News

Newly prequalified Active Pharmaceutical Ingredients (APIs)

Piperaquine (phosphate) (WHOAPI-248) manufactured by Chongqing Kangle Pharmaceutical Co Ltd and Linezolid (WHOAPI-305) manufactured by Macleods Pharmaceuticals Ltd have been prequalified by the WHO Prequalification Team: medicines (PQTm) under its active pharmaceutical ingredient (API) prequalification procedure.

  • WHOAPI-248 - Piperaquine (phosphate) - Chongqing Kangle Pharmaceutical Co Ltd - CHINA
    • FPPs containing piperaquine are used in the therapeutic area of Malaria
       
  • WHOAPI-305 - Linezolid - Macleods Pharmaceuticals Ltd - INDIA
    • FPPs containing linezolid are used in the therapeutic area of Tuberculosis. This is the first linezolid API to be prequalified.

 

Good-quality APIs are vital to the production of good-quality medicines.  WHO prequalification of APIs facilitates production of quality medicines by identifying such APIs for use by manufacturers of finished pharmaceutical products (FPPs).

API prequalification consists of a comprehensive evaluation procedure that has two components: assessment of the API master file (APIMF) to verify compliance with WHO norms and standards, and evaluation of the sites of API manufacture to verify compliance with WHO Good Manufacturing Practice requirements.