Alembic Pharma receives USFDA final approval for Bosutinib tablets

Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bosutinib Tablets.

Bosutinib tablets are indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who have shown resistance or intolerance to prior therapy.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Bosulif Tablets, marketed by PF Prism C.V. (Pfizer).

According to IQVIA, Bosutinib Tablets have an estimated market size of $ 291 million for the twelve months ending March 2025.

Alembic has a cumulative total of 223 ANDA approvals (200 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. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.

The company?s consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24.

The counter rose 0.97% to Rs 1,015.30 on the BSE.

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