Zydus Lifesciences has obtained final approval from the US Food and Drug Administration (USFDA) to manufacture Apalutamide Tablets, also known as Erleada Tablets, 60 mg. The drug is an androgen receptor inhibitor, primarily used to treat patients with metastatic castration-sensitive prostate cancer. With this approval, Zydus Lifesciences Ltd, located in Ahmedabad, will produce the medicine.
According to IQVIA, Apalutamide tablets generated $1.099 billion in annual sales in the United States as of January 2025. This significant revenue milestone highlights the importance of this medication in the market. The drug has been increasingly in demand in recent years due to its ability to slow or stop the growth of prostate cancer cells.
The approval is a significant achievement for Zydus Lifesciences, demonstrating the company’s capabilities in manufacturing complex pharmaceutical products. With this approval, Zydus Lifesciences will be able to cater to the growing demand for Apalutamide tablets in the United States and other markets where it is approved for use. The company’s ability to produce this critical medication will ensure a steady supply chain and availability of the drug for patients who rely on it for treatment.
The production of Apalutamide tablets at Zydus Lifesciences Ltd’s facility in Ahmedabad will further strengthen the company’s position as a key player in the global pharmaceutical market. The facility’s state-of-the-art infrastructure and experienced team will ensure the highest quality and compliance with international standards, guaranteeing the production of high-quality medicine that meets the required regulations and standards.
In summary, the approval by the USFDA to manufacture Apalutamide Tablets 60 mg (Erleada Tablets, 60 mg) is a significant milestone for Zydus Lifesciences, as it expands the company’s product portfolio and increases its global presence in the pharmaceutical industry. The production of this critical medication will also ensure a steady supply of the drug for patients who rely on it for treatment, thereby making a positive impact on public health.