Facility Overview
Shilpa Biologicals Private Ltd, a material subsidiary of Shilpa Medicare Ltd, has commissioned a state-of-the-art Antibody–Drug Conjugate (ADC) GMP Manufacturing Facility. The facility is purpose-built and designed to meet global regulatory approval standards including US FDA, EMA, and other major health authority requirements.
Operational Status
The facility is fully operational with GMP qualification protocols now actively underway, placing Shilpa on a clear path to commercial readiness.
Technical Capabilities
The facility offers fully integrated, end-to-end ADC Drug Substance development and manufacturing capabilities encompassing:
- Payload synthesis
- Linker development and manufacturing
- Monoclonal antibody production
- ADC conjugation
- Purification of GMP-scale Drug Substance
The manufacture of ADC Drug Substance requires specialised cytotoxic payload containment, precise conjugation chemistry, and rigorous biologic purification within a GMP-validated environment.
Strategic Significance
This commissioning makes Shilpa Medicare Ltd one of the very few companies in India to offer comprehensive ADC manufacturing services. It leverages the company's over 25 years of deep-rooted expertise in highly potent compound manufacturing and existing High Potency API (HPAPI) platforms.
Management Commentary
Sridevi Khambhampaty, CEO of Shilpa Biologicals Pvt Ltd, stated: "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."
Vishnukant Bhutada, Managing Director of Shilpa Medicare Ltd, added: "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."
Business Impact
The commissioning reinforces Shilpa's commitment to high-value biologics, complex oncology Drug Substance platforms, and innovation-driven GMP manufacturing. It represents a decisive step in the company's long-term strategy to become a globally relevant CDMO partner for advanced oncology ADC Drug Substance manufacturing, positioning Shilpa as a compelling, cost-competitive CDMO partner for global pharmaceutical and biotech companies.