ANMAT disqualifies Laboratorio Trifarma and bans its products

The National Administration of Drugs, Foods and Medical Devices (ANMAT) has preventively disabled the production, quality control, marketing, and distribution activities of Laboratorio Trifarma S.R.L. and prohibited the use, marketing, and distribution of all its products throughout the national territory. The measure was formalized in Provision 5865/2026, published in the Official Gazette of the Argentine Republic on September 16, 2026, and is a response to the lack of a Technical Director and the failure to comply with the registration requirements for its pharmacopeia products.

The provision, with reference DI-2026-5865-APN-ANMAT#MS, was signed by the national administrator Luis Eduardo Fontana on September 14, 2026, in the City of Buenos Aires and is processed under File EX-2026-39367714-APN-DFYGR#ANMAT. It is based on Law No. 16,463, Decree No. 1490/1992, and ANMAT Provision No. 8417/2016, and relies on the powers of Article 8, subsections i), l), and n), of the aforementioned decree, which authorize the agency to adopt preventive measures to protect public health.

The proceedings were initiated following inspection tasks by the Directorate of Inspection and Risk Management (DFYGR), under the National Institute of Medicines (INAME), after a communication from the Ministry of Health of the Province of Santa Fe, which had ordered the preventive closure of the establishment and prohibited the manufacture and marketing of the firm’s pharmacopeia products.

Detected Non-Compliances

• Lack of designation and registration of a responsible Pharmaceutical Technical Director, in violation of Article 2 of Law No. 16,463.
• The firm, located at Bolivia 586 Bis (formerly 581 bis), Rosario, Province of Santa Fe, is authorized by DI-2019-8502-APN-ANMAT#MSYDS as a manufacturer of pharmacopeia products in liquid, solid, and semi-solid pharmaceutical forms.
• In 2021, the company began the registration for marketing authorization of ten products and to date has not fulfilled the regulatory requirements; due to their silence, the intervening directorate processed the expiration of the files.

Affected Products

The prohibition covers all products manufactured and/or marketed by the firm, including the ten whose marketing authorization remained incomplete:

• Solid Vaseline (Ex-2021-61170999-APN-DGA#ANMAT)
• Compound Zinc Oxide Ointment (Lassar Paste) (Ex-2021-113753735-APN-DGA#ANMAT)
• Boric Acid (Ex-2021-113759761-APN-DGA#ANMAT)
• Calcareo Oil (Ex-2021-113757891-APN-DGA#ANMAT)
• Magnesium Chloride (Ex-2021-113781232-APN-DGA#ANMAT)
• Hydrogen Peroxide 10 volumes (Ex-2021-61152274-APN-DGA#ANMAT)
• Diadermina (Ex-2021-113755565-APN-DGA#ANMAT)
• Sodium Bicarbonate (Ex-2021-61173903-APN-DGA#ANMAT)
• Liquid Vaseline (Ex-2021-61165980-APN-DGA#ANMAT)
• Lugol’s Solution (Ex-2021-61177486-APN-DGA#ANMAT)

Scope of the measure and means of appeal

Article 1 preventively disqualifies the production, quality control, marketing, and distribution activities of the firm identified with CUIT No. 30-71586480-7. Article 2 prohibits the use, marketing, and distribution throughout the national territory of all products manufactured and/or marketed by Laboratorio Trifarma S.R.L.

Notification is carried out under the terms of articles 41 and 43 of Decree No. 1759/72 (t.o. 2017). Against this act, which exhausts the administrative route, the firm may file a request for reconsideration within twenty (20) administrative business days and an appeal for review within thirty (30) administrative business days; judicial action may be brought within one hundred and eighty (180) judicial business days, pursuant to article 25 of Law No. 19,549.

Article 4 orders the communication of the measure to the provincial health authorities, the Autonomous Government of the City of Buenos Aires, the National Directorate of Regulatory Management and Control of the Undersecretariat for Consumer Defense and Commercial Loyalty of the Secretariat of Industry and Commerce of the Ministry of Economy, INAME, and the Directorate of Technical Information Management. The instruction of the health summary will be processed subsequently, once the alleged infractions have been identified.

The decision directly impacts pharmacies, distributors, and patients: products from Laboratorio Trifarma S.R.L. are removed from circulation nationwide and cannot be used or sold, while the agency proceeds with the health summary that will define the responsibilities for the identified non-compliances.

Source: Official Gazette of the Argentine Republic, September 16, 2026, First Section (official reference: DI-2026-5865-APN-ANMAT#MS).