US FDA Tentative Nod for Bosutinib Strength Expands Alembic Portfolio

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration for its supplemental Abbreviated New Drug Application (sANDA) for Bosutinib tablets, 400 mg, strengthening the company’s US oncology generics market presence.

The tentative approval confirms that Alembic’s Bosutinib 400 mg tablets meet regulatory requirements for quality, safety and efficacy and are therapeutically equivalent to the reference listed drug Bosulif tablets, marketed by PF Prism C.V.. Bosutinib is a kinase inhibitor indicated for the treatment of adult patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), including newly diagnosed patients as well as those who are resistant or intolerant to prior therapy.

Alembic had earlier obtained final US FDA approvals for Bosutinib tablets in 100 mg and 500 mg strengths. With the addition of the 400 mg strength, the company is positioned to offer a complete dosage portfolio aligned with prescribing needs in the US oncology generics market. The approval also reflects Alembic’s ongoing focus on complex and specialty pharmaceuticals, particularly in the cancer therapy segment.

According to data cited from IQVIA, the US market for Bosutinib tablets is estimated at approximately US $251 million market size for the 12-month period ending September 2025, indicating meaningful commercial potential once final approval is secured and product launch timelines are met.

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With this development, Alembic’s cumulative US FDA ANDA approvals now stand at 232 approvals, comprising 212 final approvals and 20 tentative approvals. The company continues to expand its regulatory pipeline, supported by in-house research, manufacturing capabilities and compliance with global quality standards. Founded in 1907, Alembic Pharmaceuticals remains focused on supplying affordable generic medicines across regulated and emerging markets worldwide.