Shilpa Biologicals, a material subsidiary of Shilpa Medicare, has commissioned one of India’s few fully integrated Antibody–Drug Conjugate (ADC) GMP manufacturing facilities, marking a major expansion in the country’s advanced biologics capabilities.
The state-of-the-art facility is designed to meet global regulatory expectations, including US FDA, EMA, and other leading health authority standards. It is now fully operational, with GMP qualification protocols underway, positioning the site for near-term commercial readiness.
The move builds on more than 25 years of Shilpa Medicare’s experience in highly potent compound manufacturing. The company has long operated in the demanding high-potency API (HPAPI) space, where strict containment, safety engineering, and regulatory compliance are essential.
“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,” said Sridevi Khambhampaty, CEO, Shilpa Biologicals.
“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 joins a very small group of Indian companies capable of offering end-to-end ADC Drug Substance development and manufacturing. The facility covers the full value chain — from payload synthesis and linker development to monoclonal antibody production, ADC conjugation, and GMP-scale purification.
ADC manufacturing requires highly specialised cytotoxic handling systems, precision conjugation chemistry, and biologics-grade purification under tightly controlled GMP conditions. Shilpa says this positions it as a strong, cost-competitive CDMO partner for global biotech and pharmaceutical firms working in oncology.
“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,” said Vishnukant Bhutada, Managing Director, Shilpa Medicare.
“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.”
The company says the commissioning strengthens its push into high-value biologics and complex oncology platforms, reinforcing its ambition to become a globally relevant CDMO in advanced ADC manufacturing.
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