Deferasirox Supplier in Saudi Arabia
DEFRATAJ — WHO-GMP Deferasirox dispersible tablets, supplied direct from the manufacturer to SFDA-registered importers.
Supply & Market
Saudi Arabia represents the largest single-country pharmaceutical market in the GCC, and Taj Pharma supplies DEFRATAJ Deferasirox dispersible tablets through SFDA-registered local importers, MoH NUPCO (National Unified Procurement Company) hospital tenders, and Saudi Aramco / military-medical-services networks. The Eastern Province has a notably high beta-thalassemia and sickle-cell prevalence (Hofuf, Qatif, Dammam clusters), making oral iron chelation a high-volume therapeutic line.
The SFDA Saudi Drug Registration (SDR) system runs entirely electronically, and Taj Pharma submits CTD dossiers via the SFDA-Track portal with Saudi-specific Module 1, Arabic SmPC, and bilingual pack artwork. Bioequivalence is referenced against the EU originator unless the SFDA scientific committee requires Saudi-population PK data — a study we can sponsor through CROs in Riyadh or Jeddah.
Logistics from Mumbai (JNPT) to Dammam King Abdul Aziz Port typically run 8–10 days via Jebel Ali transhipment, or 14 days direct. NUPCO tenders are issued quarterly; our team has prepared price-build-up sheets and 36-month supply commitments aligned to the NUPCO Generic Drug Reference Price framework.
Supply Capability for Saudi Arabia
DEFRATAJ ships to Saudi Arabia in all five strengths with Arabic/English bilingual labelling meeting SFDA artwork standards (SDR registration number, retail price imprint, batch / expiry in Hijri-Gregorian dual calendar, halal-compliance text where required).
- Strengths: 100 mg, 125 mg, 250 mg, 400 mg, 500 mg dispersible tablets
- Pack formats: HDPE bottles (30/60/100s), Alu-Alu blisters, NUPCO hospital institutional packs (250s)
- MOQ: 100,000 tablets per strength for tender lots, 50,000 per strength for retail supply
- Lead time: 5 weeks ex-Mumbai · transit to Dammam 8–14 days
- Cold-chain: not required, but reefer containers offered on Gulf-summer lanes
- Documentation: CoA, CoO, free-sale certificate (legalized at MOFA + Saudi embassy), halal declaration, batch protocol, Saudi-arabic translation of SmPC/PIL
- NUPCO support: price-build-up sheets, 36-month supply commitments, performance-bond compliance
Regulatory Pathway in Saudi Arabia
The Saudi Food and Drug Authority (SFDA) regulates drug registration under the SDR (Saudi Drug Registration) framework. Taj Pharma submits the CTD dossier through the SFDA-Track portal with Saudi Module 1, Arabic SmPC, halal compliance, and Zone IVb stability data. The standard SDR timeline for generics is 12–18 months; a fast-track is available for products listed on the GCC Central Procurement formulary.
Pricing approval is handled by the SFDA Drug Pricing Committee referencing the GCC reference basket plus 5-country external reference pricing (Egypt, Jordan, Turkey, France, Spain). Pharmacovigilance reporting to the National Pharmacovigilance Centre (NPC) uses E2B(R3) electronic submissions; serious-unexpected ADRs are expedited within 7 days.
- SDR-format CTD with Saudi Arabic Module 1 prepared
- WHO-GMP · SFDA-aligned plant qualification
- Bioequivalence vs. EU reference product on file
- Halal-compliant excipient declaration
- ISO code
SA· trade currency Saudi Riyal (SAR) - NUPCO tender history, price-build-up and supply-commitment templates available