API Development and Manufacturing
Prajna provides a robust chemical process development from API’s conception all the way to commercial production.
Prajna is an independent, technology-based company, specialized in the process development and the manufacturing of early or advanced intermediate and complex organic molecules as active pharmaceutical ingredients as well as innovative bio-chemicals for research purposes.
This services encompasses a set of services for Custom Synthesis, Synthesis route design, Process R&D, Process development & Optimization,Scale up, Contract Manufacturing of API’s, Advance Intermediates, Key Building blocks for in-market products and for NCEs from early phase development to commercialization stage
The experience and know-how in the development of optimal manufacturing processes is regarded as a basic requirement to achieve an outstanding product quality in high yield.
Our highly qualified development team working in purpose-built facilities is key to being able to deliver all your process development and scale-up requirements. Depending on your needs, we can tap into our API capability stream at various points during the development phase of your project.
Developing non-infringing chemical processes for API drugs and intermediates.
> Development and standardization of synthetic steps considering scalable manufacturing needs.
> Route evaluation and development of new synthetic routes for target molecules.
> Optimization of reaction conditions to reduce cost and maximize throughput.
> Optimizing and validating the process at the lab, pilot and plant scale.
> Pilot activities scaling up from 10L to 100L. > Raw material procurement and material management.
> Providing complete impurity profiles as required by competent regulatory bodies.
> Providing complete documentation for DMF filing.
> Raw material procurement and material management.
> Development and validation of analytical methods.
> Polymorphism, salt, and co-crystal screening.
> Manufacturing of generic and advanced API and key intermediate.
> Commercial scale synthesis in glass lined reactors from 100L up to 300L.
> CGMP multi-purpose manufacturing plant.
> Committed to quality, on time delivery, safety and environment.
