Country
🇲🇾 Malaysia
Regulator
National Pharmaceutical Regulatory Agency (NPRA)
Capital
Kuala Lumpur
Region
Asia
Currency
Malaysian Ringgit
Official Lang.
Malay, English
Dial Code
+60
ISO Code
MY

Supply & Market

DEFRATAJ (Deferasirox) dispersible tablets are exported to Malaysia 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 Malaysia-Pharmacopoeia compliance.

The Malaysia 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 Malaysia — from Kuala Lumpur to regional referral centres — for streamlined supply continuity.

Supply Capability for Malaysia

DEFRATAJ is supplied to Malaysia 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 Malaysia.

Regulatory Pathway in Malaysia

Deferasirox dispersible tablets are registered in Malaysia with the National Pharmaceutical Regulatory Agency (NPRA). 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 NPRA. Our regulatory desk handles queries, sample submissions and post-approval variations on behalf of local marketing-authorisation holders.

Local agent appointment, secondary packaging in Malay, English, and pharmacovigilance reporting are all coordinated from our Mumbai head office. Documentation can be couriered or e-submitted to NPRA in Kuala Lumpur.

  • 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 MY · trade currency Malaysian Ringgit

Other Markets in Asia

Vietnam DAV
Philippines FDA Phil
Indonesia BPOM
Thailand Thai FDA
Myanmar FDA-MM
Cambodia DDF