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First bedaquiline product prequalified

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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.