SAG manufacturing has been certified by ANVISA
June 7, 2016
Last May, SAG manufacturing, a company of Galenicum Health group, received the certification from The National Health Surveillance Agency of Brazil (ANVISA) for the non-sterile solid and coated tablets plant. This certification represents a step forward in the process of entry into the Brazilian market.
During 2012, in the early internationalization phase of the company, Galenicum beat on Brazil creating a subsidiary in São Paulo. Brazil is the biggest South American market and one of the most advanced regarding pharmaceutical regulation. Specifically, in order to register a product, companies have to perform a bioequivalence study on their products against the reference original local product. Moreover, ANVISA has to certify the plant where the product is manufactured.
Galenicum Health has signed agreements to license more that 5 products with the main leader companies of Brazil and it is expected that the number of alliances will grow in the coming years.