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Overview of ABRIFAR: Leading Association for Pharmaceutical Distribution in Brazil

The Brazilian Association of Distributors and Importers of Pharmaceuticals Raw Materials (ABRIFAR) plays a vital role in the pharmaceutical supply chain, representing 31 companies that account for 95% of imports of Active Pharmaceutical Ingredients (APIs) and excipients in Brazil. With a focus on complying with ANVISA regulations, ABRIFAR ensures that both generic and similar suppliers meet strict qualification criteria. The organization supports local industries and pharmacies by facilitating API supply and enhancing registration and certification processes to strengthen relationships between manufacturers, importers, and clients.

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Overview of ABRIFAR: Leading Association for Pharmaceutical Distribution in Brazil

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  1. Brazilian Association of Distributors and Importers of Pharmaceuticals Raw Materials. www.abrifar.org.br São Paulo 2011

  2. ABRIFAR Afiliates • 31 Companies; • - 95% of the total imports of API/Excipients that are distributed to local companies; • - Clients: Industries and manipulation pharmacies.

  3. Supplying API to Brazil • With ANVISA • Without ANVISA Generic Similar Suppliers qualification with individual criteria Qualification DMF RDC 249 RDC 204 RDC 17 API

  4. ANVISA Resolution 57/09 Manufacturers / Importers Diploma API Register International Plant Inspection Certification

  5. Model of API Registration ANVISA Resolution 57/09 API Registration Suppliers qualification Approval / Certification of the Plant DMF/AMD International Plant Inspection Presentation of Documents and Payment R$ 37.000,00 (around US$ 20.000)

  6. New Commercial Model After ANVISA Resolution 57/09 Finished Dosage Forms API API New model Registration of Medicine Reduction of the level of freedom for changing suppliers X High Production Costs Suppliers “Plant Inspection” Certificate ANVISA Selection Qualification Biostudies API Registration Stability

  7. Brazilian Particularities Registration belongs to the Brazilian Company – (AFE); R$ 37.000,00: API/Plant - Every 12 months; PS: Intermediates “X” are the possibilities of API registration numbers.

  8. Reliable partnerships In the Past: “Price only” API supplier selection • Company documents • API documents • Supplier qualification • ANVISA inspection • Price of API

  9. Thank you for your attention! www.abrifar.org.br abrifar@abrifar.org.br For technical questions: fabiana@abrifar.org.br Rua Afonso Celso, 1221- Cj. 61 – São Paulo/SP – Brasil Phone: +55 11 5071 1681 Fax: +55 11 2578 1047

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