Shilpa Biologicals Commissions Antibody-Drug Conjugate GMP Manufacturing Facility in Dharwad, Karnataka
Shilpa Biologicals, a material subsidiary of Shilpa Medicare, has announced the commissioning of a state-of-the-art Antibody-Drug Conjugate (ADC) GMP manufacturing facility in Dharwad, Karnataka. The facility is purpose-built to meet global regulatory standards, including US FDA, EMA and other major health authority requirements.
The facility is now fully operational, with GMP qualification protocols actively underway, placing the company on track for commercial readiness. The commissioning reinforces Shilpa's focus on high-value biologics and complex oncology drug substance platforms, supporting its strategy to become a global contract development and manufacturing organisation (CDMO) partner for advanced oncology ADC drug substance manufacturing.
The new facility builds on Shilpa Biologicals' existing bioconjugation suite at the same Dharwad campus, which became operational in 2025 and includes 200-litre single-use bioconjugation reactors along with lyophilisation capacity of up to 65 kg. Together, the co-located facilities allow the company to offer integrated ADC development and manufacturing services spanning payloads, linkers, monoclonal antibodies and bioconjugation within a single campus.
Shilpa currently manufactures around 40 per cent of the oncological high-potency active pharmaceutical ingredients (HPAPIs) in use today from its US FDA-approved facilities. The new GMP facility is expected to strengthen the company's positioning with global biotech and pharmaceutical companies seeking integrated ADC manufacturing partners in India