Product/Composition:- | Prednisolone tablets |
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Strength:- | 5 mg, 20 mg, 50 mg |
Form:- | Tablets |
Reference Brands:- | Generics & generic brands available in EU &US |
MOQ | As per the manufacturer batch size |
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Prednisolone is an anti-inflammatory corticosteroid that suppresses immune responses by inhibiting multiple pathways, reducing swelling, redness, and allergic reactions. It effectively treats autoimmune diseases, allergies, and inflammatory conditions. Benefits include symptom relief, decreased inflammation, improved organ function, and enhanced quality of life, especially in chronic autoimmune and allergic disorders
Prednisolone tablets, marketed as various generic brands, are approved in the US by the FDA and in the EU via EMA for treating inflammation, allergies, and autoimmune disorders. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety, efficacy, and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regulatory adherence supports swift approval, safe usage, and global availability of prednisolone tablets, supporting effective management of inflammatory and autoimmune conditions worldwide.