Alembic Pharma gets USFDA nod for Docetaxel injection

The drug maker announced that it has received final approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Docetaxel injection.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hospira Inc.

Docetaxcel injections are indicated for the breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck.

Docetaxel injection have an estimated market size of $11 million for twelve months ending Dec 2022 according to IQVIA.

Alembic has a cumulative total of 181 ANDA approvals (158 final approvals and 23 tentative approvals) from 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 drug maker reported 29% drop in consolidated net profit to Rs 121.92 crore despite a 18.7% rise in net sales to Rs 1509.02 crore in Q3 FY23 over Q3 FY22.

Shares of Alembic Pharmaceuticals were down 0.42% to Rs 507.90 on the BSE.

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