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Germany suspends 80 products linked to Indian CRO problems

This article was originally published in Scrip

Executive Summary

The German regulatory agency BfARM has suspended 80 generic products whose marketing authorizations relied on bioequivalence tests conducted by the Indian CRO GVK Biosciences. The company's procedures have been called into doubt following a GCP inspection earlier this year which suggested shortcuts had been taken with BE studies.

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