Newly prequalified Active Pharmaceutical Ingredients (APIs)

News

12 December, 2018 - 12:00 (CET)

Praziquantel (WHOAPI-243) manufactured by Solara Active Pharma Sciences Ltd, tenofovir disoproxil fumarate (WHOAPI-317) manufactured by Lupin Ltd and sulfadoxine (WHOAPI-356) manufactured by Mangalam Drugs & Organics Ltd have been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure.

WHOAPI-243 - Praziquantel - Solara Active Pharma Sciences Ltd - INDIA
- FPPs containing praziquantel are used in the therapeutic area of Neglected Tropical Diseases (NTD)
WHOAPI-317 - Tenofovir disoproxil fumarate - Lupin Ltd - INDIA
- FPPs containing tenofovir disoproxil fumarate are used in the therapeutic area of HIV/AIDS

WHOAPI-356 - Sulfadoxine - Mangalam Drugs & Organics Ltd - INDIA
- FPPs containing sulfadoxine are used in the therapeutic area of Malaria

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.

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