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São Paulo 2011

Brazilian Association of Distributors and Importers of Pharmaceuticals Raw Materials. www.abrifar.org.br. São Paulo 2011. ABRIFAR. Afiliates. 31 Companies; - 95% of the total imports of API/Excipients that are distributed to local companies;

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São Paulo 2011

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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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