Zydus Lifesciences Limited has informed the Exchange regarding a press release dated November 27, 2025, titled "Zydus receives tentative approval from USFDA for Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg".
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Zydus Lifesciences has received a tentative approval from the US health regulator (USFDA) for its generic version of Empagliflozin and Linagliptin Tablets in two strengths — 10 mg/5 mg and 25 mg/5 mg. This combination drug is commonly used for treating type 2 diabetes. A tentative approval means the regulator has found the product safe and effective, but Zydus cannot launch it in the US market immediately due to existing patent or exclusivity protections on the brand-name version. Once those restrictions expire, Zydus will be eligible to market the generic in the US. The approval adds to Zydus's growing portfolio of generic drugs targeting the US market, which is a key growth area for the company.
Positive for long-term revenue from the US generics business, though there is no immediate boost to earnings since launch depends on patent expiry. Shareholders should view this as steady progress in expanding Zydus's US product pipeline rather than a near-term catalyst.