Shilpa Biologicals Launches Advanced ADC Manufacturing Facility in Dharwad

The company said the facility has been purpose-built to meet global regulatory standards, including those of the US Food and Drug Administration (US FDA), European Medicines Agency (EMA) and other major international health authorities. The facility is now fully operational, with GMP qualification protocols actively underway, marking its progress toward commercial readiness.

According to the company, the commissioning represents a significant expansion of Shilpa Medicare's more than 25 years of expertise in highly potent compound manufacturing. The company stated that it has developed one of India's most comprehensive High Potency API (HPAPI) manufacturing platforms, requiring stringent containment systems, safety engineering, process controls and regulatory compliance.

Commenting on the development, Sridevi Khambhampaty, CEO, Shilpa Biologicals Pvt. Ltd., said that manufacturing highly potent compounds has been a core strength of the company and that the new ADC Drug Substance facility adds another advanced capability to the Shilpa Group. She added that the integrated facility combines the company's experience in high-potency manufacturing with advanced ADC capabilities to support global biotechnology and pharmaceutical partners.

With the commissioning of the new plant, Shilpa Medicare stated that it has become one of the very few companies in India offering a fully integrated, end-to-end ADC Drug Substance development and manufacturing platform. The facility provides capabilities covering payload synthesis, linker development and manufacturing, monoclonal antibody production, ADC conjugation, and purification of GMP-scale Drug Substance.

The company explained that manufacturing ADC Drug Substance requires specialised containment for cytotoxic payloads, precise conjugation chemistry and rigorous biologic purification within a GMP-validated manufacturing environment. According to the company, these capabilities position Shilpa as a cost-competitive Contract Development and Manufacturing Organization (CDMO) partner for global pharmaceutical and biotechnology companies seeking integrated ADC Drug Substance manufacturing solutions.

Vishnukant Bhutada, Managing Director, Shilpa Medicare Ltd., said India possesses both the scientific talent and, with this facility, the infrastructure required to become a trusted global partner in ADC Drug Substance manufacturing. He noted that the company's 25-year legacy in high-potency manufacturing provides a significant advantage and that the addition of the new facility enables Shilpa to offer comprehensive one-stop solutions for leading oncology innovators worldwide.

The company stated that the commissioning further strengthens its focus on high-value biologics, complex oncology Drug Substance platforms and innovation-driven GMP manufacturing. It also aligns with Shilpa's long-term strategy of becoming a globally relevant CDMO partner for advanced oncology ADC Drug Substance manufacturing while supporting the development of differentiated, high-impact therapies for patients.

Shilpa Biologicals Ltd., a wholly owned subsidiary of Shilpa Medicare Ltd., focuses on the development and contract manufacturing of complex biologics and oncology biologics, with capabilities extending from early-stage development to GMP-scale Drug Substance manufacturing.

Shilpa Medicare Limited is engaged in the development, manufacture and marketing of active pharmaceutical ingredients (APIs), formulations and biologics across oncology, infectious diseases and specialty therapeutic segments. The company also has capabilities in complex generics, novel drug delivery systems and CDMO services, and serves patients in more than 80 countries.

The commissioning of the integrated ADC Drug Substance GMP manufacturing facility marks an important milestone in strengthening the company's advanced biologics and oncology manufacturing capabilities while expanding its presence in the global CDMO market.