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Dicyclomine injection bulk supplier for pharma manufacturers

Dicyclomine Injection 10mg/ml Suppliers & Bulk Manufacturers

Available Forms: injection

Available Strengths: 10mg/ml

Reference Brands: Bentyl(US), Dicylot (India)

Category: Gastrointestinal Drugs

Dicyclomine is an antispasmodic that blocks muscarinic receptors, reducing smooth muscle contractions in the gastrointestinal tract. It relieves severe GI spasms, cramping, and associated pain. Benefits include symptom relief, improved digestion, decreased abdominal discomfort, and support for diagnostic procedures involving bowel relaxation and motility assessment.

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📘 Sourcing Guide

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.

Dicyclomine Injection — third party manufacturing & bulk supply

Dicyclomine Injection 10mg/ml is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Dicyclomine Injection listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions

Dicyclomine injection is used to relieve intestinal and abdominal cramps caused by smooth muscle spasms in the gastrointestinal tract. It is commonly prescribed for conditions such as irritable bowel syndrome (IBS), gastrointestinal colic, and other functional bowel disorders where antispasmodic therapy is indicated.

Dicyclomine injection is made from dicyclomine hydrochloride, an anticholinergic agent that works by inhibiting muscarinic receptors in the smooth muscles of the gastrointestinal tract, thereby reducing spasms and associated pain.

Common trade names include Bentyl Injection, Dicylot Injection, and other generic formulations.

Dicyclomine injection is manufactured by multiple pharmaceutical companies, including Solco Healthcare, Sun Pharma, Cipla, Intas Pharmaceuticals, and other generic manufacturers.

The generic name is dicyclomine hydrochloride injection.

Brand names include Bentyl Injection, Dicylot Injection, and other region-specific generics.

Dicyclomine injection is manufactured globally, with major production in India, Europe, and the United States by pharmaceutical companies.

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