English version

Argentina’s regulator ANMAT is taking measures over ranitidine. On the local market, the leading brand is Taural from Roemmers group, but there are many generics distributed through hospitals and retail. The order only affects oral versions.

The ranitidine alert is expanding in Latin America, with Argentina’s ANMAT stopping production of new lots and other regional regulators issuing their own orders.

Argentina’s ANMAT has ordered the suspension of production of new lots of oral formulas containing the medication, although it has not ordered a recall of products already on the market. See announcement in Spanish

The majority of companies that manufacture the product will have to follow the ruling immediately. The company that will be most affected is the Roemmers group, whose brand Taural has close to 70% of the market. Although there are dozens of brands that are distributed through hospitals and retail.

A survery by Pharmabiz found  19 products based on ranitidine on the Argentine market, the majority made by generics manufacturers since ranitidine is a mature drug.

Pharmabiz understands that ANMAT has tabled a meeting with all the companies that use the ingredient at the body’s headquarters on Tuesday October 8.

Measures takes over ranitidine in Latam have been varied so far. While Brazil’s regulator, ANVISA, has halted imports, use and sale of a ranitidine produced by India’s Saraca; Peru’s DIGEMID has requested only that companies communicate the name of the manufacturer and origin of the API used in their products and Chile’s ISP has taken off the market all lots of the product manufactured by local company Andrómaco. See ANVISASee DIGEMID. See ISP

The first alert over ranitidine emerged via an announcement from the US FDA, which warned that some products based on the ingredient had been found to contain low quantities of a chemical known as a probable carcinogen – the same chemical that led to the global recall of  valsartan last year.

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