The international recall of valsartan is directly impacting the cardio segment in Latin America. After the EMA made the first move and the FDA also stepped in, Pharmabiz analyzes the position of the Latin American regulators.
The region’s regulators have acted following the EMA’s July 5 announcement of the revision of medicines based on valsartan manufactured with defective raw materials.
Colombia, one of the countries to acknowledge receipt of the product announced yesterday, July 16, through head of the INVIMA regulator, Javier Guzmán Cruz, that it would remove products from the companies: American Generics; Genfar; Humax Pharmaceutical; Lafrancol; Laboratorios MK; Procaps; Sanofi; Altadis; Coaspharma; Galenicum; Winthrop; and Tecnoquímicas. See release. See video.
Chile was also quick to react. The Institute of Public Health said on Thursday July 12 that eight commpanies must conduct recalls: Eurofarma; Recalcine; Chemofarma; Laboratorio Chile; Laboratorio Lafi; Andrómaco; Pharma Investi; and Galenicum. See release.
Colombia has ordered the recall of products from 12 drugmakers, while Chile’s regulator has withdrawn those of eight firms. In Uruguay three companies are affected, including Lazar which has a base in Argentina and sells the same brand there.
In the case of Uruguay, three firms have been affected: Celsius; Lazar; and Szabo. The Uruguayan agency published an official release on July 12 announcing the removal of products as a precaution. See release.
Peru’s DIGEMID was one of the fastest of the region’s regulators to react, publishing a release on Tuesday July 10 that announced the withdrawal of ten brands belonging to Farmindustria; Lafrancol; Galenicum; Genfarm and IQFarma; among others. See release.
However, two key countries, Mexico and Brazil, have yet to take any measures on the issue. Neither Mexico’s COFEPRIS nor Brazil’s ANVISA have made any communication regarding the withdrawal of any lots of products containing valsartan.
Argentina’s ANMAT is also yet to make any decision. The body led by Carlos Chiale is analyzing strategies but has not officially announced which products containing the Chinese-made API are being studied.