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  • Regulatory NewsRegulatory News

    EMA Recommends Suspending Alkem Drug Over Flawed Studies

    The European Medicines Agency (EMA) on Friday recommended suspending the marketing authorization of a drug made by Indian generic manufacturer Alkem Laboratories over data integrity issues at the company's bioequivalence facility in Taloja, India. In light of the issues, EMA says that studies conducted by Alkem at the facility between March 2013 and March 2015 cannot be relied on to support marketing authorizations. The recommendations stem from a review EMA launched i...