Shilpa Biologicals Commissions Advanced ADC GMP Manufacturing Facility in India

Shilpa Biologicals Commissions Advanced ADC GMP Manufacturing Facility in India​

Shilpa Biologicals Ltd, a material subsidiary of Shilpa Medicare Ltd (NSE: SHILPAMED), has successfully commissioned a state-of-the-art Antibody-Drug Conjugate (ADC) GMP Manufacturing Facility. The facility is built to meet global regulatory standards, including those set by the US FDA and EMA, marking a significant advancement for the company in the advanced oncology segment.

The newly operational facility is now undergoing GMP qualification protocols, positioning Shilpa Biologicals for commercial readiness in complex biologic manufacturing. This commissioning reinforces Shilpa Medicare's dedication to high-value biologics and sophisticated oncology Drug Substance platforms.

Defining India’s Integrated ADC Capability​

This strategic milestone elevates Shilpa Medicare Ltd into the group of a few companies in India offering fully integrated, end-to-end ADC Drug Substance development and manufacturing services. The scope of this capability is extensive, encompassing critical steps including payload synthesis, linker development and manufacturing, monoclonal antibody production, ADC conjugation, and the purification of GMP-scale Drug Substance.

The manufacture of ADC Drug Substance requires specialized expertise in cytotoxic payload containment, precise conjugation chemistry, and rigorous biologic purification, all within a validated GMP environment. This positions Shilpa as a competitive CDMO partner for international pharmaceutical and biotech companies seeking high-quality integrated solutions.

Sridevi Khambhampaty, CEO of Shilpa Biologicals Pvt Ltd, noted that the ADC Drug Substance facility adds a sophisticated dimension to the existing expertise in highly potent compound manufacturing held by the group. She stated, "We now offer global biotech and pharma partners a uniquely integrated ADC facility built with the knowledge of our existing high potency manufacturing excellence."

Legacy in High Potency Manufacturing​

The commissioning builds upon Shilpa Medicare's more than 25 years of expertise in highly potent compound manufacturing—a discipline that demands stringent standards of safety engineering, process rigor, and regulatory compliance.

Vishnukant Bhutada, Managing Director of Shilpa Medicare Ltd, commented on the significance of this development for India’s biopharma sector. He said, "India has the scientific talent and now, with this facility, the infrastructure as well to be a serious and trusted partner in global ADC Drug Substance manufacturing." He added that their 25-year legacy in high potency manufacturing provides them a unique advantage for offering comprehensive one stop solutions to leading oncology innovators globally.

Shilpa Medicare Limited continues to serve patients in over 80 countries, having built expertise across APIs, formulations, and biologics across the oncology and infectious diseases segments.

SHILPAMED Stock Price Movement​

Shares of Shilpa Medicare Limited are shedding value in live trading as of 10:02 AM, dipping by 0.85% to reach ₹586.15. The stock remains above the day's low of ₹582.4, with a volume exceeding 392,962 shares recorded so far this morning.