Indian firm's US FDA-approved facility to undertake cartridge fill-finish work, marking a boost for country's high-value biologics manufacturing ambitions

Shantha Biologics has signed an agreement with Danish pharmaceutical giant Novo Nordisk to manufacture cartridges for injectable medicines at its Hyderabad facility, marking a major endorsement of the Indian company's sterile manufacturing capabilities and strengthening India's position in the global biologics contract manufacturing market.
Under the agreement, Shantha Biologics will undertake cartridge fill-finish manufacturing—the final stage of the production process in which medicines are filled into pre-filled cartridges and prepared for use in pen injectors. While the companies did not disclose financial terms or production volumes, the partnership will be executed at Shantha's US FDA-approved manufacturing facility in Hyderabad.
Cartridge fill-finish is one of the most critical stages in injectable drug manufacturing, requiring highly sterile conditions, contamination-free production and precise dosing accuracy before medicines reach patients. The format is widely used for therapies treating chronic conditions such as diabetes, obesity, growth hormone deficiencies, autoimmune disorders and certain cancers.
For Shantha Biologics, the partnership represents more than a manufacturing contract, serving as validation of its ability to meet the stringent quality standards expected by one of the world's leading diabetes care and biopharmaceutical companies.
"Novo Nordisk choosing us as a CDMO partner for this work is a strong endorsement of the quality of our site, our processes and our technical capability," said Dr. Vishy Chebrol, director, Shantha Biologics.
"It validates years of investment in building manufacturing systems that meet the standards global innovators expect, and it strengthens our case that India can be a serious partner in advanced manufacturing, not just a low-cost production base," he added.
The agreement comes as global pharmaceutical companies increasingly outsource manufacturing of complex biologic medicines to specialised contract development and manufacturing organisations (CDMOs).
According to industry estimates cited by the company, the global biologics CDMO market was valued at $25.32 billion in 2025 and is expected to grow to $38.29 billion by 2031, driven by rising demand for biologic drugs and injectable therapies.
Shantha Biologics currently operates two businesses—its vaccine business and a cartridge fill-finish manufacturing unit built to cater to the growing demand for injectable medicines, including insulin, GLP-1 therapies and antibody-based treatments. The company said both businesses operate under the same quality and regulatory standards.
Founded in 1993 by Dr. K. I. Varaprasad Reddy, Shantha Biologics entered a new phase in 2024 under a consortium led by Dr. Ravi Penmetsa and Dr. Vishy Chebrol, while Dr. Reddy now serves as chairman of the board. The company said it plans to further expand its presence in vaccines, biologics and injectable manufacturing as global demand rises and expects its Hyderabad workforce to grow to around 500 employees in the near future.