News

Newly prequalified Active Pharmaceutical Ingredients (APIs)

Tenofovir disoproxil fumarate (WHOAPI-236) manufactured by Strides Shasun Ltd and Dolutegravir (Sodium) (WHOAPI-310) manufactured by Mylan Laboratories Ltd have been prequalified by the WHO Prequalification Team: medicines (PQTm) under its active pharmaceutical ingredient (API) prequalification procedure.

  • WHOAPI-236 - Tenofovir disoproxil fumarate - Strides Shasun Ltd - INDIA
    • FPPs containing tenofovir disoproxil fumarate are used in the therapeutic area of HIV/AIDS
       
  • WHOAPI-310 - Dolutegravir (Sodium) - Mylan Laboratories Pharmaceuticals Ltd - INDIA
    • FPPs containing dolutegravir are used in the therapeutic area of HIV/AIDS. This is the first dolutegravir 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.