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First bedaquiline product prequalified

M
Announcement
16 November, 2023 - 10:00 (CET)

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

  • TB396 - Bedaquiline fumarate - 100mg - Tablet - Lupin Ltd - INDIA

Update on N-nitrosamine impurities

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Alerts
18 September, 2023 - 09:00 (CEST)

Applicants are reminded of the latest N-nitrosamines assessment policies for active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs):

Newly prequalified Active Pharmaceutical Ingredient (API)

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Announcement
14 September, 2023 - 15:00 (CEST)

Nirmatrelvir (WHOAPI-469) manufactured by Shanghai Desano Chemical Pharmaceutical Co Ltd, has been prequalified by the WHO Prequalification Team: Medicines under its API prequalification procedure.

Human Insulin Master File (h-IMF)

M
Announcement
28 August, 2023 - 10:00 (CEST)

Diabetes mellitus is a public health challenge due to its high and increasing prevalence and associated morbidity and mortality that have health and economic impact on ind

Resolution of Notice of Concern (NOC)

IS
Alerts
16 August, 2023 - 20:00 (CEST)

A-31 Clinical Unit I at Accutest Research Laboratories (I) Pvt. Ltd has addressed the concerns highlighted in the Notice of Concern (NOC) by the WHO.

Malaria Rapid Diagnostic Tests: Intended Use Statement

IVD
Announcement
13 July, 2023 - 14:00 (CEST)

The In Vitro Diagnostics Assessment Team acknowledges that there have been inconsistencies in the intended use statements presented in various Instructions for Use (IFUs) of prequalified malaria Ra