
Oxybutynin Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablet(IR & ER)
Available Strengths: IR: 5 mg, 10 mg; ER: 5 mg, 10 mg
Reference Brands: Ditropan, Oxybutynin XL(US)
Category: Multiple sclerosis
Oxybutynin tablets is available in Tablet(IR & ER) and strengths such as IR: 5 mg, 10 mg; ER: 5 mg, 10 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, Oxybutynin 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) |
Oxybutynin 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: Oxybutynin IR and ER tablets, marketed as Ditropan and Ditropan XL, are approved in the US by the FDA and in the EU via EMA for overactive bladder management. Regulatory approval requires a detailed dossier containing clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical and quality data, while the EMA ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance is essential for timely approval, safe use, and global availability of oxybutynin tablets, supporting effective long-term management of bladder overactivity worldwide.
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