Zydus Lifesciences Ltd Share Price – NSE /  BSE

Pharmaceuticals, Mid Cap

Zydus Lifesciences announced that the USFDA has granted Orphan Drug Designation (ODD) to Desidustat, a novel oral HIF-PHI, for the treatment of Sickle Cell Disease (SCD). The USFDA's Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States.

Orphan drug designation by the USFDA for Desidustat, provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and a potential seven-year marketing exclusivity upon the USFDA approval.

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Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg (USRLD: Farxiga? Tablets, 5 mg and 10 mg).

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

Dapagliflozin tablets will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad.

Dapagliflozin tablets had annual sales of USD 10,486.9 mn in the United States (IQVIA MAT December 2025).

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Zydus Lifesciences will hold a meeting of the Board of Directors of the Company on 9 February 2026.

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Zydus Lifesciences announced that the USFDA conducted an inspection at the group's Unit ? 2 manufacturing plant at Ankleshwar, Gujarat. The inspection was conducted from 19th to 23rd January, 2026 and concluded with 3 observations. There were no data integrity related observations. The Company will closely work with the USFDA to address the observations expeditiously.

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