API Manufacturing

TBD-Biodiscovery supplies high quality Active Pharmaceutical Ingredients and advanced intermediates to pharmaceutical industry. We operate in small scale, so the batch sizes are in the range from grams to several kilos.

TBD-Biodiscovery is focused on API custom manufacturing, including development and validation of technology for manufacturing and the corresponding analytical methods for control of materials.

 In most cases the customer has an idea about API or a preliminary synthesis route, which TBD-Biodiscovery can develop into a technology for manufacturing, which will be validated by TBD-Biodisovery. TBD-Biodiscovery also compiles the Active Substance Master File for the API. Regular production of API is started typically after both ASMF for API and  the final drug form are registered.

Manufacturing in compliance with GMP regulations:

  • Original API (NCE, New Chemical Entity)
  • Generic API
  • Excipient
  • Pre-formulations for clinical studies
  • Precursors for PET (Positron Emission Tomography)