Newly prequalified Active Pharmaceutical Ingredients (APIs)

WHO Prequalification wishes to announce the prequalification of three new prequalified APIs, namely:

  • WHOAPI-264 - Zidovudine - Anhui Biochem United Pharmaceutical Co Ltd - CHINA

  • WHOAPI-271 - Medroxyprogesterone acetate - Jiangsu Grand Xianle Pharmaceutical Co Ltd - CHINA
  • WHOAPI-283 - Efavirenz - Zhejiang Jiangbei Pharmaceutical Co Ltd - CHINA

FPPs containing efavirenz and zidovudine are used in the therapeutic area of HIV/AIDS.  FPPs containing medroxyprogesterone acetate are used in the therapeutic area of Reproductive Health.

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.