Mumbai, Naples, February 02, 2026: Global pharma major Lupin Limited (Lupin) today announced the launch of Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, in the United States, following the approval for its Abbreviated New Drug Application (ANDA) from the U.S. FDA. The product was developed in partnership with Pharmascience Inc.

Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80mg, 100 mg, and 140 mg are bioequivalent to Sprycel® Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company, and indicated for the treatment of:

newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase

adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+CML with resistance or intolerance to prior therapy including imatinib

adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy

pediatric patients 1 year of age and older with Ph+ CML in chronic phase

pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy

Dasatinib Tablets (RLD Sprycel®) had an estimated annual sale of USD 930 million in the U.S. (IQVIA MAT Oct 2025).

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

To know more, visit www.lupin.com or follow us on LinkedIn
https://www.linkedin.com/company/lupin

About Pharmascience Inc.

Pharmascience Inc. is one of the largest pharmaceutical manufacturers in Canada, headquartered in Montreal. The company delivers high quality medicines to more than 50 countries worldwide. Pharmascience Inc.’s global presence and agile business development model support healthcare communities with dependable, Canadian-produced therapies designed to meet evolving patient needs.
For more information, please visit www.pharmascience.com.

For further information or queries, please contact

Rajalakshmi Azariah

Vice President & Global Head – Corporate Communications, Lupin

rajalakshmiazariah@lupin.com
Elise Titan

Director – U.S. Communications, Lupin

elisetitan@lupin.com

_*Safe Harbor Statement_
Sprycel® is a registered trademark of Bristol-Myers Squibb Company