Alembic Pharmaceuticals Gains USFDA Tentative Approval for Bosutinib

Alembic Pharmaceuticals Limited has announced that it received tentative approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) for Bosutinib Tablets, 400 mg. This approval is for a product that is therapeutically equivalent to the reference listed drug product, Bosulif Tablets, 400 mg, manufactured by PF Prism C.V.

The approved Bosutinib is a kinase inhibitor indicated for the treatment of adult patients with chronic phase Ph+ chronic myelogenous leukemia (CML), either newly diagnosed or resistant or intolerant to prior therapy. It is also indicated for adult patients with accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy.

Alembic Pharmaceuticals had previously received final approval for its ANDA for Bosutinib Tablets in 100 mg and 500 mg dosages. The estimated market size for Bosutinib Tablets, 400 mg, is USD 251 million for the twelve months ending September 2025, according to IQVIA.

With this tentative approval, Alembic Pharmaceuticals now has a cumulative total of 232 ANDA approvals from the USFDA, comprising 212 final approvals and 20 tentative approvals.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products globally. Alembic’s research and manufacturing facilities are approved by regulatory authorities in several developed countries, including the USFDA. The company is recognized as a leader in branded generics in India.