Otilonium Bromide Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 40 mg
Reference Brands: Spasmomen(EU)
Category: Gastrointestinal Drugs
Otilonium Bromide tablets is available in Tablets and strengths such as 40 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, Otilonium Bromide 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) |
Otilonium Bromide 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: Otilonium bromide tablets, marketed as Spasmomen, are approved in the EU for irritable bowel syndrome (IBS) and colonic spasms, with regional dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, it is not widely marketed and mainly available as a generic or compounded product. Regulatory approval in the EU ensures regional safety and efficacy compliance, supporting gastrointestinal symptom management. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional adherence supports timely approval, safe use, and broad availability, helping patients worldwide manage gastrointestinal motility disorders effectively across regions.
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