Shilpa Biologicals Private Ltd, a material subsidiary of Shilpa Medicare Ltd, on Wednesday announced the commissioning of an Antibody-Drug Conjugate (ADC) GMP manufacturing facility at Dharwad, Karnataka, designed to meet global regulatory standards including those of the US FDA and the European Medicines Agency.
The facility is fully operational, with GMP qualification protocols currently underway.
Shilpa Medicare becomes one of the few in India with end-to-end ADC capability
With the new facility, Shilpa Medicare becomes one of the few companies in India offering fully integrated, end-to-end ADC drug substance development and manufacturing, spanning payload synthesis, linker development and manufacturing, monoclonal antibody production, ADC conjugation, and GMP-scale drug substance purification.
The commissioning builds on Shilpa Medicare’s more than 25 years of experience in highly potent compound manufacturing, during which the company built a High Potency API (HPAPI) platform.
“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 Pvt Ltd.
Company positions facility for global oncology partnerships
Vishnukant Bhutada, Managing Director, Shilpa Medicare Ltd, 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 can provide comprehensive one-stop solutions to the world’s leading oncology innovators.”
The commissioning reinforces Shilpa Medicare’s commitment to high-value biologics and innovation-driven GMP manufacturing, strengthening its position in the Indian pharmaceutical industry while representing a decisive step in its strategy to become a globally relevant CDMO partner for advanced oncology ADC Drug Substance manufacturing.
Shilpa Biologicals Ltd is a wholly owned subsidiary of Shilpa Medicare, focused on the development and contract manufacturing of complex and oncology biologics.
