Small Molecules CDMO Services
Porton Small Molecule CDMO Service Platform operates R&D centers and GMP manufacturing sites across the United States, Europe, and China. We provide global pharmaceutical companies and new drug R&D organizations with end-to-end CDMO services that span all stages of drug development and commercialization—from intermediate (INT), drug substance (DS) to drug product (DP) —in compliance with international standards. Leveraging our globally leading technical platform capabilities, our primary service offerings include: route scouting, design, development and optimization for INT and DS processes; pre-formulation studies, formulation development and optimization for DP; process validation for DS and DP, cGMP pilot-scale and commercial manufacturing; comprehensive quality research and CMC regulatory support. Porton is committed to enabling earlier access to good medicines.
~2200+
Total Capacity (m³)
1400+
Global Customers
5000+
Milestone Projects
Why Choose Porton Pharma Solutions as Your Small Molecule CDMO Partner?
- Proven Success Across 1600+ Small Molecule Projects
- 1,200+ Scientists Globally, with Deep Chemistry Expertise
- Seamless Tech Transfer From Discovery to Commercial Scale
- Regulatory Compliance with FDA, EMA, NMPA, and PMDA
- Global Infrastructure with Sites in China, the US, and Europe
Our Services
Drug Substance
Capability
Drug Substance
Capacity
Drug Product
Capability
Drug Product
Capacity
Capability
Process Design, Route Scouting, Development, and Optimization for APIs and Intermediates
Non-GMP and GMP Manufacturing from Pre-clinical to Commercial for APIs and Intermediates
Pre-formulation Research and Process Development & Optimization
Pre-Clinical and Commercial Batches GMP Manufacturing for Drug Product
Comprehensive Analytical R&D and Quality Control
IND/NDA Dossier and CMC Solutions
Capacity
| Site |
Reactor Volume (m³) |
Reactor Volume Range (L) |
Number of Reactors |
Temperature Range (°C) |
Reaction Pressure (Mpa) |
Description |
|
Changshou, Chongqing |
978 |
5 to 10,000 |
329 |
-85 to 200 |
-0.1 to 5 |
GMP |
| Fengxian, Shanghai | 68 | 10 to 6,300 | 67 | -80 to 200 | -0.1 to 2 | GMP/HP |
| Yichun, Jiangxi | 480 | 200 to 5,000 | 199 | -70 to 140 | -0.1 to 2.5 | GMP |
| Xiaogan, Hubei | 552 | 500 to 6,300 | 122 | -90 to 150 | -0.1 to 0.2 | non-GMP |
|
New Jersey |
1 | 5 to 150 | 18 | -80 to 220 | -0.1 to 0.095 | GMP/HP |
| Total | ~2080 | 5 to 10,000 | 735 | -90 to 200 | -0.1 to 5 |
Capability
Pre Formulation
Physical Characterizations
Polymorph & Salt Selection
Excipient Compatibility
Enabling Technology
Spray Drying
Hot Melt Extrusion
Nano-milling
Emulsification
AI Aid Prediction
In-vivo Modeling
Statistical Modeling
Oral Platform
Oral Immediate Release
Oral Modified Release
Oral Instant Release
Sterile Platform
Injectable
Lyophilized Powder
Complex Injectable
Topical Platform
Semisolid
Hydrogel Patch
TTS Patch
Capacity
OSD (Tablet & Capsule)
1 B doses/year
High Potent: 60 M doses/year
Injectable
Ampoule: 30M units/year
Small Volume Injections: 25 M units/year
Lyophilized Powder Injections: 3.3 M units/year
Semisolid
Gel Patch: 35 M patches/year
Cream/Ointment/Gel Paste: 16 M Tubes/Year
End-to-end Solutions
Pre-Clinical
Phase I to III
Commercial Supply
Analytical Solution
Chemistry Research Unit (CRU)
- Discovery Synthetic Chemistry
- Discovery Process Chemistry
- Building Blocks Development
IND Enabling
- Process Optimization
- Solid Form Screen & Selection
- Quality Study
- Impurity Study
- non-GMP & GMP Deliveries
DS-DP Integration
- Leveraging our expertise in APIs and advanced crystallization technology, we have established a DP technology platform that offers integrated services from DS to DP.
Implementation of QbD Concepts
-
Final Process Development:
-Ideally Performed Before PhIII or Reg Campaigns; Reduce PMI
-Quality Improvement
-Plant Fitness Assessment
-
Justification of the Specs of RSM and Intermediates:
Study the formation, fate, and purge of impurities from the RSM synthesis, and establish RSM specs based on the purge studies of these impurities in downstream processes.
-
Quality Risk Assessment:
Comprehensive process characterization via DoE studies or OVAT studies, including FMEA, probability, impact, detectability, PAR, and NOR.
Life Cycle Management
-
R&D in Commercial Campaign:
- Cost Saving, Time Saving, andEHSPurposes (such as reducing PMI) and Troubleshooting
- Based on the Current Process, Optimize the Process to Improve Yield and Efficiency (such as replacing solvents, simplifying work-up, recycling materials, and other methods)
- 2nd Generation Process R&D
-
We manage the product lifecycle from three different aspects:
- Continuous Cost Improvement
- SustainableSupply Chain Management
- Capacity Planning
Porton's professional analytical R&D and QC teams provide clients with comprehensive quality research and stability study services for DS and DP that adhere to global IND/NDA submission requirements. Our extensive project experience spans from preclinical to commercial stages, covering method development and optimization, analytical method validation and transfer, physicochemical property studies, structural confirmation, reference standard characterization, product release testing, packaging material compatibility studies, stability studies, and the development of quality standards. These services are meticulously designed to meet the diverse needs of our clients at various stages of drug development.
What Therapeutic Areas and Compound Types Does Porton Specialize in?
- Chiral and Stereoselective Compounds
- Nitrosamine-sensitive APIs
- HPAPIs (Highly Potent APIs)
- Oncology, CNS, Antivirals, and Anti-infectives
- Complex Multi-step Synthesis and Hazardous Chemistry
Porton Sites
South Plainfield R&D and Manufacturing Site
Cranbury R&D and Manufacturing Site
Chongqing Liangjiang R&D Center
Chongqing Changshou Manufacturing Site
Chongqing DP Manufacturing Site
Shanghai Minhang R&D Center
Shanghai Fengxian Manufacturing Site
Jiangxi Yichun Manufacturing Site
Hubei Xiaogan Manufacturing Site
Case Studies
More
Biocatalysis Enables The Efficient Synthesis and Commercial Application of Unnatural Amino Acids (UAAs)
Biocatalysis is a pivotal enabler for the sustainable synthesis of unnatural amino acids. By integrating novel enzymes discovery, multi-enzyme cascades and chemo-enzymatic routes, Porton has established practical capabilities to address industry challenges in substrate specificity and enzyme stability. Moving forward, Porton remains dedicated to bridging the gap between laboratory innovation and industrial-scale application, providing customers with reliable, scalable and atom-efficient solutions for UAA production.
More
Dry Particle Coating for the Enhancement of API Flowability and Bulk Density
The mechanism of the dry particle coating and a short description of four coating techniques including comil, LabRAM, a high shear mixer and a jet mill are provided.
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The Perfect Integration of Immobilized Enzymes and Flow Chemistry: A Powerful Booster for the Commercialization of Biocatalysis Technology
Adhering to Porton’s core value of “Pursuing Excellence”, Porton biocatalysis team has designated "enzyme immobilization technology and its industrialization" as a core strategic technology.
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Process Simulation Platform: Enabling Process Development and Scale-up of Active Pharmaceutical Ingredients
Porton Crystallization team has the capability to perform process simulation of unit operations, including solvent swap, crystallization, filtration and drying.
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A Decisive Milestone for On-time, On-budget Project Delivery
This case study demonstrates how rigorous analytical logic, disciplined execution, and targeted experimentation can resolve complex chromatographic challenges.
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Optimizing Process Chemistry for Enhanced Pharmaceutical Manufacturing
Process Chemistry Optimization | Pharma Manufacturing
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Expert Q&A: How to Efficiently Apply Preparative Chromatography in Drug Research
How to Efficiently Apply Preparative Chromatography in Drug Research
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Biocatalysis: A Powerful and Possible Greener Tool for Chemists in the Pharmaceutical Industry
End-to-end Enzyme Solutions Efficient Screening & process Development Comprehensive Quality Control Extensive Successful Applications Cases Technological Innovation Enabled Cost Savings
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Expert Q&A: Molecular Simulation and Data Science Support of Porton
Explore virtual screening duration, differences from property optimization, and crystal structure requirements for impurity rejection calculations.
More
Selecting the Right Solid Form-Faster, Smarter, Better
At Porton J-Star, we employ an integrated approach to identify and select the most suitable solid form for development (Figure 2). We conduct effective screen and rigorous assessments for polymorphs, salts, cocrystals, as well as amorphous solid dispersions, by applying our comprehensive expertise and experience.
More
Multiple Approaches to Address the Challenges of Oral Absorption of PROTAC Drugs
As a global CDMO serving global innovative pharmaceutical companies and research institutions, Porton has an extensive experience in research and manufacturing services, especially in the field of PROTAC drug development. Porton is committed to the development and production of PROTAC oral formulations and provides customers with comprehensive, reliable, fast, and compliant one-stop services, to meet customers' supply chain needs and facilitating the commercial success of their products from research and development to order fulfillment.
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Flow Chemistry: A New Technology to Enhance the Traditional Batch Process in the Delivery Requirement
Continuous reaction can effectively solve the problem of "amplification effect" in batch processes from research and development to pilot testing, and then again to commercial production. Porton’s continuous reaction capabilities include low-temperature lithiation reaction, ozone oxidation reaction, nitrification reaction, high-temperature reaction, and organic azide reaction, etc., which can achieve process development and technology transfer from research and development to production application.
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News
MoreNews2026-04-03
Porton & Pliant Joint Publication in ACS Catalysis
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Porton Newsletter - March 2026 Recap
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News2026-03-03
Porton Wins “2025 Best CRO” Award from Daewoong Pharma
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Porton Newsletter - February 2026 Recap
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Porton Newsletter - January 2026 Recap
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Porton Newsletter - Q4 2025 Recap
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News2026-01-08
A Porton Publication in ACS Journal on Polymorphic Crystallization Kinetics Study and Control
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News2025-12-30
Porton Achieves EU QP Certification for Chongqing Manufacturing Facility
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News2025-11-27
Porton Pharma Solutions Ranks Among China's Top 100 Premier Pharmaceutical Suppliers and Top 10 in ESG Competitiveness
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News2025-10-20
Porton Warmly Congratulates Partner XZenith on Its Listing on the Main Board of the Hong Kong Stock Exchange
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Porton's End-to-End CMC Development Accelerates Market Approval for Innovative ALK Inhibitor Dirozalkib (Xuanfeining) Tablets
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News2025-08-29
Porton Supports BioNova's BN104 Program in Achieving Milestone Entry into Overseas Markets
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