Shilpa CDMO, a dedicated complex small-molecule contract development and manufacturing organization is launching at CPHI Milan. The new brand, separate from parent company Shilpa Medicare, provides specialist development and commercial manufacturing services for pharma and biopharma customers with complex small molecules.
Building on Shilpa’s 30 years of oncology expertise, Keshav Bhutada, Chief Executive Officer of Shilpa CDMO, said: “We have long been known among our existing partners as incredibly capable, particularly for challenging molecules such as HPAPIs and peptides, and more recently ADC payloads and linkers, PROTACs and oligonucleotides.”
“However, with the growth and opportunity we are now seeing in the CDMO division, it became clear that we needed a much stronger and more distinct business that shows a broader range of innovators our extensive contract service capabilities for novel and complex molecules. Shilpa Pharma’s CDMO division will therefore now go to market as Shilpa CDMO and is dedicated to complex molecule development. Essentially, we love working on our partners’ most challenging projects,” said Bhutada.
The launch comes as U.S. and European biopharma companies increasingly seek to diversify their development and manufacturing strategies beyond China. Shilpa CDMO aims to provide the expertise and infrastructure required to advance complex molecules.
“Available capacity is not the same as capable capacity,” Yagnesh Solanki, Director – CDMO at Shilpa CDMO, said. “For a next-generation compound, the choice of CDMO can be the difference between a program progressing successfully and encountering years of avoidable redevelopment, delay and additional cost.”
To meet this rising demand, Shilpa CDMO is continuing to invest in what is already one of India’s largest small-molecule development and manufacturing platforms. Its infrastructure includes 230 kL of reactor capacity, three R&D centers, more than 400 scientists and two dedicated API manufacturing sites.
In addition to significant commercial infrastructure, the new CDMO brings together dedicated R&D teams for HPAPIs and oncology, peptides, ADC payloads and linkers, oligonucleotides and PROTACs. Shilpa CDMO’s capabilities extend from discovery and route scouting through process and analytical development to commercial drug-substance and finished-dose manufacturing. The complete small-molecule platform aims to help U.S.-based and European biopharma partners advance more quickly through development.
Shilpa CDMO’s payload and linker chemistry sits within 200 miles of sister company Shilpa Biologicals, which provides antibody production, conjugation and fill-finish. For ADC and conjugate programs, this removes intercontinental shipping of intermediates, helps shorten development timelines, and simplifies the supply chain.
At CPHI Milan, Shilpa CDMO will also announce details of its new commercial-scale peptide manufacturing capabilities, further strengthening its ability to support complex peptide programs from development through to commercial supply.
