AfricaRegulatory
African Pharmaceutical Regulatory Intelligence
METHOTREXATE
56 registrations across 8 African markets— 32 active
Markets with METHOTREXATE
Recent registrations
| Brand / Product | Market | Holder | Status | Expires |
|---|---|---|---|---|
| HI-TREX-PF Powder for Injection | 🇿🇲Zambia | VHB Medi Sciences Limited | active | Aug 2030 |
| METHOTREXATE TABLET, COATED; ORAL | 🇿🇼Zimbabwe | REMEDICA LTD | active | Dec 2027 |
| METHOTREXATE-LERDELE TABLET; ORAL | 🇿🇼Zimbabwe | PFIZER LABORATORIES (PTY) LTD, S.A | active | Dec 2027 |
| METHOTREXATE-LEDERLE 2.5MG TABLET TABLET | 🇲🇼Malawi | — | expired | Mar 2024 |
| METHOTREXATE-FAULDING 25 mg/ml | 🇿🇦South Africa | Pfizer Laboratories (Pty) Ltd | suspended | Feb 2024 |
| P & U METHOTREXATE CSV 500 mg/20 ml INJECTION | 🇿🇦South Africa | Pfizer Laboratories (Pty) Ltd | suspended | Feb 2024 |
| P & U METHOTREXATE CSV 50 mg/2 ml INJECTION | 🇿🇦South Africa | Pfizer Laboratories (Pty) Ltd | suspended | Feb 2024 |
| P&U METHOTREXATE CSV 1000 mg/10 ml INJECTION | 🇿🇦South Africa | Pfizer Laboratories (Pty) Ltd | suspended | Feb 2024 |
| METHOTREXATE Comprimé pelliculé / 2.5 mg | 🇹🇳Tunisia | REMEDICA LTD | expired | Jul 2023 |
| CYTOTREXATE HD 5g/ 50ml Solution injectable / 100 MG/ML | 🇹🇳Tunisia | CYTOPHARMA | expired | Jul 2023 |
| CYTOTREXATE HD 500mg/5ml Solution injectable / 100 MG/ML | 🇹🇳Tunisia | CYTOPHARMA | expired | Jul 2023 |
| CYTOTREXATE Solution injectable / 5 mg/ 2 ml | 🇹🇳Tunisia | CYTOPHARMA | expired | Sept 2021 |
| CYTOTREXATE Solution injectable / 50 mg/2 ml | 🇹🇳Tunisia | CYTOPHARMA | expired | Sept 2021 |
| METHOTREXATE ACCORD Solution injectable / 500 mg/20ml | 🇹🇳Tunisia | ACCORD HEALTHCARE LTD | expired | Jul 2019 |
| METHOTREXATE ACCORD Solution injectable / 25 mg/ml | 🇹🇳Tunisia | ACCORD HEALTHCARE LTD | expired | Jul 2019 |
| METHOTREXATE BIODIM Solution injectable / 5mg/2ML | 🇹🇳Tunisia | NEURAXPHARM FRANCE | expired | Apr 2017 |
| METHOTREXATE BIODIM Solution injectable / 25 mg/ml | 🇹🇳Tunisia | NEURAXPHARM FRANCE | expired | Apr 2017 |
| LEDERTREXATE Solution injectable / 50mg/ 2ml | 🇹🇳Tunisia | NEURAXPHARM FRANCE | expired | Apr 2017 |
| EMTHEXATE 50 mg | 🇿🇦South Africa | PHARMACHEMIE (PTY) LTD | suspended | Aug 2015 |
| EBETREXAT Solution injectable pour perfusion / 5000 mg/50ml | 🇹🇳Tunisia | EBEWE Pharma | expired | Jan 2008 |
| METHOTREXATE VIATRIS Solution injectable / 100mg/ml | 🇹🇳Tunisia | VIATRIS SANTE | expired | Nov 2003 |
| METHOTREXATE VIATRIS Solution injectable / 5 mg/2ml | 🇹🇳Tunisia | VIATRIS SANTE | expired | Nov 2003 |
| METHOTREXATE VIATRIS Solution injectable / 25 mg/ml | 🇹🇳Tunisia | VIATRIS SANTE | expired | Nov 2003 |
| METHOTREXATE VIATRIS Solution injectable / 50 mg/2ml | 🇹🇳Tunisia | VIATRIS SANTE | expired | Nov 2003 |
| METOTREKSAT EBEWE Comprimé / 2.5 MG | 🇹🇳Tunisia | EBEWE Pharma | expired | Jan 2001 |
| METHOTREXAT-EBEWE Solution injectable / 500 MG | 🇹🇳Tunisia | EBEWE Pharma | expired | Jun 2000 |
| METHOTREXATE EBEWE Solution injectable / 50 MG | 🇹🇳Tunisia | EBEWE Pharma | expired | May 1992 |
| ABITREXATE 1 g | 🇿🇦South Africa | Teva Pharmaceuticals (Pty) Ltd | active | Jan 1900 |
| ABITREXATE 500 | 🇿🇦South Africa | Teva Pharmaceuticals (Pty) Ltd | active | Jan 1900 |
| ABITREXATE 50 | 🇿🇦South Africa | Teva Pharmaceuticals (Pty) Ltd | active | Jan 1900 |
| ABITREXATE 5g | 🇿🇦South Africa | Teva Pharmaceuticals (Pty) Ltd | active | Jan 1900 |
| ABITREXATE 2,5 mg | 🇿🇦South Africa | Teva Pharmaceuticals (Pty) Ltd | active | Jan 1900 |
| METHOTREXATE MYLAN SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| IMENOR comprimé / 10 mg | 🇸🇳Senegal | NORDIC PHARMA | active | — |
| METHOTREXATE ORAL SOLID
ORDINARY TABLETS | 🇺🇬Uganda | REMEDICA LTD | active | — |
| METHOTREXATE BIODIM SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| LEDERTREXATE SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| LEDERTREXATE POUDRE POUR SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| METHOTREXATE MYLAN SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| METHOTREXATE BELLON (H) SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| METHOTREXATE BELLON SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| METHOTREXATE BELLON SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| METHOTREXATE BIODIM SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| METHOTREXATE MYLAN 50 MG/2 ML SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| METHOTREXATE MYLAN 50 MG/2 ML SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| LEDERTREXATE 50 MG SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| METHOTREXATE BIODIM SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| METHOTREXATE MYLAN 100MG/ML SOLUTION INJECTABLE | 🇲🇦Morocco | — | active | — |
| METHOTREXATE ORAL SOLID
ORDINARY TABLETS | 🇺🇬Uganda | REMEDICA LTD | active | — |
| IMENOR comprimé / 10 mg | 🇸🇳Senegal | NORDIC PHARMA | active | — |
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METHOTREXATE in Africa — Regulatory Overview
METHOTREXATE is registered across 8 African markets with 56 total product registrations on file. Data is sourced directly from official national drug regulatory authorities including Tunisia, Morocco, South Africa, Uganda and 4 more. AfricaRegulatory refreshes this data daily from official government sources.
Of the 56 registrations, 32 (57%) are currently active. Regulatory affairs teams use AfricaRegulatory to track registration expiry dates, identify market incumbents, and monitor approval status across African markets without manual monitoring of each national regulator.