100 generics on hold in Europe while Indian CRO is questioned

23 May 2022

About 100 generic medicines are set to be suspended from use in Europe, after a scientific panel of the European Medicines Agency reviewed evidence of irregularities at an Indian contract research organization (CRO).

Located in Ahmedabad, Synchron Research Services has come under fire after an inspection from the US Food and Drug Administration in 2019.

The agency’s findings, related in a letter, raise “serious concerns about the company’s quality management system and the reliability of data from that site,” the EMA said.

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