Monthly Archives: November 2013

Mexico at the vanguard with new combination drug

Posted on November 29, 2013 by Maria I. Guaia

In the past days, COFEPRIS granted approval for the combination drug containing fluticasone furoate and vilanterol, indicated for treatment of chronic obstructive pulmonary disease (COPD) and asthma. Although the product had already been approved in the US by the FDA in … Continue reading →

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Argentina: Site Master File now required by ANMAT for national sites

Posted on November 27, 2013 by Maria I. Guaia

Starting on November 19th, 2o13, sites in Argentina approved by ANMAT to manufacture or package, in own or contract facility, or import or export, both drug products and APIs, have to submit their Site Master Files (SMF) annually. This is … Continue reading →

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Brazil: ANVISA bans Lorcaserin (Belviq)

Posted on November 6, 2013 by Maria I. Guaia

Today ANVISA, the Brazilian health authority with competence on the control of pharmaceutical products and APIs, banned the manufacturing, import, commercialization, manipulation and use of the API Lorcaserin. Lorcaserin is the drug substance of Belviq, an innovative weight-loss product that … Continue reading →

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MoU between Mexican and Chinese health authorities

Posted on November 4, 2013 by Maria I. Guaia

In the framework of the bilateral agreements recently signed by the presidents of Mexico and China, Enrique Peña Nieto and Xi Jinping, respectively, the representatives of both sanitary agencies, subscribed the first Memorandum of Understanding to strengthen cooperation in matters … Continue reading →

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