Alembic Pharmaceuticals Gains USFDA Approval For Cancer Treatment Drug, Share Price Rises

Alembic Pharma has added another product to its growing US portfolio of over 200 Abbreviated New Drug Application (ANDA) approvals.

The company has received final approval from the US Food and Drug Administration (USFDA) for its Methotrexate Injection, a drug widely used in cancer treatment and autoimmune conditions.

After the announcement, Alembic Pharmaceuticals shares rose by over 1.5% to reach ₹747.10 on 16 April 2026 at 12:53 pm.

What Does The Approval Mean?

Alembic Pharmaceuticals has received approval to sell a generic version of a key drug in the US. The approval is for an ANDA, which is the standard route used to launch generic medicines in the US market.

The drug is Methotrexate Injection, an injectable medicine used in both cancer treatment and certain autoimmune diseases. Methotrexate is already widely used. It prevents or slows the growth of certain cells, including cancer cells; that's why it is prescribed for cancers such as leukaemia and lymphoma and also for other diseases like rheumatoid arthritis.

This approval allows Alembic to enter the US market with a proven and cost-effective drug.

What Is The Market Size For This Drug?

The approval gives Alembic Pharmaceuticals access to a US market worth about $35 million (₹290–300 crore) for this product, based on IQVIA data. That may not sound very large, but for an injectable generic, it’s still a good opportunity. These products usually have less competition and better margins compared to regular oral medicines.

Globally, the methotrexate market is much bigger. It was valued at around $555 million in 2024 and is expected to grow to about $681 million by 2032. This steady demand is mainly driven by a rise in cancer cases and an increase in autoimmune diseases worldwide.

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Bigger Picture

Alembic has steadily built its US pipeline with 236 ANDA approvals in place. This ongoing approval flow is quite important as it ensures a continuous pipeline for new product launches. The rise in the company's share price reflects that the investors have welcomed the news.

Sources:

CNBCTV18

Data Bridge