ANMAT prohibits products from two Argentine laboratories

Argentina's National Administration of Drugs, Foods and Medical Technology (ANMAT) has issued a preventive inhibition against two laboratories, prohibiting the use, sale, and distribution of all their products nationwide.

The measures target Laboratorio Trifarma S. R. L., based in Rosario, Santa Fe, and Ugal Farmacéutica S. A., located in Ramos Mejía, Buenos Aires. These actions follow inspections that revealed significant non-compliance with production and quality control standards.

For Trifarma, irregularities included the lack of a designated technical director and issues regarding product registration. For Ugal Farmacéutica, inspections conducted by the National Institute of Medicines (INAME) identified critical deficiencies in Good Manufacturing Practices. Specific failures at Ugal included systemic issues in the pharmaceutical quality system, particularly affecting the production and control of sterile medications, inadequate environmental monitoring, and problems with data integrity and batch traceability.