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Drug Substance

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.

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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.

In detail: What we can do for you

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Complex APIs

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High potency APIs

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Controlled substances

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Highly pure mPEG & PEG linkers

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 APIs

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.

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High potency APIs

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 and 0.1 μg/m³ for large-scale production

We help pharmaceutical partners meet regulatory standards and respond to growing demand for HPAPI contract manufacturing.

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Controlled substances

Evonik specializes in scheduled drug manufacturing, offering:

  • Integrated on-site development, synthesis, and quality control
  • Expertise in generic APIs and custom CDMO services

With advanced containment and strong regulatory experience, we ensure secure and compliant API supply for controlled substances.

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Highly pure mPEG and PEG linkers

We supply GMP-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 following all regulatory standards.

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Our differentiating technologies: 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:

TechnologyDescriptionDownload
Catalysis & BiocatalysisFrom catalyst screening to scale-up, including recycling via organic solvent nanofiltration.Download flyer
Microbial fermentationSupporting biotechnological production routes 
Continuous processingEnhancing efficiency and safety for high-energy reactions. 
Chemistry in waterSustainable synthesis using micellar catalysis in aqueous media 
Advanced processes Download flyer
Chiral chemistry Download flyer
Cryogenic chemistryIncluding one of the world’s largest GMP cryogenic capacities 
Particle engineering & CrystallizationOptimizing purity, stability, and performance 
ChromatographyFrom ultra-HPAPI small-scale GMP to commercial-scale purification 

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

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

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More about our offerings for drug substance

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Drug substance

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CDMO for High Potency APIs (HPAPI)

Extracting liquid from vial with syringe

Pharma & Biopharma