Prequalification Update - 03 May 2012
Emtricitabine Active Pharmaceutical
Ingredient (API) Prequalified
Emtricitabine manufactured by Laurus Labs Pvt Ltd has been prequalified by the WHO Prequalification
of Medicines Programme (PQP) under its API
prequalification procedure, launched in October 2010.
Good-quality APIs are
vital to the production of good-quality medicines.
WHO's prequalification of APIs will facilitate production of
quality medicines by identifying such APIs for manufacturers
of finished pharmaceutical products.
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 GMP requirements.