Alembic Pharmaceuticals Limited receives USFDA Tentative Approval for Darolutamide Tablets, 300 mg.

Regulatory product approvalBusiness Updates View source PDF Explain this filing

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₹770.00

prior close

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announcement price

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Nifty Microcap 250market · index membership as recorded later (tracked since Jun 2026)+0.2%+1.7% vs market

Pharmaceuticals peers, median of 161sector+0.4%+1.6% vs sector

On the reaction day the stock moved 1.7 pts more than Nifty Microcap 250 and 1.6 pts more than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.

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AI summary

Alembic Pharmaceuticals has received tentative approval from the USFDA for its generic Darolutamide Tablets, 300 mg. The drug is equivalent to Bayer's Nubeqa and treats prostate cancer conditions including non-metastatic and metastatic castration-resistant prostate cancer. The US market for this drug is estimated at US$ 3,155 million annually. With this approval, Alembic has now received 238 ANDA approvals from USFDA cumulatively.

Likely market impact

This approval opens a significant revenue opportunity in the large US prostate cancer market. The tentative approval signals Alembic's continued ability to secure US regulatory clearances, which could positively influence investor sentiment.