Alembic Pharma gains after USFDA tentative nod for Acalabrutinib capsules

Alembic Pharmaceuticals rose 1.19% to Rs 559 after the company received tentative approval from US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Acalabrutinib capsules.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Calquence capsules, 100 mg, of AstraZeneca UK (AstraZeneca).

Acalabrutinib capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Acalabrutinib capsules have an estimated market size of US $1.5 billion for twelve months ending Sep 2022 according to IQVIA.

Alembic has a cumulative total of 180 ANDA approvals (157 final approvals and 23 tentative approvals) from USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

On consolidated basis, the company's net profit declined 18.7% to Rs 133.35 crore despite of 14.1% jump in revenue from operations to Rs 1,475.01 crore in Q2 FY23 over Q2 FY22

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