Alembic Pharma gains after receiving USFDA nod for Darolutamide tablets

Alembic Pharmaceuticals rose 1.57% to Rs 780.50 after the company announced that it had received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Darolutamide Tablets, 300 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Nubeqa Tablets, 300 mg, marketed by Bayer HealthCare Pharmaceuticals.

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

According to IQVIA, Darolutamide Tablets, 300 mg, have an estimated market size of US$ 3,155 million for the 12 months ended March 2026.

With this approval, Alembic Pharmaceuticals now has a cumulative total of 238 ANDA approvals from the USFDA, comprising 219 final approvals and 19 tentative approvals.

Alembic Pharmaceuticals is a vertically integrated research and development company engaged in the manufacture and marketing of generic pharmaceutical products across global markets. The company had reported a 3.9% decline in consolidated net profit to Rs 132.97 crore despite a 10.8% increase in net sales to Rs 1,876.31 crore in Q3 FY26 compared with Q3 FY25.

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