Product/Composition:- | Hydroxychloroquine tablets |
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Strength:- | 200 mg |
Form:- | Tablets |
Reference Brands:- | Plaquenil(US & EU) |
MOQ | As per the manufacturer batch size |
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Hydroxychloroquine inhibits antigen processing and immune activation, reducing inflammation and autoimmune responses. It effectively manages rheumatoid arthritis and lupus, providing benefits like symptom relief, decreased disease progression, and improved quality of life. Its safety profile and oral administration make it a valuable therapy for autoimmune conditions.
Hydroxychloroquine tablets are approved in the EU and US for treating rheumatoid arthritis and lupus. In the EU, Sanofi’s Plaquenil and generics are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is based on extensive clinical data and biosimilarity assessments. Both regions require detailed dossiers for initial approval and ongoing pharmacovigilance. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support efficient market access for hydroxychloroquine tablets, ensuring adherence to European and American standards for safe, effective treatment of autoimmune diseases.