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Nitrosamine contamination – Recent international alerts

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Alerts
6 November, 2019 - 02:00 (CET)

The WHO  Prequalification Team (PQT) is aware, and monitoring closely, announcements by major regulators regarding the presence of nitrosamine impurities in batches of sartan-related products, piog

Guidance on amendments has been revised

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Announcement
18 October, 2019 - 04:00 (CEST)

The guidance document on amendments to an Active Pharmaceutical Ingredient Master File (APIMF) submitted in support of a Prequalified Pharmaceutical Product (FPP) or Prequalified Active Pharmaceuti

Oxytocin injections prequalified

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Announcement
14 October, 2019 - 04:00 (CEST)

WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list: