Overview

• Disposición N° 7254/2025, published today, provisionally inhibits all activities at Laboratorios Beta and suspends Exotran’s registration.
• ANMAT and INAME ordered the immediate market withdrawal and ban on use, sale and distribution of ten Exotran (mesalazina 500 mg) lots expiring between July 2025 and May 2027.
• Inspectors reported critical and major deficiencies in quality control, supplier qualification, traceability and documentation for both the active ingredient and the finished product.
• The API supplier, Lianyungang Fengheng Biopharm CO LTD in China, lacked recognized GMP certification and key production and stability records, according to the inspection findings.
• No serious adverse events were cited, but regulators warned of probable loss of efficacy for affected lots; Beta disputed the action and must submit a corrective action plan.