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Our Process | API.

Your Partner for Generic API

Integrated Project Management for Custom Development & Manufacturing of API.

The first step in our process is to sign a CDA to allow open and detailed comunication about the project goals of the particular chemical API.
Avanthera provides a thorough Project Evaluation which serves as the basis for formal engagement between our companies. We believe that clear communications and shared goals are the keys to successful collaboration.
Kicking off a project is an important milestone that sets in motion all of the time lines and tasks. It is the best moment to make sure all of the people involved are clear about the expectations and shared ambitions of the project.
Process Development is fundamental to scale-up from milligram quantities of the API at the lab bench to kilogram quantities in a pilot plant. Our process chemistry expertise in API scale-up, as well as novel route development focuses on:

  • Robust and Reproducible Process
  • Well Documented and Transferable
  • Cost-effective
  • Safe
  • Minimal Environmental Impact

The delivery of the first samples allows the necessary purity and quality analyses to be performed.
“A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.”
The Production launch is the official launch of the first batches of product. All of the unknowns of the process have now been defined in detail.
Either in our own facilities in Vacallo, Switzerland, or together with our strong network of manufacturing partners, the commercial production phase is the final result of the entire project and relies on tight project management, excellent supply chain coordination and rigorous total quality control

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