apnarpharma.com > Services > Impurity Profiling

We have the combination of development expertise, manufacturing equipment and state-of-the-art facilities to be your strategic partner for reliable, cost effective long term supplies of your intermediates and API.

At STA we understand the need to develop robust and cost efficient processes for large scale manufacture. Our technical teams have experience in optimizing existing processes and developing new or second generation safe and environmentally sound routes.

Our dedicated late stage development teams have extensive experience in the following:

  • Commercial synthesis route scouting
  • Commercial process development and optimization through DoE and QbD
  • Stepwise unit operation studies and defining critical process parameters
  • Impurity profiling, fate and control
  • Regulatory starting material definition

Our commercial manufacturing facility is co-located with our pilot plant, providing true “end-to-end” API service from early phase R&D to commercial launch. Integrating the two facilities eliminates the need for tech transfers when a project advances through each development phase, allowing us to help reduce your time to market while providing consistent and cost-effective services.

Working alongside our highly experienced project management and dedicated customer service team, the technical teams have the expertise to ensure a seamless technical information transfer, as programs advance from Phase 1 to commercial, using our end-to-end process R&D and API manufacturing capabilities.