Otilonium Bromide tablets bulk supplier for pharma manufacturers

Otilonium Bromide Tablets 40 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 40 mg

Reference Brands: Spasmomen(EU)

Otilonium bromide 40 mg tablets, a gut-selective antispasmodic used for abdominal pain and cramping in irritable bowel syndrome. For licensed importers, gastroenterology distributors and pharmacies where registered.

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Product Description:

Otilonium bromide is a quaternary ammonium antispasmodic. Its charged structure keeps absorption from the gut very low, so it acts mostly in the wall of the colon, where it blocks L-type calcium channels and also muscarinic and tachykinin receptors in smooth muscle. The result is fewer painful contractions with little of the dry mouth or blurred vision of systemic anticholinergics. The 40 mg film-coated tablet is the standard strength. It is registered in a number of markets but is not authorised in the United States.

It is used for abdominal pain, cramping and bloating in irritable bowel syndrome, and for other painful spasm of the lower gut. The usual dose is one tablet two or three times a day before meals. Side effects are uncommon and mild. Caution is still usual in glaucoma, prostatic enlargement and bowel obstruction, and data in pregnancy and children are limited. New bowel symptoms after middle age, weight loss or rectal bleeding need investigation before a spasmolytic is started.

Sourcing notes. Check registration first, since availability is patchy and some regulators will want a full rather than an abridged dossier where no local reference product exists. The dossier should be in CTD or ACTD format, with zone IVb data for hot humid markets. Film-coated tablets come in PVC/alu or alu-alu blister strips at room temperature; no cold chain is needed. Request a CoA per batch with assay, dissolution and related substances, the GMP certificate and a CoPP. It is prescription-only in most markets. Ask which reference product any bioequivalence study used.

Otilonium Bromide Tablets — third party manufacturing & bulk supply

Otilonium Bromide Tablets 40 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.

Indicative minimum order quantity

Otilonium Bromide Tablets is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Otilonium Bromide Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Otilonium Bromide tablets is listed as Tablets in 40 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Otilonium Bromide tablets is referenced against Spasmomen(EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.