Shilpa Biologicals announces commission of ADC GMP facility in Dharwad

Shilpa Biologicals, a subsidiary of Shilpa Medicare, has announced the commissioning of a state-of-the-art Antibody–Drug Conjugate (ADC) GMP manufacturing facility in Dharwad, purpose-built and designed to meet global regulatory approval standards including US FDA, EMA, and other major health authority requirements.

The facility is fully operational, with GMP qualification protocols now actively underway, placing Shilpa on a clear path to commercial readiness.

This commissioning marks a natural and powerful evolution of Shilpa Medicare’s over 25 years of deep-rooted expertise in highly potent compound manufacturing. Since its early years, Shilpa has built one of India’s most robust high potency API platforms — a discipline demanding the most exacting standards of containment, safety engineering, process rigour, and regulatory compliance. 

Sridevi Khambhampaty, CEO, Shilpa Biologicals 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.”

With this commissioning, Shilpa Medicare becomes one of the very few companies in India to offer fully integrated, end-to-end ADC drug substance development and manufacturing — encompassing payload synthesis, linker development and manufacturing, monoclonal antibody production, ADC conjugation, and purification of GMP-scale drug substance.

The manufacture of ADC drug substance demands specialised cytotoxic payload containment, precise conjugation chemistry, and rigorous biologic purification — all within a GMP-validated environment.  This positions Shilpa as a compelling, cost-competitive CDMO partner for global pharmaceutical and biotech companies seeking high-quality, integrated ADC drug substance solutions.