DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/zv37g7/brazilian_generic) has announced the addition of the "Brazilian Generic Industry Guide" report to their offering.
The Brazilian pharma market is growing rapidly into one of the largest pharma markets in the world. Unbranded and branded generics are among the fastest growing segments within this market.
For 2012, IMS monetary values for the prescription market were around 26 billion dollars, with unbranded and branded generics representing an approximate combined 40% share, and over 1.2 billion manufacturing units with unbranded and branded generics representing a combined 50% share, showing a growing trend. For unbranded generics alone, the market counts on 400 different actives spread over 4000 individual registration approvals with approx. 18,000 different presentations, with solid perspectives of continued strong growth.
Ever since the genesis of the Brazilian unbranded generics segment in 2000, the interest of international suppliers and manufacturers of non-patented formulations in the Brazilian market has grown steadily and significantly. However, as they start to deal with the local business and institutional culture, most of these companies face serious and unexpected difficulties.
Key Topics Covered:
1) Brief Introduction & Background
2) types of registrations for Medicines
3) regulatory requirements
- GMP Requirements
- Dossier Format
- International Manufacturers Certification
- DMF of Active Pharmaceutical Ingredients
- Notification of Production / Pilot Batches
- Stability Report
- Pharmaceutical Equivalence (P.E.)
- Bioequivalence
- Registration and Certification Process for APIs
- Clinical Trials
- Registration of Imported Medication in Brazil/Requirements
Production report:
- Quality Control Report of Raw Materials:
- Excipients
- Pharmaceutical Products
Stability studies:
- Data about Primary Packaging and Dosage Accessories
- Bio-Pharmaco-Technical Tests Report GuIde C
4) relevant Fees and Costs
- ANVISA
- Stability Testing
- Pharmaceutical Equivalence
- Bioequivalence Studies
5) unofficial requirements
6) local Manufacturing vs. Imports
7) distribution Channels
8) relevant taxes
9) pricing & reimbursement
10) Select Market data
- Brazilian Pharma Market
- Innovators Vs. Generics Vs. Otc
- Physicians´ Rx
- Fastest Growing Rx Indications
For more information visit http://www.researchandmarkets.com/research/zv37g7/brazilian_generic