
Cefuroxime Axetil Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 250 mg, 500 mg
Reference Brands: Ceftin(US)
Category: ENT
Cefuroxime Axetil Tablets is available in Tablets and strengths such as 250 mg, 500 mg. 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, Cefuroxime Axetil Tablets 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) |
Cefuroxime Axetil Tablets 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: Cefuroxime axetil tablets, marketed as Ceftin, are approved in the US by the FDA and in the EU via EMA for treating respiratory, skin, and urinary tract infections. Regulatory approval requires a comprehensive dossier, including clinical efficacy, safety data, manufacturing practices, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for timely approval, while the EMA ensures regional safety and manufacturing compliance. For dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Proper adherence supports swift approval, safe use, and global availability, enabling healthcare providers worldwide to effectively combat bacterial infections with high-quality formulations supported by regional regulations.
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