Home / Drug Substances CDMO Companies | Drug Substance Contract Manufacturing Services
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 site focuses on the early-stage development and manufacturing of small-molecule pharmaceutical products within a fully integrated drug substance and drug product facility. [See CDMO profile]
ChemCon: German-based CDMO specializing in the synthesis of APIs and fine chemicals, with extensive expertise in transferring R&D processes into fully cGMP-compliant manufacturing. [See CDMO profile]
Pharmaron: Offers advanced small molecule development and manufacturing services for drug substances under strict regulatory standards. [See CDMO profile]
Laboratori Alchemia: Provides tailored chemical synthesis services for complex and novel compounds, including non-commercial and literature-unknown molecules. [See CDMO profile]
Viswa Laboratories: CDMO offering end-to-end services in APIs, intermediates, and specialty chemicals with strong expertise in CRAMS projects. [See CDMO profile]
Actylis: Partner for chemical process discovery, development, and cGMP manufacturing of small molecules and intermediates for pharmaceutical applications. [See CDMO profile]
Seacross Pharma: Global CMO/CDMO delivering customized API manufacturing solutions across three state-of-the-art production sites. [See CDMO profile]
VIVEbiotech: GMP-certified CDMO exclusively focused on the development and large-scale production of lentiviral vectors for gene and cell therapy. [See CDMO profile]
53Biologics Production Plant: Biologics-focused CDMO offering end-to-end services from DNA to protein, covering preclinical development to full cGMP manufacturing. [See CDMO profile]
BDI Biotech: Operates as an outsourced R&D department specializing in microbial strain engineering, bioprocess optimization, and biomanufacturing scale-up. [See CDMO profile]
HISTOCELL S.L: Develops and manufactures advanced cell therapies based on iPSCs, MSCs, secretomes, and exosomes, alongside medical devices and dermocosmetic products. [See CDMO profile]
Cultiply: Provides development and optimization of production and purification processes for recombinant proteins, enzymes, plasmid DNA, and other bioproducts. [See CDMO profile]
Mabion: Comprehensive CDMO offering biotherapeutic development and GMP manufacturing, including monoclonal antibodies and recombinant protein-based products. [See CDMO profile]
Shilpa Biologicals: Full-service CDMO supporting process development from gene and cell line creation to GMP production, formulation, analytical testing, fill-finish, and packaging. [See CDMO profile]
Aenova Group: Competence center in sterile manufacturing and animal health products, offering development and production of injectable and aseptic formulations. [See CDMO profile]
HIPRA Biotech Services: Provides integrated solutions covering the entire value chain, from cell line development to commercial-scale biopharmaceutical manufacturing. [See CDMO profile]
CARBOGEN AMCIS: Expert in developing and manufacturing highly potent APIs at small scale, including specialized capabilities in chromatography and lyophilization. [See CDMO profile]
Sichuan Huiyu Pharmaceuticals Co.: Offers comprehensive services for the development and production of APIs and finished dosage forms under GMP conditions. [See CDMO profile]
MENADIONA S.L: Spanish-based CDMO focused on APIs, intermediates, and fine chemicals, with proven expertise in scaling R&D projects to cGMP manufacturing. [See CDMO profile]
Apeloa Pharmaceutical Co: Global provider of discovery, process development, and GMP manufacturing services for APIs, intermediates, and registered starting materials (RSMs). [See CDMO profile]
Lukas Heil-Betriebsstätte: Operates a high-performance GMP facility for the sterile and aseptic manufacturing of liquid pharmaceuticals, including glass ampoules. [See CDMO profile]
Rodon Biologics: Provides high-quality biopharmaceutical development and manufacturing services for third-party clients worldwide. [See CDMO profile]
Basic Pharma Manufacturing: Specializes in scaling up pharmaceutical production from laboratory to early clinical phases and market introduction. [See CDMO profile]
Adragos Pharma: Offers aseptic manufacturing of sterile lyophilized and liquid (bio)pharmaceutical products through state-of-the-art fill-and-finish technologies. [See CDMO profile]
CZ Vaccines: Commercial-scale vaccine manufacturing facility supporting investigational and marketed biological products. [See CDMO profile]
SINOWAY INDUSTRIAL CO: Provides one-stop CDMO solutions for APIs and key intermediates, from early-stage process development to large-scale manufacturing. [See CDMO profile]
Synfine: Reliable manufacturer and exporter of Active Pharmaceutical Ingredients (APIs) and intermediates, committed to global regulatory and quality standards. [See CDMO profile]
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At MAI CDMO Network, 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.
