Alembic Pharmaceuticals Limited said it has received final approval from the US Food and Drug Administration for Fingolimod Capsules, 0.5 mg, as per an exchange filing dated April 25, 2026. The approval is for its Abbreviated New Drug Application (ANDA).
The product is therapeutically equivalent to Gilenya, the reference listed drug of Novartis.
Fingolimod is used in the treatment of relapsing forms of multiple sclerosis. This includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
The drug is approved for patients aged 10 years and above, according to the company’s filing.
As per IQVIA data, the drug recorded an estimated market size of $145 million in the United States for the 12 months ended December 2025.
The segment remains relatively limited in size compared to other chronic therapies but continues to see steady demand.
Following this approval, the company’s cumulative USFDA approvals stand at 237. This includes 219 final approvals and 18 tentative approvals.
Alembic Pharmaceuticals manufactures and markets generic medicines across multiple geographies and continues to focus on regulated markets.
Earlier this month, the company received USFDA approval for Dapagliflozin tablets in 5 mg and 10 mg strengths. The drug is used in the treatment of type 2 diabetes and related conditions, with an estimated US market size of $10.49 billion.
It also received approval for Methotrexate Injection across multiple strengths, used in oncology and autoimmune conditions.
As of April 27, 2026, 10:58 am, Alembic Pharmaceuticals Ltd share price was trading at ₹768.15, up 2.28% from the previous closing price.
With this clearance, Alembic Pharmaceuticals continues to expand its US generics pipeline. The total number of USFDA approvals now stands at 237, including both final and tentative clearances.
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Published on: Apr 27, 2026, 12:31 PM IST
Team Angel One
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