Alembic Pharma Gets US FDA Tentative Approval for Acalabrutinib Capsules


Alembic Pharmaceuticals gained 1.19 percent to Rs 559 following the tentative approval of its Acalabrutinib capsules from the US Food and Drug Administration (USFDA).

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

Acalabrutinib capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, as well as for the treatment of adult patients with CLL or SLL.

According to IQVIA, the market for acalabrutinib capsules is expected to be worth $1.5 billion US dollars in the year that ends in September 2022.

Alembic has received 157 final and 23 tentative ANDA approvals from the US Food and Drug Administration.

Alembic Pharmaceuticals is a pharmaceutical research and development firm with a vertically integrated structure. It is a global manufacturer and distributor of generic pharmaceutical products.

Despite a 14.1% increase in revenue from operations to Rs 1,475.01 crore in Q2 FY23 compared to Q2 FY22, the company’s net profit fell 18.7% to Rs 133.35 crore on a consolidated basis.

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