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Europe suspends hundreds of generic drugs over serious data concerns

Some 365 generic drugs have had their European Union marketing authorisations suspended after an investigation raised concerns about the reliability of the company that tested them.1 The European Medicines Agency’s human medicines committee reviewed 400 generic medicines that have been tested by Synapse Labs, a contract research organisation (CRO) located in Pune, India.2 Of these, just 35 …
Elisabeth Mahase European Medicines Agency European Union Synapse Labs
Source: bmj.com

19 medicines in Sweden are under investigation in a major EMA inquiry

19 medicines marketed in Sweden are affected by an ongoing extensive European investigation into suspected fraud at an Indian contract research organisation. Among them are medicines for HIV, epilepsy, cancer and Parkinson’s, which may be withdrawn unless new evidence can be provided that they are up to standard.
Posaconazole Stada Erlotinib Sandoz Erlotinib Stada Lacosamide Stada Darunavir Sandoz Darunavir Stada

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