Alembic Pharma spurts on USFDA nod for leukemia drug

Alembic Pharmaceuticals rallied 4.43% to Rs 915.25 after the company said that it has received a tentative approval from US Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Bosutinib tablets.

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.

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