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.

India's Directorate General of Trade Remedies (DGTR) has concluded in its preliminary findings that there is dumping of Ethambutol Hydrochloride imports from China and Thailand, identifying this practice as causing material injury to domestic pharmaceutical manufacturers. This regulatory determination could have significant implications for the Indian pharmaceutical industry, particularly companies involved in manufacturing this essential anti-tuberculosis medication.

Preliminary Dumping Findings

The DGTR's preliminary assessment has established that imports of Ethambutol Hydrochloride from Chinese and Thai manufacturers are being sold at prices below fair market value. This practice, known as dumping, involves exporting products at prices lower than those charged in the domestic market of the exporting country or below the cost of production.

Impact on Domestic Industry

The trade regulator has specifically flagged the dumping practice as causing material injury to domestic players in the pharmaceutical sector. Lupin and other Indian pharmaceutical manufacturers producing Ethambutol Hydrochloride domestically stand to benefit from potential protective measures that may follow these preliminary findings.

Regulatory Implications

The DGTR's preliminary conclusions represent an important step in India's trade remedy process. These findings typically precede the implementation of anti-dumping duties or other protective measures designed to level the playing field for domestic manufacturers. The determination of material injury is a crucial component in establishing grounds for trade remedial action under international trade regulations.

Ethambutol Hydrochloride is a critical pharmaceutical ingredient used in the treatment of tuberculosis, making this determination particularly significant for India's healthcare sector and pharmaceutical manufacturing capabilities. The preliminary nature of these findings suggests that further investigation and final determinations may follow in due course.