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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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