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Alembic Pharmaceuticals gets USFDA’s tentative approval for Bosutinib Tablets
Jan-12-2026

Alembic Pharmaceuticals (Alembic) has received tentative approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) Bosutinib Tablets, 400 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 400 mg, of PF Prism C.V. (PF Prism C.V.). Bosutinib is a kinase inhibitor indicated for the treatment of i) adult patients with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy, and ii) adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.

Bosutinib Tablets, 400 mg, have an estimated market size of $251 million for twelve months ending September 2025 according to IQVIA. The company has a cumulative total of 232 ANDA approvals (212 final approvals and 20 tentative approvals) from USFDA.

Previously, the company had received final approval for its ANDA Bosutinib Tablets, 100 mg and 500mg. 

Alembic Pharmaceuticals (Alembic Pharma) is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.

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