India, June 24 -- Shilpa Biologicals Ltd, a subsidiary of Shilpa Medicare Ltd, has announced the commissioning of a state-of-the-art Antibody–Drug Conjugate (ADC) Drug Substance GMP Manufacturing Facility, positioning the company among the few players in India with integrated end-to-end ADC manufacturing capabilities.
The facility has been designed to meet global regulatory standards, including those of the US FDA, European Medicines Agency (EMA), and other major health authorities. While the plant is now fully operational, GMP qualification protocols are currently underway to prepare it for commercial operations.
The new facility builds on Shilpa Medicare's more than 25 years of expertise in high-potency active pharmaceutical ingre...