Zydus Life gets tentative FDA nod for empagliflozin and linagliptin tablets to treat type 2 diabetes

Pharmaceutical firm Zydus Lifesciences Ltd on Thursday (November 27) has received tentative approval from the United States Food and Drug Administration (FDA) for empagliflozin and linagliptin tablets in strengths of 10 mg/5 mg and 25 mg/5 mg. The reference drug for these combinations is Glyxambi tablets, 10 mg/5 mg and 25 mg/5 mg.

The combination of empagliflozin and linagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when

treatment with both empagliflozin and linagliptin is appropriate. The tablets will be produced at the group’s formulation manufacturing facility at the SEZ in Ahmedabad.

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Empagliflozin and linagliptin tablets recorded annual sales of $215.8 million in the United States for the period ended September 2025, according to IQVIA MAT data. With this tentative approval, the group now has 428 approvals and has filed 487 ANDAs since the commencement of the filing process in FY2003-04.

Second Quarter Results

Zydus Lifesciences' consolidated net profit rose 39% year-on-year to ₹1,259 crore, compared with ₹911 crore in the same period last year. The growth was supported by healthy business momentum across geographies and a sharp rise in forex gains.

The company recorded a foreign exchange gain of ₹414 crore, compared with ₹45 crore in the previous year. Research and development (R&D) expenditure stood at ₹482 crore, or 7.9% of revenue, reflecting continued investment in innovation and complex generics.

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Revenue for the quarter climbed 17% year-on-year to ₹6,123 crore, led by strong performance in the company’s US and India formulations businesses. Operating profitability improved significantly, with EBITDA surging 38% to ₹2,014 crore, while margins expanded to 32.9% from 27.9% a year earlier, aided by a richer product mix and disciplined cost control.

Shares of Zydus Lifesciences Ltd ended at ₹936.50, down by ₹3.95, or 0.42%, on the BSE today, November 27.