The 11th invitation to manufacturers of active pharmaceutical ingredients (APIs) to submit an expression of interest (EOI) for API prequalification to the WHO Prequalification Team: medicines (PQTm) has been published.
The new expression of interest includes the additional API: gatifloxacin
API prequalification is intended to support national and global efforts to increase access to and the affordability of care and treatment of HIV/AIDS, hepatitis B and C, tuberculosis, malaria, neglected tropical diseases, diarrhoea, influenza and to support the area of reproductive health by identifying suppliers of high quality APIs for prospective finished pharmaceutical product manufacturers and national medicines regulatory agencies.
Manufacturers of APIs, particularly, those already involved in WHO prequalification through the API master file procedure, are encouraged to consider the benefits that recognition as a prequalified API might offer to them.