DCAT Week

Shilpa Medicare launched a new full service ‘hybrid’ CDMO at DCAT 2025. The newly formed CDMO will serve both small and large molecule customers as well as peptides – with oncology as a therapeutic specialty.

In addition to offering discovery, clinical, and commercial outsourcing services, Shilpa’s ‘hybrid CDMO model’ includes commercially ready ‘off-the-shelf’ novel formulations for exclusive b2b licensing. This dual approach aims to enable pharmaceutical companies to leverage Shilpa’s oncology expertise without the direct risks and lengthy timelines associated with development.

Shilpa currently has multiple assets in its pipeline and three late-stage products available for licensing. Through this model, pharma companies can expedite their market entry by licensing fully developed products while leveraging Shilpa’s development and manufacturing capabilities.

Its peptide capabilities span both solid and solution phase peptide synthesis or a combination of both. The integrated facilities provide fill/finish services for both cartridges and devices, with an annual capacity of 20 million units, and peptide drug substance production capacity of 40kg API/year.

For biologics customers, Shilpa operates a dedicated facility covering drug substance, product, and packaging. The company has 8KL capacity for monoclonal antibodies (mAb) that can increase 16KL, with an additional 200KL microbial fermentation facility set to be operational later this year.

Shilpa’s CDMO formulation services span oral solids, topicals, injectables, transdermal patches, ophthalmic delivery and oral thin films. Shilpa’s manufacturing sites have approvals from global regulators including the FDA, EMA, PMDA, TGA and MHRA.

Vishnukant C. Bhutada, Managing Director of Shilpa Medicare, commented, “Our goal is to offer pharmaceutical and biotech customers multiple flexible pathways to bring commercial products to market. 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.”