Alembic Pharmaceuticals Limited has announced that the US Food and Drug Administration (USFDA) has granted tentative approval for its supplemental Abbreviated New Drug Application (sANDA) for Bosutinib Tablets, 400 mg. The product is considered therapeutically equivalent to Bosulif® Tablets, 400 mg, the reference listed drug marketed by PF Prism CV. Bosutinib is a kinase inhibitor indicated for the treatment of Philadelphia chromosome–positive (Ph+) chronic myelogenous leukemia (CML). It is approved for use in adult patients with newly diagnosed chronic-phase CML, as well as those who are resistant or intolerant to prior therapies. The drug is also indicated for adult patients with accelerated or blast-phase Ph+ CML who have shown resistance or intolerance to previous treatment.
Alembic had earlier secured final USFDA approvals for Bosutinib Tablets in the 100 mg and 500 mg strengths. The 400 mg dosage further strengthens the company’s oncology portfolio in the US market. Detailed prescribing information is available in the approved product label.
According to IQVIA, Bosutinib Tablets 400 mg recorded an estimated market size of US$ 251 million for the twelve-month period ending September 2025. With this approval, Alembic now holds a total of 232 ANDA approvals from the USFDA, comprising 212 final approvals and 20 tentative approvals.
Alembic Pharmaceuticals Limited is a leading Indian pharmaceutical company with a strong presence in branded generics, generic medicines, and active pharmaceutical ingredients (APIs). Founded in 1907, the company has a long legacy of innovation, quality, and ethical business practices. Alembic’s core strength lies in therapeutic areas such as cardiology, diabetology, anti-infectives, gynecology, dermatology, and oncology, catering to both domestic and international markets.
The company has established world-class manufacturing facilities that comply with global regulatory standards, including approvals from the US FDA, UK MHRA, and other international agencies. Alembic Pharmaceuticals has built a robust research and development infrastructure, focusing on the development of complex generics, novel drug delivery systems, and specialty products. Its strong pipeline of ANDAs and increasing footprint in regulated markets like the United States and Europe have contributed significantly to its growth.
In India, Alembic is recognized for its strong branded formulations business and extensive marketing network. The company also emphasizes sustainability, corporate social responsibility, and environmental stewardship as part of its long-term strategy. By combining scientific expertise, operational excellence, and a patient-centric approach, Alembic Pharmaceuticals continues to strengthen its position as a trusted global pharmaceutical player.
