The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Arranon Injection of Sandoz Inc.
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Nelarabine Injection has an estimated market size of US$ 23 million for twelve months ending March 2024 according to IQVIA.
Alembic has a cumulative total of 211 ANDA approvals (183 final approvals and 28 tentative approvals) from US FDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.
The company reported 16.78% increase in consolidated net profit to Rs 178.21 crore on 7.85% rise in revenue from operations to Rs 1,516.98 in Q4 FY24 over Q4 FY23.
The scrip rose 0.28% to currently trade at Rs 1219 on the BSE.