Country
🇲🇲 Myanmar
Regulator
Myanmar Food and Drug Administration (FDA-MM)
Capital
Naypyidaw
Region
Asia
Currency
Myanmar Kyat
Official Lang.
Burmese
Dial Code
+95
ISO Code
MM

Supply & Market

DEFRATAJ (Deferasirox) dispersible tablets are exported to Myanmar by Taj Pharma India Ltd. as a long-standing manufacturing partner for South-East Asian markets. Tablets are produced under WHO-GMP at the Sarigam plant and reach Taj Pharma India Ltd. via Singapore, Port Klang, Ho Chi Minh City and Manila ports with full Myanmar-Pharmacopoeia compliance.

The Myanmar market for iron-chelation therapy is driven by a high regional prevalence of thalassemia and other transfusion-dependent anaemias, where Deferasirox is the preferred once-daily oral chelator.

Our regulatory and commercial team in Mumbai partners directly with importers, hospital procurement officers and Ministry-of-Health tender desks across Myanmar — from Naypyidaw to regional referral centres — for streamlined supply continuity.

Supply Capability for Myanmar

DEFRATAJ is supplied to Myanmar across all five strengths — 100 mg, 125 mg, 250 mg, 400 mg and 500 mg dispersible tablets — in HDPE bottles (30s/60s/100s) and Alu-Alu blister packs. Minimum-order quantities start at 50,000 tablets per strength with a typical lead time of 4–6 weeks from PO confirmation.

  • Strengths shipped: 100 mg, 125 mg, 250 mg, 400 mg, 500 mg dispersible tablets
  • Pack sizes: bottles (30/60/100 tabs), Alu-Alu blisters (10x10), hospital institutional packs
  • MOQ: 50,000 tablets per strength per shipment (mixed pallets supported)
  • Lead time: 4–6 weeks ex-Mumbai (JNPT / Nhava Sheva)
  • Shelf life: 24 months at 25°C / 60% RH (Zone IVb stability data on file)
  • Documents per shipment: CoA, CoO, packing list, invoice, BL/AWB, free-sale certificate
  • Private label / co-branding: available with own artwork and brand registration

Cold-chain is not required for dispersible tablets, but climatised containers can be arranged on request for hot-route lanes into Myanmar.

Regulatory Pathway in Myanmar

Deferasirox dispersible tablets are registered in Myanmar with the Myanmar Food and Drug Administration (FDA-MM). Taj Pharma submits the full CTD dossier (Modules 1–5) along with our WHO-GMP certificate, CoPP, manufacturing licence, plant master file and validated stability data to FDA-MM. Our regulatory desk handles queries, sample submissions and post-approval variations on behalf of local marketing-authorisation holders.

Local agent appointment, secondary packaging in Burmese, and pharmacovigilance reporting are all coordinated from our Mumbai head office. Documentation can be couriered or e-submitted to FDA-MM in Naypyidaw.

  • CTD dossier (Modules 1–5) ready
  • WHO-GMP · ISO 9001 · PIC/S-aligned plant
  • CoPP & manufacturing licence on request
  • Stability data (long-term & accelerated, Zone IVb)
  • Country code MM · trade currency Myanmar Kyat

Other Markets in Asia

Vietnam DAV
Philippines FDA Phil
Indonesia BPOM
Thailand Thai FDA
Cambodia DDF
Malaysia NPRA