Triokris (Trientine 250 Mg Capsules) | Supplier & Exporter From India

Description

Trientine Supplier from India

Indian Generic Medicines (IGM) is a WHO-GMP-certified manufacturer, supplier, and exporter of Trientine Hydrochloride capsules — marketed under our own brand Triokris™ — supporting hospitals, importers, distributors, wholesalers, and NGOs across global markets with a reliable, compliant supply of this essential Wilson’s disease therapy.

What is Trientine?

Trientine (trientine hydrochloride, also written as trientine dihydrochloride) is an oral copper-chelating agent used in the long-term management of Wilson’s disease, a rare inherited disorder in which the body is unable to eliminate copper normally, leading to toxic accumulation in the liver, brain, and other organs. Left untreated, Wilson’s disease can cause progressive liver failure and irreversible neurological damage.

Trientine works by binding excess copper in body tissue and carrying it to the kidneys, where it is excreted in the urine. It may also reduce copper absorption from the gastrointestinal tract. Trientine is most commonly prescribed as a second-line chelating agent for patients who cannot tolerate D-penicillamine, the traditional first-line therapy, due to penicillamine’s higher rate of adverse effects such as hypersensitivity reactions and bone marrow suppression.

Because Wilson’s disease requires lifelong treatment, and trientine is not manufactured or registered in every country, a dependable international supply chain is essential for hospitals, treating physicians, and patient-access organizations sourcing this therapy on an ongoing basis.

Product Overview: Triokris™ (Trientine Hydrochloride)

Specification	Detail
Generic Name	Trientine Hydrochloride USP
Brand Name	Triokris™
Strength	250 mg
Dosage Form	Hard gelatin capsules
Pack Size	100 capsules per bottle
Standard	USP (United States Pharmacopeia)
Manufacturing Facility	US FDA-approved, WHO-GMP certified, India
Shelf Life	24 months from date of manufacture
Storage	Store below 25°C, protected from moisture and light
Therapeutic Class	Chelating agent / rare disease / metabolic disorder therapy
Indication	Wilson’s disease, especially in patients intolerant to D-penicillamine

Why Source Trientine from India Through IGM

International buyers increasingly look to India for rare-disease and chelation therapies because Indian manufacturers combine regulatory-grade quality with significantly more competitive pricing than originator brands, without compromising on compliance. Indian Generic Medicines works specifically within this space, and buyers choose us for the following reasons:

US FDA-approved, WHO-GMP certified manufacturing: Triokris is produced in a facility that meets the quality standards required for regulated and semi-regulated export markets alike, giving importers confidence in batch-to-batch consistency.
Complete export documentation, prepared in advance: Every consignment can be supplied with a Certificate of Analysis (COA), GMP certificate, Certificate of Pharmaceutical Product (CoPP) or free-sale certificate where required, commercial invoice, and packing list — reducing customs delays at the buyer’s end.
No cold-chain complexity: Unlike some biologic or injectable rare-disease therapies, Triokris is a room-temperature-stable oral capsule (stored below 25°C), which simplifies freight, customs clearance, and last-mile delivery, particularly to markets with limited cold-chain infrastructure.
Flexible order volumes: IGM supports both single-patient / named-patient supply requests and bulk institutional or tender-scale orders, so hospitals, government procurement bodies, and distributors can order at the volume that matches their requirement.
Established rare-disease export experience: Trientine sits within IGM’s broader rare disease and Named Patient Program portfolio, alongside other hard-to-source specialty medicines, giving buyers a single, experienced point of contact for complex regulatory and logistics questions rather than a first-time exporter.
Transparent, responsive communication: Buyers get direct access to a dedicated export team by phone, WhatsApp, or email, with quotations and documentation typically turned around quickly rather than routed through multiple intermediaries.

Global Export Reach

Indian Generic Medicines supplies Trientine to importers, distributors, hospitals, and government/NGO procurement channels across:

Asia: Philippines, Vietnam, Cambodia, Myanmar, Indonesia, Hong Kong, Singapore, China, Nepal, Bangladesh, Sri Lanka, Bhutan

Export is always carried out in line with the importing country’s pharmaceutical regulations — whether that means standard commercial distributor registration, hospital-tender supply, or a named-patient / compassionate-access import route where the product is not yet locally registered. Our team will confirm the applicable pathway for your country before finalizing a quotation.

Regulatory Documentation We Provide

To support a smooth import process, IGM can furnish the following with every Trientine export order, as applicable to the destination country:

Certificate of Analysis (COA) for the specific batch
WHO-GMP / manufacturing site GMP certificate
Certificate of Pharmaceutical Product (CoPP) or Free Sale Certificate
Commercial Invoice and Packing List
Certificate of Origin
Product insert / Summary of Product Characteristics (SmPC)
Import permit support and guidance where the buyer requires it

Buyers evaluating tenders or first-time registration in a new market are welcome to request a full document checklist before placing an order.

Clinical Snapshot (For Regulatory & Medical Reference)

This section is provided for the reference of importing pharmacists, regulatory affairs teams, and prescribing physicians. It is not intended as prescribing guidance for patients.

Trientine is dosed based on the salt form and clinical indication, and dosing is always determined by the treating physician according to local prescribing information. As a general reference: trientine dihydrochloride is typically dosed in the range of 800–1,600 mg daily in two to four divided doses, taken on an empty stomach — at least one hour before or two hours after meals — and at least one hour apart from any other medicine, food, or milk, since calcium, magnesium, and iron can reduce its absorption.

Regular monitoring of liver function, blood counts, serum copper, and ceruloplasmin is recommended during treatment, and iron supplementation may be required in some patients due to trientine’s effect on iron levels. Concomitant use with zinc is generally not recommended without specific guidance. Buyers requiring the complete prescribing information for regulatory submission can request the manufacturer’s product dossier.

Who Buys Trientine from IGM

International pharmaceutical importers and distributors seeking a consistent, documented Trientine supply for their national market
Hospitals and specialty pharmacies managing Wilson’s disease patients who require single-patient or small-batch procurement
Government and NGO procurement programs sourcing rare-disease medicines for public health or humanitarian supply
Named Patient Program facilitators and patient-access organizations arranging compliant import of Trientine into countries where it is not locally registered

Frequently Asked Questions

Is Trientine available for export from India?

Yes. Indian Generic Medicines (IGM) supplies Trientine Hydrochloride capsules, marketed as Triokris, for export to importers, distributors, hospitals, NGOs, and government tenders across regulated and semi-regulated markets, subject to the destination country's import requirements.

What is the price of Trientine from India?

Trientine pricing depends on order quantity, destination country, strength, and the regulatory documentation required. IGM offers competitive, transparent FOB/CIF pricing for both bulk institutional orders and single-unit or named-patient orders — contact our export team for a current quotation.

Who manufactures Triokris?

Triokris (Trientine Hydrochloride Capsules USP 250 mg) is manufactured in a US FDA-approved, WHO-GMP certified facility in India and distributed globally by Indian Generic Medicines, part of the Ikris Pharma Network group of companies.

What is Trientine used for?

Trientine is a copper-chelating agent used in the long-term management of Wilson's disease, a rare inherited disorder of copper metabolism, particularly in patients who are intolerant to D-penicillamine, the standard first-line chelation therapy.

What documents are required to import Trientine?

Standard export documentation includes a Certificate of Analysis (COA), a Certificate of Pharmaceutical Product (CoPP) or free-sale certificate where applicable, a GMP certificate, commercial invoice, packing list, and any import permit or prescription required under the destination country's pharmaceutical regulations.

What strength and pack sizes does Triokris come in?

Triokris is supplied as Trientine Hydrochloride USP 250 mg hard gelatin capsules, packed in bottles of 100 capsules per bottle, with other pack configurations available for bulk and tender orders on request.

Which countries can IGM export Trientine to?

IGM exports Trientine to Africa, Latin America, the Gulf and Middle East, Southeast Asia, and the SAARC region, subject to each country's pharmaceutical import regulations and, where applicable, named-patient or hospital-supply import provisions.

How is Trientine stored and shipped?

Triokris is stored at controlled room temperature, below 25°C, protected from moisture and light, with a shelf life of 24 months from the date of manufacture. It does not require cold-chain logistics, which simplifies packaging, freight, and customs clearance for international buyers.

Dosage & Side Effects

The recommended dosage of Trientine Hydrochloride for adults and adolescents typically ranges between 750 mg and 1500 mg/day, administered in two to four divided doses. The medicine is taken on an empty stomach, at least one hour before or two hours after meals, to optimize absorption. Avoid the concomitant use with iron, zinc, calcium, or magnesium supplements, as these may interfere with drug absorption. Dosage adjustments must be made under medical supervision, depending on clinical response, laboratory monitoring, and individual patient requirements. Therapy should always be started and managed by a qualified healthcare professional.

The most commonly reported side effects of Trientine Hydrochloride 250 capsules are abdominal pain, change of bowel movements, rash, alopecia, mood swings, difficulty in moving, muscle pain, iron deficiency anemia, and hypersensitivity skin reactions.

Warning and Precautions

Do not use Trientine Capsules if you are allergic to this medicine or any other components. Continuous medical supervision is required throughout treatment to ensure safety, monitor for side effects, and manage copper levels effectively in those with Wilson’s Disease.
Constant medical oversight during therapy is critical. Regular blood tests are needed to monitor free copper concentration, iron levels, and overall treatment response, particularly in women, to avoid iron deficiency anemia and ensure safe, effective disease management.
Trientine Capsule acts as a chelating agent that may reduce serum iron levels. In some cases, iron supplementation becomes necessary. When taking oral iron, it should be administered separately—at least two hours apart—to prevent interference with Trientine absorption and activity.
Concurrent use of Trientine Capsules with zinc is not recommended due to insufficient clinical data on their combined safety and dosage. Limited research prevents establishing appropriate dosage guidelines; therefore, physicians typically advise avoiding simultaneous administration to maintain consistent therapeutic efficacy.
Patients who previously received D-Penicillamine have reported lupus-like symptoms after switching to Trientine 250 mg Capsules. However, a direct cause-and-effect relationship remains unclear. Physicians should monitor such patients closely during early therapy to detect any immune-related complications.
For patients with hepatic or renal impairment, consistent monitoring is important during treatment with Trientine (Tryprine). Regular assessment of liver enzymes, kidney function, and copper balance helps maintain treatment safety and optimize dosage while preventing potential toxicity or metabolic complications.

Triokris™ (Trientine 250 mg Capsules)