Zydus Lifesciences gets USFDA’s final approval for Apalutamide tablets

“Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer,” Zydus explained in a statement to the stock exchanges.

Apalutamide tablets had annual sales of $1,099.8 million in the United States.

The new medicine will be produced from the Ahmedabad plant of Zydus Lifesciences Ltd (SEZ).

Zydus Lifesciences further said that the group now has 420 approvals and has so far filed 483 (as of December 31, 2024) ANDAs since the commencement of the filing process in FY 2003-04.

The announcement came after the trading hours. Shares of Zydus on Tuesday closed at ₹904.65 apiece on the National Stock Exchange, gaining 1.34%.

According to stock exchange data, its market capitalisation stands at ₹91,028.96 crore. The scrip had touched its 52-week low of ₹855.10 per share last month on February 19.

Zydus on March 5 had received approval from the US FDA to manufacture generic leukaemia tablets. The pharma company had launched ANVIMO (Letermovir), a breakthrough drug that will be used in the prevention of cytomegalovirus (CMV) infection for haematopoietic stem cell transplant (HSCT) and kidney transplant patients.

For the October-December quarter, Zydus Lifesciences reported a 29.6% jump in its net profit to ₹1,024 crore as compared to ₹790 crore posted in the year-ago period. The company’s revenue from operations stood at ₹5,269 crore, up 17% as compared to ₹4,505 crore reported in Q3 FY24.

Earnings before interest, taxes, depreciation and amortisation (EBITDA) of the company stood at ₹1,388 crore for the reporting quarter, up 26% YoY as compared to ₹1,102 crore in Q3 FY24. EBITDA margin was 26.3% for Q3 FY25.

For the first nine months of the current fiscal year (9M FY25), the company posted a net profit of ₹3,355 crore as against ₹2,677 crore in the year-ago period.