Prednisolone syrup bulk supplier for pharma manufacturers

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.

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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.

Frequently Asked Questions

Yes, Prednisolone syrup is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Prednisolone syrup is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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