Your CDMO for Small Molecule Drug Substance Manufacturing
As a leading contract development and manufacturing organization (CDMO), Evonik offers the confidence and expertise you need to tackle complex drug development and manufacturing challenges. Partnering with us means gaining access to a global network of services and deep technical know-how.
Evonik is one of the world’s largest CDMOs, with core strengths in chemistry, engineering, and biotechnology. Our proven track record is built on quality, supply security, and a strong commitment to sustainability.
With our business-for-business (B4B) philosophy, we focus on shared success—supporting companies of all sizes through purposeful collaboration and a commitment to long-term partnerships.
Your technology experts for API & intermediate manufacturing
For over 20 years, Evonik has supported customers with innovator-focused HPAPI projects and complex API processes. Our robust manufacturing network delivers APIs, HPAPIs, and intermediates—from clinical trial quantities to large-scale commercial volumes. Whether your project is small or highly complex, we offer reliable, high-quality production with a sustainable supply chain.
Complex API manufacturing
Evonik’s Western-based facilities are designed for complex pharmaceutical manufacturing, offering:
- Advanced infrastructure and regulatory compliance
- A broad portfolio of differentiating technologies
Our scalable and sustainable solutions ensure high-quality drug substance development and reliable contract manufacturing for complex APIs.
Highly potent API (HPAPI) manufacturing
Evonik provides safe and compliant manufacturing of highly potent APIs, supported by:
- 170 m³ total reactor capacity, with volumes up to 7,600 liters
- Occupational exposure limits:
- 5 ng/m³ for small-scale HPAPI
- 0.1 μg/m³ for large-scale production
We help pharmaceutical partners meet regulatory standards and respond to growing demand for HPAPI contract manufacturing.
Controlled substance manufacturing
Evonik specializes in scheduled drug manufacturing, offering:
- Integrated on-site development, synthesis, and quality control
- Expertise in generic APIs and custom CDMO services
- Support from early research to commercial production
With advanced containment and strong regulatory experience, we ensure secure and compliant API supply for controlled substances.
Generic APIs and intermediates
We offer tailored solutions for genering API and intermediate manufacturing alongside full support from clinical trials to market launch. As your project progresses, scalability becomes critical.
Our experts work closely with you to:
- Scale up processes efficiently and safely
- Design robust process control and impurity control strategies
- Ensure compliance with GMP standards and regulatory requirements
High-purity PEG and mPEG linkers for drug formulation
Evonik supplies pharmaceutical-grade PEG and mPEG for PEGylation and linker conjugation, featuring:
- Molecular weights from 2,000 to 50,000 kDa
- Precise polydispersity for consistent purity
- Standard and custom PEG solutions available
Our products support optimized synthesis, streamlined development, and compliance with pharmaceutical regulatory standards.
Excellence from process development to commercial scale
We offer a highly differentiated portfolio of technologies to support even the most complex syntheses of APIs, HPAPIs, and intermediates. Our flexible solutions span the entire development lifecycle—from early-stage process development to full-scale commercial manufacturing.
Leveraging deep expertise in chemical innovation and advanced engineering, we tailor our approach to meet specialized requirements with precision, safety, and scalability.
Our integrated capabilities include:
- Catalysis & Biocatalysis: From catalyst screening to scale-up, including recycling via organic solvent nanofiltration.
- Continuous Processing: Enhancing efficiency and safety for high-energy reactions.
- Chiral Chemistry
- Cryogenic Reactions: Including one of the world’s largest GMP cryogenic capacities.
- Particle Engineering & Crystallization: Optimizing purity, stability, and performance.
- Chromatography: From ultra-HPAPI small-scale GMP to commercial-scale purification.
- Chemistry in Water: Sustainable synthesis using micellar catalysis in aqueous media.
- Microbial Fermentation: Supporting biotechnological production routes.
Our technologies are designed to meet the growing demand for efficient, safe, and sustainable manufacturing of high-potency and complex molecules. Through continuous investment in state-of-the-art facilities and novel process technologies, we empower pharmaceutical innovators to advance their pipelines with confidence and agility.
Sustainable pharmaceutical manufacturing
At Evonik, sustainability is embedded in how we support our customers—by enabling the development of effective therapies while minimizing environmental impact.
For our drug substance CDMO business, we focus on:
- Technical expertise
- Safe production of HPAPIs and complex APIs
- Innovative, scalable solutions
We apply sustainable practices across the entire pharmaceutical lifecycle—from lab to large-scale production. Our tailored approaches include:
- Green chemistry and process design: Reducing waste and emissions through solvent optimization, catalyst innovation, and continuous processing.
- “First time right” philosophy: Minimizing out-of-spec batches through deep process understanding and advanced monitoring tools.
- Solvent and waste reduction: Leveraging technologies like solvent recycling and membrane filtration for precious metal recovery.
- Chemistry in Water: Replacing organic solvents with water-based micellar systems to lower environmental impact.
Our commitment to sustainability drives smarter, safer, and more efficient pharmaceutical manufacturing.
Our locations
Our sites in Europe, the U.S. and China have capacities from lab-scale through to small, medium or large-scale production:
Take the first step to tackling your complex drug development and manufacturing challenges. Get in touch!
ANY QUESTIONS LEFT? JUST CONTACT US.
"Exploring options for the development and manufacture of your cGMP small molecule drug substance or associated intermediates? Reach out and we'll help you make well informed choices as Evonik aims at getting clients practical solutions faster and easier."
Eric Neuffer
Head of Drug Substance Sales
