Small Molecule CDMO Services | Custom Synthesis & Process Scale-Up

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Small Molecule CDMO

Small molecules continue to play an important role in pharmaceutical development, supported by established synthetic routes, scalable manufacturing processes, and mature analytical methods. As development programs progress, a capable small molecule CDMO partner can help address challenges in route optimization, process scale-up, intermediate supply, and manufacturing consistency.Shandong Juntai Pharmaceutical supports pharmaceutical and biotech companies with small molecule R&D, process development, scale-up, custom synthesis, and manufacturing services. Our capabilities cover key starting materials, pharmaceutical intermediates, and API-related projects, with support for route evaluation, process optimization, analytical testing, quality documentation, and project-specific manufacturing requirements. By connecting R&D, process development, and production capabilities, we help customers move small molecule projects from laboratory evaluation toward scalable and reliable manufacturing.

One-Stop Small Molecule CDMO Platform

From R&D to commercialization, we integrate CRO & CDMO capabilities across small molecules—delivering end-to-end services in RSM, intermediate, API, HPAPI and drug products.

Green Chemistry & Enabling Technology

We specialize in complex chemistry—chiral molecules, HPAPI, heterocycles, ADC linkers, and etc.— with enabling technologies including flow chemistry, High Throughput Experimentation, biocatalysis, and Solubility-Enhancing Technologies.

Global Compliance & Cost Efficiency

With Multiple GMP-compliant sites, we ensure regulatory excellence. Our tailored CDMO strategies help reduce costs, minimize tech transfer, and accelerate the path to market.

Our Services

ChemExpress combines deep chemistry expertise with global regulatory compliance experience, supporting the small molecule CDMO landscape to accelerate development and minimize risk—empowering our clients to seize market opportunities faster.

Our Service Scope Includes

Drug Discovery Services

Skilled in Complex Synthesis Routes
Full-Time Equivalent (FTE) and Fee for Service (FFS) Services
Cost-Effectiveness and Efficient Delivery
IP Protection

Process Development

Route Scouting and Optimization
Scalable and Cost-Effective Processes
Seamless Transition to GMP Manufacturing
End-to-End Tech Transfer and Scale-Up Support

Drug Substance Manufacturing

Therapy Area: Anti-tumor, antiviral, diabetic, cardiovascular , gastrointestinal tract, cerebrovascular diseases and etc.
cGMP-Compliant Facilities
Outstanding Synthesis Capability

Highly Potent API Manufacturing

OEB-5 Compliant Workshop
Rich Experience in HPAPI Handling

Drug Product Manufacturing

Oral Solid: tablets, hard capsules, granules, powders; Semi-solid: creams, ointments and gels
cGMP Manufacturing
Solubility-Enhancing Technologies (Hot-Melt Extrusion, Spray Dryer)
20 Years of Rich Experience
Served ＞200 New Drug Formulation Projects

Regulatory CMC Support

IND/NDA Dossier Preparation
US-China Dual IND Filing Support
eCTD-Compliant Document Preparation
Communication Support with Regulatory Authorities

Analytical Development & Quality Control

Comprehensive Coverage of Method Development and Validation
Stability Studies and ICH-Compliant Testing
Release Testing for RSM, Intermediate, API, and Drug Product
Fully Equipped with Analytical Instruments

Our Sites

R&D Sites

Juancheng R&D Center

Manufacturing Sites

Zaozhuang Fermentation Production Base

Related Services

Drug Discovery Services

We specialize in complex synthesis routes and accelerate drug discovery through flexible collaboration models and cost-effective R&D strategies.

Process Development

We provide scalable and cost-effective processes, ensuring a smooth transition to GMP production and supporting technology transfer.

Drug Substance Manufacturing

We provide integrated Drug Substance services—from early-stage process optimization to GMP production and regulatory support.

Drug Product Manufacturing

We provide comprehensive manufacturing capabilities for multiple dosage forms, including oral solids (tablets, capsules, granules, powders) and semi-solids (creams, ointments, gels).

Regulatory CMC Support

Well experienced with the regulatory management and requirements for pharmaceutical products in the USA, China, Japan and EU. We successfully assisted clients in a total of 150+ US-China dual IND filing cases.

Analytical Development & Quality Control

We provide comprehensive method development, validation, stability studies, ICH-compliant testing, and have fully equipped analytical instruments and GMP labs to ensure the quality of drug substances and drug products.

FAQs

An API is the chemically active substance in a medication that produces the intended therapeutic effect. Drug products (formulations) combine APIs with excipients (such as starch, lactose) in specific ratios to create the final dosage forms for patient use, including tablets, capsules, and injections. Simply put, APIs are the "active components" while drug products are the "finished medicines."

We possess deep expertise in complex small molecule synthesis, specializing in challenging chemical structures including chiral molecules, highly potent APIs (HPAPIs), heterocyclic compounds, and ADC payloads. Our advanced technology platforms encompass continuous flow chemistry, high-throughput experimentation (HTE), biocatalysis, and bioavailability enhancement technologies. We maintain comprehensive analytical capabilities ensuring end-to-end quality control from starting materials to final products.

We have established a comprehensive cGMP quality management system with manufacturing facilities compliant with international regulatory standards including FDA, EMA, and NMPA requirements. We rigorously follow ICH guidelines and have implemented complete quality risk management and deviation handling procedures. Our professional stability study capabilities support clients throughout the entire regulatory journey from IND to NDA, facilitating successful regulatory approvals across major global markets.