Alembic Pharmaceuticals receives USFDA tentative approval for Darolutamide Tablets

Yash Agarwal — Thu, 14 May 2026 04:38:15 +0000

Alembic Pharmaceuticals Limited has secured tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Darolutamide Tablets, 300 mg. This approval marks a significant step for Alembic as the product is therapeutically equivalent to Bayer HealthCare Pharmaceuticals Inc.’s Nubeqa Tablets, 300 mg.

Darolutamide, an androgen receptor inhibitor, is indicated for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). It is also approved for use in combination with docetaxel for mCSPC. The estimated market size for Darolutamide Tablets, 300 mg, stands at US$ 3,155 million for the twelve months ending March 2026, according to IQVIA.

Alembic Pharmaceuticals has an impressive track record with a cumulative total of 238 ANDA approvals from the USFDA, comprising 219 final approvals and 19 tentative approvals. This latest approval further strengthens Alembic’s position in the global pharmaceutical market.

Alembic Pharmaceuticals Limited, established in 1907, is a vertically integrated research and development pharmaceutical company based in India. It is known for manufacturing and marketing generic pharmaceutical products worldwide. The company boasts state-of-the-art research and manufacturing facilities approved by regulatory authorities in several developed countries, including the USFDA. Alembic is a leader in branded generics in India, with a field force of over 5,500 professionals.

For more information about Alembic Pharmaceuticals, visit their website at www.alembicpharmaceuticals.com.

Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).

Bayer HealthCare Pharmaceuticals | Business Upturn

Alembic Pharmaceuticals receives USFDA tentative approval for Darolutamide Tablets