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São Paulo 2011 - PowerPoint PPT Presentation


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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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Presentation Transcript
slide1

Brazilian Association of Distributors and Importers of Pharmaceuticals Raw Materials.

www.abrifar.org.br

São Paulo

2011

slide2

ABRIFAR

Afiliates

  • 31 Companies;
  • - 95% of the total imports of API/Excipients that are distributed to local companies;
  • - Clients: Industries and manipulation pharmacies.
slide3

Supplying API to Brazil

  • With ANVISA
  • Without ANVISA

Generic

Similar

Suppliers qualification with individual criteria

Qualification

DMF

RDC 249

RDC 204

RDC 17

API

slide4

ANVISA Resolution 57/09

Manufacturers /

Importers

Diploma

API Register

International Plant Inspection

Certification

slide5

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)

slide6

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

slide7

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.

slide8

Reliable partnerships

In the Past: “Price only”

API supplier selection

  • Company documents
  • API documents
  • Supplier qualification
  • ANVISA inspection
  • Price of API
slide9

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