API & Intermediate
Understanding API Intermediates
Active Pharmaceutical Ingredients (APIs) are the key substances in finished pharmaceutical products. APIs give medications their identity and pharmacological activity for disease diagnosis, treatment or prevention. These are chemical compounds produced during the multi-step synthesis of an active pharmaceutical ingredient (API). APIs are the biologically active components of drugs, and their production is a complex process involving numerous chemical reactions and purification steps. Each step generates an intermediate compound that is subsequently used to chemically transform into the next intermediate. These intermediates build toward the final API molecule. API intermediates allow for the step-wise assembly of complex drug molecules and are often purified and isolated for use in further reaction stages. They are crucial to efficiently manufacturing APIs at commercial scales.
At Aquigen, we focus on developing specialized intermediates through precision chemical synthesis. A wide variety of drug molecules rely on our intermediates for both large-scale production and early R&D activities. As a trusted Contract Development and Manufacturing Organization, we produce intermediates and APIs adhering to the highest quality and compliance standards. Our goal is to support pharmaceutical partners from lab to commercialization through efficient, cGMP-compliant manufacturing processes. In addition to API/intermediate synthesis, we offer analytical testing services and process impurity isolation to help expedite client development timelines. All of our products and services are designed strictly for research purposes. Aquigen is committed to streamlining the drug development process from concept to market! Get in touch with us for API Intermediates!
“Identification and quantification of impurities are necessary for regulatory approvals. FDA and EMA have set threshold limits for acceptable levels of impurities in drug substances.”