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Tag Archives: registration
Mexico at the vanguard with new combination drug
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
Brazil: Overview of API registration
In Brazil, the health authority (ANVISA) will require that all Active Pharmaceutical Ingredients (APIs) manufactured in Brazil, imported for manufacturing of drug products, or included in imported finished products, are registered with the agency. This regulation has been put in … Continue reading
Posted in Brazil
Tagged Active Pharmaceutical Ingredients, anvisa, API, brazil, import, Latin America, manufacturing, registration
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Regulatory Affairs in Latin America 