Country
🇻🇳 Vietnam
Regulator
Drug Administration of Vietnam (DAV)
Capital
Hanoi
Region
Asia
Currency
Vietnamese Dong
Official Lang.
Vietnamese
Dial Code
+84
ISO Code
VN

Supply & Market

Vietnam has a meaningful beta-thalassemia burden, with organised public-sector hematology programmes driving demand for affordable long-term iron chelation. The Drug Administration of Vietnam (DAV) operates an ACTD-harmonised registration pathway. Taj Pharma supplies DEFRATAJ Deferasirox dispersible tablets through registered Vietnamese distributors.

Supply to Vietnam is via CIF Ho Chi Minh City / Hai Phong port (typical sea transit 10-14 days from Mumbai/Nhava Sheva) or Ho Chi Minh City / Hanoi airfreight (2-4 days). Vietnamese-language leaflet preparation and carton overprint are fully supported. Packaging is tailored to Vietnamese MoH requirements including GMP certificate reference and local MAH details where applicable.

DAV registration follows the ASEAN Common Technical Dossier (ACTD) format. Required parts include Module 1 (Vietnam-specific administrative, Vietnamese SmPC/PIL), Module 2 (summaries), Module 3 (quality, full), and bioequivalence study in Module 5. Stability data per ICH Q1A Zone IVb recommended. Typical registration timeline 12-24 months depending on pathway. Post-approval variations are handled through MAV category system with our RA team coordinating responses.

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