Shilpa Commissions Integrated ADC Drug Substance GMP Manufacturing Facility

India-based Shilpa Biologicals has officially commissioned a state-of-the-art antibody–drug conjugate (ADC) GMP manufacturing facility, strategically designed to comply with global regulatory standards, including those set forth by the U.S. FDA and EMA. This facility is now fully operational, with GMP qualification protocols currently in progress.

Sridevi Khambhampaty, CEO of Shilpa Biologicals, emphasized that the production of highly potent compounds is a fundamental aspect of Shilpa’s identity. The new ADC drug substance facility enhances the company’s capabilities, allowing them to provide global biotech and pharmaceutical partners with a uniquely integrated manufacturing solution built on their existing expertise in high-potency production.

Vishnukant Bhutada, managing director of Shilpa Medicare, noted that India possesses both the scientific talent and the necessary infrastructure to emerge as a reliable partner in the global ADC drug substance manufacturing landscape. The facility positions Shilpa to collaborate with leading innovators in oncology, further solidifying its role in the evolving pharmaceutical supply chain.