Shilpa Biologicals has announced the commissioning of a state-of-the-art Antibody Drug Conjugate (ADC) Good Manufacturing Practice (GMP) Manufacturing Facility, purpose-built and designed to meet global regulatory approval standards including US Food and Drug Administration (FDA), European Medicines Agency (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 significant 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 (HPAPI) platforms—a discipline demanding the most exacting standards of containment, safety engineering, process rigor, and regulatory compliance.

Sridevi Khambhampaty, CEO, Shilpa 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.”

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 GMPvalidated 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.

Vishnukant Bhutada, Managing Director (MD), Shilpa Medicare, said, “India has the scientific talent and now, with this facility, the infrastructure as well to be a serious and trusted partner in global ADC Drug Substance manufacturing. Our 25-year legacy in high potency manufacturing gives us a head start that very few can match. With the addition of this facility, we are able to provide comprehensive one stop solution to the world’s leading oncology innovators.”

This commissioning reinforces Shilpa’s commitment to high-value biologics, complex oncology drug substance platforms, and innovation-driven GMP manufacturing. It is a decisive step in its long-term strategy to become a globally relevant CDMO partner for advanced oncology ADC drug substance manufacturing—contributing to differentiated, high-impact treatments for patients worldwide.