HPAPI CDMO: End-to-End High Potent API Development and Manufacturing
Isolator-based containment · OEL Band 1 to 5 · Oncology and non-oncology high-potent compounds · Preclinical to commercial scale
Shilpa Pharma is a globally trusted HPAPI CDMO partner, delivering integrated high potent API development and manufacturing to pharmaceutical innovators, biotech companies, and generic drug developers across North America, Europe, Japan, Australia, and emerging markets. As the first company in India to establish a complete isolator-based HPAPI manufacturing system, we provide end-to-end containment-controlled solutions for both oncology and non-oncology high-potent molecules. Our high-containment infrastructure is engineered to safely handle OEL Band 1 to 5 compounds, supporting your project from early-stage development through scale-up to long-term commercial supply, all within a single regulatory framework.
Global Regulatory Approvals
Our cGMP-compliant high-containment facilities are approved by seven major regulatory authorities, giving global partners the confidence to outsource even the most sensitive high-potency programs. As a High Potent API CDMO company in India, we combine world-class containment infrastructure with cost-competitive Indian manufacturing to deliver HPAPIs that consistently meet and exceed international quality standards.
Comprehensive HPAPI CDMO Capabilities
Process Development for High Potent APIs
From route scouting to GMP commercial supply, we cover every stage of the high potent API lifecycle under one integrated, containment-controlled roof.
- Project Assessment: Feasibility review of molecule, target market, regulatory landscape, existing IP position, and timeline goals
- Route Scouting: Multi-route evaluation with comparative analysis of yields, costs, safety profiles, containment requirements, and raw material availability
- Process Optimization: DoE-driven optimization, impurity profiling, genotoxic impurity control, and Quality-by-Design (QbD) implementation
- Potency Assessment: Occupational exposure banding, hazard assessment, and containment strategy defined before scale-up begins
- Analytical Development: Method development and validation in an independent analytical laboratory dedicated to high-potent compounds
Containment Technologies and Handling
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:
cGMP Manufacturing: Clinical to Commercial
Our cGMP-compliant peptide manufacturing infrastructure is designed for flexibility, scalability, and regulatory readiness across every phase of drug development:
Advanced High-Potency Capabilities
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:
Specialized HPAPI Classes We Manufacture
Our high potent API portfolio spans oncology and non-oncology therapeutic segments, backed by decades of high-potency chemistry expertise.
Oncology & Cytotoxic APIs
A broad portfolio of anti-cancer high potent APIs, including tyrosine kinase inhibitors, alkylating agents, antimetabolites, and targeted therapy molecules, manufactured under full containment with complete regulatory documentation.
Hormonal & High-Potency Compounds
Potent hormonal and endocrine-active molecules that demand contained handling and strict cross-contamination controls throughout synthesis and isolation.
ADC Payloads & Conjugate Components
High-potent payloads and advanced payload intermediates that enable next-generation antibody-drug conjugate and peptide-drug conjugate therapies, integrating with the wider Shilpa linker and conjugation ecosystem.
Non-Oncology Potent APIs
High-potency molecules outside oncology, including immunosuppressants and other low-dose, high-activity compounds requiring specialized containment.
Representative HPAPI Molecule Classes
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 for HPAPI
End-to-End Under One Roof
From route scouting and process development to clinical supply and commercial-scale manufacturing.
Independent Analytical Laboratory
A dedicated analytical ecosystem for high-potent sample testing, separated from general operations.
Nine Dedicated Cytotoxic Blocks
Segregated manufacturing blocks purpose-built for cytotoxic and high-potent compound production.
India's First Isolator-Based HPAPI System
The first company in India to establish a complete isolator-based high-containment HPAPI manufacturing system.
OEL Band 1 to 5 Coverage
High-containment infrastructure engineered to safely handle the full occupational exposure band range.
Regulatory & IP Strength
Seven-authority approvals, zero-observation USFDA audit history, and rigorous IP protection.
Our HPAPI CDMO Process
Questions & Answers
Our FAQ's
What is an HPAPI CDMO?
An HPAPI CDMO is a contract development and manufacturing organization specialized in highly potent active pharmaceutical ingredients, compounds so potent that they are effective at very low doses and require dedicated containment. Shilpa Pharma provides end-to-end HPAPI CDMO services, from process development through commercial manufacturing, using isolator-based high-containment infrastructure across OEL Band 1 to 5.
What OEL bands can Shilpa handle?
Shilpa’s high-containment facilities are engineered to safely handle OEL Band 1 to 5 compounds. Each molecule is assessed and assigned an occupational exposure band during development, and containment design follows the assigned band.
Do you manufacture both oncology and non-oncology high potent APIs?
Yes. Shilpa manufactures cytotoxic oncology APIs, including tyrosine kinase inhibitors, alkylating agents, and antimetabolites, as well as non-oncology high-potent compounds such as hormonal and immunosuppressant molecules.
What scale of HPAPI manufacturing do you support?
We support all phases, from gram-scale preclinical synthesis and multi-kilogram clinical batches through to commercial-scale production, with seamless technology transfer within the same regulatory framework across nine dedicated cytotoxic blocks.
Which regulatory authorities have approved your HPAPI facilities?
Our cGMP high-containment facilities are approved by seven major regulators: US FDA, EU GMP, PMDA (Japan), TGA (Australia), ANVISA (Brazil), COFEPRIS (Mexico), and KFDA/MFDS (South Korea).
Can you support ADC payloads and conjugate intermediates?
Yes. Shilpa develops and manufactures high-potent payloads and advanced payload intermediates that support antibody-drug conjugate and peptide-drug conjugate programs, integrated with the wider Shilpa linker and conjugation ecosystem.
What regulatory documentation do you provide?
We provide comprehensive regulatory support, including US FDA DMF preparation and filing, European CEP and EDMF applications, Japanese Drug Master File support, IMPD preparation, and CTD-format technical dossier compilation.
How do you protect confidential HPAPI projects?
All HPAPI programs are handled under strict confidentiality agreements with robust IP protection, data integrity controls, and segregated project execution. Detailed portfolio and molecule information is shared only after a signed confidentiality agreement.
Countries We Serve in
As a global HPAPI CDMO partner, Shilpa Pharma supplies high potent APIs and development services to pharmaceutical and biotech companies across regulated and emerging markets, including:
