News
18 December, 2018 - 11:20 (CET)
Announcement
M
Sofosbuvir (WHOAPI-319) manufactured by Laurus Labs Ltd has been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure.
- WHOAPI-319 - Sofosbuvir - Laurus Labs Ltd - INDIA
- FPPs containing sofosbuvir are used in the therapeutic area of Hepatitis
- FPPs containing sofosbuvir are used in the therapeutic area of Hepatitis
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.