Deferasirox Supplier in South Africa
DEFRATAJ — WHO-GMP Deferasirox dispersible tablets, supplied direct from the manufacturer to SAHPRA-registered importers.
Supply & Market
South Africa is one of Sub-Saharan Africa's most regulated and commercially mature pharmaceutical markets, and Taj Pharma supplies DEFRATAJ Deferasirox dispersible tablets here through SAHPRA-registered importers, hospital-group procurement (Netcare, Mediclinic, Life Healthcare) and provincial Department-of-Health tenders. The country has an established population of beta-thalassemia and sickle-cell-disease patients in KwaZulu-Natal, Limpopo and Western Cape, and Deferasirox dispersible tablets are routinely prescribed for transfusion-related iron overload alongside hydroxyurea regimens.
Our regulatory desk in Mumbai supports the full SAHPRA fast-track / Section 21 generics pathway with a CTD dossier already aligned to ICH-Zone IVb stability requirements. Importers in Johannesburg, Cape Town and Durban have direct line access to our export team for shipment scheduling, COA verification and post-arrival query resolution. Supply lead time from JNPT (Mumbai) to Durban is typically 21–28 days door-to-port, and we can pre-position stock in Johannesburg bonded warehouses on rolling-inventory contracts.
Where SAHPRA registration is not yet complete, DEFRATAJ can be supplied to South African patients under Section 21 named-patient authorization through accredited specialist pharmacies, particularly for paediatric thalassemia cohorts where the dispersible formulation is preferred over film-coated tablets. Our medical-affairs team supplies prescriber leaflets in English and isiZulu on request.
Supply Capability for South Africa
DEFRATAJ is shipped to South Africa in all five strengths — 100 mg, 125 mg, 250 mg, 400 mg, 500 mg dispersible tablets — with secondary packaging artwork compliant to SAHPRA labelling standards (English plus optional isiZulu/Afrikaans patient information leaflet).
- Pack formats: HDPE bottles (30/60/100 tablets) with child-resistant closure; Alu-Alu blister cartons (10x10) for hospital wards
- MOQ: 50,000 tablets per strength · mixed-pallet shipments accepted from 100,000 total tablets
- Lead time: 4–5 weeks ex-Mumbai (JNPT/Nhava Sheva) · Durban arrival 21–28 days
- Stability: 24-month shelf life under Zone IVb (30°C / 75% RH) accelerated and long-term data on file
- Documentation per shipment: CoA, CoO (with SADC Trade Protocol declaration where applicable), packing list, BL, free-sale certificate, batch protocol
- Tender support: Provincial DoH and central PEO bid documents prepared on request, including price-build-up sheets and BBBEE empowerment-partner declarations through our SA distributor
- Private label: own-brand registration supported with artwork in English / isiZulu
Regulatory Pathway in South Africa
Marketing authorisation is held by the South African Health Products Regulatory Authority (SAHPRA) under the Medicines and Related Substances Act 101 of 1965. Taj Pharma submits a CTD dossier (Modules 1–5) with the ZA-specific Module 1, BMR and BPR samples, validation reports for assay/dissolution/related-substances, and 12 months of long-term plus 6 months of accelerated stability data per ICH Zone IVb.
The standard SAHPRA generic pathway runs 18–30 months; the fast-track route under Section 21 for products on the WHO Essential Medicines List can be used for orphan/limited-access supply pending full registration. Our Mumbai team handles all queries from the SAHPRA Clinical and Pharmaceutical Evaluations units, sample submissions to the National Control Laboratory in Bloemfontein, and post-approval variations including pack-size additions and label-language updates.
- Full ZA-format CTD dossier ready (Module 1 in eCTD-lite)
- WHO-GMP · ISO 9001 · PIC/S-aligned plant (Sarigam, India)
- CoPP from CDSCO + manufacturing licence on request
- Stability data: long-term (Zone IVb), accelerated, in-use
- Pharmacovigilance contact: PV.RSA@tajpharma.com (24h ICSR turnaround)