
Prednisolone Syrup Suppliers & Bulk Manufacturers
Available Forms: Syrup
Available Strengths: 15 mg/5ml
Reference Brands: Orapred(US)
Category: Transplant
Prednisolone syrup is available in Syrup and strengths such as 15 mg/5ml. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Prednisolone syrup is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
Technical Specifications & Supply Details | |
---|---|
Lead Time | 7 to 60 days (depending on batch size & schedule) |
MOQ | As per manufacturer’s batch size |
COA | Available with every batch |
Regulatory Dossier / DMF | Available upon request |
Export Documentation | FSC, COA, Manufacturing License, Product Permission |
Standards | IP, BP, USP |
Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Prednisolone syrup can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: Prednisolone syrups, available as various strengths such as 5 mg/mL, 15 mg/mL, and 30 mg/mL, are approved in the US by the FDA and in the EU via EMA for inflammatory and autoimmune conditions. Regulatory approval requires a comprehensive dossier including safety data, clinical efficacy, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality information, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports timely approval, safe use, and global availability of prednisolone syrups, ensuring effective treatment for pediatric and adult inflammatory conditions worldwide.
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