Shares of Zydus Lifesciences Ltd. recovered from the lows of the day to surge after the company announced that it has managed to get a tentative approval for a cancer treatment drug from the US drug regulator.The pharma company, in an exchange filing, said that it has received tentative approval from the United States Food and Drug Administration (USFDA) for Ibrutinib tablets 140 mg, 280 mg, and 420 mg variants (USRLD: Imbruvica® tablets, 140 mg, 280 mg and 420 mg).
Ibrutinib is used for the treatment of chronic lymphocytic leukaemia (CLL) / small lymphocytic lymphoma (SLL) with 17p deletion and Waldenstrom’s macroglobulinemia (WM).
This drug will be manufactured in the company’s Ahmedabad facility in Gujarat.
Ibrutinib tablets had annual sales of $2,148.9 million in the United States, as per the IQVIA data dated May 2025.Previously, the company had announced that an inspection by the United States Food and Drug Administration (FDA) at its oncology injectable facility in Ahmedabad, which had concluded with two observations, and none pertaining to data integrity.
Ibrutinib is used for the treatment of chronic lymphocytic leukaemia (CLL) / small lymphocytic lymphoma (SLL) with 17p deletion and Waldenstrom’s macroglobulinemia (WM).
This drug will be manufactured in the company’s Ahmedabad facility in Gujarat.
Ibrutinib tablets had annual sales of $2,148.9 million in the United States, as per the IQVIA data dated May 2025.Previously, the company had announced that an inspection by the United States Food and Drug Administration (FDA) at its oncology injectable facility in Ahmedabad, which had concluded with two observations, and none pertaining to data integrity.
Read More: Zydus Lifesciences Ahmedabad oncology injectable plant gets two FDA observations
For the March quarter, Zydus Life reported a net profit of ₹1,170.9 crore, which was lower than the same quarter last year. Revenue grew by 18% from last year to ₹6,527.9 crore.
Shares of Zydus Lifesciences recovered from the lows of the day, and are currently trading 0.8% higher at ₹969.25. The stock has remained flat in the last one month and also on a year-to-date basis.
