API Contract Manufacturing Organization

A Leading Global API Contract Manufacturing Organization

Peace-of-mind for even your largest or most specialized API projects through contract manufacturing by Evonik 

Evonik is one of the world’s largest contract manufacturing organizations, with a Western-centered manufacturing network that can be relied upon to supply APIs, HPAPIs and intermediates up to the largest commercial volumes. Our unique core competencies across chemistry, biotechnology and engineering, combined with a proud record of performance for quality, supply security and sustainability, also make us a strong choice to serve as your preferred partner regardless of project size or complexity. Few custom contract manufacturing organizations in the world can rival our ability to combine the right advanced technologies, processes and manufacturing sites to minimize regulatory and scale-up risks. Whether you are a pharmaceutical company, or seeking to commercialize advanced food ingredients or nature-identical products through microbial fermentation, we have the global scale, expertise and flexibility to address your specific project requirements.

A preferred contract manufacturing organization for APIs and intermediates

When it comes to the high-quality production of active pharmaceutical ingredients (API), intermediates and amino acids, Evonik is one of the largest and most dependable contract manufacturing organizations in the world.

  • With more than 1,400m³ of cGMP reactor volume across a network of FDA-inspected sites in the U.S., Europe and Asia, we can reliably produce APIs (bulk or controlled) from few grams to thousands of tons per year.

  • In particular, we have earned a reputation amongst many of the world’s largest and most innovative pharmaceutical companies as a trusted contract manufacturing organization for complex, multi-step API projects.

  • Our portfolio of advanced technologies combines the world’s largest cryogenic capacity, with decades of expertise across organometallic chemistry, chiral chemistry, carbohydrate chemistry, catalysis, and the production of polymeric API and highly pure PEGs and mPEGs.

In addition to extensive particle design, API conjugation and continuous processing capabilities, we have more than 25 lab groups available to support your chemical development projects.

A preferred contract manufacturing organization for HPAPIs

Evonik is the world’s largest custom contract manufacturing organization for high potency and anti-cancer APIs, with more than 20 years of expertise in this specialized area. To address emerging market needs for these complex substances:

  • We have significantly expanded our asset footprint and added additional capacities from lab-scale through to small, medium or large-scale production of HPAPIs.

  • Up to seven different HPAPI steps can be produced in parallel.

  • Our Tippecanoe Laboratories site near Lafayette in the U.S. State of Indiana has a total HPAPI capacity of 170m³, with reactors up to 7,600 liters in capacity and OEL down to 0.1 μg / m³ for large-scale production. 

  • We also have a cGMP suite in Hanau, Germany for the small-scale production of HPAPI and ultra-HPAPI with OEL down to down to 0.05 µg/m³. 

A preferred contract manufacturing organization for fermentation and biotechnological technologies

Evonik is one of the world’s leading custom contract manufacturing organizations for the production of high-quality substances including advanced food ingredients, cosmetics, nature-identical materials and APIs that leverage microbial fermentation.

  • We provide customers with a comprehensive array of services from strain development through to large-scale commercial production.

  • Our track record for performance spans more than 30 years, with our teams having helped industrialize and bring to market more than 25 commercial products based upon fermentation and biocatalytic technologies.

  • In total, we provide more than 4,000m³ of fermentation capacity across multiple high-quality sites, including a new flexible downstream processing unit in Slovakia. 

Winner of the Life Science Leader CMO Leadership Awards 2020

For the third consecutive year, companies participating in the 2020 Contract Manufacturing Quality Benchmarking survey by Life Science Leader and Industry Standard Research voted for Evonik to earn awards for its Capabilities, Compatibility, Expertise, Quality, Reliability and Service. Because Evonik was rated as a top performer compared to its CMO peers, each category award was upgraded to a special Champion status. We would like to thank our customers for the trust they place in us every day to manufacture their life-saving APIs and intermediates. Being named as Champion CMO across all categories is a tremendous honour.

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