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EMA recommends suspension of generic medicines tested by CRO

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Published on: 27 May 2022
Published by LNB News

LNB News 27/05/2022

Document Information

Issue Date: 27 May 2022

Published Date: 27 May 2022

Jurisdiction(s): European Union

Article summary

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the suspension of marketing authorisations of roughly 100 generic medicines that were tested by Synchron Research Services, a contract research organisation (CRO) in Ahmedabad, India. The recommendation comes after 'flawed' data and 'irregularities' were identified from bioequivalence studies conducted by the CRO.

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Jurisdiction(s):
European Union

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