Alembic Pharmaceuticals Receives USFDA Tentative Approval for Darolutamide Tablets, 300 mg
Alembic Pharmaceuticals Limited announced on May 14, 2026, that it has received tentative approval from the US Food & 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 product (RLD), Nubeqa Tablets, 300 mg, which is manufactured by Bayer HealthCare Pharmaceuticals Inc. Darolutamide is an androgen receptor inhibitor used in the treatment of adult patients for specific prostate cancer conditions.
The drug’s indications cover multiple stages of prostate cancer care, including:
- Non-metastatic castration-resistant prostate cancer (nmCRPC).
- Metastatic castration-sensitive prostate cancer (mCSPC).
- Metastatic castration-sensitive prostate cancer (mCSPC) when combined with docetaxel.
Market Snapshot and Company Milestones
The market potential for Darolutamide Tablets, 300 mg, is substantial, with an estimated market size of US$ 3,155 million for the twelve months ending March 2026, according to IQVIA.This latest approval adds to a strong track record for the pharmaceutical company. Alembic reports that it has achieved a cumulative total of 238 ANDA approvals from the USFDA, comprising 219 final approvals and 19 tentative approvals.
| Metric | Details | Count/Value |
|---|---|---|
| Total ANDA Approvals | Final Approvals | 219 |
| Total ANDA Approvals | Tentative Approvals | 19 |
| Total Cumulative ANDA Approvals | 238 |
About Alembic Pharmaceuticals
Established in 1907, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed entity that manufactures and markets generic pharmaceutical products globally. The company operates state-of-the-art research and manufacturing facilities that are approved by regulatory authorities in several developed countries, including the USFDA. Alembic is recognized as one of the leaders in branded generics within India, with its brands marketed through a field force of over 5500.APLLTD Stock Price Movement
Shares of Alembic Pharmaceuticals Limited are edging higher to ₹778.2 as of 10:10 AM, rallying 1.35% in live trading. The equity currently trades on strong buying interest, registering a volume of 16,655 shares so far.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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