Dicyclomine Injection Suppliers & Bulk Manufacturers

Available Forms: injection

Available Strengths: 10mg/ml

Reference Brands: Bentyl(US)

Category: Gastrointestinal Drugs

Dicyclomine injection is available in injection and strengths such as 10mg/ml. 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, Dicyclomine injection is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Dicyclomine injection 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.

Product Description: Dicyclomine injection, marketed as Bentyl, is approved in the US by the FDA and in the EU via EMA for severe gastrointestinal spasms and diagnostic procedures. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For dossier preparation, regulatory pathways, and market access guidance, visit PharmaTradz. Regulatory adherence supports swift approval, safe administration, and global availability, enabling effective management of severe GI conditions and supporting patient care worldwide.