Shares of Alembic Pharmaceuticals witnessed a positive move, gaining 2%, on 14 May after the company secured tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Darolutamide Tablets, 300 mg. 

The approval marks another important step in the company’s expanding presence in the oncology and specialty pharmaceutical segments in the United States. According to the company’s regulatory filing, the product is therapeutically equivalent to Bayer HealthCare Pharmaceuticals’ prostate cancer drug Nubeqa.

Darolutamide is an androgen receptor inhibitor prescribed for the treatment of advanced prostate cancer in adult patients. 

The medicine is used for non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic castration-sensitive prostate cancer (mCSPC), and in combination with docetaxel for certain mCSPC cases. 

IQVIA estimates the US market opportunity for the drug at nearly $3.16 billion for the 12 months ending March 2026, highlighting the commercial significance of the approval.

Following the announcement, Alembic Pharma shares climbed close to 3% during intraday trade before trimming gains later in the session. The stock was trading around Rs 778 in morning trade, reflecting investor optimism around the company’s regulated market pipeline.

The latest development adds to Alembic’s growing list of USFDA approvals. With the Darolutamide nod, the company has now secured a total of 238 ANDA approvals from the US regulator, including 219 final approvals and 19 tentative approvals.

Earlier, in April 2026, the company also received final approval from the USFDA for Fingolimod Capsules, 0.5 mg, a generic version of Novartis’ multiple sclerosis drug Gilenya. The medicine targets relapsing forms of multiple sclerosis and had an estimated US market size of $145 million. Alembic additionally expanded its international footprint recently by incorporating a wholly owned subsidiary in Germany to strengthen its European operations.

At 2:57 pm, the shares of Alembic Pharma were trading 2.72% higher at Rs 788.75 on NSE.

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