Shilpa Medicare has commissioned a state-of-the-art Antibody Drug Conjugate (ADC) manufacturing facility, marking a significant step forward in its biopharmaceutical growth strategy. Designed to comply with global regulatory requirements, including those of the US FDA, European Medicines Agency (EMA), and other major health authorities, the facility is now fully operational, with Good Manufacturing Practice (GMP) qualification activities underway.
The new facility builds on Shilpa Medicare’s more than 25 years of expertise in manufacturing highly potent active pharmaceutical ingredients (HPAPIs). It offers comprehensive, end-to-end ADC drug substance development and manufacturing capabilities under one roof. These include payload synthesis, linker development and production, monoclonal antibody manufacturing, ADC conjugation, and GMP-scale purification.
ADC production is a highly specialized process requiring advanced containment systems, sophisticated conjugation technologies, and stringent biologic purification standards. The newly commissioned facility incorporates all these critical capabilities, enabling the company to support the growing global demand for advanced oncology therapeutics.
With this development, Shilpa Medicare becomes one of the few Indian companies capable of providing fully integrated ADC drug substance manufacturing services. The facility further strengthens the company’s position as a competitive Contract Development and Manufacturing Organization (CDMO), allowing it to offer cost-effective, high-quality manufacturing solutions to pharmaceutical and biotechnology companies worldwide.
