Product/Composition:- | Azathioprine tablets |
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Strength:- | 50 mg, 75 mg, 100 mg |
Form:- | Tablets |
Reference Brands:- | Imuran(US) |
MOQ | As per the manufacturer batch size |
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Azathioprine inhibits purine synthesis, suppressing lymphocyte proliferation and immune response. It's effective in reducing inflammation in autoimmune diseases like RA. Benefits include disease progression slowing, symptom relief, and corticosteroid-sparing effects. It offers immunosuppressive control with a well-established safety profile when monitored properly.
Azathioprine tablets are approved in the EU and US for autoimmune diseases and transplantation. In the EU, brands like Imurel are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is based on extensive clinical data, with generic versions available. Both regions require detailed dossiers for initial approval and rigorous pharmacovigilance for ongoing safety. For expert assistance with regulatory dossiers, compliance, and registrations, visit PharmaTradz. We help facilitate efficient market access for azathioprine tablets, ensuring adherence to European and American standards for safe, effective immunosuppressive therapy in autoimmune and transplant patients.