Country
🇲🇽 Mexico
Regulator
Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Capital
Mexico City
Region
LATAM
Currency
Mexican Peso
Official Lang.
Spanish
Dial Code
+52
ISO Code
MX

Supply & Market

Mexico is Latin America's second-largest pharmaceutical market and a strategic supply destination for DEFRATAJ Deferasirox dispersible tablets. Public-sector procurement is consolidated under INSABI and the IMSS-Bienestar federal scheme, both of which include iron chelation therapy in their listing of specialised medicines. Taj Pharma supports Mexican MAH partners through COFEPRIS registration, INSABI / IMSS / ISSSTE tender preparation and direct private-pharmacy supply through chains such as Farmacias del Ahorro and Farmacias Guadalajara.

Mexican generic registration follows NOM-073-SSA1-2015 for stability and NOM-177-SSA1 for bioequivalence. COFEPRIS recognises GMP-equivalence for plants holding WHO PQ, EMA, US FDA, Health Canada or Swissmedic certificates — our Sarigam plant qualifies under WHO-GMP, simplifying the foreign-GMP recognition step. Bioequivalence is mandatory and can be conducted in Mexican CROs accredited by COFEPRIS.

Logistics from JNPT (Mumbai) to Manzanillo (Pacific) or Veracruz (Atlantic) run 35–45 days via Singapore transhipment. Our team coordinates Mexican Pedimento de Importacion via licensed customs agents, and supports Spanish-language SmPC, FRASCO artwork, peso pricing strategy aligned to the IMSS reference and the INSABI consolidated-procurement reverse-auction mechanism.

Supply Capability for Mexico

DEFRATAJ supplies to Mexico ship with full Spanish labelling, FRASCO/CAJA artwork compliant to NOM-072-SSA1-2012, and Mexican GTIN/CPF identifiers for the IMSS / INSABI traceability mandate.

  • Strengths: 100 mg, 125 mg, 250 mg, 400 mg, 500 mg dispersible tablets
  • Pack formats: HDPE bottles (30/60/100s), Alu-Alu blisters, IMSS institutional packs (250s)
  • MOQ: 100,000 tablets per strength for IMSS / INSABI lots, 50,000 for retail
  • Lead time: 6–8 weeks ex-Mumbai · Manzanillo / Veracruz arrival 35–45 days
  • Documentation: CoA, CoO, free-sale certificate (Apostille per Hague Convention), CPP, NOM-073 stability annex, NOM-177 bioequivalence summary, batch protocol
  • Tender support: IMSS / INSABI / ISSSTE consolidated-procurement bids, reverse-auction price floor analysis, 24-month supply commitments
  • Private label: own-brand via local MAH partner with COFEPRIS Registro Sanitario

Regulatory Pathway in Mexico

COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios) regulates drug registration through the Registro Sanitario framework. Taj Pharma supports the Mexican MAH with the CTD dossier (Spanish Module 1, English Modules 2–5), bioequivalence data conducted in COFEPRIS-accredited centres, and stability data per NOM-073-SSA1-2015.

Standard generic timeline is 18–30 months, but the COFEPRIS Equivalencia route accepts WHO-PQ, EMA, US FDA or Swissmedic GMP certificates without separate Mexican plant inspection. Pharmacovigilance reporting follows the RNF (Red Nacional de Farmacovigilancia) with E2B(R3) submissions; serious unexpected ADRs are expedited within 7 days.

  • COFEPRIS-format CTD with Spanish Module 1 prepared
  • WHO-GMP recognised under COFEPRIS Equivalencia
  • Bioequivalence vs. originator on file
  • NOM-073 stability data (Zone IVb, 24 months)
  • ISO code MX · trade currency Mexican Peso (MXN)
  • RNF pharmacovigilance template ready for E2B(R3)

Other Markets in LATAM

Brazil ANVISA
Peru DIGEMID
Colombia INVIMA
Venezuela INHRR
Bolivia AGEMED
Ecuador ARCSA