Shilpa Biologicals Commissions One Of India's Very Few Integrated ADC Drug Substance GMP Manufacturing Facilities

Ready to take on global ADC development and manufacturing programmes

Shilpa Biologicals Ltd, a subsidiary of Shilpa Medicare Ltd today announced the commissioning of a state-of-the-art Antibody–Drug Conjugate (ADC) GMP manufacturing facility, 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 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.”

With this commissioning, Shilpa Medicare Ltd 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.

“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.”

This commissioning reinforces Shilpa’s commitment to high-value biologics, complex oncology drug substance platforms, and innovation-driven GMP manufacturing, and marks 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.

About Shilpa Biologicals Ltd
Shilpa Biologicals Ltd is a wholly owned subsidiary of Shilpa Medicare Ltd focused on the development and contract manufacturing of complex biologics and oncology biologicals, with capabilities spanning early development through GMP-scale Drug Substance manufacturing.

About Shilpa Medicare Ltd
Shilpa Medicare Ltd is a vertically integrated pharmaceutical company headquartered in Raichur, Karnataka, India, with over 25 years of expertise across oncology APIs, high potency manufacturing, finished dosage forms, and biologics. Listed on NSE and BSE.