Boutique CDMO Projekte made in Germany
Arevipharma is your “one-stop shop” for tailored CDMO solutions.
Contract manufacturing projects have been an integral part of our business operations for over 20 years. As a medium-sized enterprise, we distinguish ourselves through short decision-making paths, a high degree of flexibility for our customers, and rapid project execution.
Arevipharma supplies global pharmaceutical clients with exclusive active ingredients—whether high-volume products for originators or small quantities for clinical trials conducted by startups.
We are open to all inquiries and place no restrictions on business models. Are you looking for a reliable partner for a critical product? Do you need something highly specialized—something you haven’t managed to source successfully from any other manufacturer? Are you dissatisfied with your current supplier, or do you have concerns about future supply chain issues?
Feel free to contact us at any time. We look forward to hearing from you!
Project plan
For us, the processing of a CDMO project includes the following milestones in the project plan, which can be adapted as desired depending on the requirements of our customers.
Step 1: Feasibility Study
Projects start with a feasibility study on a laboratory scale. Within the framework of this, either the customer’s synthesis is examined for its general adaptability and scalability, or it is developed in a basic way within the scope of development.
Step 2: Development
This is followed by the chemical development of the process and, simultaneously, the development of all the required analytical methods. The aim is to investigate the synthesis in detail and optimize it for production on an industrial scale.
Step 3: Validate/Transfer
Step 4: Stability Program
Following the validation, the stability studies are performed according to ICHQ1 and to the storage conditions requested by our customer.
Step 5: Approval & Commercialization
Our regulatory affairs team prepares regulatory documentation on behalf of our clients for any desired global pharmaceutical market. Our clients can always choose whether they themselves or Arevipharma will hold the marketing authorization. After successfully completing validation and obtaining all required approvals, we transition the project into routine commercial production. The product is then managed by our Sales Operations and Supply Chain teams. Thanks to our five production facilities of varying sizes, we can support the commercialization of the product at any stage of its product life cycle with scalable production volumes.
Step 6: Logistics
Numerous storage facilities of many substance- and hazard classes and temperature ranges are available at the Radebeul site. Arevipharma handles the logistics of our CDMO products either under its own responsibility or on behalf at a qualified external warehouse on our site.
