Alembic Pharma gets USFDA tentative approval for Darolutamide tablets

Alembic Pharmaceuticals has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Darolutamide Tablets, 300 mg.

The company informed the exchanges on May 14, 2026, that the approved ANDA is therapeutically equivalent to the reference listed drug Nubeqa Tablets, 300 mg, of Bayer HealthCare Pharmaceuticals.

Darolutamide is an androgen receptor inhibitor indicated for the treatment of adult patients with non-metastatic castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, and metastatic castration-sensitive prostate cancer in combination with docetaxel.

According to the company, Darolutamide Tablets, 300 mg, have an estimated market size of US$ 3,155 million for the twelve months ended March 2026, as per IQVIA.

Alembic Pharmaceuticals said it now has a cumulative total of 238 ANDA approvals from the USFDA. This includes 219 final approvals and 19 tentative approvals.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company headquartered in India. The company manufactures and markets generic pharmaceutical products globally and has research and manufacturing facilities approved by regulatory authorities including the USFDA.

Overall, the tentative approval adds to Alembic Pharmaceuticals’ U.S. generics pipeline and strengthens its presence in oncology-linked therapies.

Disclaimer: This article is based on a regulatory filing submitted by Alembic Pharmaceuticals to the stock exchanges. The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions.