Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated May 14, 2026, titled "Alembic Pharmaceuticals Limited receives USFDA Tentative Approval for Darolutamide Tablets, 300 mg.".
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Alembic Pharmaceuticals received USFDA tentative approval for Darolutamide Tablets, 300 mg, an ANDA equivalent to Bayer's Nubeqa. The drug treats prostate cancer including non-metastatic castration-resistant and metastatic castration-sensitive forms. The estimated market size for this product is US$ 3,155 million for the twelve months ending March 2026. With this approval, Alembic has a cumulative total of 238 ANDA approvals (219 final and 19 tentative) from USFDA.
The approval opens a large-addressable market opportunity (~$3.2bn US) for Alembic, strengthening its oncology portfolio and US generics pipeline, which is positive for long-term revenue growth.