Shilpa Medicare has announced the launch of a dedicated complex small-molecule contract development and manufacturing organisation (CDMO), launching next month at CPHI in Milan, marking a major push into the specialised CDMO space.
The new entity, named Shilpa CDMO, will be separate from parent company Shilpa Medicare and provide end-to-end solutions for complex small molecules for biotech and pharma customers.
Keshav Bhutada, CEO of Shilpa CDMO, said that while the company's existing partners were capable, the growth in the company's CDMO division warranted a separate company focused on complex molecule development.
...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."
The company said it has noticed an increase in US and European biotech companies seeking to diversify their development and manufacturing strategies beyond China, but finding a lack of CDMO options with the expertise and infrastructure needed to advance genuinely complex molecules.
“Available capacity is not the same as capable capacity,” explained Yagnesh Solanki, Director – CDMO at Shilpa CDMO.
For a next-generation compound, the choice of CDMO can be the difference between a programme progressing successfully and encountering years of avoidable redevelopment, delay and additional cost.
Thus, the company is investing in one of India’s largest small-molecule development and manufacturing platforms, which already includes 230 kL of reactor capacity, three R&D centres, more than 400 scientists and two dedicated API manufacturing sites.
Shilpa CDMO will bring dedicated R&D teams to the site for HPAPIs and oncology, peptides, ADC payloads and linkers, oligonucleotides and PROTACs, along with its significant commercial infrastructure.
The site's capabilities will span discovery and route scouting through process and analytical development to commercial drug-substance and finished-dose manufacturing — giving Shilpa CDMO "one of the world’s most complete small-molecule platforms."
The new company's site will also sit within 200 miles of sister company Shilpa Biologicals, which provides antibody production, conjugation and fill-finish.
For ADC and conjugate programmes, this removes intercontinental shipping of intermediates, shortens development timelines and materially simplifies the supply chain
Dipak Kalita, Senior Vice President – CDMO Services at Shilpa CDMO, said: “What has often surprised new customers – and demonstrated why we need a clearer brand — is the breadth and depth of our capabilities beyond our established position in oncology."
"We are also investing heavily in PROTACs and peptides. When paired with our sister company, Shilpa Biologicals ... we offer payload and linker chemistry, antibody production, conjugation and fill-finish, all from sites inside 200 miles of each other."
This is near unique among global CDMOs and means development timelines are faster and supply chains much simpler.
The news follows the announcement in May that Shilpa Medicare signed a new long-term development and commercial manufacturing agreement with NXI Therapeutics AG — its third named partnership deal announced in the past year.
The firm has expanded rapidly amid strengthening demand from Western biotechs for its integrated R&D capabilities and advanced GMP manufacturing, with the company seeing "strong momentum in high-value biologics and speciality therapeutics."
Shilpa CDMO will announce further details about its new commercial-scale peptide manufacturing capabilities at the upcoming CPHI Milan trade show.
