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

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

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

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

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

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

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

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

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