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# EMA Recommends Suspending Generics Tested by Synchron
- URL: https://www.fdaweb.com/ema-recommends-suspending-generics-tested-by-synchron/
- Published: 2022-05-23T12:00:00.000Z
- Updated: 2026-09-14T17:45:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151873

The European Medicines Agency’s human medicines committee has recommended suspending the marketing authorizations of several generic medicines tested by India’s Synchron Research Services, a contract research organization. An EMA [notice](https://www.ema.europa.eu/en/news/synchron-research-service-suspension-medicines-over-flawed-studies?ref=fdaweb.com) says the recommendation comes after irregularities were found in how Synchron carried out bioequivalence studies, which raised serious concerns about the firm’s quality management system and the reliability of data from that site.

In 9/2021, FDA [informed](https://www.fdaweb.com/panexcell-synchron-studies-are-unacceptable-fda/) NDA and ANDA sponsors that clinical and bioanalytical studies conducted by Synchron were not acceptable due to data integrity concerns. Sponsors were told the studies must be repeated.