The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif tablets, of PF Prism C.V. (PF Prism).

Bosutinib tablets are indicated for the treatment of a certain type of leukemia called Philadelphia chromosome-positive chronic myelogenous leukemia.

According to IQVIA, Bosutinib Tablets have an estimated market size of $275 million for the twelve months ending March 2024.

Alembic has a cumulative total of 206 ANDA approvals (179 final approvals and 27 tentative approvals) from US Food & Drug Administration (USFDA).

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.