Shilpa Medicare has officially launched its innovative "hybrid CDMO" model at DCAT 2025, offering pharmaceutical companies a dual-pathway approach to drug development and commercialization. The newly formed contract development and manufacturing organization (CDMO) will serve clients across small molecules, large molecules, and peptides, with a particular therapeutic focus on oncology.
The hybrid model distinguishes itself by combining traditional CDMO services with commercially ready "off-the-shelf" novel formulations available for exclusive B2B licensing. This approach allows pharmaceutical partners to either develop products through conventional outsourcing or license fully developed assets, significantly reducing development risks and accelerating time-to-market.
"Our goal is to offer pharmaceutical and biotech customers multiple flexible pathways to bring commercial products to market," said Vishnukant C. Bhutada, Managing Director of Shilpa Medicare. "On the one hand, they can leverage our development teams, cutting-edge technologies, and world-class facilities in a traditional CDMO partnership – with both our GLP-1 and biologics services in high demand at DCAT. On the other, we have a pipeline of fully developed products that are available for exclusive licensing, eliminating development risks for our partners. However, we remain strictly a B2B-only company, ensuring we never compete with our clients."
Comprehensive Infrastructure and Capabilities
Shilpa Medicare has experienced rapid growth, achieving a turnover exceeding $150 million. The company has built an extensive infrastructure comprising five state-of-the-art R&D centers and six manufacturing facilities. These include two dedicated drug substance plants, three drug product plants, and advanced platform technologies for specialized applications.
The company's manufacturing capabilities are particularly robust, featuring:
- Total API reactor volume exceeding 800 KL
- Two separate commercial drug product lines
- Advanced formulation technologies including liquid-lyophilization, nano liposomes, and microfluidization
- Peptide capabilities spanning both solid and solution phase synthesis
- Annual capacity for 20 million units of fill/finish services for cartridges and devices
- Peptide drug substance production capacity of 40kg API/year
Expanding Biologics Capabilities
For biologics customers, Shilpa operates dedicated facilities covering drug substance, product, and packaging. The company currently maintains 8KL capacity for monoclonal antibodies (mAb) with potential to increase to 16KL. Additionally, a large 200KL microbial fermentation facility is scheduled to become operational later this year, addressing increasing global demand.
"We are building an integrated platform company and we have a very clear expansion vision to sell global partners," explained Keshav Bhutada, Director at Shilpa Medicare Group. "There is a real shortage globally of full-service partners with our breadth of capabilities from discovery to commercial supply and across multiple modalities whether small molecule, biological, peptide and even GLP-1. Consequently, demand is growing incredibly quickly as those with large drug substance and drug product capabilities are able to advance projects more quickly for partners."
Diverse Service Portfolio
Shilpa's CDMO formulation services encompass a wide range of delivery systems:
- Oral solids
- Topicals
- Injectables
- Transdermal patches
- Ophthalmic delivery
- Oral thin films
The company's manufacturing sites have secured approvals from major global regulatory authorities, including the US FDA, European Medicines Agency (EMA), Japan's PMDA, Australia's TGA, and the UK's MHRA. This comprehensive regulatory coverage enables Shilpa to serve clients targeting multiple international markets.
Pipeline Assets Ready for Licensing
The CDMO currently has multiple assets in its development pipeline, with three late-stage products immediately available for licensing at DCAT. This model enables pharmaceutical companies to expedite market entry by licensing fully developed products while still benefiting from Shilpa's development and manufacturing expertise.
Supporting these operations is a diverse talent pool of over 3,000 professionals, including more than 350 scientists and 1,000 manufacturing specialists, positioning Shilpa Medicare as a significant player in the evolving CDMO landscape with its innovative hybrid approach.
