Brazil blocks Paraguayan T36 pen over unverified safety

Brazil blocks Paraguayan T36 pen over unverified safety
Brazil’s health regulator Anvisa has banned the import, storage, distribution, sale, advertising and use of the Paraguayan T36 slimming pen, widening its restrictions on tirzepatide-based products entering the country outside Brazil’s approval system. The agency said T36 has no Brazilian sanitary registration and that its safety and efficacy have not been assessed domestically.

The decision places Brazil’s regulatory standard against the product’s status in Paraguay. T36, made by Paraguayan laboratory Catedral, received authorization from Paraguay’s Dinavisa in June, valid until April 2031. Its registration describes multi-dose vials in strengths from 2.5 mg to 15 mg for type 2 diabetes and weight management in adults with obesity or overweight linked to comorbidities.

Anvisa’s position is that foreign authorization alone is insufficient for sale or use in Brazil. The regulator has already explicitly barred several other Paraguayan tirzepatide brands, including TG, Lipoless, Lipoland, Gluconex, Tirzec and Tirzedral, also produced by Catedral. T36 had not initially been named in those measures, creating room for individual purchases by Brazilian consumers, according to reporting on the new resolution.

Laboratory research cited in the reporting found the active molecule in seized Paraguayan tirzepatide samples, including Tirzedral. But identifying the molecule does not answer whether the products contain impurities, remain stable through transport and refrigeration, or perform safely and effectively in patients. The T36 leaflet was also reported to cite studies without enough references to verify whether they involved the product itself.

The agency has paired the ban with a broader warning about informal online sales. “Any product acquired outside these environments has no guarantee of origin, composition or conservation,” Anvisa said, referring to channels other than authorized pharmacies and drugstores. Brazil and Paraguay have meanwhile signed a five-year cooperation agreement to exchange information on manufacturing practices, clinical trials, alerts and illegal-product seizures.

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