Lupin has announced the successful launch of Dasatinib tablets in the United States market following FDA approval for its Abbreviated New Drug Application (ANDA). This strategic product launch, developed in partnership with Pharmascience Inc., marks another milestone in the pharmaceutical company's expansion in the competitive US generics market.

Product Launch Details

The company has made Dasatinib tablets available across six comprehensive dosage strengths to meet diverse patient needs. The tablets are bioequivalent to Sprycel® Tablets of Bristol-Myers Squibb Company:

Therapeutic Applications

Dasatinib tablets are indicated for multiple cancer treatment applications, including treatment of newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, adults with chronic, accelerated, or blast phase Ph+CML with resistance or intolerance to prior therapy including imatinib, and adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy. The medication is also approved for pediatric patients 1 year of age and older with Ph+ CML in chronic phase and newly diagnosed Ph+ ALL in combination with chemotherapy.

Market Opportunity and Partnership

The launch positions Lupin to capitalize on a substantial market opportunity in the US pharmaceutical sector:

Strategic Significance

The FDA approval and subsequent launch of Dasatinib tablets demonstrates Lupin's continued commitment to expanding its presence in the US generics market. The partnership with Pharmascience Inc., one of Canada's largest pharmaceutical manufacturers, strengthens the development capabilities for this complex oncology product. The comprehensive dosage range allows the company to address various therapeutic requirements across both adult and pediatric patient populations.

This product addition strengthens Lupin's portfolio in the oncology segment, where Dasatinib is commonly prescribed for specific cancer treatments. The expected annual sales figure of USD 930.00 million highlights the substantial commercial potential of this product launch for Lupin's overall revenue performance in the US market.

Lupin Limited has announced a strategic collaboration with TB Alliance under Regulation 30 of SEBI Listing Obligations to advance the clinical development and commercialization of Telacebec, an investigational drug for treating multiple mycobacterial diseases including tuberculosis, leprosy, and Buruli ulcer.

Regulatory Disclosure and Partnership Framework

The collaboration was formally disclosed to stock exchanges on February 02, 2026, pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015. Under the partnership terms, TB Alliance will continue leading the development process while Lupin provides comprehensive support through its global capabilities.

Strategic Collaboration Details

The partnership combines TB Alliance's deep expertise in drug development with Lupin's manufacturing scale and global distribution capabilities. Lupin will leverage its expertise in global manufacturing, regulatory affairs, and supply chain management to ensure global access to Telacebec for patients affected by these diseases.

"This collaboration with TB Alliance underscores Lupin's enduring commitment to improving patient outcomes in areas of significant unmet medical need," said Ramesh Swaminathan, Executive Director, Global CFO, and Head of IT and API Plus SBU, Lupin. "By leveraging our manufacturing scale and global distribution capabilities alongside TB Alliance's deep expertise in drug development, we aim to enable timely and equitable access to Telacebec."

Addressing Multiple Mycobacterial Diseases

Telacebec represents a significant advancement in treating mycobacterial diseases that have long been neglected. The collaboration focuses on developing treatment options for tuberculosis, leprosy, and Buruli ulcer, addressing critical global health challenges through innovative pharmaceutical development.

"Telacebec represents the kind of scientific innovation that has the potential to transform treatment for diseases that have long been neglected," said Mel Spigelman, MD, President and CEO, TB Alliance. "By partnering with Lupin, we are combining deep scientific expertise with global Chemistry, Manufacturing and Controls and access capabilities to help move this promising compound forward as quickly and responsibly as possible."

This strategic alliance demonstrates Lupin's commitment to expanding its presence in infectious disease treatment while contributing to global health initiatives, combining specialized tuberculosis research with established pharmaceutical manufacturing and regulatory capabilities.