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Hyoscine Butylbromide tablet bulk supplier for pharma manufacturers

Hyoscine Butylbromide Tablet 10 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 10 mg

Reference Brands: Buscopan(EU)

Category: Gastrointestinal Drugs

Hyoscine Butylbromide tablets are antispasmodics that block parasympathetic nerve signals, relaxing smooth muscles in the gastrointestinal tract. They effectively reduce stomach and bowel spasms, relieving cramps, pain, and discomfort associated with gastrointestinal motility disorders. Benefits include symptom relief and improved digestive comfort.

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📘 Sourcing Guide

Product Description:

Hyoscine Butylbromide tablets, marketed as Buscopan, are approved in the EU for relief of bowel and stomach spasms. In the US, it is available as a generic for short-term spasm relief. Regulatory approval requires dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The EU’s EMA evaluates safety and quality, while the FDA reviews clinical trial and manufacturing information for US approval. For dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance supports timely approval, safe use, and global availability, helping patients manage gastrointestinal spasms effectively across regions worldwide.

Hyoscine Butylbromide Tablet — third party manufacturing & bulk supply

Hyoscine Butylbromide Tablet 10 mg 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 Hyoscine Butylbromide Tablet 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

Hyoscine butylbromide is used to relieve pain and spasms in the gastrointestinal tract, biliary tract, and urinary system. It is commonly prescribed for conditions such as abdominal cramps, irritable bowel syndrome, renal colic, and gallbladder colic.

The active ingredient is hyoscine butylbromide, a quaternary ammonium anticholinergic compound that relaxes smooth muscles. Formulations may include excipients like lactose, microcrystalline cellulose, and suitable solvents for injectable forms.

The most recognized trade name is Buscopan®. Generic versions are available in several regions.

It is manufactured by multiple pharmaceutical companies worldwide, including Boehringer Ingelheim (Buscopan®) and various licensed generic manufacturers in India, Europe, and the Middle East.

The generic name is Hyoscine Butylbromide.

Brand name examples include Buscopan® and regional generic equivalents.

It is manufactured in GMP-certified pharmaceutical facilities in Europe, India, and other countries under regulated conditions for oral and parenteral use.

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