Custom synthesis of API and intermediates

Evonik manufactures API and intermediates across the globe.

Our outstanding expertise and resources enable us to ramp up capacity for lab or bulk quantities, while ensuring best-in-class conditions at all times. Moreover, we use continuous processes to manufacture two-thirds of our products – an approach built on over 50 years’ experience in this field.

Whatever challenge you face, Evonik has the answer.

Active pharmaceutical ingredients at Evonik

Evonik is one of the world’s leading manufacturers of active pharmaceutical ingredients (API) for clinical and commercial supply. At our FDA-inspected plants in Germany, the USA and China, we can produce API at almost any scale – from just a few kilograms to hundreds of metric tons per year.

We provide a complete, end-to-end service, from process development and particle design to optimization and production. We can assist with the manufacturing of both bulk and controlled API. In addition, we are specialists in API conjugation (e.g. PEGylation), and offer wide-ranging expertise in the field of linker chemistry.

Partnering with Evonik is your guarantee for first-class support, service and product quality – wherever you are, and whatever your API requirements.

High Potency API at Evonik

Evonik is the world’s largest High Potency API (HPAPI) producer, with a total manufacturing capacity of 170 m³.

We can manufacture to any scale – from R&D laboratory quantities up to a reactor volume of nearly 8,000 liters. Moreover, because we employ primary containment techniques, we can operate with an OEL as low as 0.1 µg/m³.

Our main HPAPI production site, at Tippecanoe laboratories in the USA, is equipped to handle manufacturing projects of almost any size, while our facility in Hanau, Germany includes laboratories for the development and optimization of high potency intermediates – and API with an OEL as low as 5 ng/m³.

Intermediates at Evonik

Evonik supplies a broad range of intermediates to the pharmaceutical industry. Many of our intermediates are based on amino acids – which act as valuable precursor compounds for chiral substances – or benzophenones. We also offer extensive expertise in the manufacture and purification of derivatives of a variety of readily available L-amino acids.

Our API intermediates include phosphonium salts and benzophenones. In terms of API applications, we specialize in Wittig synthesis for pharmaceutical applications, and in intermediates for benzodiazepines.

We manufacture intermediates at sites across the globe, and can scale up or down from lab-size quantities to major projects, in line with your specific needs.

Best-in-class technology

Evonik’s expertise in the field of API and intermediates is backed by a best-in-class technology and chemistry portfolio.

For example, we have the world’s largest cryogenic capacity, with a reactor volume of over 200 m³. We also offer an exceptional end-to-end portfolio for homogeneous and heterogeneous catalysis, from screening to commercialization.
And we use continuous processes to manufacture two-thirds of our products – an approach built on over 50 years’ experience in this field.

We can also provide valuable support with the construction or tailoring of new or existing plants. Our process technology and process engineering capabilities mean we can assist you at every stage – from the initial feasibility study to final execution.

Expect the best - Quality

Evonik is recognized as a world-leading specialist in the custom synthesis of API and intermediates. Its portfolio in this field is unique, and combines exceptional production scalability with hands-on expertise gained and nurtured over many decades.

Our production facilities for APIs and intermediates in the USA (Tippecanoe), Germany (Hanau and Dossenheim) and Nanning (China) have been inspected and approved by the U.S. Food and Drug Administration (FDA), an agency known for its rigorous approach to quality assessments. Further, we operate many of our plants in line with the FDA’s current Good Manufacturing Practice (cGMP) regulations.

In short, not only do we understand your challenges – we have the experience and the technology to meet your specific needs and deliver consistently outstanding API and intermediates, every single time.