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Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fingolimod Capsules, 0.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis).
Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in patients 10 years of age and older.
Fingolimod Capsules, 0.5 mg, have an estimated market size of US$ 145 million for twelve months ending December 2025 according to IQVIA.
Consequent to the aforementioned transfer, the paid up share capital of the Company shall stand remain same i.e. 24,67,84,266 equity shares at a face value of Rs 2 each aggregating to Rs 49,35,68,532
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