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The drug substance, whether a small molecule API or a complex biologic, is the foundation of every pharmaceutical product. Its quality, consistency, and regulatory readiness are critical to therapeutic success. That’s why pharma and biotech companies rely on experienced drug substance CDMO companies for scalable, compliant, and cost-effective manufacturing.
With specialized drug substance contract manufacturing services, these CDMOs support your active ingredient from early development through commercial production under strict GMP conditions.
When selecting among drug substance CDMO companies, key evaluation points include:
Molecule type compatibility: Small molecules, peptides, oligonucleotides, biologics, or HPAPIs
Process development and optimization from preclinical to commercial scale
Facility and equipment readiness for chemical synthesis, fermentation, or cell culture
Containment capabilities for potent or hazardous materials
Analytical support for impurity profiling, stability, and release testing
Tech transfer and scale-up experience
Regulatory success with FDA, EMA, PMDA, and other health authorities
The right partner ensures your drug substance meets global quality standards from the start.
Comprehensive drug substance contract manufacturing services typically include:
Route scouting and synthetic pathway design for small molecules
Cell line development and fermentation for biologics
Upstream and downstream processing under GMP
Purification and crystallization optimization
Micronization or spray drying for final API form
Process validation and analytical method development
Batch record generation and GMP documentation
Regulatory support for IND, NDA, and global submissions
These services ensure your active ingredient is consistent, stable, and ready for formulation.
Working with top-tier drug substances CDMO companies offers clear benefits:
Reduced development risk through proven platforms and expertise
Speed to clinic or market with integrated R&D and GMP capabilities
High product quality supported by rigorous analytical testing
Global regulatory alignment with inspection-ready facilities
Custom scalability from milligram development to metric ton production
A trusted CDMO helps you advance your molecule from lab bench to large-scale supply efficiently and safely.
Some of the most trusted drug substance CDMO companies include:
Cambrex: Cambrex Longmont location specializes in the early development of small molecule pharmaceutical products in a fully integrated drug substance and drug product facility. [See CDMO profile]
ChemCon: Based in Germany, ChemCon specializes in APIs and fine chemicals, offering expertise in transferring R&D projects into fully cGMP-compliant production processes. [See CDMO profile]
Pharmaron: Small molecule, drug substances, manufacturing facilities. [See CDMO profile]
Laboratori Alchemia: Custom synthesis of complex products or those which are even unknown in literature. [See CDMO profile]
Viswa Laboratories: CRAMS/CDMO, APIs, Intermediates and specialty chemicals. [See CDMO profile]
Actylis: Chemical Process Discovery, Development, cGMP, and Commerical Manufacturing Services. [See CDMO profile]
Seacross Pharma: With three facilities, Seacross Pharma provides a range of CMO/CDMO custom API services to global clients. [See CDMO profile]
Chemical CMO companies | Custom Synthesis and Chemical CMO Solutions
Fine Chemicals CDMO Companies | Fine Chemicals Contract Manufacturing Services
Organic CDMO Companies | Organic Contract Manufacturing Services
At MAI CDMO, we specialize in matching pharma and biotech companies with the most qualified drug substance CDMO companies worldwide. Whether you need early-phase synthesis or global commercial API supply, our network of drug substance contract manufacturing partners delivers quality, compliance, and reliability.
Looking to accelerate your drug substance development or scale-up? Contact us today and find your perfect CDMO partner.
If you have any questions or suggestions, click here. We will be happy to assist you.