Download - São Paulo 2011
São Paulo2011
Brazilian Association of Distributors
and Importers of Pharmaceuticals
Raw Materials.
www.abrifar.org.br
ABRIFAR
- 31 Companies;
- 95% of the total imports of API/Excipients that are distributed to local companies;
- Clients: Industries and manipulation pharmacies.
Afiliates
Supplying API to Brazil
Without ANVISA With ANVISA
DMF
APIRDC 249RDC 204RDC 17
Qualification
Generic Similar
Suppliers qualification with individual criteria
International Plant Inspection
Certification
API Register
ANVISA Resolution 57/09
Manufacturers /
ImportersDiploma
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 Registrati
on
New Commercial Model After ANVISA Resolution 57/09
Registration of
MedicineSuppliers
Selection
Qualification
Biostudies
Stability
API Registrati
on
Reduction of the level of freedom for
changing suppliers
X
High Production
Costs
“Plant Inspection”Certificate
ANVISA
API New model
API Finished Dosage Forms
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);
Reliable partnerships
API supplier selection
• Company documents• API documents
• Supplier qualification• ANVISA inspection
• Price of API
In the Past: “Price only”
Thank you for your attention!www.abrifar.org.br
For technical questions: [email protected]
Rua Afonso Celso, 1221- Cj. 61 – São Paulo/SP – Brasil
Phone: +55 11 5071 1681
Fax: +55 11 2578 1047
