NEW DELHI: Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (USFDA) for its generic version of Fingolimod Capsules 0.5 mg, a drug used in the treatment of multiple sclerosis (MS).
The approval allows the company to market the medicine in the United States as a therapeutically equivalent alternative to Gilenya, the branded drug manufactured by Novartis.
Fingolimod belongs to a class of medicines known as sphingosine 1-phosphate receptor modulators and is prescribed for patients suffering from relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease. The treatment is approved for patients aged 10 years and above.
Multiple sclerosis is a chronic neurological disorder in which the body’s immune system attacks the protective covering of nerves, affecting communication between the brain and the body. The disease can lead to symptoms such as muscle weakness, balance problems, fatigue and impaired vision.
According to market research firm IQVIA, the Fingolimod Capsules 0.5 mg market in the United States was estimated at around $145 million for the 12 months ending December 2025.
With this latest clearance, Alembic continues to strengthen its presence in the regulated US generics market. The company now has a cumulative total of 237 approvals from the USFDA, including 219 final approvals and 18 tentative approvals for abbreviated new drug applications (ANDAs).
Founded in 1907, Alembic is among India’s established pharmaceutical companies with a strong presence in branded generics and international markets. The company operates integrated research, development and manufacturing facilities that have received approvals from several global regulatory authorities, including the USFDA.
Headquartered in India, the company markets generic pharmaceutical products across multiple countries and maintains a large domestic presence through a field force of more than 5,500 representatives.
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