Alembic Pharmaceuticals has received tentative approval from the USFDA for its supplemental Abbreviated New Drug Application (sANDA) for Bosutinib Tablets, 400 mg. The approved ANDA is therapeutically equivalent to Bosulif Tablets, 400 mg. This approval marks a total of 232 ANDA approvals from USFDA, including 212 final and 20 tentative approvals. Bosutinib has an estimated market size of US$ 251 million.
USFDA Approval Received
Alembic Pharmaceuticals Limited announced on January 12, 2026, that it has received tentative approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) for Bosutinib Tablets, 400 mg. The ANDA approval confirms therapeutic equivalence to the reference listed drug product (RLD), Bosulif Tablets, 400 mg.
Details on Bosutinib Tablets
Bosutinib is a kinase inhibitor designed for the treatment of adult patients with chronic phase Ph+ chronic myelogenous leukemia (CML), encompassing both newly-diagnosed patients and those resistant or intolerant to prior therapy. It also addresses adult patients with accelerated or blast phase Ph+ CML who show resistance or intolerance to prior treatments.
Market Size and Previous Approvals
Bosutinib Tablets, 400 mg, have an estimated market size of US$ 251 million for the twelve months ending September 2025, according to IQVIA.
Total ANDA Approvals
Alembic Pharmaceuticals now holds a cumulative total of 232 ANDA approvals from the USFDA. This includes 212 final approvals and 20 tentative approvals, further solidifying the company’s position in the pharmaceutical market.
Source: BSE
