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EDQM’s actions to evaluate impact of the detection of an impurity in the active substance paracetamol

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Certification of suitability (CEP)
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10 July 2020
Strasbourg, France

Following the publication of an article in the Dutch newspaper Nieuwe Rotterdamsche Courant Handelsblad (NRC) concerning an impurity (4-chloroaniline) in the active substance paracetamol manufactured by a specific company which holds a certificate of suitability, the EDQM is actively working with the company and other stakeholders to better understand the potential impact of this impurity and the extent of the issue.

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