Shilpa Biologicals Ltd, a subsidiary of Shilpa Medicare Ltd, has officially commissioned an advanced integrated Antibody–Drug Conjugate (ADC) GMP manufacturing site in Dharwad. Announced on 25 June 2026, the facility was specifically engineered to satisfy the rigorous global regulatory standards of the US FDA, EMA, and other prominent health authorities. This ADC manufacturing facility is currently fully operational, with active GMP qualification protocols establishing a definitive timeline for commercial availability. This milestone serves as a significant expansion of Shilpa Medicare’s established 25-year background in producing highly potent compounds, a field that necessitates exceptional safety engineering, containment protocols, and regulatory adherence.
With the launch of this site, Shilpa Medicare Ltd emerges as one of the rare organizations in India capable of delivering comprehensive, end-to-end drug substance development. The unit’s integrated capabilities encompass monoclonal antibody production, payload synthesis, and linker development, alongside conjugation and GMP-scale purification. These processes require specialized cytotoxic containment and exact chemical precision within a validated environment. By offering these combined services, the company intends to serve as a competitive CDMO partner for international pharmaceutical and biotechnology firms. This ADC manufacturing facility represents a strategic move toward becoming a prominent global collaborator for advanced oncology drug platforms.
Sridevi Khambhampaty, CEO, Shilpa Biologicals Pvt Ltd commented, “The manufacturing of highly potent compounds has been a core pillar of Shilpa’s identity and this ADC drug substance facility adds a new sophisticated dimension to the capabilities of the Shilpa group, we now offer global biotech and pharma partners a uniquely integrated ADC facility built with the knowledge of our existing high potency manufacturing excellence.”
The project reinforces the group’s dedication to high-value biologics and innovative manufacturing solutions for complex oncology treatments. “India has the scientific talent and now, with this facility, the infrastructure to be a serious and trusted partner in global ADC drug substance manufacturing,” said Vishnukant Bhutada, Managing Director, Shilpa Medicare Ltd. “Our 25-year foundation in high potency manufacturing gives us a head start that very few can match. We are ready to partner with the world’s leading oncology innovators.” Through this investment, Shilpa aims to contribute significantly to differentiated medical treatments for patients across the globe.
