Alembic Pharmaceuticals Limited announces USFDA Final Approval for Fingolimod Capsules, 0.5 mg

Alembic Pharmaceuticals Limited (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. Refer label for a detailed indication.

Fingolimod Capsules, 0.5 mg, have an estimated market size of US$ 145 million for twelve months ending December 2025 according to IQVIA.

Alembic has a cumulative total of 237 ANDA approvals (219 final approvals and 18 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 751.10 as compared to the previous close of Rs. 769.80. The total number of shares traded during the day was 6797 in over 423 trades.

The stock hit an intraday high of Rs. 784.00 and intraday low of 750.00. The net turnover during the day was Rs. 5162308.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval FingolimodCapsules