Zydus gets USFDA nod, brings cheaper cancer drug to India

Zydus Lifesciences Ltd on Friday, January 23, said the US Food and Drug Administration (USFDA) concluded an inspection at its Unit-2 manufacturing plant in Ankleshwar, Gujarat, which ran from 19 to 23 January, 2026.

The inspection closed with three observations, none of which were related to data integrity. The company said it will work closely with the USFDA to address the observations expeditiously.

In a separate development, Zydus also announced the launch of Tishtha™, the world’s first biosimilar

of the cancer immunotherapy drug Nivolumab, in India. The therapy, used to treat multiple cancers, will be available at nearly one-fourth the cost of the reference drug, marking a major step in improving access to advanced oncology treatments. Tishtha™ will be sold in two dosages — 100 mg at ₹28,950 and 40 mg at ₹13,950 — allowing oncologists to optimise dosing while minimising drug wastage.

Meanwhile, in response to reports that Zydus is in talks to acquire US biopharmaceutical firm Ardelyx, the company declined to comment on business development activities. Sources told CNBC-TV18 on 20 January that Zydus may acquire a controlling stake in Ardelyx or buy select molecules as part of the proposed transaction.

Shares of Zydus Lifesciences Ltd ended lower on Friday, January 23, by 0.26% at 883.00 on the NSE.

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