting glycaemic control in adults with type 2 diabetes. The therapy has been introduced in multiple dosage strengths, including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg and 10 mg/1,000 mg, enabling flexible treatment options for patients.

This launch reinforces Lupin’s strategy to strengthen its presence in the US generics market, particularly in high-demand therapeutic segments such as diabetes care. The combination drug offers an extended-release formulation, which is designed to improve patient compliance by reducing dosing frequency while maintaining effective glucose control. With a strong footprint across global markets and a diversified portfolio covering generics, branded formulations and complex therapies, the company continues to focus on expanding access to affordable medicines. The US remains a critical market for Indian pharmaceutical companies, and such product introductions highlight ongoing efforts to capitalise on regulatory approvals and growing demand for cost-effective treatment alternatives in chronic disease management.

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