First sofosbuvir active pharmaceutical ingredient (API) prequalified

News

31 March, 2017 - 02:00 (CEST)

Sofosbuvir (WHOAPI-290) manufactured by Mylan Laboratories Ltd has been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure.

WHOAPI-290 - Sofosbuvir - Mylan Laboratories Ltd - INDIA - This is the first sofosbuvir API to be prequalified.
- Sofosbuvir is one of a small group of important active pharmaceutical ingredients that is being used in a new series of finished pharmaceutical products (FPPs) that offers improved outcomes when treating hepatitis C infection.

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 FPPs.

API prequalification consists of a comprehensive evaluation procedure that has two components: assessment of the API master file 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.

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WHO Prequalification is inviting you to review the draft working document on Technical Specifications Series for submission to WHO Prequalification – Medical Device Assessment Screening and Triage of TB using Computer Aided Detection Software for Interpretation of Chest X-Ray Images (CAD for TB).   Deadline for submission of comments is 30 April, 2024 Please click this link to visit a page with more details.

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First products for Ebola Virus Disease prequalified

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