Country
🇧🇷 Brazil
Regulator
Agencia Nacional de Vigilancia Sanitaria (ANVISA)
Capital
Brasilia
Region
LATAM
Currency
Brazilian Real
Official Lang.
Portuguese
Dial Code
+55
ISO Code
BR

Supply & Market

Brazil is the largest pharmaceutical market in Latin America and a strategic destination for DEFRATAJ Deferasirox dispersible tablets from Taj Pharma. The Brazilian Unified Health System (SUS) procures iron-chelation therapy centrally for thalassemia and sickle-cell-disease patients (Brazil has the second-largest sickle-cell cohort outside Sub-Saharan Africa), and Deferasirox is included in the SUS specialised-component pharmacy list.

ANVISA RDC 200/2017 governs generic drug registration and accepts CTD dossiers in Portuguese (or English with Portuguese Module 1). Taj Pharma works with Sao Paulo and Rio de Janeiro-based marketing-authorisation-holder partners who handle local registration, ANVISA petitions, GMP inspection logistics and Lei 13.021/2014 compliance. Bioequivalence vs. the originator is mandatory and can be conducted in ANVISA-accredited Brazilian CROs.

Logistics from JNPT (Mumbai) to Santos Port run on a 28–35 day transit via Cape Town transhipment; Itajai and Pecem are alternate gateways. Our Mumbai export team coordinates ANVISA shipment-by-shipment Licenca de Importacao (LI), RFB (Receita Federal) clearances and Anvisa post-arrival sampling protocols.

Supply Capability for Brazil

DEFRATAJ for Brazil ships with full Portuguese (Brazilian) labelling, FRASCO/CARTUCHO artwork compliant to ANVISA RDC 71/2009, and EAN-13 barcodes registered with ABRAS for retail traceability. Track-and-trace serialization (SNCM) is supported for shipments destined to RDC 157-regulated SUS distribution.

  • Strengths: 100 mg, 125 mg, 250 mg, 400 mg, 500 mg dispersible tablets
  • Pack formats: HDPE bottles (30/60s), Alu-Alu blisters (10x10), SUS institutional packs (100s)
  • MOQ: 100,000 tablets per strength for SUS lots, 50,000 for retail / private supply
  • Lead time: 6 weeks ex-Mumbai · Santos arrival 28–35 days
  • Documentation: CoA, CoO, packing list, BL, free-sale certificate (legalized at Brazilian consulate), GMP certificate, ANVISA Registration No. linkage, batch protocol with bioequivalence reference
  • SUS tender support: price floor commitments, lot serialization compliance, 24-month supply contracts
  • Private label: own-brand registration via local MAH partner

Regulatory Pathway in Brazil

ANVISA (Agencia Nacional de Vigilancia Sanitaria) regulates drug registration through resolution RDC 200/2017 for generics. Taj Pharma supports the local MAH with the full CTD dossier (Portuguese Module 1, English Modules 2–5), bioequivalence data conducted in ANVISA-accredited centres (or accepted from EU/US studies under RDC 31/2014), and a Brazilian-format Plano de Gerenciamento de Risco (PGR).

Standard ANVISA generic timeline is 18–24 months; priority review under RDC 204/2017 applies for products treating rare diseases (thalassemia qualifies). GMP inspection of the Indian plant is performed jointly with ANVISA inspectors; we have a recent satisfactory inspection on record. Pharmacovigilance reporting follows the VigiMed E2B(R3) standard with 15-day expedited timelines.

  • ANVISA-format CTD ready (Portuguese Module 1)
  • Bioequivalence vs. originator (EU or local)
  • Plano de Gerenciamento de Risco (PGR) drafted
  • Recent satisfactory ANVISA GMP inspection on record
  • SNCM serialization compliance for SUS supply
  • ISO code BR · trade currency Brazilian Real (BRL)

Other Markets in LATAM

Mexico COFEPRIS
Peru DIGEMID
Colombia INVIMA
Venezuela INHRR
Bolivia AGEMED
Ecuador ARCSA