The approval covers the 40 mg and 80 mg tablets as bioequivalent to Astellas' reference listed drug (RLD), Xtandi, for the approved indication. While Xtandi is currently marketed in 40 mg and 80 mg strengths, Lupin's tentatively approved 120 mg and 160 mg tablets are expected to provide healthcare providers and patients with additional dosing flexibility.

Enzalutamide is indicated for the treatment of certain types of prostate cancer.

Lupin is a global pharmaceutical company focused on branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients across multiple therapeutic segments. The company’s consolidated profit after tax stood at Rs 1,468.70 crore in Q4 FY26, up 87.72% from Rs 782.40 crore in Q4 FY25. Net sales rose 32.9% to Rs 7391.91 crore in Q4 FY26 from Rs 5562.2 crore in Q4 FY25.