Peptide CDMO: End-to-End Custom Peptide Development & Manufacturing
From milligram-scale synthesis to commercial-scale GMP supply — a US FDA, EU GMP, PMDA, TGA & ANVISA approved peptide CDMO partner for regulated markets worldwide.
Shilpa Pharma is a globally trusted peptide CDMO, delivering integrated custom peptide development and contract manufacturing services to pharmaceutical innovators, biotech companies, and generic developers across North America, Europe, Japan, Australia, and emerging markets. Our cGMP-compliant peptide manufacturing facilities approved by seven major regulatory authorities provide complete peptide lifecycle support: from sequence design and route selection through process development, clinical manufacturing, scale-up, and long-term commercial supply. With deep expertise in solid-phase (SPPS), solution-phase (LPPS), and hybrid synthesis, plus advanced modification chemistry — lipidation, PEGylation, cyclization, and conjugation — we combine world-class infrastructure with cost-competitive manufacturing to deliver peptides that consistently meet and exceed international quality standards.
Global Regulatory Approvals: Peptide Manufacturing Certified for Every Major Regulated Market
When selecting a peptide CDMO partner, regulatory approval history is the single most critical factor. Shilpa Pharma’s manufacturing facilities hold certifications from seven major international regulatory authorities, ensuring that every peptide we manufacture is accepted in the most demanding regulated markets globally.
Comprehensive Peptide CDMO Capabilities at Shilpa Pharma
Peptide Process Development
Our peptide chemistry team designs robust, scalable, and cost-efficient synthesis routes tailored to your sequence, modification profile, and target-market timeline. Key services include:
- Sequence feasibility analysis and synthesis strategy selection (SPPS vs. LPPS vs. hybrid)
- Resin, linker, and protecting-group strategy optimization (Fmoc / Boc)
- Fragment-condensation design for long and complex peptides
- Process optimization using DoE and Quality-by-Design (QbD)
- Peptide-related impurity profiling and control strategy (deletion, truncated, insertion sequences, D-isomers, aggregation)
- Counter-ion exchange and salt-form selection (acetate, hydrochloride, TFA removal)
- Lyophilization cycle development and solid-state characterization
- Technology transfer from research to GMP
Peptide Synthesis Technologies
Shilpa Pharma offers the full spectrum of peptide synthesis platforms, allowing us to select the most efficient and economical route for your molecule at every scale:
| Technology | Best For | Capability |
|---|---|---|
| Solid-Phase Peptide Synthesis (SPPS) | Short-to-medium peptides, rapid development | Fmoc & Boc strategies, automated and manual |
| Solution / Liquid-Phase (LPPS) | Large-scale, specific fragments, cost efficiency | High-volume commercial batches |
| Hybrid SPPS–LPPS | Long, complex peptides at commercial scale | Fragment condensation, optimized cost-per-gram |
| Recombinant / Fermentation | Larger peptides and small proteins | Biocatalytic and expression-based routes |
| Native Chemical Ligation | Long sequences via chemoselective coupling | Convergent assembly of difficult peptides |
cGMP Peptide Manufacturing — From Clinical to Commercial
Our cGMP-compliant peptide manufacturing infrastructure is designed for flexibility, scalability, and regulatory readiness across every phase of drug development:
| Phase | Scope & Output |
|---|---|
| Pre-Clinical | Milligram to gram scale; sequence confirmation, tox-batch supply, route proof-of-concept |
| Phase I / II Clinical | Gram to multi-100g; GMP batches, impurity profiling, stability initiation |
| Phase III Clinical | Multi-kilogram; optimized process, regulatory package preparation |
| Commercial Scale-Up | Multi-kilogram to high-volume; validated processes, full regulatory submissions, QA review |
| Post-Approval | Continuous supply, process improvements, life-cycle management |
Advanced Peptide Modification & Conjugation Chemistry
What sets Shilpa Pharma apart as a peptide CDMO partner is our depth of modification chemistry. We handle complex modifications that many contract manufacturers cannot, enabling partners to source difficult peptides from a single, trusted source:
| Lipidation / fatty-acid acylation (half-life extension) | PEGylation (linear & branched) |
| Head-to-tail & side-chain cyclization | Selective / regioselective disulfide bridging |
| Stapled peptides | N-methylation & backbone modification |
| Non-canonical / unnatural amino acid incorporation | C-terminal amidation |
| Peptide–drug conjugation (PDC) | Phosphorylation & glycosylation |
| Fluorescent labeling & biotinylation | Chelator conjugation (e.g., DOTA) |
| Multi-disulfide folding | Macrocyclization |
Specialized Peptide Classes We Manufacture
Shilpa Pharma supports the full range of therapeutic and commercial peptide categories under cGMP, with complete regulatory documentation for global submission.
GLP-1 & Metabolic Peptides
The fastest-growing peptide segment worldwide. We support the development and manufacture of GLP-1 receptor agonists and related metabolic peptides — including lipidated, long-acting sequences requiring fatty-acid side-chain conjugation for albumin binding and extended half-life — with the purification and analytical rigor these high-demand molecules require.
Therapeutic Peptides
Hormonal, oncology-support, cardiovascular, and rare-disease peptides manufactured to USP/EP monograph standards, with full related-substance and sequence-verification control.
Peptide Conjugates & ADC Components
Peptide–drug conjugates (PDCs), linkers, and payload-adjacent chemistry — leveraging our broader ADC and conjugation infrastructure for targeted-therapy programs.
Cosmetic & Specialty Peptides
Active cosmetic peptides and specialty sequences for the dermatology and personal-care industries, manufactured to pharmaceutical-grade quality.
Key Peptides We Manufacture
Shilpa Pharma manufactures a broad portfolio of peptide APIs across multiple therapeutic classes, including:
| GLP-1 / Metabolic | Hormonal / Oncology Support | Specialty / Other |
|---|---|---|
| Semaglutide | Octreotide Acetate | Bivalirudin |
| Tirzepatide | Leuprolide Acetate | Desmopressin Acetate |
| Liraglutide | Goserelin Acetate | Teriparatide |
| Dulaglutide | Lanreotide | Glucagon |
| Exenatide | Triptorelin | Atosiban |
| Semaglutide intermediates | Somatostatin | Carbetocin |
Contact for End-to-End Peptide CDMO Services in India
Happy Customers
Projects Successfully Completed
Established
PhD Experts Driving R&D Excellence
Team Size
World-Class API Manufacturing Sites
Global Audits Successfully Completed
Comprehensive CDMO Service Offerings
Why Global Pharma Companies Partner with Shilpa Pharma as Their Peptide CDMO
End-to-End Peptide Solutions
From sequence design and route selection to GMP commercial supply, we cover every stage of the peptide lifecycle.
State-of-the-Art R&D
Advanced laboratories for formulation, biologics, and peptide research.
Advanced Modification Expertise
Lipidation, PEGylation, cyclization, and conjugation chemistry that many CDMOs cannot offer.
Global Quality Standards
cGMP-compliant facilities approved by seven regulatory authorities, ensuring submission-ready production.
Scalable Manufacturing
Seamless scale-up from milligram clinical batches to high-volume commercial supply within the same regulatory framework.
Trusted by Pharma Innovators
Reliable partnerships delivering complex peptide programs on time and within budget.
Our Peptide Contract Development & Manufacturing Process
Questions & Answers
Our FAQ's
What is a peptide CDMO?
A peptide CDMO (Contract Development and Manufacturing Organization) is a specialized partner that develops and manufactures peptide active pharmaceutical ingredients on behalf of pharmaceutical and biotech companies. It provides end-to-end services, from synthesis route design and process development through clinical manufacturing, scale-up, and commercial-scale peptide production, including regulatory filing support.
What makes Shilpa Pharma a reliable peptide CDMO partner for global markets?
Shilpa Pharma operates cGMP-compliant peptide manufacturing facilities approved by seven major regulatory authorities — US FDA, EU GMP, PMDA (Japan), TGA (Australia), ANVISA (Brazil), COFEPRIS (Mexico), and KFDA (South Korea). Combined with a full range of synthesis platforms, advanced modification chemistry, PhD-level scientists, and proven scale-up capabilities, we deliver peptides that meet the most stringent international standards.
Which peptide synthesis technologies do you offer?
We offer solid-phase peptide synthesis (SPPS, both Fmoc and Boc strategies), solution/liquid-phase synthesis (LPPS), hybrid SPPS–LPPS for long and complex peptides, recombinant/fermentation-based routes, and native chemical ligation. We select the most efficient and economical platform for your sequence and target scale.
Can you manufacture GLP-1 and lipidated peptides?
Yes. We support the development and manufacture of GLP-1 receptor agonists and other metabolic peptides, including long-acting sequences that require fatty-acid lipidation for albumin binding and extended half-life, with the advanced purification and analytical controls these high-demand molecules require.
What scale of peptide manufacturing can you support?
We support peptide manufacturing across all development phases from milligram-scale pre-clinical and tox batches to gram and multi-100g clinical batches (Phase I, II, III) and high-volume commercial supply. Our facilities are designed for seamless technology transfer and scale-up within the same regulatory framework.
Do you support peptide DMF filing and regulatory submissions?
Yes. We provide comprehensive regulatory support including US FDA Drug Master File (DMF) preparation and filing, European EDMF and Certificate of Suitability (CEP) applications, Japanese Drug Master File (JDMF) support, IMPD preparation, and CTD-format technical dossier compilation, along with regulatory response support for deficiency letters.
What advanced peptide modifications can you handle?
Our capabilities include lipidation/fatty-acid acylation, PEGylation, head-to-tail and side-chain cyclization, selective disulfide bridging and multi-disulfide folding, stapled peptides, non-canonical amino acid incorporation, C-terminal amidation, peptide–drug conjugation, and labeling chemistry (fluorescent, biotin, chelators).
How do I initiate a partnership with Shilpa Pharma for peptide CDMO services?
Contact our business development team via the form on this page or email info@shilpapharma.com. Share your sequence details, modification profile, development stage, target markets, and timeline. Our technical team will respond within 2 business days with an initial assessment and proposed scope.
Countries We Serve in
Learn About Peptide Contract Manufacturing development globally
Peptide CDMO: End-to-End Custom Peptide Design, Development & Production
At Shilpa Pharma, we offer comprehensive peptide CDMO (Contract Development and Manufacturing Organization) services, supporting pharmaceutical and biotech companies from early-stage development to full-scale commercial production. Our integrated capabilities ensure speed, compliance, and scalability across the entire peptide lifecycle.
What Is Peptide CDMO Manufacturing?
Peptide CDMO manufacturing refers to the outsourced contract development and manufacturing of peptide Active Pharmaceutical Ingredients (APIs), which are short chains of amino acids that act as the therapeutic agent in a fast-growing range of drugs, from GLP-1 metabolic therapies to hormonal and oncology-support medicines. A CDMO specializing in peptides provides end-to-end support across the entire peptide lifecycle, including:- Synthesis strategy & route scouting: identifying the most efficient, cost-effective platform (SPPS, LPPS, hybrid, or recombinant)
- Peptide process development & optimization: de-risking scale-up through systematic DoE and quality-by-design
- cGMP manufacturing: from milligram-scale clinical batches to high-volume commercial production
- Advanced modification chemistry: lipidation, PEGylation, cyclization, and conjugation
- Analytical development & method validation: per ICH guidelines, with peptide-specific impurity control
- Regulatory documentation: DMF filing, CEP applications, IMPD preparation
- Technology transfer: seamless handover to internal or third-party sites
Global Regulatory Approvals: Peptide Manufacturing Certified for Every Major Regulated Market
When choosing a peptide CDMO partner, regulatory approval history is the single most critical factor. Shilpa Pharma’s manufacturing facilities hold certifications from seven major international regulatory authorities, ensuring that every peptide we manufacture is accepted in the most demanding regulated markets globally.| Authority | Full Name | Market Access |
| US FDA | United States Food & Drug Administration | USA, Canada (by reference) |
| EU GMP | European Union Good Manufacturing Practice | EU-27 + UK, Switzerland, EEA |
| PMDA | Pharmaceuticals & Medical Devices Agency | Japan |
| TGA | Therapeutic Goods Administration | Australia, New Zealand |
| ANVISA | National Health Surveillance Agency | Brazil, LATAM |
| COFEPRIS | Federal Commission for Protection Against Sanitary Risk | Mexico, Central America |
| KFDA | Korea Food & Drug Administration | South Korea |
DMF & Regulatory Filing Support
Beyond manufacturing, Shilpa Pharma provides full regulatory documentation support to accelerate your market access:- US FDA Drug Master File (DMF) preparation and filing
- European Drug Master File (EDMF) and Certificate of Suitability (CEP) applications
- Japanese Drug Master File (JDMF) support
- IMPD (Investigational Medicinal Product Dossier) preparation
- CTD-format technical dossier compilation
- Regulatory response support for deficiency letters
- Annual product review and change management documentation
Why Global Pharma Companies Partner with a Peptide CDMO
Peptide therapeutics are one of the fastest-growing segments in global pharma, driven by GLP-1 metabolic drugs, hormonal therapies, and targeted conjugates, yet specialized peptide manufacturing capacity remains scarce worldwide. Pharmaceutical companies across North America, Europe, and Asia Pacific increasingly choose proven peptide CDMOs for the following strategic advantages:| Advantage | What It Means for You |
| Cost Competitiveness | Significantly lower manufacturing costs vs. European or US CDMOs without compromising quality or compliance |
| Regulatory-Ready Infrastructure | USFDA-inspected, EU GMP-certified facilities, with peptides accepted directly in regulated markets |
| Full Platform Range | SPPS, LPPS, hybrid, and recombinant synthesis under one roof, the right route for every sequence |
| Modification Depth | Lipidation, PEGylation, cyclization, and conjugation expertise unavailable at many CDMOs |
| Supply Chain Resilience | Diversified, audit-ready peptide supply that reduces single-source and geographic dependency |
| Scale Flexibility | Seamless scale-up from clinical to commercial volumes within the same facility network |
Peptide CDMO Manufacturing Across Therapeutic Areas
Shilpa Pharma has established peptide manufacturing expertise across the following therapeutic categories:| ✓ Metabolic & Diabetes (GLP-1) | ✓ Oncology & Hormonal Therapy |
| ✓ Cardiovascular & Anti-thrombotic | ✓ Bone & Endocrine Disorders |
| ✓ Rare Diseases & Orphan Drugs | ✓ Women’s Health & Obstetrics |
| ✓ Dermatology & Cosmetic Peptides | ✓ Infectious & Antimicrobial Peptides |
Partner With a Trusted Peptide CDMO Manufacturing Company
If you are looking for a dependable peptide CDMO manufacturing partner, Shilpa Pharma offers the expertise, infrastructure, and flexibility to support your success, from sequence to commercialization.
Contact us today to explore how our custom peptide CDMO solutions can accelerate your product journey.
