Shilpa Biologics, a subsidiary of Shilpa Medicare, has commissioned an advanced integrated Antibody-Drug Conjugate (ADC) GMP manufacturing site in Dharwad
The facility has been engineered to satisfy the global regulatory standards of the US FDA, EMA, and other prominent health authorities.
This ADC manufacturing facility is fully operational, with active GMP qualification protocols establishing a definitive timeline for commercial availability. This milestone is an important expansion of Shilpa Medicare’s background in producing highly potent compounds.
With the launch of this site, Shilpa Medicare has become one of the few organisations in India capable of providing comprehensive, end-to-end drug substance development. The unit’s integrated capabilities include monoclonal antibody production, payload synthesis, linker development, conjugation, and GMP-scale purification.
These processes require specialised cytotoxic containment and exact chemical precision in a validated environment. By providing these combined services, the company is set to act as a competitive CDMO partner for international pharmaceutical and biotechnology firms. This ADC manufacturing facility represents a strategic shift toward becoming a global collaborator for advanced oncology drug platforms.
Sridevi Khambhampaty, CEO, Shilp Biologicals, said, “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 strengthens the group’s dedication to high-value biologics and innovative manufacturing solutions for complex oncology treatments.
Vishnukant Bhutada, managing director, Shilpa Medicare, said, “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. 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.”
This investment will enable Shilpa to contribute significantly to differentiated medical treatments for patients around the world.
