India Pharma Outlook Team | Thursday, 25 June 2026
India gets a rare end-to-end ADC manufacturing facility as Shilpa Biologicals, a material subsidiary of Shilpa Medicare, commissioned one of the country’s few fully integrated Antibody-Drug Conjugate (ADC) manufacturing plants.
The new facility marks a significant step for India’s advanced biologics sector and strengthens the company’s position in the fast-growing global oncology market.
With operations now underway and GMP qualification activities in progress, the site is being prepared for commercial manufacturing aligned with international regulatory standards.
The commissioning of the facility highlights India’s growing capabilities in ADC manufacturing, a highly specialized segment of cancer drug development. Designed to meet the requirements of global regulators including the US FDA, EMA, and other leading health authorities, the plant is expected to support biotech and pharmaceutical companies seeking integrated development and manufacturing services.
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Shilpa Medicare brings more than 25 years of experience in high potency API (HPAPI) manufacturing, a field that demands advanced containment systems, stringent safety measures, and strict regulatory compliance. The company believes this expertise provides a strong foundation for entering the complex ADC manufacturing segment.
According to Sridevi Khambhampaty, CEO of Shilpa Biologicals, the manufacturing of highly potent compounds has long been a key strength of the company. She said the new ADC Drug Substance facility adds a sophisticated layer to the group’s capabilities and enables Shilpa to offer global biotech and pharmaceutical companies an integrated ADC manufacturing platform backed by years of high-potency manufacturing experience.
With the launch of the new plant, Shilpa joins a small group of Indian companies capable of delivering end-to-end ADC Drug Substance development and manufacturing services.
The facility supports the complete ADC production chain, including:
This integrated approach allows customers to access multiple critical services under one roof, reducing development timelines and simplifying supply chain management.
ADC manufacturing is considered one of the most complex areas in pharmaceutical production. It requires specialized cytotoxic handling systems, advanced conjugation chemistry, and biologics-grade purification processes performed under tightly controlled GMP conditions.
Shilpa Medicare believes the new facility can help position India as a stronger player in the global oncology manufacturing and biologics manufacturing landscape.
Vishnukant Bhutada, Managing Director of Shilpa Medicare, said India now has both the scientific talent and infrastructure needed to become a trusted partner for global ADC Drug Substance manufacturing. He added that the company’s 25-year legacy in high-potency manufacturing provides a competitive advantage and enables Shilpa to offer a comprehensive one-stop solution to oncology innovators worldwide.
The company expects the facility to strengthen its presence in high-value biologics and complex cancer treatment platforms. It also supports Shilpa’s broader strategy of becoming a globally recognized CDMO partner for biotechnology and pharmaceutical companies developing next-generation oncology therapies.
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