Zydus Lifesciences Secures USFDA Approval for Generic Prostate Cancer Drug

Zydus Lifesciences Limited has established itself as a strong player in the world oncology market with its recent FDA approval to manufacture and sell a generic version of Apalutamide 60 mg tablets for the treatment of prostate cancer. The drug will be produced at the Ahmedabad SEZ, reinforcing India's position as a leading supplier of low-cost cancer treatment. Apalutamide is an androgen receptor inhibitor approved for treating metastatic castration-sensitive prostate cancer that progresses during hormonal therapy.

According to IQVIA MAT January 2025, apalutamide generates $1,099.8 million in annual sales in the USA, making it a highly lucrative market. Zydus' entry into this space will enhance affordable cancer therapy access, benefiting patients seeking cost-effective prostate cancer treatment. This move highlights India's growing role in generic drug manufacturing and its contribution to global healthcare.

The approval further strengthens Zydus Lifesciences' oncology portfolio, solidifying its commitment to expanding oncology treatment options. With the rising demand for high-quality generic cancer drugs, Zydus' presence in the US pharmaceutical market underscores India's expanding influence in drug innovation and its ability to deliver FDA-approved generics at competitive prices.