Shilpa Medicare’s material subsidiary -- Shilpa Biologicals has commissioned a state-of-the-art Antibody-Drug Conjugate (ADC) GMP Manufacturing Facility, purpose-built and designed to meet global regulatory approval standards including US FDA, EMA, and other major health authority requirements. The facility is fully operational, with GMP qualification protocols now actively underway, placing Shilpa on a clear path to commercial readiness.

This commissioning marks a significant evolution of Shilpa Medicare’s over 25 years of deep-rooted expertise in highly potent compound manufacturing. Since its early years, Shilpa has built one of India’s most robust High Potency API (HPAPI) platforms--a discipline demanding the most exacting standards of containment, safety engineering, process rigour, and regulatory compliance

With this commissioning, Shilpa Medicare becomes one of the very few companies in India to offer fully integrated, end-to-end ADC Drug Substance development and manufacturing--encompassing payload synthesis, linker development and manufacturing, monoclonal antibody production, ADC conjugation, and purification of GMP-scale Drug Substance. The manufacture of ADC Drug Substance demands specialised cytotoxic payload containment, precise conjugation chemistry, and rigorous biologic purification--all within a GMP-validated environment. This positions Shilpa as a compelling, cost-competitive CDMO partner for global pharmaceutical and biotech companies seeking high-quality, integrated ADC Drug Substance solutions.

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.

Shilpa Medicare Ltd.