Contract Development & Manufacturing (CDMO) for APIs & Intermediates

Evonik is a global leader in Contract Development and Manufacturing (CDMO) for active pharmaceutical ingredients (APIs) and pharmaceutical intermediates, including high-potency APIs (HPAPIs). With decades of experience in custom synthesis, drug development, and process optimization, we support pharmaceutical innovators from early-stage development to commercial-scale manufacturing.

Our CDMO offering spans the full lifecycle of drug substance development:

• Custom synthesis of complex APIs and intermediates
• Development and scale-up of HPAPI projects with containment down to 0.1 μg/m³
• Advanced process development, route scouting, and analytical method development
• Manufacturing under cGMP conditions across FDA/EU-inspected sites in the U.S., Germany, and Asia
• HPAPI capacity exceeding 170 m³, supporting batch sizes over 450 kg

Evonik operates one of the world’s largest and most versatile CDMO networks, with:

• 3 cGMP production sites and 3 supporting facilities for fermentation and isolation
• 11 differentiating technologies, including:
  • Catalysis
  • Biocatalysis
  • Microbial fermentation
  • Continuous processing
  • Chemistry in Water
  • Advanced processes
  • Chiral chemistry
  • Cryogenic chemistry
  • Crystallization
  • Particle Engineering
  • Chromatography

• Proven track record with >300 projects and >13 of the top 20 global pharma companies
• Expertise in chemistry, engineering, and biotechnology
• Strong focus on quality, supply security, and sustainability
• A Business-for-Business (B4B) approach that fosters collaboration and innovation

• Oncology and other high-potency drug development
• Generic and innovator APIs
• Complex multi-step synthesis
• Controlled substances and specialized intermediates
• Highly pure mPEG and PEG linkers

Selecting a CDMO partner is a strategic decision. Look for:

• Proven expertise in complex APIs and HPAPIs
• Strong regulatory track record and cGMP compliance
• Scalable capabilities from clinical to commercial
• Advanced technologies and transparent communication

Partnering with a CDMO like Evonik brings:

• Faster development through integrated services
• Cost savings from established infrastructure
• Reduced risk with robust quality systems
• Flexibility to adapt to evolving project needs

We help you stay focused on innovation while we handle the complexities of manufacturing.

Whether you're developing a new drug substance, scaling up a high-potency API, or seeking a reliable partner for custom synthesis, Evonik offers the capabilities, technologies, and expertise to bring your project to life.