Case Study

Securing Provision K Status For A Client's API Helps To Expedite Shipping And Reduce US Importation Costs


Active pharmaceutical ingredients (APIs) also known as bulk active pharmaceutical ingredients, are defined by the US Food and Drugs Administration (FDA) as ‘any component that provides pharmacological activity or other effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of man or animals.’ Generally, APIs are therapeutic components of drug formulations or finished pharmaceutical products that also contain fillers, binders’ excipients and other inactive ingredients. APIs are routinely evaluated or used by pharmaceutical companies for preclinical testing during new drug development, human clinical trials testing and commercial manufacturing of approved pharmaceutical products.