Zydus Lifesciences shares in focus as firm gets USFDA nod to produce prostate cancer treatment drug

The approval by the US Food and Drug Administration (USFDA) is to manufacture Apalutamide tablets of 60 mg strength, Zydus Lifesciences said in a regulatory filing.

The approved Apalutamide tablets will be produced at Zydus Lifesciences (SEZ), Ahmedabad, it added.

Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer.

It had annual sales of $1,099.8 million in the US, the company said, citing IQVIA MAT January 2025 data.

Zydus Life Q3 FY25 Results

Zydus Lifesciences said its consolidated net profit increased by 30% to ₹1,023 crore for the third quarter ended December 31, 2024, aided by robust sales across domestic and US markets.

The drug firm reported a net profit of ₹790 crore in the October-December quarter of the previous fiscal year.

Revenue from operations increased to ₹5,269 crore in the third quarter as against ₹4,505 crore in the year-ago period, Zydus Lifesciences said in a statement.

"We are pleased with the sustained growth momentum across our key businesses that has driven our Q3 performance. Our robust product portfolio execution in the US, market share gain in focused therapy segments and brands in India, and strategic leveraging of our global portfolio in international markets position us well for future growth," Managing Director Sharvil Patel stated.

The company is on track to achieve its fiscal year 2025 goal of double-digit growth across key businesses, coupled with improved profitability, Patel added.

"Looking ahead, we are strategically building growth levers to ensure sustained success, with patient centricity and quality at the core of our operations," Patel said.