Drug product manufacturing
Your drug substance and drug product custom manufacturing solution.
Decades of experience and a successful track record as a CMO have earned Evonik a place along the value chain of both large and small pharma developers and manufacturers around the world. From drug substance development to drug product clinical and commercial supply, we have the people, the infrastructure and the capacity to meet your manufacturing needs.
Spread across five production sites on three continents, our operations become your manufacturing platform. Our teams of chemists, biotechnologists, pharmacists and engineers become your experienced collaborators. We are fully in compliance with cGMP standards worldwide and our facilities are regularly audited. At the same time, we ensure maximum reliability and on-schedule delivery. As all facilities are wholly owned by Evonik, we maintain complete control over all stages of production worldwide and guarantee maximum security for your intellectual property.
From drug substance production …
We believe that the advantages of having a manufacturing partner for the drug substances your project requires go beyond the availability of state-of-the-art infrastructure. That is because the quality, consistency, reliability, and speed you get with Evonik come from decades of experience and an unswerving innovative drive. And decades of substantial investments in advanced technologies. That is why we can produce custom active pharmaceutical ingredients with the quality consistency and supply security that sets new benchmarks.
… to drug product manufacturing with excellence built-in
Our best-in-industry capabilities for manufacturing complex parenteral dosage forms are not just about technologies and facilities. At Evonik, custom manufacturing follows through on our core competencies in drug substance manufacturing, functional excipients and formulation development. Entrusting your drug product project to us means you benefit from our upstream experience and expertise. From engineering and scale-up to final product, terminal sterilization or aseptic manufacturing, our capabilities are as flexible as you need them to be. And if a highly potent API is involved, you will be relieved to know that Evonik’s primary and secondary containment systems set industry benchmarks, too.
Drug product manufacturing
MORE THAN 60 YEARS AGO, WE STARTED WITH THE EUDRAGIT® PRODUCT RANGE
Today we are experts in coating technologies, melt extrusion, matrix formulation and the development of multiple-unit dosage forms. We offer development services for commercially viable formulations. Our team supports and guides you during the development of your new oral dosage form. With a track record of many successful customer projects in the last 15 years, Evonik offers you strong expertise and broad capabilities for your development.
OUR CAPABILITIES TO FORMULATE YOUR ACTIVE SUBSTANCE:
We manufacture commercially viable formulations, including early-stage feasibility studies, formulation development / optimization programs and preclinical / clinical trial material manufacturing
We have experience and capabilities to formulate small molecules, biologic macromoleculs, like proteins and nucleic acids, including highly potent actives following international safety and quality guidelines
Our global laboratories are equipped with state-of-the-art equipment to manufacture oral dosage forms, also providing you with extensive analytical capabilities and scale-up support / commercial production support
Our team consists of highly-qualified scientists with industry experience in NCE development and generic formulations
Your partner for advanced formulations.