Shares of Zydus Lifesciences Ltd are trading flat after hitting a day’s high of Rs 947.95 on 28th November, despite the firm announced on Thursday (27th November) that it 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 empagliflozin and linagliptin combination is used alongside diet and exercise to help adults with type 2 diabetes control blood sugar. The tablets will be made at Zydus Lifesciences’ formulation facility in Ahmedabad SEZ.

In the US, these tablets recorded annual sales of $215.8 million for the year ending September 2025. With this tentative FDA approval, Zydus now has 428 approvals and has filed 487 ANDAs since FY2003-04.

Zydus Lifesciences Second Quarter Results

Zydus Lifesciences’ consolidated net profit rose 39% YoY to Rs 1,259 crore from Rs 911 crore. This was boosted by strong business across markets and higher forex gains. The company reported a forex gain of Rs 414 crore, up from Rs 45 crore last year. R&D spending was Rs 482 crore, or 7.9% of revenue, demonstrating continued focus on innovation and complex generics.

Quarterly revenue grew 17% YoY to Rs 6,123 crore. This growth was driven by strong US and India formulations sales. EBITDA jumped 38% to Rs 2,014 crore, with margins rising to 32.9% from 27.9%. This was helped by a better product mix and cost control.

At 1:03 PM, shares of Zydus Lifesciences were trading 0.36% higher at Rs 940.60 on NSE.

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