Trientine Tetrahydrochloride bulk supplier for pharma manufacturers

Trientine Tetrahydrochloride 150 mg Suppliers & Bulk Manufacturers

Available Forms: Film-coated tablets

Available Strengths: 150 mg

Reference Brands: Cuprior (EU/UK)

Trientine tetrahydrochloride tablets, a room-temperature-stable copper chelator for Wilson's disease in patients intolerant of penicillamine. For hospital pharmacies, rare disease distributors and licensed importers.

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Product Description:

Trientine, chemically triethylenetetramine, is a chelating agent that binds copper and carries it out in the urine. The tetrahydrochloride salt is a newer, more stable form that keeps at room temperature, whereas dihydrochloride capsules have traditionally needed refrigeration. This page covers the 150 mg film-coated tablet of the tetrahydrochloride salt; the older 250 mg capsules contain the dihydrochloride, a different salt. The salts are not interchangeable milligram for milligram, so doses are written in trientine base and any switch needs recalculating.

Its established use is Wilson's disease, the inherited copper storage disorder, in patients who cannot tolerate penicillamine; some centres also use it first line. Tablets are taken on an empty stomach, at least one hour before or two hours after food, and an hour apart from other medicines, iron and minerals. Treatment is lifelong. Serum and urinary copper monitoring guards against under-treatment and over-chelation, which can cause copper deficiency and anaemia. Neurological symptoms can worsen early on. Pregnancy needs specialist planning, as stopping risks relapse.

Sourcing notes. This is an orphan medicine, often supplied through hospital specialist channels, so check whether a full registration, an import licence for an unregistered medicine or a named-patient route applies in your market. Be precise about the salt in every document, with strength expressed as base. Ask for a CoA per batch, the GMP certificate, a CoPP and stability data supporting the label storage conditions, including zone IVb data for hot humid markets. It is prescription-only. State salt, strength, form and quantity per patient month.

Trientine Tetrahydrochloride — third party manufacturing & bulk supply

Trientine Tetrahydrochloride 150 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

Trientine Tetrahydrochloride is supplied as Film-coated 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 Trientine Tetrahydrochloride 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

Trientine tetrahydrochloride is used for the treatment of Wilson’s disease, a rare inherited disorder characterized by excessive accumulation of copper in the liver, brain, and other organs. It is indicated for patients who are intolerant to penicillamine or require alternative copper-chelating therapy.

Trientine tetrahydrochloride is a synthetic polyamine compound that functions as a copper-chelating agent. It binds free copper in the body to form stable complexes that are eliminated mainly through urinary excretion.

Trientine tetrahydrochloride is marketed under the trade name Cuprior in the European Union and the United Kingdom. In the United States, trientine is available as trientine hydrochloride under the brand name Syprine.

Cuprior is marketed by Orphalan in the EU and UK, while Syprine is marketed in the United States by Bausch Health Companies Inc.

The generic name is trientine tetrahydrochloride. In the U.S. market, the salt form used is trientine hydrochloride.

The brand name of trientine tetrahydrochloride is Cuprior in the EU and UK markets.

Trientine tetrahydrochloride is manufactured in GMP-compliant facilities approved by EU and U.S. regulatory authorities, with production depending on the registered brand and target market.