Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Apalutamide Tablets, 60 mg (Erleada® Tablets, 60 mg) in the U.S.
Apalutamide is an androgen receptor inhibitor used for treating metastatic castration-sensitive prostate cancer (mCSPC). The approved tablets will be produced at Zydus Lifesciences Ltd’s SEZ facility in Ahmedabad.
According to IQVIA MAT January 2025, the annual sales of Apalutamide tablets in the U.S. stood at $1,099.8 million, reflecting strong market potential.
With this latest approval, Zydus Lifesciences now holds 420 approvals and has filed 483 Abbreviated New Drug Applications (ANDAs) since FY 2003-04. The company continues to expand its portfolio, reinforcing its commitment to providing affordable, high-quality generics for global markets.
In the meantime, on March 12, the company secured final approval from the USFDA to manufacture and market Methenamine Hippurate Tablets USP, 1 gram, the generic version of Hiprex® Tablets. These tablets are used for the long-term prevention of recurring urinary tract infections (UTIs) and will be produced at Zydus’ SEZ facility in Ahmedabad, India. The U.S. market for Methenamine Hippurate tablets was valued at USD 32.6 million as of January 2025, and this approval strengthens Zydus’ foothold in the UTI treatment segment. With 419 USFDA approvals and 483 ANDA filings since FY 2003-04, Zydus continues to expand its global pharmaceutical presence.
