Shilpa Biologicals commissions ADC GMP manufacturing facility in Dharwad

Shilpa Biologicals, a subsidiary of Shilpa Medicare, announced the commissioning of a state-of-the-art Antibody–Drug Conjugate (ADC) GMP manufacturing facility in Dharwad, Karnataka. The company informed that the facility which is fully operational, is designed to meet global regulatory approval standards including US FDA, EMA, and other major health authority requirements.

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.”

In a press statement, the company informed, “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 pharma and biotech companies seeking high-quality, integrated ADC drug substance solutions.”

“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,” said Vishnukant Bhutada, MD, Shilpa Medicare.