Alembic Pharma gains after tentative USFDA approval for Rivaroxaban tablets

Alembic Pharmaceuticals gained 2.86% to Rs 977 after the company said it has received US drug regulator's tentative approval for Rivaroxaban tablets in 10 mg, 15 mg, and 20 mg strengths.

Alembic Pharmaceuticals in a regulatory filing on Monday announced that the company has received tentative approval from the US Food & Drug Administration for its Abbreviated New Drug Application (ANDA) Rivaroxaban tablets.

The approved ANDA is therapeutically equivalent to Xarelto tablets of Janssen Pharmaceuticals. The drug is indicated for the reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; the treatment of deep vein thrombosis (DVT); the treatment of pulmonary embolism (PE); the reduction in the risk of recurrence of deep vein thrombosis and of pulmonary embolism following initial 6 months treatment for DVT and/or PE; the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surge.

According IQVIA, Rivaroxaban Tablets have an estimated market size of $6.1 billion for twelve months ending March 2020. Alembic now has a total of 124 ANDA approvals (110 final approvals and 14 tentative approvals) from USFDA.

The stock has surged nearly 79% in last three months compared with 46.5% rise in the Nifty Pharma index.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. Its consolidated net profit jumped 54.8% to Rs 203.52 crore on a 30.2% rise in net sales to Rs 1,206.83 crore in Q4 March 2020 over Q4 March 2019.

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