Shilpa Medicare Ltd has commissioned a state-of-the-art Antibody-Drug Conjugate (ADC) GMP manufacturing facility in Dharwad, India, through its subsidiary Shilpa Biologicals Pvt Ltd. According to the latest regulatory filing submitted to the National Stock Exchange of India (NSE), the facility is fully operational with GMP qualification protocols actively underway. The facility is purpose-built and designed to meet global regulatory approval standards including US FDA, EMA, and other major health authority requirements. This development marks a significant milestone for Shilpa Medicare, leveraging over 25 years of expertise in highly potent compound manufacturing.
The new ADC facility enhances Shilpa Medicare's capabilities by offering end-to-end ADC Drug Substance development and manufacturing. As reported in the regulatory filing, the facility enables comprehensive capabilities including payload synthesis, linker development, monoclonal antibody production, ADC conjugation, and purification of GMP-scale Drug Substance. With integrated capabilities spanning payload synthesis, linker development, monoclonal antibody production and ADC conjugation and purification, Shilpa becomes one of the few Indian companies offering end-to-end ADC drug substance services. This integrated approach positions Shilpa as a cost-competitive CDMO partner for global pharmaceutical and biotech companies seeking integrated ADC solutions.
This commissioning reinforces Shilpa's commitment to high-value biologics, complex oncology Drug Substance platforms, and innovation-driven GMP manufacturing. The expansion strengthens its position as a cost-competitive CDMO for global oncology innovators and supports its strategy to become a globally relevant partner in advanced ADC drug substance manufacturing. The facility is positioned to contribute to differentiated, high-impact treatments for patients worldwide. Vishnukant Bhutada, Managing Director of Shilpa Medicare Ltd, highlighted the strategic importance, stating that "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."
The facility has been specifically designed to meet global regulatory approval standards including US FDA, EMA, and other major health authority requirements. This regulatory-ready approach positions Shilpa to serve international pharmaceutical markets with compliant manufacturing capabilities for advanced biologics. The facility's design leverages Shilpa's established expertise in highly potent compound manufacturing, providing a competitive advantage in the global ADC market. Shilpa Medicare Ltd is an Indian pharmaceutical and biologics company with more than 25 years of expertise in manufacturing highly potent compounds and high potency APIs.
