European Medicines Agency Recommends Suspension of 100 Drugs Due to CRO Data Concerns

Data integrity issues at Synchron Research Services spurred the European Medicines Agency to recommend the suspension of 100 drugs. Synchron, an India-based CRO, runs quality control tests for generics from several manufacturers. The firm has faced similar critiques from the US Food and Drug Administration (FDA) in recent years, with the agency citing “unusual and unexplainable study records,” that “resulted in the submission of falsified study data to the FDA.”

According to Zachary Brennan of Endpoints News, “Companies with affected generic drugs include J&J, Sandoz, Viatris, Teva, Jubilant, Wockhardt, Accord Healthcare, Aurora Biofarma, Strides Pharma, Tillomed Pharma, Orifarm Generics, Stada, Brillpharma, Micro Labs, ratiopharm, Bennet Pharmaceutica, Medicair Bioscience Laboratories, Pinewood Laboratories and more.”

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(Source: Endpoints News, May 20^th 2022)