Shilpa CDMO*, the complex chemistry CDMO, is investing $50 million to expand its peptide manufacturing capabilities as global demand accelerates for GLP-1s and a new generation of more complex peptide therapeutics.
The phased investments will span the next few years and add 10 KL of solid-phase peptide synthesis (SPPS) reactor capacity to the three existing clinical-phase manufacturing lines. A fourth line for commercial manufacturing at Shilpa’s Raichur Unit-I campus is already scheduled to open in December 2026, with commercial supply ramping up through 2027. The CDMO plans to add further 2 KL, 3 KL and 5 KL SPPS reactors, which will establish one of the largest multi-tonne peptide capacities in India.
The new commercial line features 500 L and 1,000 L reactors in a single block supporting annual production of up to one metric tonne. Purification includes two 2-metre DAC columns with a 10000 LPH preparative HPLC system. The line will also include 1000L/hr nano filtration and a large scale lyophilizer of 1000 L capacity.
The expansion builds on Shilpa’s existing cytotoxic and peptide conjugate product development capabilities, with one line dedicated to cytotoxic peptide manufacturing usings solid-phase peptide synthesis.
Keshav Bhutada, Chief Executive Officer of Shilpa CDMO, said: “Peptides are becoming one of the most important areas of pharmaceutical development, but the opportunity goes well beyond current GLP-1 demand. Innovator pipelines in oncology and rare diseases are producing increasingly sophisticated molecules and conjugates that require much greater expertise in route design, synthesis, purification and scale-up.
We are investing for where the peptide market is going next. Our aim is to give biotech and pharmaceutical partners a platform that can take challenging peptide programmes from early development through to reliable commercial supply.”
Shilpa CDMO’s expanded peptide operation will comprise six parallel cGMP manufacturing lines, allowing multiple programmes to run independently. The platform supports solid-phase peptide synthesis (SPPS), liquid-phase peptide synthesis (LPPS) and hybrid synthesis (SPPS + LPPS), allowing manufacturing routes to be tailored to the molecule, its development stage and intended commercial scale. Capabilities span linear, cyclic and branched peptides, including molecules incorporating unnatural and D-amino acids, lipidation, conjugation and radioligand peptides etc.
More than 100 scientists and manufacturing specialists already work within Shilpa’s peptide business, including a 50+ strong R&D team dedicated to peptide chemistries and 45 chemists working across production and purification. The team is also backed by the wider Shilpa groups 350+ PhDs.
Dipak Kalita, Senior Vice President – CDMO Services at Shilpa CDMO, said: “As peptides become longer and more complex, the manufacturing route can determine whether a programme can scale successfully. We start with the molecule and its potential commercial requirements, then determine whether solid-phase, liquid-phase or a hybrid approach offers the most robust route. For longer peptides, that can mean moving from solid-phase synthesis to a hybrid fragment-based route as volumes grow. Considering commercial scale from the outset helps customers avoid reaching late-stage development with a process that is no longer technically or economically viable.”
Shilpa CDMO’s peptide operations are based at its 34-acre Unit-I campus in Raichur, Karnataka. The peptide unit operates within the wider site, with dedicated R&D and cGMP manufacturing infrastructure for APIs, commercial linkers, HPAPIs spanning OEB 1-6 and peptide drug conjugates.
The new peptide facility also boasts a centralised Distributed Control System (DCS), with integrated Process Analytical Technology (PAT) and UV monitoring. Design of Experiments (DoE) and process simulation will be used to establish operating parameters ahead of scale-up and technology transfer, while automated data capture will support data integrity and regulatory compliance.
The latest investment follows the recent launch of Shilpa CDMO as a dedicated complex-molecule CDMO brand in October 2026.
*Shilpa CDMO is the customer-facing brand of Shilpa Pharma Lifesciences Limited.
