Alembic Pharmaceuticals Limited has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fingolimod Capsules, 0.5 mg. This approval marks a significant milestone for Alembic as the capsules are therapeutically equivalent to the reference listed drug product, Gilenya Capsules, 0.5 mg, manufactured by Novartis Pharmaceuticals Corporation.
Fingolimod is a sphingosine 1-phosphate receptor modulator used in the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in patients aged 10 years and older. The market size for Fingolimod Capsules, 0.5 mg, is estimated at US$ 145 million for the twelve months ending December 2025, according to IQVIA.
Alembic Pharmaceuticals has accumulated a total of 237 ANDA approvals from the USFDA, comprising 219 final approvals and 18 tentative approvals. The company, established in 1907, is a vertically integrated research and development pharmaceutical entity with a strong presence in the global healthcare market. Alembic is recognised for its branded generics in India and operates with a field force of over 5,500.
Alembic’s research and manufacturing facilities are approved by regulatory authorities in several developed countries, including the USFDA. The company’s commitment to quality and innovation has positioned it as a leader in the pharmaceutical industry.
For further information about Alembic Pharmaceuticals and its products, visit their website at www.alembicpharmaceuticals.com.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).