Zydus Lifesciences gets USFDA nod for prostate cancer drug

3 Oct 2024 , 01:11 PM

On Wednesday, Zydus Lifesciences said that the US health regulator has given the company permission to develop a generic medication for the treatment of prostate cancer.

The product would be produced at the Group’s Ahmedabad SEZ manufacturing facility.

The medicine manufacturer stated in a regulatory filing that the US Food and medicine Administration (USFDA) has given the company provisional approval to produce Enzalutamide tablets (40 mg and 80 mg).

Patients with metastatic castration-sensitive prostate cancer and castration-resistant prostate cancer are recommended to be treated with enzalutamide tablets, which are androgen receptor inhibitors.

Since the filing procedure began in FY 2003–04, the Zydus group has submitted over 465 Abbreviated New Drug Applications (ANDAs) and currently has 400 approvals, according to the report.

Zydus Group is headquartered in Ahmedabad, and is ranked fourth in the Indian pharmaceutical business. The group has production and research facilities in five Indian states (Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim), as well as the United States and Brazil.

Zydus’ global business is well-established in the regulated markets of the United States, Europe (France and Spain), and the high-profile markets of Latin America and South Africa. It is also widely distributed in 25 additional emerging markets throughout the world.

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