News

Newly prequalified Active Pharmaceutical Ingredients (APIs)

Artemether (WHOAPI-259) manufactured by Micro Labs Ltd and Piperaquine (phosphate) (WHOAPI-227) manufactured by Ipca Laboratories Ltd have been prequalified by the WHO Prequalification Team: medicines (PQTm) under its active pharmaceutical ingredient (API) prequalification procedure.
 

  • WHOAPI-227 - Piperaquine (phosphate) - Ipca Laboratories Ltd - INDIA
    • FPPs containing piperaquine are used in the therapeutic area of malaria
       
  • WHOAPI-259 - Artemether - Micro Labs Ltd - INDIA
    • FPPs containing artemether are used in the therapeutic area of malaria

 

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.