ANMAT prohibits the activity of the HLB Pharma laboratory and requests an investigation into fetanyl adulteration.

After repeated noncompliance, the National Administration of Drugs, Food, and Medical Technology ( ANMAT ) took a drastic decision with the HLB Pharma Group laboratory. The agency banned the company's operations after finding serious quality defects and filed legal proceedings against those responsible. The decision came after nine deaths from adulterated fetanyl were reported in the Province of Buenos Aires.

ANMAT announced the news through the Official Gazette on Tuesday, May 13. It bluntly ordered the suspension of productive activities of the firm HLB Pharma Group SA. A company that had presented several irregularities and is linked to power, since Ariel García Furfaro , its shareholder, is a partner of the Peronist union leader and businessman, Víctor Santamaría .

In its official ruling, ANMAT ( National Agency for the Protection of Industrial Property) declared a ban on the "use, distribution, and marketing of all products registered in the name of the firm throughout the Argentine Republic, until the technical and sanitary conditions are met to lift this measure." In other words, it did not set a date for the reopening of the plant located at Av. Tomkinson 2054 , San Isidro, Province of Buenos Aires.

The agency justified the decision by recalling the various sanctions it had imposed on the laboratory in 2023, 2024, and 2025 for "multiple irregularities and non-compliance with current regulations." "Since the administrative deadlines granted to the firm for its implementation and reporting have elapsed, it has not complied with the requirements since it did not submit the relevant documentation and did not respond to the request," it also emphasized.

The sanction also applies to Laboratorios Ramallo SA , which manufactured HLB Pharma's products. The ruling cited the warning issued by the National Institute of Medicines ( INAME ) regarding "the incident reported regarding the product FENTANYL HLB, which was categorized as "CRITICAL" and treatment priority "HIGH," based on the risk it poses to the patient's health or to public health."

Regarding this issue, the deaths of nine patients hospitalized in intensive care at the Italian Hospital in La Plata, victims of pneumonia, were confirmed in recent days. The patients were infected with Klebsiella pneumoniae , and ANMAT requested an investigation into HLB Pharma's responsibility, given that the bacteria was present in the batches of fetanyl administered to the patients as part of their treatment, which had been marketed by the company.

ANMAT's final decision follows other previous sanctions for "deviation of quality." It implies a change in the position of the agency under the Ministry of Health , which, along with INAME, had not taken any action of this magnitude under previous administrations. This has always heightened suspicion due to the close ties between the HLB Pharma laboratory and the Peronist political leadership , through its owner, García Furfaro.

The decision against HLB Pharma, a firm that gained significant prominence during the COVID-19 pandemic as it had expressed its intention to market the Sputnik vaccine in the country, had a strong impact on the local pharmaceutical sector. While the sanctions fall exclusively on the firm, business leaders lament that a veil of suspicion has been cast over the sector, according to testimony collected by this outlet.