Overview

• Disposition 7254/2025 orders the preventive inhibition of Laboratorios Beta’s operations and the immediate nationwide withdrawal and prohibition of ten Exotran 500 mg lots.
• INAME’s inspection, triggered by complaints about lot 66.087, found major failures in quality systems, supplier qualification, traceability and analytical documentation.
• Official testing determined the questioned lot was out of specification for dissolution, consistent with reports of lack of therapeutic effect in inflammatory bowel disease treatment.
• The mesalazine active ingredient came from Lianyungang Fengheng Biopharm in China without a Drug Master File or recognized GMP certification, with deficient stability and impurity data.
• ANMAT suspended Exotran’s registration (REM No. 53.080) and required validated corrective plans and proof of lot recovery before any reauthorization, while Beta disputes the measure as unilateral within a broader regulatory crackdown.