API – Development services

Results… through adaptability

At Saneca Pharma, we offer a range of generic API development services including route of synthesis optimisation.

Our API development and manufacturing facilities use the same equipment to simplify the transfer of your project from pilot to commercial scale production.

Our API development services include:

  • selecting synthetic routes
  • optimising a selected synthetic route
  • evaluating scale-up and safety
  • producing pilot batches
  • preparing validations including cleaning validations
  • producing  pre-validation and validation batches
  • stability testing at all stages
  • synthesising and characterising  impurities

We endeavour to develop the most cost effective manufacturing route for your project, without compromising Saneca Pharma´s  high quality standards. To do so, our API development services include testing the robustness of lower-cost raw materials and creating new, more efficient production routes.

Our facilities and expert team are well suited to custom API development, including multi-step products and complex molecules. In particular, Saneca Pharma has the track record and development expertise to create new, improved routes for the manufacture of controlled substance APIs. Our four API plants, including two dedicated to morphine production, have the capability to take on your opiate API development and manufacturing challenges.

To find out more about our API development services, phone us

at +421 33 736 2813 or email api@saneca.com.

Did our portfolio meet your needs? Let´s discuss starting business with us.

Contact us